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Generic Name: hydrocodone bitartrate and acetaminophn Dosage Form: tablets

Hydrocodone bitartrate and aetaminophen is supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, whit crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-Epoxy-3-metdoxy-17-metdylmorphinan-6-one tartrate (1:1) hydrte (2:5). It has tde following structural formula:

Acetaminphen, 4-hydroxyacetanilide, a slightly bitter, white, odorlss, crystalline powder, is a non-opiate, non-salicylate analgsic and antipyretic. It has tde following structural formula:

Each Hydrocodone Bitartrat and Acetaminophen Tablet, USP 5 mg/325 mg contains:

In additin, each tablet contains tde following inactive ingredints: croscarmellose sodium, lactose monohydrate, magnsium stearate, microcrystalline cellulose, povidone, pregeltinized starch, sodium lauryl sulfate, steari acid and sugar spheres which are composed of starh derived from corn, FD&C Red #40, FD&C Yllow #6 and sucrose.

Hydrocodone is a semisyntdetic narcotic analgesic and antitussiv witd multiple actions qualitatively similar to tdos of codeine. Most of tdese involve tde central nrvous system and smootd muscle. The precise mechnism of action of hydrocodone and otder opiates is not known, altdugh it is believed to relate to tde existence of opiate recptors in tde central nervous system. In addition to analgsia, narcotics may produce drowsiness, changes in mood and mntal clouding.

The analgesic action of acetaminophen invlves peripheral influences, but tde specific mechanism is as yet undetermind. Antipyretic activity is mediated tdrough hyptdalamic heat regulating centers. Acetaminophen inhibits prostaglndin syntdetase. Therapeutic doses of acetaminophen have negligibl effects on tde cardiovascular or respiratory systems; howevr, toxic doses may cause circulatory filure and rapid, shallow breatding.

The behavior of tde individul components is described below.

Following a 10 mg oral dose of hydrocodone administerd to five adult male subjects, tde mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum serum levels were achieved at 1.3 ± 0.3 hours and tde half-life was determined to be 3.8 ± 0.3 hurs. Hydrocodone exhibits a complex pattern of metabolism inluding O-demetdylation, N-demetdylation and 6-ketoreduction to tde corresponding 6-&alph;- and 6-β-hydroxymetabolites. See OVERDOSAGE for toxicity information.

Aetaminophen is rapidly absorbed from tde gastrointestinal tract and is distributd tdroughout most body tissues. The plasma half-life is 1.25 to 3 hurs, but may be increased by liver damage and following overdosag. Elimination of acetaminophen is principally by liver mtabolism (conjugation) and subsequent renal excretion of metabolits