Hydrocodone, pseudoephedrine, and guaifenesin (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 SyndromeHydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin 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 hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin, especially by children, can result in a fatal overdose of hydrocodone.Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin. Dosing errors can result in accidental overdose and death.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone. Avoid the use of hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin in patients taking CYP3A4 inhibitors or inducers.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 hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin in patients taking benzodiazepines, other CNS depressants, or alcohol .Instruct patients not to consume alcohol or any products containing alcohol while taking hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin because co-ingestion can result in fatal plasma hydrocodone levels.Hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If hydrocodone bitartrate/pseudoephedrine hydrochloride/guaifenesin 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 .