CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone, like other opium derivatives, will depress respiration. The effects of hydrocodone in therapeutic doses on the cardiovascular system are insignificant. Hydrocodone can produce miosis, euphoria, physical and psychological dependence.
Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23 . 6 + 5 . 2 ng/mL. Maximum serum levels were achieved at 1 . 3 + 0 . 3 hours and the half-life was determined to be 3 . 8 + 0 . 3 hours. Hydrocodone exhibits a complex pattern of metabolism including O-demethylation, N-demethylation and 6-keto reduction to the corresponding 6-α- and 6-ß-hydroxymetabolites.
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