The clinical significance of these findings is unknown.

Overall, the effects of opioids appear to be modestly immunosuppressive.

In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration.

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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 [see WARNINGS, PRECAUTIONS; Drug Interactions].

Reserve concomitant prescribing of hydrocodonebitartrate and acetaminophen oral solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

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].

The concomitant use of hydrocodonebitartrate and acetaminophen oral solution with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression.

WARNING: RISK OF MEDICATION ERRORS; 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 DEPRESSANTSEnsure accuracy when prescribing, dispensing, and administering hydrocodonebitartrate and acetaminophen oral solution.

Dosing errors due to confusion between mg and m L, and other hydrocodonebitartrate and acetaminophen oral solutions of different concentrations can result in accidental overdose and death [see WARNINGS, DOSAGE AND ADMINISTRATION].Hydrocodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum.Digestion of food in the small intestine is delayed and propulsive contractions are decreased.Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodonebitartrate and acetaminophen oral solution.Follow patients for signs of respiratory depression, especially during initiation of hydrocodonebitartrate and acetaminophen oral solution or following a dose increase [see WARNINGS].Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as symptoms as low libido, impotence, erectile dysfunction, amenorrhea, or infertility.