Codeine Phosphate And Chlorpheniramine Maleate
Generic Name: codeine phosphate and chlorpheniramine maleate
Brand Names:
Tuxarin
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.
Overview
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.
Uses
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.
Dosage
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) ].
Side Effects
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 (...
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.
Warnings
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; U... 5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. ( 5.5 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.7 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.11 ) Seizures in patients with seizure disorders: Monitor during therapy. ( 5.12 ) Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. 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) ].
Pregnancy
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 ).
Storage
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.
Frequently Asked Questions
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.
What are the side effects of Codeine Phosphate And Chlorpheniramine Maleate?▼
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 (...
Can I take Codeine Phosphate And Chlorpheniramine Maleate during pregnancy?▼
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 ).
What are the important warnings for Codeine Phosphate And Chlorpheniramine Maleate?▼
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; U... 5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. ( 5.5 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.7 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. ( 5.11 ) Seizures in patients with seizure disorders: Monitor during therapy. ( 5.12 ) Severe hypotension: Monitor during initiation of therapy. Avoid use in patients with circulatory shock. 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.