TussiCaps (Oral)

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone polistirex/chlorpheniramine polistirex exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone polistirex/chlorpheniramine polistirex 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 hydrocodone polistirex/chlorpheniramine polistirex, prescribe hydrocodone polistirex/chlorpheniramine polistirex 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 treatmentLife-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone polistirex/chlorpheniramine polistirex. Monitor for respiratory depression, especially during initiation of hydrocodone polistirex/chlorpheniramine polistirex or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of hydrocodone polistirex.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone polistirex/chlorpheniramine polistirex.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone polistirex/chlorpheniramine polistirex with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone polistirex/chlorpheniramine polistirex in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant 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 hydrocodone polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use presc..