Chlorpheniramine and codeine polistirex (Oral)

Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression, Accidental 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 3A4; Concomitant Use with Benzodiazepines or Other CNS Depressants; Neonatal Opioid Withdrawal SyndromeCodeine polistirex/chlorpheniramine polistirex 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.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk.Accidental ingestion of codeine polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of codeine.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. Codeine polistirex/chlorpheniramine polistirex is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine polistirex/chlorpheniramine polistirex 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 codeine polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death.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 codeine polistirex/chlorpheniramine polistirex in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor.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 codeine polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol. Codeine polistirex/chlorpheniramine polistirex is not recommended for use in pregnant women. Prolonged use of codeine polistirex/chlorpheniramine polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If codeine polistirex/chlorpheniramine polistirex 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 .