Hydron PSC (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 bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride 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 bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, prescribe hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride 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 bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride 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 CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Av..