Diclofenac Epolamine Topical Patch (Flector Patch)
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Diclofenac Epolamine Topical Patch (Flector Patch)

FLECTOR PATCH®
(diclofenac epolamine) Patch 1.3%

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [See WARNINGS AND PRECAUTIONS].
  • Flector Patch (diclofenac epolamine topical patch) is contraindicated in the peri-operative setting of coronary artery bypass graft (CABG) surgery [See CONTRAINDICATIONS].

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [See WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Flector Patch (diclofenac epolamine topical patch) (10 cm x 14 cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.

Diclofenac epolamine is a non-opioid analgesic chemically designated as 2-[(2,6-dichlorophenyl) aminojbenzeneacetic acid, (2-(pyrrolidin-l-yl) ethanol salt, with a molecular formula of C20H24Cl2N2O3 (molecular weight 411.3), an n-octanol/water partition coefficient of 8 at pH 8.5, and the following structure:

FLECTORPATCH®
  (diclofenac epolamine) Structural Formula Illustration

Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water.

What are the possible side effects of diclofenac topical (Pennsaid, Solaraze, Voltaren Topical)?

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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or...

Read All Potential Side Effects and See Pictures of Flector Patch »

What are the precautions when taking diclofenac epolamine topical patch (Flector Patch)?

Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestine problems (e.g.,...

Read All Potential Precautions of Flector Patch »

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

DOSAGE AND ADMINISTRATION

General Instructions

The recommended dose of Flector Patch (diclofenac epolamine topical patch) is one (1) patch to the most painful area twice a day.

Special Precautions

  • Patients should be informed that, if Flector Patch (diclofenac epolamine topical patch) begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
  • Do not apply Flector Patch (diclofenac epolamine topical patch) to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
  • Do not wear a Flector Patch (diclofenac epolamine topical patch) when bathing or showering.
  • Wash your hands after applying, handling or removing the patch.
  • Avoid eye contact.

HOW SUPPLIED

Dosage Forms and Strengths

Patch (10 x 14 cm) containing 180 mg of diclofenac epolamine, embossed with "FLECTOR PATCH < DICLOFENAC EPOLAMINE TOPICAL PATCH > 1.3%"

The Flector Patch (diclofenac epolamine topical patch) is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (NDC 60793-411-30). Each individual patch is embossed with "FLECTOR PATCH < DICLOFENAC EPOLAMINE TOPICAL PATCH > 1.3%".

  • Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%).
  • The product is intended for topical use only.
  • Keep out of reach of children and pets.
  • ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE.
  • Curad® Hold Tite™ is a trademark of Medline Industries, Inc., and Surgilast® Tubular Elastic Dressing is a trademark of Derma Sciences, Inc.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Distributed by: King Pharmaceuticals Inc. 501 Fifth Street, Bristol TN 37620 USA. Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan. Version November, 2010

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Studies Experience

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 practice.

In controlled trials during the premarketing development of Flector Patch (diclofenac epolamine topical patch) , approximately 600 patients with minor sprains, strains, and contusions have been treated with Flector Patch (diclofenac epolamine topical patch) for up to two weeks.

Adverse Events Leading to Discontinuation of Treatment

In the controlled trials, 3% of patients in both the Flector Patch (diclofenac epolamine topical patch) and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the Flector Patch (diclofenac epolamine topical patch) and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Localized Reactions

Overall, the most common adverse events associated with Flector Patch (diclofenac epolamine topical patch) treatment were skin reactions at the site of treatment.

Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of Flector Patch (diclofenac epolamine topical patch) . A majority of patients treated with Flector Patch (diclofenac epolamine topical patch) had adverse events with a maximum intensity of "mild" or "moderate."

Table 1. Common Adverse Events (by body system and preferred term) in ≥ 1% of Patients treated with Flector Patch (diclofenac epolamine topical patch) or Placebo Patch1

  Diclofenac
N=572
Placebo
N=564
N Percent N Percent
Application Site Conditions 64 11 70 12
  Pruritus 31 5 44 8
  Dermatitis 9 2 3 < 1
  Burning 2 < 1 8 1
  Other2 22 4 15 3
Gastrointestinal Disorders 49 9 33 6
  Nausea 17 3 11 2
  Dysgeusia 10 2 3 < 1
  Dyspepsia 7 1 8 1
Other3 15 3 11 2
Nervous System Disorders 13 2 18 3
  Headache 7 1 10 2
  Paresthesia 6 1 8 1
  Somnolence 4 1 6 1
  Other4 4 1 3 < 1
1 The table lists adverse events occurring in placebo-treated patients because the placebo-patch was comprised of the same ingredients as Flector Patch (diclofenac epolamine topical patch) except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients.
2 Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles.
3 Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth.
4 Includes: hypoaesthesia, dizziness, and hyperkinesias.

Foreign labeling describes that dermal allergic reactions may occur with Flector Patch treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

Read the Flector Patch (diclofenac epolamine topical patch) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Aspirin

When diclofenac is administered with aspirin, the binding of diclofenac to protein is reduced, although the clearance of free diclofenac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

Anticoagulants

The effects of anticoagulants such as warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

ACE-inhibitors

NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors. Consider this interaction in patients taking NSAIDs concomitantly with ACE-inhibitors.

Diuretics

Clinical studies, as well as post marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe the patient closely for signs of renal failure [see WARNINGS AND PRECAUTIONS], as well as to assure diuretic efficacy.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Use caution when NSAIDs, including diclofenac, are administered concomitantly with methotrexate.

Cyclosporine

Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with diclofenac may increase cyclosporine's nephrotoxicity. Use caution when diclofenac is administered concomitantly with cyclosporine.

Oral Nonsteroidal Anti-inflammatory Drugs

Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with Flector Patch (diclofenac epolamine topical patch) and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Inform patients about the signs and/or symptoms of serious CV events and the steps to take if they occur.

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS].

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and NSAIDs, such as diclofenac, does increase the risk of serious GI events.

Gastrointestinal Effects - Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

Prescribe NSAIDs, including Flector Patch (diclofenac epolamine topical patch) , with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event, use the lowest effective dose for the shortest possible duration. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during diclofenac therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high risk patients, consider alternate therapies that do not involve NSAIDs.

Hepatic Effects

Borderline elevations (less than 3 times the upper limit of the normal [ULN] range) or greater elevations of transaminases occurred in about 15% of oral diclofenac-treated patients in clinical trials of indications other than acute pain. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury.

In clinical trials of an oral diclofenac - misoprostol combination product, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) occurred in about 2% of approximately 5,7000 patients at some time during diclofenac treatment (ALT was not measured in all studies).

In an open-label, controlled trial of 3,700 patients treated for 2-6 months, patients with oral diclofenac were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of the 3,700 patients and included marked elevations ( > 8 times the ULN) in about 1% of the 3,700 patients. In this open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked ( > 8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis. Almost all meaningful elevations in transaminases were detected before patients became symptomatic.

Abnormal tests occurred during the first 2 months of therapy with oral diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

Measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, monitor transaminases within 4 to 8 weeks after initiating treatment with diclofenac. However, severe hepatic reactions can occur at any time during treatment with diclofenac.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), discontinue Flector Patch (diclofenac epolamine topical patch) immediately. To minimize the possibility that hepatic injury will become severe between transaminase measurements, inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms), and the appropriate action patients should take if these signs and symptoms appear.

To minimize the potential risk for an adverse liver related event in patients treated with Flector Patch (diclofenac epolamine topical patch) , the lowest effective dose should be used for the shortest duration possible. Exercise caution when prescribing Flector Patch (diclofenac epolamine topical patch) with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, certain antibiotics, anti-epileptics). Caution patients to avoid taking unprescribed acetaminophen while using Flector Patch (diclofenac epolamine topical patch) .

Hypertension.

NSAIDs, including Flector Patch (diclofenac epolamine topical patch) , can lead to new onset or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use Flector Patch (diclofenac epolamine topical patch) , with caution in patients with hypertension. Monitor blood pressure (BP) closely during the initiation of treatment and throughout the course of therapy.

Patients taking ACE inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs, including Flector Patch (diclofenac epolamine topical patch) . Use Flector Patch (diclofenac epolamine topical patch) with caution in patients with fluid retention or heart failure.

Renal Effects

Use caution when initiating treatment with Flector Patch (diclofenac epolamine topical patch) in patients with considerable dehydration.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

No information is available from controlled clinical studies regarding the use of Flector Patch (diclofenac epolamine topical patch) in patients with advanced renal disease. Therefore, treatment with Flector Patch (diclofenac epolamine topical patch) is not recommended in these patients with advanced renal disease. If Flector Patch (diclofenac epolamine topical patch) therapy is initiated, close monitoring of the patient's renal function is advisable.

Anaphylactic Reactions

As with other NSAIDs, anaphylactic reactions may occur both in patients with the aspirin triad and in patients without known sensitivity to NSAIDs or prior exposure to Flector Patch (diclofenac epolamine topical patch) . Do not prescribe Flector Patch (diclofenac epolamine topical patch) to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Anaphylaxis type reactions have been reported with NSAID products, including diclofenac products, such as Flector Patch [see CONTRAINDICATIONS]. Seek emergency help in cases where an anaphylactic reaction occurs.

Skin Reactions

NSAIDs, including Flector Patch (diclofenac epolamine topical patch) , can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and discontinue use of the drug at the first appearance of skin rash or any other signs of hypersensitivity.

Pregnancy

Starting at 30 weeks gestation, Flector Patch (diclofenac epolamine topical patch) , and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see Use In Specific Populations].

Corticosteroid Monitoring

Flector Patch (diclofenac epolamine topical patch) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Slowly taper patients on prolonged corticosteroid therapy if a decision is made to discontinue corticosteroids.

Inflammation

The pharmacological activity of Flector Patch (diclofenac epolamine topical patch) in reducing inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Flector Patch (diclofenac epolamine topical patch) , should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Carefully monitor patients receiving Flector Patch (diclofenac epolamine topical patch) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants.

Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, do not administer Flector Patch (diclofenac epolamine topical patch) to patients with this form of aspirin sensitivity and use with caution in patients with preexisting asthma.

Accidental Exposure in Children

Even a used Flector Patch contains a large amount of diclofenac epolamine (as much as 170 mg). The potential therefore exists for a small child or pet to suffer serious adverse effects from chewing or ingesting a new or used Flector Patch (diclofenac epolamine topical patch) . It is important for patients to store and dispose of Flector Patch (diclofenac epolamine topical patch) out of the reach of children and pets.

Eye Exposure

Avoid contact of Flector Patch (diclofenac epolamine topical patch) with eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour.

Oral Nonsteroidal Anti-inflammatory Drugs

Concomitant use of oral and topical NS AIDs may result in a higher rate of hemorrhage, more frequent abnormal creatinine, urea and hemoglobin. Do not use combination therapy with Flector Patch (diclofenac epolamine topical patch) and an oral NSAID unless the benefit outweighs the risk.

Monitoring

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, monitor for signs or symptoms of GI bleeding. Check CBC and a chemistry profile periodically in patients on long-term treatment with NSAIDs. Discontinue Flector Patch (diclofenac epolamine topical patch) if abnormal liver tests or renal tests persist or worsen.

Patient Counseling Information

See Medication Guide

Information on Medication Guide

Inform patients of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Encourage patients to read the NSAID Medication Guide that accompanies each prescription dispensed prior to using Flector Patch (diclofenac epolamine topical patch) .

Cardiovascular Effects

Flector Patch (diclofenac epolamine topical patch) , like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, instruct patients to be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to ask for medical advice when observing any indicative sign or symptoms. Inform patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Effects

Flector Patch (diclofenac epolamine topical patch) , like other NSAIDs, may cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, inform patients to be alert for the signs and symptoms of ulceration and bleeding, and to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Instruct patients of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Adverse Skin Reactions

Flector Patch (diclofenac epolamine topical patch) , like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious systemic skin reactions may occur without warning, instruct patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and to ask for medical advice when observing any indicative signs or symptoms [see WARNINGS AND PRECAUTIONS]. Advise patients to stop Flector Patch (diclofenac epolamine topical patch) immediately if they develop any type of generalized rash and contact their physicians as soon as possible.

Flector Patch (diclofenac epolamine topical patch) can cause a localized skin reaction at the application site. Advise patients to contact their physicians as soon as possible if they develop any type of localized application site rash.

Instruct patients not to apply Flector Patch (diclofenac epolamine topical patch) to open skin wounds or infections.

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop therapy with Flector Patch (diclofenac epolamine topical patch) and seek immediate medical therapy [see WARNINGS AND PRECAUTIONS].

Weight gain and edema

Patients should promptly report to their physician signs or symptoms of unexplained weight gain or edema following treatment with Flector Patch (diclofenac epolamine topical patch) [see WARNINGS AND PRECAUTIONS].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help. Anaphylaxis type reactions have been reported with diclofenac products, including Flector Patch (diclofenac epolamine topical patch) [see WARNINGS AND PRECAUTIONS].

Preexisting Asthma

Inform patients not to use Flector Patch (diclofenac epolamine topical patch) if they have an aspirin-sensitive asthma. Flector Patch (diclofenac epolamine topical patch) , like other NSAIDs, could cause severe and even fatal bronchospasm in these patients [see WARNINGS AND PRECAUTIONS]. Instruct patients to discontinue use of Flector Patch (diclofenac epolamine topical patch) and to immediately seek emergency help if they experience wheezing or shortness of breath.

Eye Exposure

Instruct patients to avoid contact of Flector Patch (diclofenac epolamine topical patch) with the eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour [see WARNINGS AND PRECAUTIONS].

Effects during pregnancy

Starting at 30 weeks gestation, instruct patients to avoid the use of Flector Patch and other NSAIDS, as premature closure of the ductus arteriosus in the fetus may occur [see WARNINGS AND PRECAUTIONS and Use in Specific Populations].

General Information on Use

  • Instruct patients and caregivers to wash their hands after applying, handling or removing the patch.
  • Inform patients that, if Flector Patch (diclofenac epolamine topical patch) begins to peel off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
  • Instruct patients not to wear Flector Patch (diclofenac epolamine topical patch) during bathing or showering. Bathing should take place in between scheduled patch removal and application [see DOSAGE AND ADMINISTRATION].
  • Instruct patients to store Flector Patch (diclofenac epolamine topical patch) and to discard used patches out of the reach of children and pets. If a child or pet accidentally ingests Flector Patch (diclofenac epolamine topical patch) , instruct patients to seek medical help immediately [see WARNINGS AND PRECAUTIONS].
  • Inform patients that Flector Patch (diclofenac epolamine topical patch) should be used only on intact skin.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch.

Mutagenesis

Diclofenac epolamine is not mutagenic in Salmonella typhimurium strains, nor does it induce an increase in metabolic aberrations in cultured human lymphocytes, or the frequency of micronucleated cells in the bone marrow micronucleus test performed in rats.

Impairment of Fertility

Male and female Sprague Dawley rats were administered 1, 3, or 6 mg/kg/day diclofenac epolamine via oral gavage (males treated for 60 days prior to conception and during mating period, females treated for 14 days prior to mating through day 19 of gestation). Diclofenac epolamine treatment with 6 mg/kg/day resulted in increased early resorptions and postimplantation losses; however, no effects on the mating and fertility indices were found. The 6 mg/kg/day dose corresponds to 3-times the maximum recommended daily exposure in humans based on a body surface area comparison.

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation.

Starting at 30 weeks gestation, avoid use of Flector Patch (diclofenac epolamine topical patch) , and other NSAIDS, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur, Flector Patch (diclofenac epolamine topical patch) can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. If this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus. There are no adequate and well-controlled studies in pregnant women. Prior to 30 weeks gestation, Flector Patch (diclofenac epolamine topical patch) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregnant Sprague Dawley rats were administered 1, 3, or 6 mg/kg diclofenac epolamine via oral gavage daily from gestation days 6-15. Maternal toxicity, embryotoxicity, and increased incidence of skeletal anomalies were noted with 6 mg/kg/day diclofenac epolamine, which corresponds to 3-times the maximum recommended daily exposure in humans based on a body surface area comparison. Pregnant New Zealand White rabbits were administered 1, 3, or 6 mg/kg diclofenac epolamine via oral gavage daily from gestation days 6-18. No maternal toxicity was noted; however, embryotoxicity was evident at 6 mg/kg/day group which corresponds to 6.5-times the maximum recommended daily exposure in humans based on a body surface area comparison.

Nonteratogenic Effects

Male rats were orally administered diclofenac epolamine (1, 3, 6 mg/kg) for 60 days prior to mating and throughout the mating period, and females were given the same doses 14 days prior to mating and through mating, gestation, and lactation. Embryotoxicity was observed at 6 mg/kg diclofenac epolamine (3-times the maximum recommended daily exposure in humans based on a body surface area comparison), and was manifested as an increase in early resorptions, post-implantation losses, and a decrease in live fetuses. The number of live born and total born were also reduced as was Fl postnatal survival, but the physical and behavioral development of surviving Fl pups in all groups was the same as the deionized water control, nor was reproductive performance adversely affected despite a slight treatment-related reduction in body weight.

Labor and Delivery

The effects of Flector Patch (diclofenac epolamine topical patch) on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia, delayed parturition, and decreased pup survival.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human-milk and because of the potential for serious adverse reactions in nursing infants from Flector Patch (diclofenac epolamine topical patch) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Flector Patch (diclofenac epolamine topical patch) 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.

Diclofenac, as with any NSAID, is known to be substantially excreted by the kidney, and the risk of toxic reactions to Flector Patch (diclofenac epolamine topical patch) may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken when using Flector Patch (diclofenac epolamine topical patch) in the elderly, and it may be useful to monitor renal function.

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There is limited experience with overdose of Flector Patch (diclofenac epolamine topical patch) . In clinical studies, the maximum single dose administered was one Flector Patch containing 180 mg of diclofenac epolamine. There were no serious adverse events.

Should systemic side effects occur due to incorrect use or accidental overdose of this product, the general measures recommended for intoxication with non-steroidal anti-inflammatory drugs should be taken.

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

CONTRAINDICATIONS

  • Flector Patch (diclofenac epolamine topical patch) is contraindicated in patients with a known hypersensitivity to diclofenac.
  • Flector Patch (diclofenac epolamine topical patch) is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS].
  • Flector Patch (diclofenac epolamine topical patch) is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].
  • Flector Patch (diclofenac epolamine topical patch) is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). In pharmacologic studies, diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. As with other NSAIDs, its mode of action is not known; its ability to inhibit prostaglandin synthesis, however, may be involved in its anti-inflammatory activity, as well as contribute to its efficacy in relieving pain associated with inflammation.

Pharmacodynamics

Flector Patch applied to intact skin provides local analgesia by releasing diclofenac epolamine from the patch into the skin.

Pharmacokinetics

Absorption

Following a single application of the Flector Patch (diclofenac epolamine topical patch) on the upper inner arm, peak plasma concentrations of diclofenac (range 0.7 - 6 ng/mL) were noted between 10 - 20 hours of application. Plasma concentrations of diclofenac in the range of 1.3 - 8.8 ng/mL were noted after five days with twice-a-day Flector Patch (diclofenac epolamine topical patch) application.

Systemic exposure (AUC) and maximum plasma concentrations of diclofenac, after repeated dosing for four days with Flector Patch (diclofenac epolamine topical patch) , were lower ( < 1%) than after a single oral 50-mg diclofenac sodium tablet.

The pharmacokinetics of Flector Patch (diclofenac epolamine topical patch) has been tested in healthy volunteers at rest or undergoing moderate exercise (cycling 20 min/h for 12 h at a mean HR of 100.3 bpm). No clinically relevant differences in systemic absorption were observed, with peak plasma concentrations in the range of 2.2 - 8.1 ng/mL while resting, and 2.7 - 7.2 ng/mL during exercise.

Distribution

Diclofenac has a very high affinity ( > 99%) for human serum albumin.

Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac.

Metabolism

Five diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac. The major diclofenac metabolite, 4'hydroxy-diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy diclofenac is primarily mediated by CPY2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CPY2C8 may also play a role in diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3'-hydroxy- diclofenac.

Excretion

The plasma elimination half-life of diclofenac after application of Flector Patch (diclofenac epolamine topical patch) is approximately 12 hours. Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged diclofenac plus metabolites.

Clinical Studies

Ankle sprains

Efficacy of Flector Patch (diclofenac epolamine topical patch) was demonstrated in two of four studies of patients with minor sprains, strains, and contusions. Patients were randomly assigned to treatment with the Flector Patch (diclofenac epolamine topical patch) , or a placebo patch identical to the Flector Patch minus the active ingredient. In the first of these two studies, patients with ankle sprains were treated once daily for a week. In the second study, patients with sprains, strains and contusions were treated twice daily for up to two weeks. Pain was assessed over the period of treatment. Patients treated with the Flector Patch (diclofenac epolamine topical patch) experienced a greater reduction in pain as compared to patients randomized to placebo patch as evidenced by the responder curves presented below.

Figure 1: Patients Achieving Various Levels of Pain Relief at Day 3; 14-Day Study

Patients Achieving Various Levels of Pain Relief at Day 3; 14-Day Study - Illustration

Figure 2: Patients Achieving Various Levels of Pain Relief at End of Study; 14-Day Study

Patients Achieving Various Levels of Pain Relief at End of Study; 14-Day Study - Illustration

Figure 3: Patients Achieving Various Levels of Pain Relief at Day 3; 7-Day Study

Patients Achieving Various Levels of Pain Relief at Day 3; 7-Day Study - Illustration

Figure 4: Patients Achieving Various Levels of Pain Relief at End of Study; 7-Day Study

Patients Achieving Various Levels of Pain Relief at End of Study; 7-Day Study - Illustration

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft" (CABG).

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and "anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant, NSAID medicines should not be used past 30 weeks of pregnancy.
  • if you are breastfeeding, talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gam
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

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

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, 600 Tolectin DS, Tolectin

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft" (CABG).

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and "anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant, NSAID medicines should not be used past 30 weeks of pregnancy.
  • if you are breastfeeding, talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gam
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

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

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, 600 Tolectin DS, Tolectin

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Flector Patch 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.

DICLOFENAC PATCH - TOPICAL

(dye-KLOE-fen-ack)

COMMON BRAND NAME(S): Flector

WARNING: This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning at any time during treatment with diclofenac. The elderly are at increased risk for serious stomach/intestinal bleeding.

Nonsteroidal anti-inflammatory drugs (including diclofenac) may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).

Stop using diclofenac and seek immediate medical attention if you notice any of the following rare but very serious side effects: black/bloody stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, shortness of breath, weakness on one side of the body, sudden vision changes, slurred speech.

USES: Diclofenac patches are used to relieve pain from various conditions (e.g., sprained ankle). This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using diclofenac and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

The patch comes in a resealable envelope. When opening the envelope for the first time, cut it open as instructed. Remove a patch from the envelope and reseal the envelope. It is important to reseal the envelope after each opening, or the remaining patches will not stick correctly.

Before applying the patch, remove the clear liner. Apply the patch to the skin to cover the most painful area. Do not apply the patch on burns, cuts, or irritated skin (e.g., eczema). Change the patch usually every 12 hours or as directed by your doctor. Fold the used patch in half with the sticky sides together, and discard out of reach of children and pets.

If the patch begins to peel off, you may tape the edges to the skin.

Do not wear the patch during bathing or showering. Take baths/showers at times that you normally change the patch.

To avoid getting the medication in your eyes, nose, mouth, or vaginal area, wash your hands after handling the patch. If the medication or patch does come in contact with those areas, flush with plenty of water. Contact your doctor immediately if irritation persists.

Dosage is based on your medical condition and response to treatment. To reduce side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or use it more often than prescribed. Discuss the risks and benefits with your doctor or pharmacist.

If you are using this drug "as needed" (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medicine may not work as well.

Tell your doctor if your pain persists or worsens.

Disclaimer

Flector Patch Consumer (continued)

SIDE EFFECTS: See also Warning section.

Itching, burning, irritation, redness, or dry skin may occur at the application site. Nausea or change in taste may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 right away if you have any serious side effects, including: swelling of the ankles/feet/hands (edema), sudden/unexplained weight gain, unusual tiredness.

This drug may rarely cause serious (possibly fatal) liver problems. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Flector Patch (diclofenac epolamine topical patch) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestine problems (e.g., bleeding, ulcers), kidney disease, liver disease, poorly controlled diabetes, heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, water retention), a severe loss of body water (dehydration), blood disorders (e.g., anemia, bleeding/clotting problems), asthma, growths in the nose (nasal polyps).

Before having surgery, tell your doctor or dentist that you are using this medication.

If you are going to have an MRI test, notify testing personnel that you are using this patch. Serious burns may occur during MRI tests because of the aluminum contained in these patches. It should be removed just before the MRI test or consult your doctor for specific instructions.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney effects.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). 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 is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

Based on information from related drugs, this medication may pass into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Disclaimer

Flector Patch Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), anti-platelet drugs (e.g., clopidogrel), "blood thinners" (e.g., warfarin, heparin, enoxaparin), cidofovir, corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, lithium, methotrexate, pemetrexed, probenecid, SSRI antidepressants (e.g., fluoxetine, sertraline), tenofovir.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to diclofenac and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, liver and kidney function tests) should be performed periodically to check for side effects. Consult your doctor for more details. Keep all doctor appointments and lab visits so your therapy can be monitored closely.

MISSED DOSE: If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store patches in the envelope at room temperature at 77 degrees F (25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Always reseal envelope after opening. The patches expire 3 months after the envelope is first opened. Keep all medicines 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. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Flector Patch Patient Information Including Side Effects

Brand Names: Pennsaid, Solaraze, Voltaren Topical

Generic Name: diclofenac topical (Pronunciation: dye KLOE fen ak TOP ik al)

What is diclofenac topical (Flector Patch)?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diclofenac topical 1% gel (Voltaren Topical) is used to treat joint pain in the hands, wrists, elbows, knees, ankles, or feet caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 1.5% solution (Pennsaid) is used to treat pain in the knees caused by osteoarthritis. This medication may not be effective in treating arthritis pain elsewhere in the body.

Diclofenac topical 3% gel (Solaraze) is used to treat warty overgrowths of skin (actinic keratoses) on sun-exposed areas of the body.

Diclofenac topical may also be used for purposes not listed in this medication guide.

What are the possible side effects of diclofenac topical (Flector 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.

Although the risk of serious side effects is low when diclofenac is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • pale or yellowed skin, dark colored urine, confusion;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • mild nausea, stomach pain, upset stomach;
  • diarrhea, gas; or
  • mild itching, dryness, redness, scaling, or other skin irritation where the medicine was applied.

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 Flector Patch (diclofenac epolamine topical patch) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about diclofenac topical (Flector Patch)?

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID). Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Before using this medication, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma, or nasal polyps.

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Flector Patch Patient Information including How Should I Take

What should I discuss with my healthcare provider before using diclofenac topical (Flector Patch)?

While the risk of absorbing diclofenac topical into your bloodstream is low, an NSAID can cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using diclofenac topical, especially in older adults.

Do not use this medication if you have ever had asthma or a severe allergic reaction caused by aspirin, diclofenac (Cataflam, Voltaren), or another NSAID. Do not use diclofenac just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

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

  • a history of drug allergies;
  • a history of heart attack, stroke, or blood clot;
  • heart disease, congestive heart failure, high blood pressure;
  • a history of stomach ulcer or bleeding;
  • liver or kidney disease;
  • a bleeding or blood clotting disorder; or
  • asthma, or polyps in your nose.

This medication may be harmful to an unborn baby. If you are pregnant, ask your doctor if it is safe for you to use diclofenac topical. Tell your doctor if you become pregnant during treatment.

Diclofenac topical can pass into breast milk and may harm a nursing baby. You should not breast-feed while using diclofenac topical.

How should I use diclofenac topical (Flector Patch)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. When treating osteoarthritis, keep using any oral medications your doctor has prescribed.

Do not use diclofenac topical on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury. Do not cover the treated skin with a bandage or expose it to heat from a hot tub, heating pad, sauna, or heated water bed. Heat or bandaging can increase the amount of drug you absorb through your skin and may cause harmful effects.

Wash your hands after applying this medication, unless you are treating the skin on your hands. Do not wear gloves for at least 10 minutes after applying diclofenac topical to the hands.

After you apply diclofenac topical gel, wait at least 10 minutes before dressing and at least 1 hour before you bathe or shower.

To treat actinic keratosis (with Solaraze): Apply enough gel to cover each lesion and rub in gently. Do not apply Solaraze gel more than 2 times daily and never use more than your prescribed dose.

To treat osteoarthritis knee pain (with Pennsaid): Apply the solution only to clean, dry skin. Place 10 drops at a time into your hand and spread the solution over the front, back, and sides of the knee. Apply a total of 40 drops to each affected knee, 4 times per day. You may also drop the medicine directly onto the knee, spreading after every 10 drops.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products, including sunscreen.

To treat osteoarthritis pain (with Voltaren Topical): This medicine is supplied with dosing cards that show you how much gel to use for a 2-gram dose or a 4-gram dose. Squeeze the gel onto this card along the line for your dose. Use no more gel than will fit on the length of your dosing line. Wipe the card directly onto the treatment area and rub gently into the skin.

To treat arthritis pain in the foot, spread the gel out onto all areas of the foot including the toes and soles. When treating the hand, spread the gel out onto all areas of the hand including the fingers and palms.

Store at room temperature away from moisture and heat. Do not freeze.

Flector Patch Patient Information including If I Miss a Dose

What happens if I miss a dose (Flector Patch)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Flector Patch)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using diclofenac topical (Flector Patch)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Do not use cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products on the same area you treat with diclofenac topical.

Avoid getting this medication in your mouth, nose, or eyes. If this does happen, rinse with water.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds) while you are using diclofenac topical.

Avoid taking aspirin, oral (pill form) diclofenac (Cataflam, Voltaren), or other NSAIDs without your doctor's advice. This includes ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Aspirin and other medicines similar to diclofenac are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

What other drugs will affect diclofenac topical (Flector Patch)?

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • a diuretic (water pill);
  • steroids (prednisone and others); or
  • heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

It is not likely that other drugs you take orally or inject will have an effect on topically applied diclofenac. But many drugs can interact with each other. 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 diclofenac topical.


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: 7.01. Revision date: 9/20/2011.

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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