Duragesic (Fentanyl Transdermal)
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Duragesic (Fentanyl Transdermal)

DURAGESIC
(fentanyl) Transdermal System

WARNING

ABUSE POTENTIAL , RESPIRATORY DEPRESSION and DEATH, ACCIDENTAL EXPOSURE, CYTOCHROME P450 3A4 INTERACTION, AND EXPOSURE TO HEAT

Abuse Potential

DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. DURAGESIC can be abused in a manner similar to other opioid agonists, legal or illicit. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Assess patients for their clinical risks for opioid abuse or addiction prior to prescribing DURAGESIC and then routinely monitor all patients for signs of misuse, abuse and addiction during treatment [see WARNINGS AND PRECAUTIONS and Drug Abuse and Dependence].

Respiratory Depression and Death

Respiratory depression and death may occur with use of DURAGESIC, even when DURAGESIC has been used as recommended and not misused or abused. Proper dosing and titration are essential and DURAGESIC should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. DURAGESIC is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain. Monitor for respiratory depression, especially during the first two applications following initiation of dosing, or following an increase in dosage [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Accidental Exposure

Death and other serious medical problems have occurred when children and adults were accidentally exposed to DURAGESIC. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Cytochrome P450 3A4 Interaction

The concomitant use of DURAGESIC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Monitor patients receiving DURAGESIC and any CYP3A4 inhibitor [see WARNINGS AND PRECAUTIONS, and CLINICAL PHARMACOLOGY].

Exposure To Heat

The DURAGESIC application site and surrounding area must not be exposed to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds. Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat (5.9). Patients wearing DURAGESIC systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of DURAGESIC to avoid overdose and death (5.10).

DRUG DESCRIPTION

DURAGESIC (fentanyl transdermal system) is a transdermal system containing fentanyl. The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:

DURAGESIC (Fentanyl) Structural Formula Illustration

The molecular weight of fentanyl base is 336.5, and the empirical formula is C22H28N2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4.

System Components and Structure

The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/h per 10.5 cm²). The composition per unit area of all system sizes is identical.

Dose* (mcg/h) Size (cm²) Fentanyl Content (mg) Color of Printing on Back of Patch
12** 5.25 2.1 Orange
25 10.5 4.2 Pink
50 21 8.4 Green
75 31.5 12.6 Blue
100 42 16.8 Gray
**Nominal delivery rate per hour
***Nominal delivery rate is 12.5 mcg/hr

DURAGESIC is a rectangular transparent unit comprising a protective liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:

1) a backing layer of polyester/ethyl vinyl acetate film; 2) a drug-in-adhesive layer. Before use, a protective liner covering the adhesive layer is removed and discarded.

DURAGESIC Layers - Illustration

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness, feeling like you might pass out;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Duragesic »

What are the precautions when taking fentanyl transdermal (Duragesic)?

Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

Read All Potential Precautions of Duragesic »

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DURAGESIC is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age and older when a continuous, around-the-clock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids.

Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.

DOSAGE AND ADMINISTRATION

Proper Patient Selection

Abuse Potential

Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribing DURAGESIC [see WARNINGS AND PRECAUTIONS].

Opioid Tolerance

Opioid tolerance to an opioid of comparable potency must be established before prescribing DURAGESIC [see WARNINGS AND PRECAUTIONS].

Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Dosing

Conversion to DURAGESIC in Opioid-Tolerant Patients

The recommended starting dose when converting from other opioids to DURAGESIC is intended to minimize the potential for overdosing patients with the first dose. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with DURAGESIC [see WARNINGS AND PRECAUTIONS].

In selecting an initial DURAGESIC dose, take the following factors into account:

  1. the daily dose, potency, and characteristics of the opioid the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist-antagonist);
  2. the reliability of the relative potency estimates used to calculate the DURAGESIC dose needed (potency estimates may vary with the route of administration);
  3. the degree of opioid tolerance;
  4. the general condition and medical status of the patient.

To convert adult and pediatric patients from oral or parenteral opioids to DURAGESIC, use Table 1. Do not use Table 1 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.

TABLE 11: DOSE CONVERSION GUIDELINES

Current Analgesic Daily Dosage (mg/day)
Oral morphine 60-134 135-224 225-314 315-404
Intramuscular or Intravenous morphine 10-22 23-37 38-52 53-67
Oral oxycodone 30-67 67.5-112 112.5-157 157.5-202
Oral codeine 150-447
Oral hydromorphone 8-17 17.1-28 28.1-39 39.1-51
Intravenous hydromorphone 1.5-3.4 3.5-5.6 5.7-7.9 8-10
Intramuscular meperidine 75-165 166-278 279-390 391-503
Oral methadone 20-44 45-74 75-104 105-134
 
Recommended DURAGESIC Dose 25 mcg/hour 50 mcg/hour 75 mcg/hour 100 mcg/hour
Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the conversion methodology outlined above with Table 2.
1Table 1 should not be used to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative. Use of Table 1 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible.

Alternatively, for adult and pediatric patients taking opioids or doses not listed in Table 1, use the following methodology:

1. Calculate the previous 24-hour analgesic requirement.

2. Convert this amount to the equianalgesic oral morphine dose using a reliable reference.

Refer to Table 2 for the range of 24-hour oral morphine doses that are recommended for conversion to each DURAGESIC dose. Use this table to find the calculated 24-hour morphine dose and the corresponding DURAGESIC dose. Initiate DURAGESIC treatment using the recommended dose and titrate patients upwards (no more frequently than 3 days after the initial dose and every 6 days thereafter) until analgesic efficacy is attained.

3. Do not use Table 2 to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative and will overestimate the dose of the new agent.

TABLE 21: RECOMMENDED INITIAL DURAGESIC DOSE BASED UPON DAILY ORAL MORPHINE DOSE

Oral 24-hour Morphine
(mg/day)
DURAGESIC Dose (mcg/hour)
60-134 25
135-224 50
225-314 75
315-404 100
405-494 125
495-584 150
585-674 175
675-764 200
765-854 225
855-944 250
945-1034 275
1035-1124 300
NOTE: In clinical trials, these ranges of daily oral morphine doses were used as a basis for conversion to DURAGESIC.
1Table 2 should not be used to convert from DURAGESIC to other therapies because this conversion to DURAGESIC is conservative. Use of Table 2 for conversion to other analgesic therapies can overestimate the dose of the new agent. Overdosage of the new analgesic agent is possible.

For delivery rates in excess of 100 mcg/hour, multiple systems may be used.

Hepatic Impairment

Avoid the use of DURAGESIC in patients with severe hepatic impairment. In patients with mild to moderate hepatic impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].

Renal Impairment

Avoid the use of DURAGESIC in patients with severe renal impairment. In patients with mild to moderate renal impairment, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY].

Titration and Maintenance of Therapy

Once therapy is initiated, assess pain intensity and opioid adverse reactions frequently, especially respiratory depression [see WARNINGS AND PRECAUTIONS]. Routinely monitor all patients for signs of misuse, abuse and addiction [see WARNINGS AND PRECAUTIONS].

The initial DURAGESIC dose may be increased after 3 days based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.

It may take up to 6 days for fentanyl levels to reach equilibrium on a new dose [see CLINICAL PHARMACOLOGY]. Therefore, evaluate patients for further titration after no less than two 3day applications before any further increase in dosage is made.

Base dosage increments on the daily dosage of supplementary opioids, using the ratio of 45 mg/24 hours of oral morphine to a 12 mcg/hour increase in DURAGESIC dose.

The majority of patients are adequately maintained with DURAGESIC administered every 72 hours. Some patients may not achieve adequate analgesia using this dosing interval and may require systems to be applied at 48 hours rather than at 72 hours, only if adequate pain control cannot be achieved using a 72-hour regimen. An increase in the DURAGESIC dose should be evaluated before changing dosing intervals in order to maintain patients on a 72-hour regimen. Dosing intervals less than every 72 hours were not studied in children and adolescents and are not recommended.

Discontinuation of DURAGESIC

To convert patients to another opioid, remove DURAGESIC and titrate the dose of the new analgesic based upon the patient's report of pain until adequate analgesia has been attained. Upon system removal, 17 hours or more are required for a 50% decrease in serum fentanyl concentrations. Withdrawal symptoms are possible in some patients after conversion or dose adjustment [see WARNINGS AND PRECAUTIONS].

Do not use Tables 1 and 2 to convert from DURAGESIC to other therapies to avoid overestimating the dose of the new agent potentially resulting in overdose of the new analgesic and death.

When discontinuing DURAGESIC and not converting to another opioid, use a gradual downward titration, such as halving the dose every 6 days, in order to reduce the possibility of withdrawal symptoms [see WARNINGS AND PRECAUTIONS]. It is not known at what dose level DURAGESIC may be discontinued without producing the signs and symptoms of opioid withdrawal.

Administration of DURAGESIC

DURAGESIC patches are for transdermal use, only.

Proper handling of DURAGESIC is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to DURAGESIC [see WARNINGS AND PRECAUTIONS].

Application and Handling Instructions
  • Patients should apply DURAGESIC to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm. In young children and persons with cognitive impairment, adhesion should be monitored and the upper back is the preferred location to minimize the potential of inappropriate patch removal. Hair at the application site may be clipped (not shaved) prior to system application. If the site of DURAGESIC application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.
  • Patients should apply DURAGESIC immediately upon removal from the sealed package. The patch must not be altered (e.g., cut) in any way prior to application. DURAGESIC should not be used if the pouch seal is broken or if the patch is cut or damaged.
  • The transdermal system is pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.
  • Each DURAGESIC patch may be worn continuously for 72 hours. The next patch is applied to a different skin site after removal of the previous transdermal system.
  • If problems with adhesion of the DURAGESIC patch occur, the edges of the patch may be taped with first aid tape. If problems with adhesion persist, the patch may be overlayed with a transparent adhesive film dressing.
  • If the patch falls off before 72 hours, dispose of it by folding in half and flushing down the toilet. A new patch may be applied to a different skin site.
  • Patients (or caregivers who apply DURAGESIC) should wash their hands immediately with soap and water after applying DURAGESIC.
  • Contact with unwashed or unclothed application sites can result in secondary exposure to DURAGESIC and should be avoided. Examples of accidental exposure include transfer of a DURAGESIC patch from an adult's body to a child while hugging, sharing the same bed as the patient, accidental sitting on a patch and possible accidental exposure of a caregiver's skin to the medication in the patch while applying or removing the patch.
  • Instruct patients, family members, and caregivers to keep patches in a secure location out of the reach of children and of others for whom DURAGESIC was not prescribed.
Avoidance of Heat

Instruct patients to avoid exposing the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds, while wearing the system [see WARNINGS AND PRECAUTIONS].

Disposal Instructions

Proper disposal of DURAGESIC is advised in order to prevent adverse reactions, including death, associated with accidental secondary exposure to DURAGESIC [see WARNINGS AND PRECAUTIONS].

Patients should dispose of used patches by folding the adhesive side of the patch to itself, then flush the patch down the toilet immediately upon removal.

Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed. Unused patches should be removed from their pouches, fold so that the adhesive side of the patch adheres to itself, and flush down the toilet.

HOW SUPPLIED

Dosage Forms And Strengths

DURAGESIC is available as:

  • DURAGESIC 12 mcg/hour* Transdermal System (system size 5.25 cm²) is orange in color.
  • DURAGESIC 25 mcg/hour Transdermal System (system size 10.5 cm²) is pink in color.
  • DURAGESIC 50 mcg/hour Transdermal System (system size 21 cm²) is green in color.
  • DURAGESIC 75 mcg/hour Transdermal System (system size 31.5 cm²) is blue in color.
  • DURAGESIC 100 mcg/hour Transdermal System (system size 42 cm²) is gray in color.

*This lowest dosage is designated as 12 mcg/hour (however, the actual dosage is 12.5 mcg/hour) to distinguish it from a 125 mcg/h dosage that could be prescribed by multiple patches.

Storage And Handling

DURAGESIC (fentanyl transdermal system) is supplied in cartons containing 5 individually packaged systems. See chart for information regarding individual systems.

DURAGESIC Dose (mcg/h) System Size (cm²) Fentanyl Content (mg) Color of Printing on Back of Patch NDC Number
DURAGESIC-12* 5.25 2.1 Orange 50458-090-05
DURAGESIC-25 10.5 4.2 Pink 50458-091-05
DURAGESIC-50 21 8.4 Green 50458-092-05
DURAGESIC-75 31.5 12.6 Blue 50458-093-05
DURAGESIC-100 42 16.8 Gray 50458-094-05
*This lowest dosage is designated as 12 mcg/h (however, the actual dosage is 12.5 mcg/h) to distinguish it from a 125 mcg/h dosage that could be prescribed by using multiple patches.

Store in original unopened pouch. Store up to 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

Manufactured by: ALZA Corporation, Vacaville, CA 95688. Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560. Revised: 07/2012

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Abuse Potential [see WARNINGS AND PRECAUTIONS]
  • Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Accidental Exposure [see WARNINGS AND PRECAUTIONS]
  • Elderly, Cachetic, and Debilitated Patients [see WARNINGS AND PRECAUTIONS]
  • Chronic Pulmonary Disease [see WARNINGS AND PRECAUTIONS]
  • Head Injuries and Increased Intracranial Pressure [see WARNINGS AND PRECAUTIONS]
  • Interactions with Other CNS Depressants, Alcohol, and Drugs of Abuse [see WARNINGS AND PRECAUTIONS]
  • Interactions with CYP3A4 Inhibitors [see WARNINGS AND PRECAUTIONS]
  • Application of External Heat [see WARNINGS AND PRECAUTIONS]
  • Patients with Fever [see WARNINGS AND PRECAUTIONS]
  • Cardiac Disease [see WARNINGS AND PRECAUTIONS]
  • Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Use in Pancreatic/Biliary Tract Disease [see WARNINGS AND PRECAUTIONS]
  • Avoidance of Withdrawal [see WARNINGS AND PRECAUTIONS]
  • Driving and Operating Machinery [see WARNINGS AND PRECAUTIONS]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Trial Experience

The safety of DURAGESIC was evaluated in 216 patients who took at least one dose of DURAGESIC in a multicenter, double-blind, randomized, placebo-controlled clinical trial of DURAGESIC. This trial examined patients over 40 years of age with severe pain induced by osteoarthritis of the hip or knee and who were in need of and waiting for joint replacement.

The most common adverse reactions ( ≥ 5%) in a double-blind, randomized, placebo-controlled clinical trial in patients with severe pain were nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, and anorexia. Other common adverse reactions ( ≥ 5%) reported in clinical trials in patients with chronic malignant or nonmalignant pain were headache and diarrhea. Adverse reactions reported for ≥ 1% of DURAGESIC-treated patients and with an incidence greater than placebo-treated patients are shown in Table 3.

The most common adverse reactions that were associated with discontinuation in patients with pain (causing discontinuation in ≥ 1% of patients) were depression, dizziness, somnolence, headache, nausea, vomiting, constipation, hyperhidrosis, and fatigue.

Table 3: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Patients and With an Incidence Greater Than Placebo-treated Patients in 1 Double-Blind, Placebo-Controlled Clinical Trial of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=216)
Placebo %
(N=200)
Cardiac disorders
Palpitations 4 1
Ear and labyrinth disorders
Vertigo 2 1
Gastrointestinal disorders
Nausea 41 17
Vomiting 26 3
Constipation 9 1
Abdominal pain upper 3 2
Dry mouth 2 0
General disorders and administration site conditions
Fatigue 6 3
Feeling cold 6 2
Malaise 4 1
Asthenia 2 0
Edema peripheral 1 1
Metabolism and nutrition disorders
Anorexia 5 0
Musculoskeletal and connective tissue disorders
Muscle spasms 4 2
Nervous system disorders
Somnolence 19 3
Dizziness 10 4
Psychiatric disorders
Insomnia 10 7
Depression 1 0
Skin and subcutaneous tissue disorders
Hyperhidrosis 6 1
Pruritus 3 2
Rash 2 1

Adverse reactions not reported in Table 1 that were reported by ≥ 1% of DURAGESIC-treated adult and pediatric patients (N=1854) in 11 controlled and uncontrolled clinical trials of DURAGESIC used for the treatment of chronic malignant or nonmalignant pain are shown in Table 4.

Table 4: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Patients in 11 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
C-treated Patients in DURAGESIC %
(N=1854)
Gastrointestinal disorders
Diarrhea 10
Abdominal pain 3
Immune system disorders
Hypersensitivity 1
Nervous system disorders
Headache 12
Tremor 3
Paresthesia 2
Psychiatric disorders
Anxiety 3
Confusional state 2
Hallucination 1
Renal and urinary disorders
Urinary retention 1
Skin and subcutaneous tissue disorders
Erythema 1

The following adverse reactions occurred in adult and pediatric patients with an overall frequency of < 1% and are listed in descending frequency within each System/Organ Class:

Cardiac disorders: cyanosis

Eye disorders: miosis

Gastrointestinal disorders: subileus

General disorders and administration site conditions: application site reaction, influenza-like illness, application site hypersensitivity, drug withdrawal syndrome, application site dermatitis

Musculoskeletal and connective tissue disorders: muscle twitching

Nervous system disorders: hypoesthesia

Psychiatric disorders: disorientation, euphoric mood

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction

Respiratory, thoracic and mediastinal disorders: respiratory depression

Skin and subcutaneous tissue disorders: eczema, dermatitis allergic, dermatitis contact

Pediatrics

The safety of DURAGESIC was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. Adverse reactions reported by ≥ 1% of DURAGESIC-treated pediatric patients are shown in Table 5.

Table 5: Adverse Reactions Reported by ≥ 1% of DURAGESIC-treated Pediatric Patients in 3 Clinical Trials of DURAGESIC

System/Organ Class
Adverse Reaction
DURAGESIC %
(N=289)
Gastrointestinal disorders
Vomiting 34
Nausea 24
Constipation 13
Diarrhea 13
Abdominal pain 9
Abdominal pain upper 4
Dry mouth 2
General disorders and administration site conditions
Edema peripheral 5
Fatigue 2
Application site reaction 1
Asthenia 1
Immune system disorders
Hypersensitivity 3
Metabolism and nutrition disorders
Anorexia 4
Musculoskeletal and connective tissue disorders
Muscle spasms 2
Nervous system disorders
Headache 16
Somnolence 5
Dizziness 2
Tremor 2
Hypoesthesia 1
Psychiatric disorders
Insomnia 6
Anxiety 4
Depression 2
Hallucination 2
Renal and urinary disorders
Urinary retention 3
Respiratory, thoracic and mediastinal disorders
Respiratory depression 1
Skin and subcutaneous tissue disorders
Pruritus 13
Rash 6
Hyperhidrosis 3
Erythema 3

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of DURAGESIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Cardiac Disorders: Tachycardia, Bradycardia

Eye Disorders: Vision blurred

Gastrointestinal Disorders: Ileus, Dyspepsia

General Disorders and Administration Site Conditions: Feeling of body temperature change

Immune System Disorders: Anaphylactic shock, Anaphylactic reaction, Anaphylactoid reaction

Investigations: Weight decreased

Nervous System Disorders: Convulsions (including Clonic convulsions and Grand mal convulsion), Amnesia

Psychiatric Disorders: Agitation

Respiratory, Thoracic, and Mediastinal Disorders: Respiratory distress, Apnea, Bradypnea, Hypoventilation, Dyspnea

Vascular Disorders: Hypotension, Hypertension

Read the Duragesic (fentanyl transdermal) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Agents Affecting Cytochrome P450 3A4 Isoenzyme System

Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4). Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of DURAGESIC. The concomitant use of DURAGESIC with a CYP3A4 inhibitor (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfanivir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, or grapefruit juice) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause fatal respiratory depression. Closely monitor patients receiving DURAGESIC and any CYP3A4 inhibitor and reduce the dosage of DURAGESIC if warranted [see CLINICAL PHARMACOLOGY].

Central Nervous System Depressants

The concomitant use of DURAGESIC with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation, or potentially result in coma or death. Monitor patients closely when central nervous system depressants are used concomitantly with DURAGESIC and reduce the dose of one or both agents.

MAO Inhibitors

Avoid use of DURAGESIC in the patient who would require the concomitant administration of a monoamine oxidase (MAO) inhibitor, or within 14 days of stopping such treatment because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics.

Drug Abuse And Dependence

Controlled Substance

DURAGESIC contains fentanyl, a potent Schedule II opioid agonist. Schedule II opioid substances, which include hydromorphone, methadone, morphine, oxycodone, and oxymorphone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression. DURAGESIC can be abused and is subject to criminal diversion [see WARNINGS AND PRECAUTIONS].

Abuse

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since DURAGESIC may be diverted for non-medical use, careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Dependence

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood concentration of the drug, and/or administration of an antagonist. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued [see DOSAGE AND ADMINISTRATION].

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Abuse Potential

DURAGESIC contains fentanyl, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. DURAGESIC can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing DURAGESIC in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion [see Drug Abuse and Dependence].

Assess patients for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Routinely monitor all patients receiving opioids for signs of misuse, abuse and addiction since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.

Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.

Respiratory Depression and Death

Respiratory depression is the chief hazard of DURAGESIC. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death.

DURAGESIC has a narrow indication and should be prescribed only by healthcare professionals who are knowledgeable in the administration of potent opioids and management of chronic pain [see INDICATIONS AND USAGE]. DURAGESIC is contraindicated for use in conditions in which the risk of life-threatening respiratory depression is significantly increased, including use as an as-needed analgesic, use in non-opioid tolerant patients, acute pain, and postoperative pain [see CONTRAINDICATIONS]. Proper dosing and titration of DURAGESIC are essential [see DOSAGE AND ADMINISTRATION]. Overestimating the DURAGESIC dose when converting patients from another opioid medication, can result in fatal overdose with the first dose. However, respiratory depression has also been reported with use of DURAGESIC in patients who are opioid-tolerant, even when DURAGESIC has been used as recommended and not misused or abused.

The mean half-life of fentanyl when delivered by DURAGESIC is approximately 20-27 hours. Serum fentanyl concentrations continue to rise for the first two system applications. In addition, significant amounts of fentanyl continue to be absorbed from the skin for 24 hours or more after the patch is removed [see CLINICAL PHARMACOLOGY].

Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

While serious, life-threatening or fatal respiratory depression can occur at any time during the use of DURAGESIC, the potential for serious, life threatening, or fatal respiratory depression is greatest during the first two applications following initiation of dosing, or following an increase in dosage. Closely monitor patients for respiratory depression when initiating therapy with DURAGESIC, especially within the initial 24-72 hours when serum concentrations from the initial patch will peak, and following increases in dosage. Because significant amounts of fentanyl continue to be absorbed from the skin for 24 hours or more after the patch is removed, respiratory depression may persist beyond the removal of DURAGESIC. Monitor patients for respiratory depression after patch removal to ensure that the patient's respiration has stabilized for at least 24 to 72 hours or longer as clinical symptoms dictate.

Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status [see OVERDOSAGE].

Accidental Exposure

A considerable amount of active fentanyl remains in DURAGESIC even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to DURAGESIC. Accidental or deliberate application or ingestion by a child or adolescent will cause respiratory depression that could result in death. Placing DURAGESIC in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death.

Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure to DURAGESIC (see DOSAGE AND ADMINISTRATION ).

Elderly, Cachectic, and Debilitated Patients

Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting, or altered clearance. Therefore, monitor these patients closely, particularly when initiating therapy with DURAGESIC and when given in conjunction with other drugs that depress respiration [see Use In Specific Populations].

Chronic Pulmonary Disease

Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression for respiratory depression, particularly when initiating therapy with DURAGESIC, as in these patients, even usual therapeutic doses of DURAGESIC may decrease respiratory drive to the point of apnea [see WARNINGS AND PRECAUTIONS]. Consider the use of alternative non-opioid analgesics in these patients if possible.

Head Injuries and Increased Intracranial Pressure

Avoid use of DURAGESIC in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma. In addition, opioids may obscure the clinical course of patients with head injury. Monitor patients with brain tumors who may be susceptible to the intracranial effects of CO2 retention for signs of sedation and respiratory depression, particularly when initiating therapy with DURAGESIC, as DURAGESIC may reduce respiratory drive and CO2 retention can further increase intracranial pressure.

Interactions with Other CNS Depressants, Alcohol, and Drugs of Abuse

The concomitant use of DURAGESIC with other central nervous system depressants, including, but not limited to, other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation or coma. Monitor patients prescribed concomitant CNS active drugs for signs of sedation and respiratory depression, particularly when initiating therapy with DURAGESIC, and reduce the dose of one or both agents.

Interactions with CYP3A4 Inhibitors

The concomitant use of DURAGESIC with a CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Carefully monitor patients receiving DURAGESIC and any CYP3A4 inhibitor for signs of sedation and respiratory depression for an extended period of time, and make dosage adjustments if warranted [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Application of External Heat

Exposure to heat may increase fentanyl absorption and there have been reports of overdose and death as a result of exposure to heat. A clinical pharmacology study conducted in healthy adult subjects has shown that the application of heat over the DURAGESIC system increased fentanyl exposure [see CLINICAL PHARMACOLOGY].

Warn patients to avoid exposing the DURAGESIC application site and surrounding area to direct external heat sources [see DOSAGE AND ADMINISTRATION].

Patients with Fever

Based on a pharmacokinetic model, serum fentanyl concentrations could theoretically increase by approximately one-third for patients with a body temperature of 40°C (104°F) due to temperature-dependent increases in fentanyl released from the system and increased skin permeability. Monitor patients wearing DURAGESIC systems who develop fever closely for opioid side effects and reduce the DURAGESIC dose if necessary. Warn patients to avoid strenuous exertion that leads to increased core body temperature while wearing DURAGESIC to avoid the risk of potential overdose and death.

Cardiac Disease

DURAGESIC may produce bradycardia. Monitor patients with bradyarrhythmias closely for changes in heart rate, particularly when initiating therapy with DURAGESIC.

Hepatic Impairment

A clinical pharmacology study with DURAGESIC in patients with cirrhosis has shown that systemic fentanyl exposure increased in these patients. Because of the long half-life of fentanyl when administered as DURAGESIC and hepatic metabolism of fentanyl, avoid use of DURAGESIC in patients with severe hepatic impairment. Insufficient information exists to make precise dosing recommendations regarding the use of DURAGESIC in patients with impaired hepatic function. Therefore, to avoid starting patients with mild to moderate hepatic impairment on too high of a dose, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase. [see DOSING AND ADMINISTRATION, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Renal Impairment

A clinical pharmacology study with intravenous fentanyl in patients undergoing kidney transplantation has shown that patients with high blood urea nitrogen level had low fentanyl clearance. Because of the long half-life of fentanyl when administered as DURAGESIC, avoid the use of DURAGESIC in patients with severe renal impairment. Insufficient information exists to make precise dosing recommendations regarding the use of DURAGESIC in patients with impaired renal function. Therefore, to avoid starting patients with mild to moderate renal impairment on too high of a dose, start with one half of the usual dosage of DURAGESIC. Closely monitor for signs of sedation and respiratory depression, including at each dosage increase [see DOSING AND ADMINISTRATION, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Use in Pancreatic/Biliary Tract Disease

DURAGESIC may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis for worsened symptoms. DURAGESIC may cause increases in the serum amylase concentration.

Avoidance of Withdrawal

Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and shivering) are possible in some patients after conversion to another opioid or when decreasing or discontinuing DURAGESIC. Gradual reduction of the dose of DURAGESIC is recommended [see DOSAGE AND ADMINISTRATION and Drug Abuse and Dependence].

Driving and Operating Machinery

Strong opioid analgesics impair the mental or physical abilities required for the performance of potentially dangerous tasks, such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of the DURAGESIC.

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide and Instructions for Use)

Provide patients receiving DURAGESIC patches the following information:

  • DURAGESIC patches contain fentanyl, an opioid pain medicine that can cause serious breathing problems and death, especially if used in the wrong way and therefore should be taken only as directed. Instruct patients to call their doctor immediately or seek emergency medical help if they experience breathing problems while taking DURAGESIC.
  • DURAGESIC contains fentanyl which has a high potential for abuse. Instruct patients, family members, and caregivers to protect DURAGESIC from theft or misuse in the work or home environment.
  • Instruct patients to never give DURAGESIC to anyone other than the individual for whom it was prescribed because of the risk of death or other serious medical problems to that person for whom it was not intended.
  • Advise patients never to change the dose of DURAGESIC or the number of patches applied to the skin unless instructed to do so by the prescribing healthcare professional.
  • Warn patients of the potential for temperature-dependent increases in fentanyl release from the patch that could result in an overdose of fentanyl. Instruct patients to contact their healthcare provider if they develop a high fever. Instruct patients to:
    • avoid strenuous exertion that can increase body temperature while wearing the patch
    • avoid exposing the DURAGESIC application site and surrounding area to direct external heat sources including heating pads, electric blankets, sunbathing, heat or tanning lamps, saunas, hot tubs or hot baths, and heated water beds.
  • Keep DURAGESIC in a secure place out of the reach of children due to the high risk of fatal respiratory depression. DURAGESIC can be accidentally transferred to children. Instruct patients to take special precautions to avoid accidental contact when holding or caring for children.
  • If the patch dislodges and accidentally sticks to the skin of another person, to immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual as accidental exposure may lead to death or other serious medical problems.
  • To properly disposal of used and unneeded, unused DURAGESIC, remove them from their pouches, fold them so that the adhesive side of the patch adheres to itself, and flush them down the toilet.
  • DURAGESIC may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery). Instruct patients to refrain from any potentially dangerous activity when starting on DURAGESIC or when their dose is being adjusted, until it is established that they have not been adversely affected.
  • Advise women of childbearing potential who become, or are planning to become pregnant, to consult a healthcare provider prior to initiating or continuing therapy with DURAGESIC.
  • Instruct patients not to use alcohol or other CNS depressants (e.g. sleep medications, tranquilizers) while using DURAGESIC because dangerous additive effects may occur, resulting in serious injury or death.
  • Advise patients of the potential for severe constipation.
  • When no longer needed, DURAGESIC should not be stopped abruptly to avoid the risk of precipitating withdrawal symptoms.

Non-Clinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis

In a two-year carcinogenicity study conducted in rats, fentanyl was not associated with an increased incidence of tumors at subcutaneous doses up to 33 μg/kg/day in males or 100 μg/kg/day in females (0.16 and 0.39 times the human daily exposure obtained via the 100 mcg/h patch based on AUC0-24h comparison).

Mutagenesis

There was no evidence of mutagenicity in the Ames Salmonella mutagenicity assay, the primary rat hepatocyte unscheduled DNA synthesis assay, the BALB/c 3T3 transformation test, and the human lymphocyte and CHO chromosomal aberration in-vitro assays.

Impairment of Fertility

The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments. In the male fertility study, male rats were treated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuous intravenous infusion for 28 days prior to mating; female rats were not treated. In the female fertility study, female rats were treated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuous intravenous infusion for 14 days prior to mating until day 16 of pregnancy; male rats were not treated. Analysis of fertility parameters in both studies indicated that an intravenous dose of fentanyl up to 0.4 mg/kg/day to either the male or the female alone produced no effects on fertility (this dose is approximately 1.6 times the daily human dose administered by a 100 mcg/hr patch on a mg/m² basis). In a separate study, a single daily bolus dose of fentanyl was shown to impair fertility in rats when given in intravenous doses of 0.3 times the human dose for a period of 12 days.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy C: There are no adequate and well-controlled studies in pregnant women. DURAGESIC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models. Published literature reports that administration of fentanyl (0, 10, 100, or 500 μg/kg/day) to pregnant female Sprague-Dawley rats from day 7 to 21 via implanted microosmotic minipumps did not produce any evidence of teratogenicity (the high dose is approximately 2 times the daily human dose administered by a 100 mcg/hr patch on a mg/m² basis). In contrast, the intravenous administration of fentanyl (0, 0.01, or 0.03 mg/kg) to bred female rats from gestation day 6 to 18 suggested evidence of embryotoxicity and a slight increase in mean delivery time in the 0.03 mg/kg/day group. There was no clear evidence of teratogenicity noted.

Pregnant female New Zealand White rabbits were treated with fentanyl (0, 0.025, 0.1, 0.4 mg/kg) via intravenous infusion from day 6 to day 18 of pregnancy. Fentanyl produced a slight decrease in the body weight of the live fetuses at the high dose, which may be attributed to maternal toxicity. Under the conditions of the assay, there was no evidence for fentanyl induced adverse effects on embryo-fetal development at doses up to 0.4 mg/kg (approximately 3 times the daily human dose administered by a 100 mcg/hr patch on a mg/m² basis).

Nonteratogenic Effects

Chronic maternal treatment with fentanyl during pregnancy has been associated with transient respiratory depression, behavioral changes, or seizures characteristic of neonatal abstinence syndrome in newborn infants. Symptoms of neonatal respiratory or neurological depression were no more frequent than expected in most studies of infants born to women treated acutely during labor with intravenous or epidural fentanyl. Transient neonatal muscular rigidity has been observed in infants whose mothers were treated with intravenous fentanyl.

The potential effects of fentanyl on prenatal and postnatal development were examined in the rat model. Female Wistar rats were treated with 0, 0.025, 0.1, or 0.4 mg/kg/day fentanyl via intravenous infusion from day 6 of pregnancy through 3 weeks of lactation. Fentanyl treatment (0.4 mg/kg/day) significantly decreased body weight in male and female pups and also decreased survival in pups at day 4. Both the mid-dose and high-dose of fentanyl animals demonstrated alterations in some physical landmarks of development (delayed incisor eruption and eye opening) and transient behavioral development (decreased locomotor activity at day 28 which recovered by day 50). The mid-dose and the high-dose are 0.4 and 1.6 times the daily human dose administered by a 100 mcg/hr patch on a mg/m² basis.

Labor and Delivery

Fentanyl readily passes across the placenta to the fetus; therefore, DURAGESIC is not recommended for analgesia during labor and delivery.

Nursing Mothers

Fentanyl is excreted in human milk; therefore, DURAGESIC is not recommended for use in nursing women because of the possibility of effects in their infants.

Pediatric Use

The safety of DURAGESIC was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age. Starting doses of 25 mcg/h and higher were used by 181 patients who had been on prior daily opioid doses of at least 45 mg/day of oral morphine or an equianalgesic dose of another opioid. Initiation of DURAGESIC therapy in pediatric patients taking less than 60 mg/day of oral morphine or an equianalgesic dose of another opioid has not been evaluated in controlled clinical trials.

The safety and effectiveness of DURAGESIC in children under 2 years of age have not been established.

To guard against excessive exposure to DURAGESIC by young children, advise caregivers to strictly adhere to recommended DURAGESIC application and disposal instructions [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Geriatric Use

Clinical studies of DURAGESIC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life. Moreover, elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the DURAGESIC patch in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours [see CLINICAL PHARMACOLOGY].

Monitor geriatric patients closely for signs of sedation and respiratory depression, particularly when initiating therapy with DURAGESIC and when given in conjunction with other drugs that depress respiration [see WARNINGS AND PRECAUTIONS].

Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of DURAGESIC has not been fully evaluated. A clinical pharmacology study with DURAGESIC in patients with cirrhosis has shown that systemic fentanyl exposure increased in these patients. Because there is in-vitro and in-vivo evidence of extensive hepatic contribution to the elimination of DURAGESIC, hepatic impairment would be expected to have significant effects on the pharmacokinetics of DURAGESIC. Avoid use of DURAGESIC in patients with severe hepatic impairment [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Renal Impairment

The effect of renal impairment on the pharmacokinetics of DURAGESIC has not been fully evaluated. A clinical pharmacology study with intravenous fentanyl in patients undergoing kidney transplantation has shown that patients with high blood urea nitrogen level had low fentanyl clearance. Because there is in-vivo evidence of renal contribution to the elimination of DURAGESIC, renal impairment would be expected to have significant effects on the pharmacokinetics of DURAGESIC. Avoid the use of DURAGESIC in patients with severe renal impairment [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Neonatal Opioid Withdrawal Syndrome

Chronic maternal use of fentanyl can affect the neonate with subsequent withdrawal signs. Neonatal withdrawal syndrome presents as irritability, hyperactivity, and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration and severity of neonatal withdrawal syndrome vary based on the drug used, duration of use, the dosage of last maternal use, and rate of elimination of the drug by the newborn. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening and should be treated according to protocols developed by neonatology experts.

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Clinical Presentation

Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia, hypotension and death. The pharmacokinetic characteristics of DURAGESIC must also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Deaths due to overdose have been reported with abuse and misuse of DURAGESIC.

Treatment

Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Employ supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Remove all DURAGESIC systems.

The pure opioid antagonists, such as naloxone, are specific antidotes to respiratory depression from opioid overdose. Since the duration of reversal is expected to be less than the duration of action of fentanyl, carefully monitor the patient until spontaneous respiration is reliably reestablished. After DURAGESIC system removal, serum fentanyl concentrations decline gradually, falling about 50% in approximately 20-27 hours. Therefore, management of an overdose must be monitored accordingly, at least 72 to 96 hours beyond the overdose.

Only administer opioid antagonists in the presence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose. In patients who are physically dependent on any opioid agonist including DURAGESIC, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.

CONTRAINDICATIONS

DURAGESIC is contraindicated in the following patients and situations due to the risk of fatal respiratory depression:

  • in patients who are not opioid-tolerant [see WARNINGS AND PRECAUTIONS].
  • in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time [see WARNINGS AND PRECAUTIONS].
  • in the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies) [see WARNINGS AND PRECAUTIONS].
  • in the management of mild pain [see WARNINGS AND PRECAUTIONS].
  • in patients with significant respiratory compromise, especially if adequate monitoring and resuscitative equipment are not readily available [see WARNINGS AND PRECAUTIONS].
  • in patients who have acute or severe bronchial asthma [see WARNINGS AND PRECAUTIONS].

DURAGESIC is also contraindicated:

  • in patients who have or are suspected of having paralytic ileus
  • in patients with known hypersensitivity to fentanyl or any components of the transdermal system. Severe hypersensitivity reactions, including anaphylaxis have been observed with DURAGESIC [see ADVERSE REACTIONS].

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Fentanyl is an opioid analgesic. Fentanyl interacts predominately with the opioid mu-receptor. These mu-binding sites are distributed in the human brain, spinal cord, and other tissues.

Pharmacodynamics

Central Nervous System Effects

Fentanyl exerts its principal pharmacologic effects on the central nervous system. Central nervous system effects increase with increasing serum fentanyl concentrations.

In addition to analgesia, alterations in mood, euphoria, dysphoria, and drowsiness commonly occur. Fentanyl depresses the respiratory centers, depresses the cough reflex, and constricts the pupils. Analgesic blood concentrations of fentanyl may cause nausea and vomiting directly by stimulating the chemoreceptor trigger zone, but nausea and vomiting are significantly more common in ambulatory than in recumbent patients, as is postural syncope.

Ventilatory Effects

In clinical trials of 357 non-opioid tolerant subjects treated with DURAGESIC, 13 subjects experienced hypoventilation. Hypoventilation was manifested by respiratory rates of less than 8 breaths/minute or a pCO2 greater than 55 mm Hg. In these studies, the incidence of hypoventilation was higher in nontolerant women (10) than in men (3) and in subjects weighing less than 63 kg (9 of 13). Although subjects with prior impaired respiration were not common in the trials, they had higher rates of hypoventilation. In addition, post-marketing reports have been received that describe opioid-naive post-operative patients who have experienced clinically significant hypoventilation and death with DURAGESIC.

Hypoventilation can occur throughout the therapeutic range of fentanyl serum concentrations, especially for patients who have an underlying pulmonary condition or who receive concomitant opioids or other CNS drugs associated with hypoventilation. The use of DURAGESIC is contraindicated in patients who are not tolerant to opioid therapy.

Gastrointestinal Tract and Other Smooth Muscle

Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl. Because opioids may increase biliary tract pressure, some patients with biliary colic may experience worsening rather than relief of pain.

While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination.

Cardiovascular Effects

Fentanyl may cause orthostatic hypotension and fainting. Fentanyl may infrequently produce bradycardia. The incidence of bradycardia in clinical trials with DURAGESIC was less than 1%.

Histamine assays and skin wheal testing in clinical studies indicate that clinically significant histamine release rarely occurs with fentanyl administration. Clinical assays show no clinically significant histamine release in dosages up to 50 mcg/kg.

Pharmacokinetics

Absorption

DURAGESIC is a drug-in-adhesive matrix designed formulation. Fentanyl is released from the matrix at a nearly constant amount per unit time. The concentration gradient existing between the matrix and the lower concentration in the skin drives drug release. Fentanyl moves in the direction of the lower concentration at a rate determined by the matrix and the diffusion of fentanyl through the skin layers. While the actual rate of fentanyl delivery to the skin varies over the 72-hour application period, each system is labeled with a nominal flux which represents the average amount of drug delivered to the systemic circulation per hour across average skin.

While there is variation in dose delivered among patients, the nominal flux of the systems (12.5, 25, 50, 75, and 100 mcg of fentanyl per hour) is sufficiently accurate as to allow individual titration of dosage for a given patient.

Following DURAGESIC application, the skin under the system absorbs fentanyl, and a depot of fentanyl concentrates in the upper skin layers. Fentanyl then becomes available to the systemic circulation. Serum fentanyl concentrations increase gradually following initial DURAGESIC application, generally leveling off between 12 and 24 hours and remaining relatively constant, with some fluctuation, for the remainder of the 72-hour application period. Peak serum concentrations of fentanyl generally occurred between 20 and 72 hours after initial application (see Table 6). Serum fentanyl concentrations achieved are proportional to the DURAGESIC delivery rate. With continuous use, serum fentanyl concentrations continue to rise for the first two system applications. By the end of the second 72-hour application, a steady-state serum concentration is reached and is maintained during subsequent applications of a patch of the same size (see Figure 1). Patients reach and maintain a steady-state serum concentration that is determined by individual variation in skin permeability and body clearance of fentanyl.

After system removal, serum fentanyl concentrations decline gradually, falling about 50% in approximately 20-27 hours. Continued absorption of fentanyl from the skin accounts for a slower disappearance of the drug from the serum than is seen after an IV infusion, where the apparent half-life is approximately 7 (range 3-12) hours.

A clinical pharmacology study conducted in healthy adult subjects has shown that the application of heat over the DURAGESIC system increased mean overall fentanyl exposure by 120% and average maximum fentanyl level by 61%.

TABLE 6: FENTANYL PHARMACOKINETIC PARAMETERS FOLLOWING FIRST 72-HOUR APPLICATION OF DURAGESIC

  Mean (SD) Time to Maximal Concentration Tmax(h) Mean (SD) Maximal Concentration Cmax (ng/mL)
DURAGESIC 12 mcg/h 28.8 (13.7) 0.38 (0.13)*
DURAGESIC 25 mcg/h 31.7 (16.5) 0.85 (0.26)**
DURAGESIC 50 mcg/h 32.8 (15.6) 1.72 (0.53)**
DURAGESIC 75 mcg/h 35.8 (14.1) 2.32 (0.86)**
DURAGESIC 100 mcg/h 29.9 (13.3) 3.36 (1.28)**
*Cmax values dose normalized from 4 x 12.5 mcg/h: Study 2003-038 in healthy volunteers
**Cmax values: Study C-2002-048 dose proportionality study in healthy volunteers
NOTE: After system removal there is continued systemic absorption from residual fentanyl in the skin so that serum concentrations fall 50%, on average, in approximately 20-27 hours.

Figure 1: Serum Fentanyl Concentrations Following Single and Multiple Applications of DURAGESIC 100 mcg/h

Serum Fentanyl Concentrations - Illustration

TABLE 7: RANGE OF PHARMACOKINETIC PARAMETERS OF INTRAVENOUS FENTANYL IN PATIENTS

  Clearance (L/h) Range [70 kg] Volume of Distribution Vss (L/kg) Range Half-Life t ½ (h) Range
Surgical Patients 27 - 75 3 - 8 3 - 12
Hepatically Impaired Patients 3 - 80+ 0.8 - 8+ 4 - 12+
Renally Impaired Patients 30 - 78 - -
+Estimated
NOTE: Information on volume of distribution and half-life not available for renally impaired Patients

Distribution

Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system. Fentanyl accumulates in the skeletal muscle and fat and is released slowly into the blood. The average volume of distribution for fentanyl is 6 L/kg (range 3-8; N=8).

Metabolism

Fentanyl is metabolized primarily via human cytochrome P450 3A4 isoenzyme system. In humans, the drug appears to be metabolized primarily by oxidative N-dealkylation to norfentanyl and other inactive metabolites that do not contribute materially to the observed activity of the drug.

Excretion

Within 72 hours of IV fentanyl administration, approximately 75% of the dose is excreted in urine, mostly as metabolites with less than 10% representing unchanged drug. Approximately 9% of the dose is recovered in the feces, primarily as metabolites. Mean values for unbound fractions of fentanyl in plasma are estimated to be between 13 and 21%.

Skin does not appear to metabolize fentanyl delivered transdermally. This was determined in a human keratinocyte cell assay and in clinical studies in which 92% of the dose delivered from the system was accounted for as unchanged fentanyl that appeared in the systemic circulation.

Hepatic Impairment

Information on the effect of hepatic impairment on the pharmacokinetics of DURAGESIC is limited. The pharmacokinetics of DURAGESIC delivering 50 μg/hour of fentanyl for 72 hours was evaluated in patients hospitalized for surgery. Compared to the controlled patients (n=8), Cmax and AUC in the patients with cirrhosis (n=9) increased 35% and 73%, respectively.

Because there is in-vitro and in-vivo evidence of extensive hepatic contribution to the elimination of DURAGESIC, hepatic impairment would be expected to have significant effects on the pharmacokinetics of DURAGESIC. Avoid use of DURAGESIC in patients with severe hepatic impairment [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Renal Impairment

Information on the effect of renal impairment on the pharmacokinetics of DURAGESIC is limited. The pharmacokinetics of intravenous injection of 25 μg/kg fentanyl was evaluated in patients (n=8) undergoing kidney transplantation. An inverse relationship between blood urea nitrogen level and fentanyl clearance was found.

Because there is in-vivo evidence of renal contribution to the elimination of DURAGESIC, renal impairment would be expected to have significant effects on the pharmacokinetics of DURAGESIC. Avoid the use of DURAGESIC in patients with severe renal impairment [see DOSING AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and Use In Specific Populations].

Pediatric Use

In 1.5 to 5 year old, non-opioid-tolerant pediatric patients, the fentanyl plasma concentrations were approximately twice as high as that of adult patients. In older pediatric patients, the pharmacokinetic parameters were similar to that of adults. However, these findings have been taken into consideration in determining the dosing recommendations for opioid-tolerant pediatric patients (2 years of age and older). For pediatric dosing information, refer to [see DOSING AND ADMINISTRATION].

Geriatric Use

Data from intravenous studies with fentanyl suggest that the elderly patients may have reduced clearance and a prolonged half-life. Moreover elderly patients may be more sensitive to the active substance than younger patients. A study conducted with the DURAGESIC fentanyl transdermal patch in elderly patients demonstrated that fentanyl pharmacokinetics did not differ significantly from young adult subjects, although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours. In this study, a single DURAGESIC 100 μg/hour patch was applied to a skin site on the upper outer arm in a group of healthy elderly Caucasians ≥ 65 years old (n=21, mean age 71 years) and worn for 72 hours. The mean Cmax and AUC∞ values were approximately 8% lower and 7% higher, respectively, in the elderly subjects as compared with subjects 18 to 45 years old. Inter-subject variability in AUC∞ was higher in elderly subjects than in healthy adult subjects 18 to 45 years (58% and 37%, respectively). The mean half-life value was longer in subjects ≥ 65 years old than in subjects 18 to 45 years old (34.4 hours versus 23.5 hours) [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

Drug Interactions

The interaction between ritonavir, a CPY3A4 inhibitor, and fentanyl was investigated in eleven healthy volunteers in a randomized crossover study. Subjects received oral ritonavir or placebo for 3 days. The ritonavir dose was 200 mg tid on Day 1 and 300 mg tid on Day 2 followed by one morning dose of 300 mg on Day 3. On Day 2, fentanyl was given as a single IV dose at 5 mcg/kg two hours after the afternoon dose of oral ritonavir or placebo. Naloxone was administered to counteract the side effects of fentanyl. The results suggested that ritonavir might decrease the clearance of fentanyl by 67%, resulting in a 174% (range 52%-420%) increase in fentanyl AUC0-∞. Coadministration of ritonavir in patients receiving DURAGESIC has not been studied; however, an increase in fentanyl AUC is expected [see BOX WARNING and WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Fentanyl is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore, potential interactions may occur when DURAGESIC is given concurrently with agents that affect CYP3A4 activity. Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of DURAGESIC. The concomitant use of transdermal fentanyl with all CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, or grapefruit juice) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Carefully monitor patients receiving DURAGESIC and any CYP3A4 inhibitor for signs of respiratory depression for an extended period of time and adjust the dosage if warranted [see BOX WARNING and WARNINGS AND PRECAUTIONS].

Clinical Studies

DURAGESIC as therapy for pain due to cancer has been studied in 153 patients. In this patient population, DURAGESIC has been administered in doses of 25 μg/h to 600 μg/h. Individual patients have used DURAGESIC continuously for up to 866 days. At one month after initiation of DURAGESIC therapy, patients generally reported lower pain intensity scores as compared to a prestudy analgesic regimen of oral morphine.

The duration of DURAGESIC use varied in cancer patients; 56% of patients used DURAGESIC for over 30 days, 28% continued treatment for more than 4 months, and 10% used DURAGESIC for more than 1 year.

In the pediatric population, the safety of DURAGESIC has been evaluated in 289 patients with chronic pain 2-18 years of age. The duration of DURAGESIC use varied; 20% of pediatric patients were treated for ≤ 15 days; 46% for 16-30 days; 16% for 31-60 days; and 17% for at least 61 days. Twenty-five patients were treated with DURAGESIC for at least 4 months and 9 patients for more than 9 months.

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide

DURAGESIC®
(Dur-ah-GEE-zik)
(fentanyl) Transdermal System

DURAGESIC® is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain, in people who are already regularly using opioid pain medicine.

Important information about DURAGESIC®:

  • Get emergency help right away if you use too much DURAGESIC® (overdose). DURAGESIC® overdose can cause life threatening breathing problems that can lead to death.
  • Never give anyone else your DURAGESIC®. They could die from using it. Store DURAGESIC® away from children and in a safe place to prevent stealing or abuse. Selling or giving away DURAGESIC® is against the law.

Do not use DURAGESIC® if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before applying DURAGESIC®, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you:

  • have a fever
  • are pregnant or planning to become pregnant. DURAGESIC® may harm your unborn baby.
  • are breastfeeding. DURAGESIC® passes into breast milk and may harm your baby.
  • are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

When using DURAGESIC®:

  • Do not change your dose. Apply DURAGESIC® exactly as prescribed by your healthcare provider.
  • See the detailed Instructions for Use for information about how to apply and dispose of the DURAGESIC® patch.
  • Do not wear more than 1 patch at the same time unless your healthcare provider tells you to.
  • Call your healthcare provider if the dose you are using does not control your pain.
  • Do not stop using DURAGESIC® without talking to your healthcare provider.

While using DURAGESIC® Do Not:

  • Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
  • Drive or operate heavy machinery, until you know how DURAGESIC® affects you. DURAGESIC® can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

The possible side effects of DURAGESIC® are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, itching, redness, or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, or you are feeling faint.

These are not all the possible side effects of DURAGESIC®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

DURAGESIC®
(Dur-ah-GEE-zik)
(Fentanyl Transdermal System)

Instructions for Applying a DURAGESIC® patch

DURAGESIC Patch -  Illustration

Before Applying DURAGESIC®

  • Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove a DURAGESIC® patch from the pouch until you are ready to use it.
  • Do not use a DURAGESIC® patch if the pouch seal is broken or the patch is cut, damaged or changed in any way.
  • DURAGESIC® patches are available in 5 different doses and patch sizes. Make sure you have the right dose patch or patches that have been prescribed for you.

Applying a DURAGESIC® Patch

1. Skin Areas Where the DURAGESIC® Patch May Be Figure 1 Applied:

For adults:

  • Put the patch on the chest, back, flank (sides of the waist), or upper arm in a place where there is no hair (see Figures 1-4).

For children (and adults with mental impairment):

  • Put the patch on the upper back (see Figure 2). This will lower the chances that the child will remove the patch and put it in their mouth.

Figures 1-4

Patch application areas - Illustration

For adults and children

  • Do not put a DURAGESIC® patch on skin that is very oily, burned, broken out, cut, irritated, or damaged in any way.
  • Avoid sensitive areas or those that move around a lot. If there is hair, do not shave (shaving irritates the skin). Instead, clip hair as close to the skin as possible (see Figure 5).

Figure 5

Clip hair close to the skin - Illustration

  • Talk to your doctor if you have questions about skin application sites.

2. Prepare to Apply a DURAGESIC® Patch:

  • Choose the time of day that is best for you to apply DURAGESIC®. Change it at about the same time of day (3 days or 72 hours after you apply the patch) or as directed by your doctor.
  • Do not wear more than one DURAGESIC® patch at a time unless your doctor tells you to do so. Before putting on a new DURAGESIC® patch, remove the patch you have been wearing.
  • Clean the skin area with clear water only. Pat skin completely dry. Do not use anything on the skin such as soaps, lotions, oils, or alcohol before the patch is applied.

3. Open the Pouch: Fold and tear at slit, or cut at slit taking care so as not to cut the patch, and remove the DURAGESIC® patch. Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove the DURAGESIC® patch from the pouch until you are ready to use it (see Figure 6).

Figure 6

Open the pouch - Illustration

4. Peel: Peel off both parts of the protective liner from the patch. Each DURAGESIC® patch has a clear plastic backing that can be peeled off in two pieces. This covers the sticky side of the patch. Carefully peel this backing off. Throw the clear plastic backing away. Touch the sticky side of the DURAGESIC® patch as little as possible (see Figure 7).

Figure 7

Peel off both parts - Illustration

5. Press: Press the patch onto the chosen skin site with the palm of your hand and hold there for at least 30 seconds (see Figure 8). Make sure it sticks well, especially at the edges.

Figure 8

Press the patch on -  Illustration

  • DURAGESIC® may not stick to all patients. You need to check the patches often to make sure that they are sticking well to the skin.
  • If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (see Disposing a DURAGESIC® Patch).
  • If you have a problem with the patch not sticking
    • Apply first aid tape only to the edges of the patch.
    • If you continue to have problems with the patch sticking, you may cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® patch with any other bandage or tape. Remove the backing from the Bioclusive™ or Tegaderm™ dressing and place it carefully over the DURAGESIC® patch, smoothing it over the patch and your skin.
  • If your patch falls off later, but before 3 days (72 hours) of use, discard it properly (see Disposing a DURAGESIC® patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

6. Wash your hands when you have finished applying a DURAGESIC® patch.

7. Remove a DURAGESIC® patch after wearing it for 3 days (72 hours) (see “Disposing a DURAGESIC® Patch”). Choose a different place on the skin to apply a new DURAGESIC® patch and repeat Steps 2 through 6.

Do not apply the new patch to the same place as the last one.

Water and DURAGESIC®

  • You can bathe, swim or shower while you are wearing a DURAGESIC® patch. If the patch falls off before 3 days (72 hours) after application, discard it properly (see Disposing a DURAGESIC® Patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

Disposing a DURAGESIC® Patch

Figure 9

Disposing DURAGESIC - Illustration

  • Fold the used DURAGESIC® patch in half so that the sticky side sticks to itself (Figure 9). Flush the used DURAGESIC® down the toilet right away (Figure 10). A used DURAGESIC® patch CAN be VERY dangerous for or even lead to death in babies, children, pets, and adults who have not been prescribed DURAGESIC®.

Figure 10

Flush the used DURAGESIC - Illustration

  • Throw away any DURAGESIC® patches that are left over from your prescription as soon as they are no longer needed. Remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in a trashcan.

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide

DURAGESIC®
(Dur-ah-GEE-zik)
(fentanyl) Transdermal System

DURAGESIC® is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain, in people who are already regularly using opioid pain medicine.

Important information about DURAGESIC®:

  • Get emergency help right away if you use too much DURAGESIC® (overdose). DURAGESIC® overdose can cause life threatening breathing problems that can lead to death.
  • Never give anyone else your DURAGESIC®. They could die from using it. Store DURAGESIC® away from children and in a safe place to prevent stealing or abuse. Selling or giving away DURAGESIC® is against the law.

Do not use DURAGESIC® if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before applying DURAGESIC®, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you:

  • have a fever
  • are pregnant or planning to become pregnant. DURAGESIC® may harm your unborn baby.
  • are breastfeeding. DURAGESIC® passes into breast milk and may harm your baby.
  • are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

When using DURAGESIC®:

  • Do not change your dose. Apply DURAGESIC® exactly as prescribed by your healthcare provider.
  • See the detailed Instructions for Use for information about how to apply and dispose of the DURAGESIC® patch.
  • Do not wear more than 1 patch at the same time unless your healthcare provider tells you to.
  • Call your healthcare provider if the dose you are using does not control your pain.
  • Do not stop using DURAGESIC® without talking to your healthcare provider.

While using DURAGESIC® Do Not:

  • Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
  • Drive or operate heavy machinery, until you know how DURAGESIC® affects you. DURAGESIC® can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

The possible side effects of DURAGESIC® are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, itching, redness, or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, or you are feeling faint.

These are not all the possible side effects of DURAGESIC®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

DURAGESIC®
(Dur-ah-GEE-zik)
(Fentanyl Transdermal System)

Instructions for Applying a DURAGESIC® patch

DURAGESIC Patch -  Illustration

Before Applying DURAGESIC®

  • Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove a DURAGESIC® patch from the pouch until you are ready to use it.
  • Do not use a DURAGESIC® patch if the pouch seal is broken or the patch is cut, damaged or changed in any way.
  • DURAGESIC® patches are available in 5 different doses and patch sizes. Make sure you have the right dose patch or patches that have been prescribed for you.

Applying a DURAGESIC® Patch

1. Skin Areas Where the DURAGESIC® Patch May Be Figure 1 Applied:

For adults:

  • Put the patch on the chest, back, flank (sides of the waist), or upper arm in a place where there is no hair (see Figures 1-4).

For children (and adults with mental impairment):

  • Put the patch on the upper back (see Figure 2). This will lower the chances that the child will remove the patch and put it in their mouth.

Figures 1-4

Patch application areas - Illustration

For adults and children

  • Do not put a DURAGESIC® patch on skin that is very oily, burned, broken out, cut, irritated, or damaged in any way.
  • Avoid sensitive areas or those that move around a lot. If there is hair, do not shave (shaving irritates the skin). Instead, clip hair as close to the skin as possible (see Figure 5).

Figure 5

Clip hair close to the skin - Illustration

  • Talk to your doctor if you have questions about skin application sites.

2. Prepare to Apply a DURAGESIC® Patch:

  • Choose the time of day that is best for you to apply DURAGESIC®. Change it at about the same time of day (3 days or 72 hours after you apply the patch) or as directed by your doctor.
  • Do not wear more than one DURAGESIC® patch at a time unless your doctor tells you to do so. Before putting on a new DURAGESIC® patch, remove the patch you have been wearing.
  • Clean the skin area with clear water only. Pat skin completely dry. Do not use anything on the skin such as soaps, lotions, oils, or alcohol before the patch is applied.

3. Open the Pouch: Fold and tear at slit, or cut at slit taking care so as not to cut the patch, and remove the DURAGESIC® patch. Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove the DURAGESIC® patch from the pouch until you are ready to use it (see Figure 6).

Figure 6

Open the pouch - Illustration

4. Peel: Peel off both parts of the protective liner from the patch. Each DURAGESIC® patch has a clear plastic backing that can be peeled off in two pieces. This covers the sticky side of the patch. Carefully peel this backing off. Throw the clear plastic backing away. Touch the sticky side of the DURAGESIC® patch as little as possible (see Figure 7).

Figure 7

Peel off both parts - Illustration

5. Press: Press the patch onto the chosen skin site with the palm of your hand and hold there for at least 30 seconds (see Figure 8). Make sure it sticks well, especially at the edges.

Figure 8

Press the patch on -  Illustration

  • DURAGESIC® may not stick to all patients. You need to check the patches often to make sure that they are sticking well to the skin.
  • If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (see Disposing a DURAGESIC® Patch).
  • If you have a problem with the patch not sticking
    • Apply first aid tape only to the edges of the patch.
    • If you continue to have problems with the patch sticking, you may cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® patch with any other bandage or tape. Remove the backing from the Bioclusive™ or Tegaderm™ dressing and place it carefully over the DURAGESIC® patch, smoothing it over the patch and your skin.
  • If your patch falls off later, but before 3 days (72 hours) of use, discard it properly (see Disposing a DURAGESIC® patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

6. Wash your hands when you have finished applying a DURAGESIC® patch.

7. Remove a DURAGESIC® patch after wearing it for 3 days (72 hours) (see “Disposing a DURAGESIC® Patch”). Choose a different place on the skin to apply a new DURAGESIC® patch and repeat Steps 2 through 6.

Do not apply the new patch to the same place as the last one.

Water and DURAGESIC®

  • You can bathe, swim or shower while you are wearing a DURAGESIC® patch. If the patch falls off before 3 days (72 hours) after application, discard it properly (see Disposing a DURAGESIC® Patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

Disposing a DURAGESIC® Patch

Figure 9

Disposing DURAGESIC - Illustration

  • Fold the used DURAGESIC® patch in half so that the sticky side sticks to itself (Figure 9). Flush the used DURAGESIC® down the toilet right away (Figure 10). A used DURAGESIC® patch CAN be VERY dangerous for or even lead to death in babies, children, pets, and adults who have not been prescribed DURAGESIC®.

Figure 10

Flush the used DURAGESIC - Illustration

  • Throw away any DURAGESIC® patches that are left over from your prescription as soon as they are no longer needed. Remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in a trashcan.

Last reviewed on RxList: 7/19/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Duragesic Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FENTANYL - TRANSDERMAL

(FEN-ta-nil)

COMMON BRAND NAME(S): Duragesic

WARNING: Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use transdermal patches unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you use the wrong dose/strength, or if you use it along with other drugs that might also affect breathing. Get medical help right away if you notice unusual slow/shallow breathing.

Do not use this medication to relieve mild or short-term pain (such as due to headache/migraine, dental/medical procedures, or surgeries that do not require you to stay in a hospital). This medication is not for occasional ("as needed") use.

Since they are not used the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.

Carefully follow the manufacturer's instructions for using fentanyl transdermal patches. The patches are for use on the skin only. Raising your skin/body temperature, using cut or damaged fentanyl patches, or using the patch improperly (such as by chewing it) may cause fatal overdose. Avoid increasing your skin temperature at/near the application site by using products such as heating pads, electric blankets, hot tubs, heat lamps, or tanning lamps. Avoid taking hot baths and sunbathing. However, you may bathe, shower, or swim while wearing the patch as long as you avoid hot water.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. This medication is not recommended for use in children younger than 2 years. Some manufacturers recommend that this product should not be used in children younger than 18 years. If a child accidentally swallows this drug, get medical help right away.

USES: This medication is used to help relieve moderate to severe ongoing pain (such as due to cancer). Fentanyl belongs to a class of drugs known as narcotic (opiate) analgesics. It works in the brain to change how your body feels and responds to pain.

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn how to properly use, store, and discard the patches. If you have any questions, ask your doctor or pharmacist.

Before you start using this medication, ask your doctor or pharmacist if you should stop or change the dose of your other narcotic medication(s). It may take up to 24 hours before you have pain relief from fentanyl patches. For added pain relief, your doctor may direct you to also take quick-acting narcotic or non-narcotic pain medications (such as acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions about using fentanyl safely with other drugs.

Apply this medication to the skin as directed by your doctor. Do not apply on burns, cuts, irritated skin, or skin that has been exposed to radiation (x-ray treatment). Select a dry, non-hairy area on a flat part of your body, such as the chest, sides, back, or upper arms. In young children or in people unable to think clearly (such as due to dementia), apply the patch on the upper back to lessen the chance it might be removed or placed in the mouth. If there is hair on the skin, use scissors to clip the hair as close as possible to the skin. Do not shave hair since this might cause skin irritation. If needed, use water to clean the area. Do not use soap, oils, lotions, or alcohol on the application site. Dry the skin well before applying the patch.

The patch is usually changed every 72 hours. To avoid irritation, apply to a different area each time. Be sure to remove the old patch before applying a new patch. The used patch should be folded in half with the sticky sides together and properly discarded.

Do not use the patch if it appears to be broken, cut, or damaged. Remove from the sealed pouch, peel off the protective liner, and apply immediately to the skin. Press firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete (especially around the edges). If your prescribed dose is for more than one patch, make sure the edges of the patches do not touch or overlap. After applying the patch, wash your hands with water only.

If you have problems with the patch not sticking at the application site, you may tape the edges in place with first aid tape. If this problem persists, ask your doctor for advice. If the patch falls off before 72 hours, a new patch may be applied to a different skin site. Be sure to let your doctor know if this happens.

If you accidentally touch the sticky layer to your skin or handle a cut or damaged patch, wash the area well with clear water. If the patch comes off and accidentally sticks to the skin of another person, immediately remove the patch, wash the area with water, and get medical help for them right away. Do not use soap, alcohol, or other products to wash the area.

The dosage is based on your medical condition and response to treatment. Do not apply more patches than directed, change them more frequently, or use them for a longer time than prescribed.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

Disclaimer

Duragesic Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Duragesic (fentanyl transdermal) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Tell your doctor promptly if you develop a fever, since this rise in body temperature may cause overdose (see also Warning section).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Disclaimer

Duragesic Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone), sibutramine.

Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include cimetidine, nefazodone, St. John's wort, azole antifungals including itraconazole/ ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including erythromycin, rifamycins including rifampin, certain anti-seizure medicines including carbamazepine, among others.

Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, remove the patch. This medicine may be harmful if accidentally swallowed. Contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law and the medication may cause harm to others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you leave a patch on for more than 3 days (72 hours), remove the patch and apply a new patch as soon as you remember. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not freeze. Check the product package for specific temperature ranges for your brand, or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Read the Medication Guide/Patient Information Leaflet for details. You may also consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised November 2011. Copyright(c) 2011 First Databank, Inc.

Duragesic Patient Information Including Side Effects

Brand Names: Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75

Generic Name: fentanyl transdermal (skin patch) (Pronunciation: FEN ta nil trans DERM al)

What is fentanyl transdermal (skin patch) (Duragesic)?

Fentanyl is a narcotic (opioid) pain medicine.

The fentanyl skin patch is used to treat moderate to severe chronic pain. Fentanyl is not for treating mild or occasional pain or pain from surgery.

Fentanyl transdermal may also be used for purposes not listed in this medication guide.

What are the possible side effects of a fentanyl transdermal skin patch?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have any of these serious side effects:

  • slow heart rate, weak or shallow breathing, sighing;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe weakness, feeling like you might pass out;
  • cold, clammy skin; or
  • pale skin, easy bruising or bleeding.

Less serious side effects may include:

  • fever;
  • constipation, diarrhea;
  • dry mouth, nausea, vomiting, upset stomach;
  • headache;
  • drowsiness, weakness, tired feeling;
  • feeling anxious or nervous;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • sweating, skin rash; or
  • itching, blistering, redness, or swelling where the patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Duragesic (fentanyl transdermal) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about a fentanyl transdermal skin patch?

Fentanyl may be habit forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it

Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.

The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Side Effects Centers

Duragesic Patient Information including How Should I Take

What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?

Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.

To make sure you can safely use fentanyl transdermal, tell your doctor if you have any of these other conditions:

  • a breathing disorder such as chronic obstructive pulmonary disease (COPD);
  • a history of head injury or brain tumor;
  • a heart rhythm disorder;
  • liver disease; or
  • kidney disease.

FDA pregnancy category C. It is not known whether fentanyl will harm an unborn baby. Fentanyl may cause breathing problems, seizure, or addiction and withdrawal symptoms in a newborn if the mother uses the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using fentanyl transdermal.

Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. You should not breast-feed while using fentanyl transdermal.

Older adults may be more likely to have side effects from this medicine.

Fentanyl may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Store the medication in a secure place where others cannot get to it.

The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use fentanyl transdermal skin patches?

Use exactly as prescribed by your doctor. Never use fentanyl in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label.

Read all patient instructions carefully before using a fentanyl transdermal skin patch. Follow the directions on your prescription label.

If the skin must be washed before you apply a skin patch, use clear water only. Allow the skin to dry completely before applying the patch.

Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will apply a fentanyl transdermal skin patch. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.

Apply the skin patch to a flat, dry, hairless area of the chest, back, side, or outer side of your upper arm. To remove any hair from these areas, clip the hair short but do not shave it. Press the patch firmly with the palm of your hand for 30 seconds. Make sure the patch is sticking firmly, especially around the edges. You may wear the patch for up to 72 hours. Never wear more than 1 fentanyl transdermal skin patch at a time unless your doctor has told you to.

After removing a skin patch fold it in half, sticky side in, and flush the patch down the toilet. Apply a new patch to a different skin area on the chest, back, side, or upper arm. Do not use the same skin area twice in a row.

Do not use a fentanyl transdermal skin patch if it has been cut or damaged. Doing so could expose you to too much fentanyl, which can cause a life-threatening overdose.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it.

Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Keep track of how many skin patches have been used from each new package. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers

Duragesic Patient Information including If I Miss a Dose

What happens if I miss a dose?

Since fentanyl transdermal is used as needed, you may not be on a dosing schedule. If you are using the skin patches regularly, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal.

Overdose symptoms may include extreme drowsiness, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while using a fentanyl transdermal patch?

This medication is for use only on the skin. Avoid touching the sticky side of a skin patch with your fingers. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips. If it does, rinse with water. Do not use soap or other chemicals.

Fentanyl may impair your thinking or reactions. Do not drive or do anything that requires you to be alert.

Avoid drinking alcohol, which can increase dizziness or drowsiness.

What other drugs will affect fentanyl transdermal?

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by fentanyl. Tell your doctor if you regularly use any of these medicines.

Many drugs can interact with fentanyl. Below is just a partial list. Tell your doctor if you are using:

  • aprepitant (Emend);
  • nefazodone;
  • isoniazid (for treating tuberculosis);
  • St. John's wort;
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifater, Rifadin, Rifamate), telithromycin (Ketek), and others;
  • antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and others; or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), oxcarbazepine (Trileptal), phenytoin (Dilantin), and others.

This list is not complete and other drugs may interact with fentanyl transdermal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fentanyl transdermal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision date: 3/17/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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