Codeine Phosphate And Chlorpheniramine Maleate

FDA Drug Information • Also known as: Tuxarin

Brand Names: Tuxarin
Route: ORAL
Dosage Form: TABLET, EXTENDED RELEASE
Product Type: HUMAN PRESCRIPTION DRUG

⚠ Boxed Warning (Black Box)

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTIAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPOID WITHDRAWAL SYNDROME WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTIAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION ERRORS; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPOID WITHDRAWAL SYNDROME See full prescribing information for complete boxed warning. TUXARIN ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor closely for these behaviors and conditions. ( 5.1 ) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk. ( 5.2 ) Accidental ingestion of TUXARIN ER, especially by children, can result in a fatal overdose of codeine. ( 5.2 ) Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. ( 5.3 ) TUXARIN ER is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. ( 4 ) Avoid the use of TUXARIN ER in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. Ensure accuracy when prescribing, dispensing, and administering TUXARIN ER. Dosing errors can result in accidental overdose and death. ( 2.1 , 5.6 ) The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of TUXARIN ER in these patients. ( 5.4 , 7.1 , 7.2 , 7.4 ) Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of TUXARIN ER in patients taking benzodiazepines, other CNS depressants, or alcohol. ( 5.9 , 7.5 ) TUXARIN ER is not recommended for use in pregnant women. Prolonged use of TUXARIN ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If TUXARIN ER is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. ( 5.15 , 8.1 ) Addiction, Abuse, and Misuse TUXARIN ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve TUXARIN ER for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient's risk prior to prescribing TUXARIN ER, prescribe TUXARIN ER for the shortest duration that is consistent with individual patient treatment goals , monitor all patients regularly for the development of addition or abuse, and refill only after reevaluation of the need for continued treatment. [ see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of TUXARIN ER. Monitor for respiratory depression, especially during initiation of TUXARIN ER therapy or when used in patients at higher risk [ see Warnings and Precautions (5.2) ] . Accidental Ingestion Accidental ingestion of even one dose of TUXARIN ER, especially by children, can result in a fatal overdose of codeine [ see Warnings and Precautions (5.2) ]. Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children Life threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. [ See Warnings and Precautions (5.3) ]. TUXARIN ER is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [ See Contraindications (4) ]. Avoid the use of TUXARIN ER in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine. [ See Warnings and Precautions (5.1) ]. Risk of Medication Errors Ensure accuracy when prescribing, dispensing, and administering TUXARIN ER. Dosing errors can result in accidental overdose and death. [ see Dosage and Administration (2.1) , Warnings and Precautions (5.6) ]. Interactions with Drugs Affecting Cytochrome P450 Isoenzymes The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of TUXARIN ER in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor [ see Warnings and Precautions (5.8) , Drug Interactions (7.1 , 7.2 , 7.4) ]. Risks from Concomitant Use with Benzodiazepines, CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of TUXARIN ER in patients taking benzodiazepines, other CNS depressants, or alcohol. [ see Warning and Precautions (5.9) Drug Interactions (7.5) ]. Neonatal Opioid Withdrawal Syndrome TUXARIN ER is not recommended for use in pregnant women [ see Use in Specific Populations (8.1) ]. Prolonged use of TUXARIN ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If TUXARIN ER is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [ see Warnings and Precautions (5.15) ].

Description

11 DESCRIPTION TUXARIN ER (codeine phosphate and chlorpheniramine maleate) extended-release tablets, contains codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist. Each tablet of TUXARIN ER contains 54.3 mg of codeine phosphate and 8 mg of chlorpheniramine maleate for oral administration. TUXARIN ER are white to off-white, uncoated, standard round extended-release matrix tablets. TUXARIN ER also contains the following inactive ingredients: hypromellose, lactose monohydrate, cellulose microcrystalline, polysorbate 80, magnesium stearate, and colloidal silicon dioxide. Codeine Phosphate The chemical name for codeine phosphate is [morphine3methyl ether phosphate (1:1) (salt)] hemihydrate. It has the following structural formula: Chemical Structure Chlorpheniramine Maleate The chemical name for chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)- N,N -dimethyl-, ( Z )-2-butenedioate (1:1). It has the following structural formula: Chemical Structure

What Is Codeine Phosphate And Chlorpheniramine Maleate Used For?

1 INDICATIONS AND USAGE TUXARIN ER is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. TUXARIN ER is a combination of codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. ( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve TUXARIN ER for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Important Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Population (8.4) ]. Contraindicated in pediatric patients under 12 years of age [ see Contraindications (4) , Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ]. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve TUXARIN ER for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.

Dosage and Administration

2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : 1 tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. ( 2.2 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. ( 2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Administer TUXARIN ER by the oral route only. Advise patients not to increase the dose or dosing frequency of TUXARIN ER because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2) , Overdosage (10) ]. The dosage of TUXARIN ER should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration (2.3) , Warnings and Precautions (5.5) ]. 2.2 Recommended Dosage Adults 18 years of age and older: one tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. 2.3 Monitoring, Maintenance, and Discontinuation of Therapy Prescribe TUXARIN ER for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and Precautions (5.1) ] Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ see Warnings and Precautions (5.2) ] . Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions (5.5) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with TUXARIN ER, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions (5.1) ]. Do not abruptly discontinue TUXARIN ER in a physically-dependent patient [ see Drug Abuse and Dependence (9.3) ]. When a patient who has been taking TUXARIN ER regularly and may be physically dependent no longer requires therapy with TUXARIN ER, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

Side Effects (Adverse Reactions)

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [ see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [ see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.9) , Overdosage (10) ] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [ see Warnings and Precautions (5.3) ] Accidental overdose and death due to medication errors [ see Warnings and Precautions (5.6) ] Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.7) ] Interactions with benzodiazepines and other CNS depressants [ see Warnings and Precautions (5.9) ] Paralytic ileus, gastrointestinal adverse reactions [ see Warnings and Precautions (5.10) ] Increased intracranial pressure [ see Warnings and Precautions (5.11) ] Obscured clinical course in patients with head injuries [ see Warnings and Precautions (5.11) ] Seizures [ see Warnings and Precautions (5.12) ] Interactions with MAOI [ see Warnings and Precautions (5.13) ] Severe hypotension [ see Warnings and Precautions (5.14) ] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.15) ] Adrenal insufficiency [ see Warnings and Precautions (5.16) ] The following adverse reactions have been identified during clinical studies, or during post-approval use of codeine and/or chlorpheniramine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions to TUXARIN ER include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, and sweating. Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in TUXARIN ER. Body as a whole : Coma, death, fatigue, falling injuries, lethargy. Cardiovascular : Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System : Ataxia, facial dyskinesia, insomnia, increased intracranial pressure, migraine, seizure, tremor, tinnitus, vertigo. Dermatologic : Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [ see Clinical Pharmacology (12.2) ]. Gastrointestinal : Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi). Genitourinary : Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Hematologic : Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported. Laboratory: Increases in serum amylase. Musculoskeletal : Arthralgia, backache, muscle spasm. Ophthalmic : Blurred vision, diplopia, miosis (constricted pupils), visual disturbances. Psychiatric : Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations. Reproductive : Hypogonadism, infertility. Respiratory : Bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection. Other : Drug abuse, drug dependence, opioid withdrawal syndrome....

Drug Interactions

7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with TUXARIN ER. Phenytoin : Avoid concomitant use; may increase phenytoin levels. ( 7.4 ) Serotonergic drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. ( 7.6 ) Muscle relaxants : Avoid concomitant use. ( 7.8 ) Diuretics: Codeine may reduce the efficacy of diuretics. Monitor for reduced effect. ( 7.9 ) Anticholinergic drugs : Concurrent use may cause paralytic ileus. ( 5.10 , 7.10 ) 7.1 Inhibitors of CYP3A4 The concomitant use of TUXARIN ER with CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), or protease inhibitors (e.g., ritonavir), may result in an increase in codeine plasma concentrations with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of TUXARIN ER is achieved [ see Warnings and Precautions (5.8) ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, it may result in lower codeine levels, greater norcodeine levels, and less metabolism via CYP2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to codeine. Avoid the use of TUXARIN ER while taking a CYP3A4 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. 7.2 CYP3A4 Inducers The concomitant use of TUXARIN ER and CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, can result in lower codeine levels, greater norcodeine levels, and less metabolism via 2D6 with resultant lower morphine levels [ see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence [ see Warnings and Precautions (5.8) ]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, codeine plasma concentrations may increase with subsequently greater metabolism by cytochrome CYP2D6, resulting in greater morphine levels [ see Clinical Pharmacology (12.3) ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Avoid the use of TUXARIN ER in patients who are taking CYP3A4 inducers. If concomitant use of a CYP3A4 inducer is necessary, follow the patient for reduced efficacy. 7.3 Phenytoin Adverse event reports in the literature suggest a possible drug interaction involving increased serum phenytoin levels and phenytoin toxicity when chlorpheniramine and phenytoin are co-administered. The exact mechanism for this interaction is not known, however it is believed that chlorpheniramine may inhibit the...

Contraindications

4 CONTRAINDICATIONS TUXARIN ER is contraindicated for: All children younger than 12 years of age [ see Warnings and Precautions (5.2 , 5.3 , 5.4) , Use in Specific Populations (8.4) ]. Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [ see Warnings and Precautions (5.2 , 5.3) ]. TUXARIN ER is also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [ see Warnings and Precautions (5.5) ]. Known or suspected gastrointestinal obstruction, including paralytic ileus [ see Warnings and Precautions (5.10) ]. Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within 14 days [ see Warnings and Precautions (5.13) , Drug Interactions (7.7) ]. Hypersensitivity to codeine, chlorpheniramine, or any of the inactive ingredients in TUXARIN ER [ see Adverse Reactions (6) ]. Persons known to be hypersensitive to certain other opioids may exhibit cross-reactivity to codeine. Children younger than 12 years of age ( 4 ) Significant respiratory depression. ( 4 ) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Concurrent use of monoamine oxidase inhibitor (MAOI) therapy or within the last 14 days. ( 4 ) Hypersensitivity to codeine or other opiates, chlorpheniramine, or any of the inactive ingredients in TUXARIN ER. ( 4 )

Pregnancy and Breastfeeding

8.1 Pregnancy Risk Summary TUXARIN ER is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.15) and Clinical Considerations ]. There are no available data with TUXARIN ER use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with codeine have reported inconsistent findings and have important methodological limitations ( see Data ). There are reports of respiratory depression when codeine is used during labor and delivery (see Clinical Considerations ) . Reproductive toxicity studies have not been conducted with TUXARIN ER; however, studies are available with individual active ingredients ( see Data ). In animal reproduction studies, codeine administered by the oral route to pregnant rats during the period of organogenesis increased resorptions and decreased fetal weights at a dose approximately 15 times the maximum recommended human dose (MRHD) in the presence of maternal toxicity ( see Data ). Chlorpheniramine administered by the oral route to mice throughout pregnancy was embryolethal at a dose approximately 9 times the MRHD and decreased postnatal survival when dosing was continued after parturition. Chlorpheniramine administered by the oral route to male and female rats prior to mating produced embryolethality at a dose approximately 9 times the MRHD ( see Data ). Based on the animal data, advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations...

Overdosage

10 OVERDOSAGE Clinical Presentation Codeine Acute overdose with 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, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, hypoglycemia, circulatory collapse, cardiac arrest, and death. Codeine 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 [ see Clinical Pharmacology (12.2) ]. Chlorpheniramine Signs and symptoms of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucinations, gastrointestinal symptoms, convulsions, urinary retention, cardiac arrhythmias and coma) may be observed. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported. Treatment of Overdose Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of TUXARIN ER together with institution of appropriate therapy. Give...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING TUXARIN ER (codeine phosphate and chlorpheniramine maleate) 54.3 mg/ 8 mg extended-release tablets, are white to off-white, uncoated, standard round tablets, debossed with MP on one side and CC on the other side. Supplied in bottles of 30 tablets (NDC 71269-040-30) and 100 tablets (NDC 71269-040-10). Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep this and all medicine out of reach of children.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.