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Hydrocodone produces respiratory depression by direct action on brain stem respiratory centers.The respiratory depression involves a reduction in the responsiveness of the brain stem respiratory centers to both increases in carbon dioxide tension and electrical stimulation. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings).Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death.

Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5).

The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

The principal therapeutic action of hydrocodone is analgesia.

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

Follow patients receiving hydrocodonebitartrate and acetaminophen oral solution and any cytochrome P450 3A4 inhibitor or inducer for signs and symptoms of respiratory depression and sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions].

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