Codeine Sulfate (Codeine)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Codeine Sulfate (Codeine)

Codeine
(sulfate) Tablets

DRUG DESCRIPTION

Chemically, codeine is Morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5a,6a)-, sulfate (2:1) (salt), trihydrate. Its empirical formula is C18H21NO3 and its molecular weight is 299.36.

Its structure is as follows:

Codeine sulfate Structural Formula Illustration

Each tablet contains 15, 30, or 60 mg of codeine sulfate and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, and stearic acid.

What are the possible side effects of codeine ()?

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.

Call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak pulse, fainting, shallow breathing;
  • feeling like you might pass out;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness;
  • seizure (convulsions); or
  • problems with urination.

Less serious side effects include:

  • feeling...

Read All Potential Side Effects and See Pictures of Codeine Sulfate »

What are the precautions when taking codeine (Codeine Sulfate)?

Before taking codeine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., morphine, hydrocodone, oxycodone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), 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: severe breathing problems (e.g., respiratory depression, carbon dioxide retention), a certain bowel disease (paralytic ileus), severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), intoxication with medications that can cause drowsiness...

Read All Potential Precautions of Codeine Sulfate »

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Codeine sulfate is an opioid analgesic indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

DOSAGE AND ADMINISTRATION

Selection of patients for treatment with codeine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management.

Individualization of Dosage

As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of codeine sulfate, attention should be given to the following:

  • the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  • the reliability of the relative potency estimate used to calculate the equivalent codeine sulfate dose needed;
  • the patient's degree of opioid tolerance;
  • the general condition and medical status of the patient;
  • concurrent medications;
  • the type and severity of the patient's pain;
  • risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving codeine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for noncancer-related pain, the continued need for the use of opioid analgesics should be re-assessed as appropriate.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.

Initiation of Therapy

The usual adult dosage for tablets is 15 mg to 60 mg repeated up to every four hours as needed for pain. The maximum 24 hour dose is 360 mg.

The initial dose should be titrated based upon the individual patient's response to their initial dose of codeine. This dose can then be adjusted to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the codeine by the patient.

It should be kept in mind, however, that tolerance to codeine sulfate can develop with continued use and that the incidence of untoward effects is dose-related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain and are associated with an appreciably increased incidence of undesirable side effects.

Cessation of Therapy

When the patient no longer requires therapy with codeine sulfate, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

Dosage Forms And Strengths

Each 15 mg tablet for oral administration contains 15 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Each 30 mg tablet for oral administration contains 30 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Each 60 mg tablet for oral administration contains 60 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

Storage And Handling

Codeine Sulfate

15 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-8155-24: 4 Cards per Carton

30 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-4156-24: 4 Cards per Carton
NDC 0054-0244-25: Bottles of 100 Tablets

60 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

NDC 0054-4157-25: Bottles of 100 Tablets

Storage

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

Protect from moisture and light.

Dispense in well-closed container as defined in the USP/NF.

Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient.

All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

Roxane Laboratories. Revised: August 2010

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.

Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain, and pruritis.

Other less frequently observed adverse reactions expected from opioid analgesics, including codeine sulfate, include:

Cardiovascular system: faintness, flushing, hypotension, palpitations, syncope

Digestive System: abdominal cramps, anorexia, diarrhea, dry mouth, gastrointestinal distress, pancreatitis

Nervous system: anxiety, drowsiness, fatigue, headache, insomnia, nervousness, shakiness, somnolence, vertigo, visual disturbances, weakness

Skin and Appendages: rash, sweating, urticaria

Read the Codeine Sulfate (codeine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

CNS Depressants

Concurrent use of other opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including sedatives, hypnotics, general anesthetics, antiemetics, phenothiazines, or other tranquilizers or alcohol) concomitantly with codeine sulfate tablets may result in additive CNS depression, respiratory depression, hypotension, profound sedation, or coma. Use codeine sulfate with caution and in reduced dosages in patients taking these agents.

Mixed Agonist/Antagonist Opioid Analgesics

Mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should NOT be administered to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as codeine sulfate. In these patients, mixed agonist/antagonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

Anticholinergics

Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics including codeine sulfate, may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

Antidepressants

Use of MAO inhibitors or tricyclic antidepressants with codeine sulfate may increase the effect of either the antidepressant or codeine. MAOIs markedly potentiate the action of morphine sulfate, the major metabolite of codeine. Codeine should not be used in patients taking MAOIs or within 14 days of stopping such treatment.

Metabolic Enzymes

Patients taking cytochrome P-450 enzyme inducers or inhibitors may demonstrate an altered response to codeine, therefore analgesic activity should be monitored. Codeine sulfate is metabolized by the cytochrome P-450 3A4 and 2D6 isoenzymes. [see CLINICAL PHARMACOLOGY] The concurrent use of drugs that preferentially induce codeine N-demethylation (cytochrome P-450 3A4) may increase the plasma concentrations of codeine's inactive metabolite norcodeine. Drugs that are strong inhibitors of codeine O-demethylation (cytochrome P-450 2D6) may decrease the plasma concentrations of codeine's active metabolites, morphine and morphine-6-glucuronide. The contribution of these active metabolites to the overall analgesic effect of codeine is not fully understood, but should be considered.

Drug-Laboratory Test Interaction

Codeine sulfate tablets may cause an elevation of plasma amylase and lipase due to the potential of codeine to produce spasm of the sphincter of Oddi. Determination of these enzyme levels may be unreliable for some time after an opiate agonist has been given.

Drug Abuse And Dependence

Controlled Substance

Codeine sulfate is an opioid agonist and is a Schedule II controlled substance. Codeine sulfate can be abused and is subject to criminal diversion.

Abuse

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary 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 not be accompanied by concurrent tolerance and symptoms of physical dependence. The converse is also true. 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. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Codeine is intended for oral use only. Abuse of codeine poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

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

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms. [see Use In Specific Populations]

Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including 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.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Respiratory Depression

Respiratory depression is the primary risk of codeine sulfate. Respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. Codeine produces dose-related respiratory depression. Caution should be exercised when codeine sulfate is used postoperatively, in patients with pulmonary disease or shortness of breath, or whenever ventilatory function is depressed. Opioid related respiratory depression occurs more frequently in elderly or debilitated patients and in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, in whom even moderate therapeutic doses may significantly decrease pulmonary ventilation. Opioids, including codeine sulfate, should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale and in patients having a substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of codeine sulfate may increase airway resistance and decrease respiratory drive to the point of apnea. Alternative non-opioid analgesics should be considered, and codeine sulfate should be employed only under careful medical supervision at the lowest effective dose in such patients. [see OVERDOSAGE]

Misuse and Abuse of Opioids

Codeine sulfate is an opioid agonist of the morphine-type and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders. Diversion of Schedule II products is an act subject to criminal penalty. Codeine can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing codeine sulfate in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Misuse and abuse of codeine sulfate poses a significant risk to the abuser that could result in overdose and death. Codeine may be abused by crushing, chewing, snorting or injecting the product. [see Drug Abuse and Dependence]

Concerns about abuse and addiction should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interaction with Alcohol and Drugs of Abuse

Codeine sulfate may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression, because respiratory depression, hypotension, profound sedation, coma or death may result.

Head Injury and Increased Intracranial Pressure

Respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure resulting from vasodilation following CO2 retention may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids including codeine sulfate, produce adverse reactions which may obscure the clinical course of patients with head injuries.

Hypotensive Effect

Codeine sulfate may cause severe hypotension in an individual whose ability to maintain blood pressure has already been compromised by a depleted blood volume or concurrent administration of drugs such as phenothiazines or general anesthetics.

Codeine sulfate may produce orthostatic hypotension and syncope in ambulatory patients.

Codeine sulfate should be administered with caution to patients in circulatory shock, as vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Gastrointestinal Effects

Codeine sulfate should not be administered to patients with gastrointestinal obstruction, especially paralytic ileus because codeine sulfate diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction.

Chronic use of opioids, including codeine sulfate, may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder. Codeine sulfate may cause or aggravate constipation.

Administration of codeine sulfate may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Use in Pancreatic/Biliary Tract Disease

Codeine sulfate should be used in caution in patients with biliary tract disease, including acute pancreatitis, as codeine sulfate may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.

Special Risk Patients

As with other opioids, codeine sulfate should be used with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyrodism, Addison's disease, prostatic hypertrophy or urethral stricture. [see Use In Specific Populations] The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Caution should be exercised in the administration of codeine sulfate to patients with CNS depression, acute alcoholism, and delirium tremens.

All opioids may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Ultra-Rapid Metabolizers of Codeine

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and inform their patients about these risks and the signs of morphine overdose. [see Use In Specific Populations]

Driving and Operating Machinery

Patients should be cautioned that codeine sulfate could impair the mental and/or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Patients should also be cautioned about the potential combined effects of codeine sulfate with other CNS depressants, including opioids, phenothiazines, sedative/hypnotics, and alcohol. [see DRUG INTERACTIONS]

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Two year carcinogenicity studies have been conducted in F344/N rats and B6C3F1 mice. There was no evidence of carcinogenicity in male and female rats, respectively, at dietary doses up to 70 and 80 mg/kg/day of codeine (approximately 2 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis) for two years. Similiarly there was no evidence of carcinogenicity activity in male and female mice at dietary doses up to 400 mg/kg/day of codeine (approximately 5 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis) for two years.

Mutagenesis

Codeine was not mutatgenic in the in vitro bacterial reverse mutation assay or clastogenic in the in vitro Chinese hamster ovary cell chromosome aberration assay.

Impairment of fertility

No animal studies were conducted to evaluate the effect of codeine on male or female fertility.

Use In Specific Populations

Pregnancy

Teratogenic Effects - Pregnancy Category C

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

Codeine has been shown to have embryolethal and fetotoxic effects (reduced fetal body weights and delayed or incomplete ossification) in the hamster, rat and mouse models at approximately 2-4 times the maximum recommended human dose of 360 mg/day based on a body surface area comparison. Maternally toxic doses that were approximately 7 times the maximum recommended human dose of 360 mg/day, were associated with evidence of resorptions and incomplete ossification, including meningioencephalocele and cranioschisis. In contrast, codeine did not demonstrate evidence of embrytoxicity or fetotoxicity in the rabbit model at doses up to 2 times the maximum recommended human dose of 360 mg/day based on a body surface area comparison. [see Nonclinical Toxicology]

Nonteratogenic Effects

Neonatal codeine withdrawal has occurred in infants born to addicted and non-addicted mothers who had been taking codeinecontaining medications in the days prior to delivery. Typical symptoms of narcotic withdrawal include irritability, excessive crying, tremors, hyperreflexia, seizures, fever, vomiting, diarrhea, and poor feeding. These signs occur shortly after birth and may require specific treatment.

Codeine (30 mg/kg) administered subcutaneously to pregnant rats during pregnancy and for 25 days after delivery increased neonatal mortality at birth. This dose is 0.8 times the maximum recommended human dose of 360 mg/day on a body surface area comparison.

Labor and Delivery

Opioid analgesics cross the placental barrier and may produce respiratory depression and psycho-physiologic effects in neonates. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Opioid analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required. [see OVERDOSAGE] A specific opioid antagonist, such as naloxone or nalmefene, should be available for reversal of opioid-induced respiratory depression in the neonate.

Nursing Mothers

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and the baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. [see WARNINGS AND PRECAUTIONS]

Pediatric Use

The safety and effectiveness and the pharmacokinetics of codeine sulfate in pediatric patients below the age of 18 have not been established. FDA has not required pediatric studies in ages birth to one month because there is evidence strongly suggesting that codeine would be ineffective in this pediatric group since the metabolic pathways to metabolize codeine are not mature.

Geriatric Use

Codeine may cause confusion and over-sedation in the elderly. 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.

Renal Impairment

Codeine pharmacokinetics may be altered in patients with renal failure. Clearance may be decreased and the metabolites may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function. Start these patients cautiously with lower doses of codeine sulfate or with longer dosing intervals and titrate slowly while carefully monitoring for side effects.

Hepatic Impairment

No formal studies have been conducted in patients with hepatic impairment so the pharmacokinetics of codeine in this patient population are unknown. Start these patients cautiously with lower doses of codeine sulfate or with longer dosing intervals and titrate slowly while carefully monitoring for side effects.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Symptoms

Acute overdose of codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne- Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, miosis (mydriasis may occur in terminal narcosis or severe hypoxia), skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Codeine sulfate may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Treatment

Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation as necessary. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation. Induction of emesis is not recommended because of the potential for CNS depression and seizures. Activated charcoal is recommended if the patient is awake and able to protect his/her airway. In persons who are at risk for abrupt onset of seizures or mental status depression, activated charcoal should be administered by medical or paramedical personnel capable of airway management to prevent aspiration in the event of spontaneous emesis. Severe agitation or seizures should be treated with an intravenous benzodiazepine.

The opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression resulting from overdosage or unusual sensitivity to opiate agonists, including codeine. Therefore, an appropriate dose of naloxone hydrochloride (see prescribing information for naloxone hydrochloride) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of codeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression secondary to codeine sulfate overdose.

In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed. If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and titrated with smaller than usual doses.

CONTRAINDICATIONS

Codeine sulfate is contraindicated in patients with known hypersensitivity to codeine or any components of the product. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.

Codeine sulfate is contraindicated in patients with respiratory depression in the absence of resuscitative equipment.

Codeine sulfate is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.

Codeine sulfate is contraindicated in any patient who has or is suspected of having paralytic ileus.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Codeine sulfate is an opioid analgesic, related to morphine, but with less potent analgesic properties. Codeine is selective for the mu receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.

Effects of the Central Nervous System (CNS)

The principal therapeutic action of codeine sulfate is analgesia. Although the precise mechanism of the analgesic action is unknown, specific CNS opiate receptors and endogenous compounds with morphine-like activity have been identified throughout the brain and spinal cord and are likely to play a role in the expression and perception of analgesic effects. Some other CNS effects of codeine include anxiolysis, euphoria, and feelings of relaxation. Codeine sulfate causes respiratory depression, in part by a direct effect on the brainstem respiratory centers. Codeine sulfate and other related opioids depress the cough reflex by direct effect on the cough center in the medulla. Codeine sulfate may also cause miosis.

Effects on the Gastrointestinal Tract and on Other Smooth Muscle

Gastric, biliary and pancreatic secretions may be decreased by codeine. Codeine also causes a reduction in motility and is associated with an increase in tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone is increased to the point of spasm. The end result may be constipation. Codeine can cause a marked increase in biliary tract pressure as a result of the spasm of the sphincter of Oddi. Codeine may also cause spasms of the sphincter of the urinary bladder.

Effects on the Cardiovascular System

Codeine produces peripheral vasodilation which may result in orthostatic hypotension and fainting. Release of histamine can occur, which may play a role in opioid-induced hypotension. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, and sweating.

Endocrine System

Opioid agonists such as codeine sulfate have been shown to have a variety of effects on the secretion of hormones. Opioids inhibit the secretion of ACTH, cortisol, and luteinizing hormone (LH) in humans. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagons in humans and other species, rats and dogs. Thyroid stimulating hormone (TSH) has been shown to be both inhibited and stimulated by opioids.

Immune System

Codeine has been shown to have a variety of effects on components of the immune system in in vitro and animal models. The clinical significance of these findings is unknown.

Pharmacodynamics

Codeine concentrations do not correlate with brain concentration or relief of pain.

The minimum effective concentration varies widely and is influenced by a variety of factors, including the extent of previous opioid use, age and general medical condition. Effective doses in tolerant patients may be significantly higher than in opioid-naïve patients.

Pharmacokinetics

Absorption

Codeine is absorbed from the gastrointestinal tract with maximum plasma concentration occurring 60 minutes post administration.

Food Effects

When 60 mg codeine sulfate was administered 30 minutes after ingesting a high fat/high calorie meal, there was no significant change in the rate and extent of absorption of codeine.

Steady-state

Administration of 15 mg codeine sulfate every four hours for 5 days resulted in steady-state concentrations of codeine, morphine, morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G) within 48 hours.

Distribution

Codeine has been reported to have an apparent volume of distribution of approximately 3-6 L/kg, indicating extensive distribution of the drug into tissues. Codeine has low plasma protein binding with about 7-25% of codeine bound to plasma proteins.

Metabolism

About 70-80% of the administered dose of codeine is metabolized by conjugation with glucuronic acid to codeine-6-glucuronide (C6G) and via O-demethylation to morphine (about 5-10%) and N-demethylation to norcodeine (about 10%) respectively. UDPglucuronosyltransferase (UGT) 2B7 and 2B4 are the major enzymes mediating glucurodination of codeine to C6G. Cytochrome P450 2D6 is the major enzyme responsible for conversion of codeine to morphine and P450 3A4 is the major enzyme mediating conversion of codeine to norcodeine. Morphine and norcodeine are further metabolized by conjugation with glucuronic acid. The glucuronide metabolites of morphine are morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G). Morphine and M6G are known to have analgesic activity in humans. The analgesic activity of C6G in humans is unknown. Norcodeine and M3G are generally not considered to possess analgesic properties.

Elimination

Approximately 90% of the total dose of codeine is excreted through the kidneys, of which approximately 10% is unchanged codeine. Plasma half-lives of codeine and its metabolites have been reported to be approximately 3 hours.

Reproduction and Developmental Toxicology

Studies on the reproductive and developmental effects of codeine have been reported in the published literature in hamsters, rats, mice and rabbits.

A study in hamsters administered 150 mg/kg bid of codeine (PO; approximately 7 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis) reported the development of cranial malformations (i.e., meningoencephalocele) in several fetuses examined; as well as the observation of increases in the percentage of resorptions per litter examined. Doses of 50 and 150 mg/ kg, bid resulted in fetotoxicity as demonstrated by decreased fetal body weight. In an earlier study in hamsters, doses of 73-360 mg/ kg level (PO; approximately 2-8 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis), reportedly produced cranioschisis in all of the fetuses examined.

In studies in rats, doses at the 120 mg/kg level (PO; approximately 3 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis), in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation.

In pregnant mice, a single 100 mg/kg dose (SC; approximately 1.4 times the recommended daily dose of 360 mg/day for adults on a mg/mg2 basis) reportedly resulted in delayed ossification in the offspring. No teratogenic effects were observed in rabbits administered up to 30 mg/kg (approximately 2 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m² basis) of codeine during organogenesis.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

  • Advise patients that codeine sulfate is a narcotic pain reliever and may be habit forming. It should be taken only as directed.
  • The dose of codeine sulfate should not be adjusted without consulting with your physician.
  • Advise patients that codeine may cause drowsiness, dizziness, or lightheadedness and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
  • Patients started on codeine sulfate or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected. Advise patients not to combine codeine sulfate with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  • Advise patients that codeine sulfate is a potential drug of abuse, and should be protected from theft. It should never be given to anyone other than the individual for whom it was prescribed.
  • Advise patients to keep codeine sulfate in a secure place out of the reach of children. When codeine sulfate is no longer needed the unused tablets should be destroyed by flushing down the toilet.
  • Advise patients of the potential for severe constipation when taking codeine sulfate; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of therapy.
  • Advise patients of the most common adverse events that may occur while taking codeine sulfate: drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, constipation, and sweating.
  • Advise patients that some people have a genetic variation that results in their liver changing codeine into morphine more rapidly and completely than other people. These people are more likely to have higher-than-normal levels of morphine in their blood after taking codeine, which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Nursing mothers should be advised to watch for signs of morphine toxicity in their infants which includes increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).
  • If patients have been receiving treatment with codeine sulfate for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
  • Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with codeine sulfate.
  • Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal/neonatal physical dependence, and neonatal withdrawal may occur.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

  • Advise patients that codeine sulfate is a narcotic pain reliever and may be habit forming. It should be taken only as directed.
  • The dose of codeine sulfate should not be adjusted without consulting with your physician.
  • Advise patients that codeine may cause drowsiness, dizziness, or lightheadedness and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
  • Patients started on codeine sulfate or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected. Advise patients not to combine codeine sulfate with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  • Advise patients that codeine sulfate is a potential drug of abuse, and should be protected from theft. It should never be given to anyone other than the individual for whom it was prescribed.
  • Advise patients to keep codeine sulfate in a secure place out of the reach of children. When codeine sulfate is no longer needed the unused tablets should be destroyed by flushing down the toilet.
  • Advise patients of the potential for severe constipation when taking codeine sulfate; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of therapy.
  • Advise patients of the most common adverse events that may occur while taking codeine sulfate: drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, constipation, and sweating.
  • Advise patients that some people have a genetic variation that results in their liver changing codeine into morphine more rapidly and completely than other people. These people are more likely to have higher-than-normal levels of morphine in their blood after taking codeine, which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Nursing mothers should be advised to watch for signs of morphine toxicity in their infants which includes increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).
  • If patients have been receiving treatment with codeine sulfate for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
  • Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with codeine sulfate.
  • Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal/neonatal physical dependence, and neonatal withdrawal may occur.

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Codeine Sulfate 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.

CODEINE - ORAL

(KOE-deen)

USES: This medication is used to treat mild to moderate pain. It acts on certain centers in the brain and spinal cord to give you pain relief. Codeine is a narcotic pain reliever related to morphine.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Codeine may also be used to control a cough.

HOW TO USE: Take this medication by mouth as directed by your doctor. Pain medications work best when taken at the first signs of pain. If you wait until the pain has worsened, the medication may not work as well. The dosage is based on your medical condition and response to therapy. For children, the dosage is also based on weight.

If you are using the liquid form, read the Medication Guide provided by your pharmacist before you start taking codeine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

If so directed by your doctor, you may also use long-acting narcotic medications for ongoing pain. In that case, this medication might be used when needed for sudden attacks of "breakthrough" pain. Also follow your doctor's or pharmacist's instructions for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions about your treatment.

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, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though it is very unlikely to occur, this medication can also be habit-forming and may result in abnormal drug-seeking behavior (addiction). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for a long time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your pain persists or worsens.

Disclaimer

Codeine Sulfate Consumer (continued)

SIDE EFFECTS: Nausea commonly occurs with the use of codeine and usually goes away after the first few doses. Consult your doctor or pharmacist about ways to decrease nausea (e.g., antihistamines, taking with food, lying down for 1-2 hours with as little head movement as possible).

Lightheadedness, dizziness, drowsiness, dry mouth, flushing, vomiting, constipation, and sweating may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

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: slow/shallow breathing, mental/mood changes (e.g., agitation, confusion, restlessness), fast/slow/irregular heartbeat, fainting, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), hives, 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 Codeine Sulfate (codeine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking codeine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., morphine, hydrocodone, oxycodone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), 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: severe breathing problems (e.g., respiratory depression, carbon dioxide retention), a certain bowel disease (paralytic ileus), severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), intoxication with medications that can cause drowsiness or slow/shallow breathing (e.g., alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis, ulcerative colitis), adrenal gland problems (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, low blood pressure), kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia, emphysema), personal or family history of regular drug/alcohol abuse, mental/mood disorders (e.g., toxic psychosis), spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), difficulty urinating (e.g., enlarged prostate, urethral stricture).

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.

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

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, drowsiness, and difficulty urinating.

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, take 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 your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. Discuss the risks and benefits with your doctor before breast-feeding.

Disclaimer

Codeine Sulfate Consumer (continued)

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

This drug should not be used with the following medications because very serious interactions may occur: narcotic antagonists (e.g., naltrexone, naloxone).

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting codeine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., scopolamine), other medications for pain (e.g., narcotic agonists/antagonists such as butorphanol/nalbuphine), quinidine, cimetidine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., hydrocodone), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This medication may interfere with certain laboratory tests (including amylase and lipase tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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: If overdose 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. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow breathing, slow heartbeat, cold/clammy skin, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

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 those cases.

MISSED DOSE: If you miss a dose, take 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 at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. 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 May 2012. Copyright(c) 2012 First Databank, Inc.

Codeine Sulfate Patient Information Including Side Effects

Brand Names:

Generic Name: codeine (Pronunciation: KOE deen)

What is codeine ?

Codeine is in a group of drugs called narcotic pain medicines.

Codeine is used to treat mild to moderately severe pain.

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

Codeine Phosphate 30 mg-RAN

round, white

Codeine Sulfate 15 mg-ROX

round, white, imprinted with 54 613

Codeine Sulfate 30 mg-ROX

round, white, imprinted with 54 783

Codeine Sulfate 60 mg-ROX

round, white, imprinted with 54 412

What are the possible side effects of codeine ?

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.

Call your doctor at once if you have a serious side effect such as:

  • slow heart rate, weak pulse, fainting, shallow breathing;
  • feeling like you might pass out;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • feelings of extreme happiness or sadness;
  • seizure (convulsions); or
  • problems with urination.

Less serious side effects include:

  • feeling dizzy or drowsy;
  • nausea, vomiting, stomach pain,;
  • constipation;
  • sweating; or
  • mild itching or rash.

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 Codeine Sulfate (codeine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about codeine ?

Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share codeine 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.

Never take codeine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using codeine.

Side Effects Centers

Codeine Sulfate Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking codeine ?

Do not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, OxyContin, Darvocet, Percocet, Vicodin, Lortab, and many others). You should also not take codeine if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share codeine 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.

If you have any of these other conditions, you may need a codeine dose adjustment or special tests:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • underactive thyroid;
  • curvature of the spine;
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • low blood pressure;
  • gallbladder disease;
  • a pancreas disorder;
  • an intestinal disorder;
  • Addison's disease or other adrenal gland disorders;
  • enlarged prostate, urination problems;
  • mental illness; or
  • a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether codeine will harm an unborn baby. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using codeine.

Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the effects of this medicine.

How should I take codeine ?

Take exactly as prescribed. Never take codeine in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with a full glass of water.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking codeine. Do not use a stool softener (laxative) without first asking your doctor.

Take codeine with food or milk if it upsets your stomach.

Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using codeine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

After you have stopped using this medication, flush any unused pills down the toilet.

Side Effects Centers

Codeine Sulfate Patient Information including If I Miss a Dose

What happens if I miss a dose ?

Since codeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose ?

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

Overdose symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking codeine ?

Codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect codeine ?

Do not take codeine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Before taking codeine, tell your doctor if you are using pentazocine (Talwin), nalbuphine (Nubain), butorphanol (Stadol), or buprenorphine (Buprenex, Subutex). If you are using any of these drugs, you may not be able to use codeine, or you may need dosage adjustments or special tests during treatment.

This list is not complete and other drugs may interact with codeine. 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 codeine.


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: 5.02. Revision date: 12/15/2010.

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.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com