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ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Hydrocodonebitartrate and acetaminophen tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patients risk prior to prescribing hydrocodonebitartrate and acetaminophen tablets , and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].
Life-Threatening Respiratory Depression
Serious , life-threatening, or fatal respiratory depression may occur with use of hydrocodonebitartrate and acetaminophen tablets . Monitor for respiratory depression especially during initiation of hydrocodonebitartrate and acetaminophen tablets or following a dose increase [see WARNINGS].
Accidental ingestion of hydrocodonebitartrate and acetaminophen tablets , especially by children, can result in a fatal overdose of hydrocodonebitartrate and acetaminophen tablets [see WARNINGS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydrocodonebitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts . If opioid use is required 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 [see WARNINGS].
Cytochrome P450 3A4 Interaction
The concomitant use of hydrocodonebitartrate and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations , which could increase or prolong adverse reactions 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 concentrations . Monitor patients receiving hydrocodonebitartrate and acetaminophen tablets and any cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY, WARNINGS, DRUG INTERACTIONS].