Hydrocodone Bitartrate And Acetaminophen

HYDROCODONE BITARTRATE AND ACETAMINOPHEN — acetaminophen and hydrocodone bitartrate tablet
Altura Pharmaceuticals, Inc.

DESCRIPTION

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

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

This is an image of the structural formula of Hydrocodone bitartrate.
(click image for full-size original)

Acetaminophen, 4′-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

This is an image of the structural formula of Acetaminophen.
(click image for full-size original)

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5 mg/500 mg

Each tablet contains:

Hydrocodone Bitartrate………….2.5 mg
Acetaminophen…………………….500 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Red #3, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, stearic acid, and sucrose. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg

Each tablet contains:

Hydrocodone Bitartrate……………..5 mg
Acetaminophen………………………..325 mg

In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and sugar spheres which are composed of starch derived from corn, FD&C Red #40, FD&C Yellow #6, and sucrose. Meets USP Dissolution Test 2.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/500 mg

Each tablet contains:

Hydrocodone Bitartrate………….5 mg
Acetaminophen…………………….500 mg

In addition each tablet contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, and sodium starch glycolate. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg

Each tablet contains:

Hydrocodone Bitartrate………….7.5 mg
Acetaminophen…………………….325 mg

In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid. Meets USP Dissolution Test 2.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/500 mg

Each tablet contains:

Hydrocodone Bitartrate………….7.5 mg
Acetaminophen…………………….500 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Blue #1, FD&C Yellow #5, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, stearic acid, and sucrose. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/650 mg

Each tablet contains:

Hydrocodone Bitartrate………….7.5 mg
Acetaminophen…………………….650 mg

In addition each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/750 mg

Each tablet contains:

Hydrocodone Bitartrate………….7.5 mg
Acetaminophen…………………….750 mg

In addition each tablet contains the following inactive ingredients: croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg

Each tablet contains:

Hydrocodone Bitartrate…………10 mg
Acetaminophen…………………….325 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Yellow #10 lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg

Each tablet contains:

Hydrocodone Bitartrate…………10 mg
Acetaminophen…………………….500 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Red #27 aluminum lake, D&C Red #30 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/650 mg

Each tablet contains:

Hydrocodone Bitartrate…………10 mg
Acetaminophen…………………….650 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/660 mg

Each tablet contains:

Hydrocodone Bitartrate…………10 mg Acetaminophen…………………….660 mg

In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Meets USP Dissolution Test 1.

CLINICAL PHARMACOLOGY

Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve the central nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opiates is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental clouding.

The analgesic action of acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.

Pharmacokinetics:

The behavior of the individual components is described below.

Hydrocodone:

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-ketoreduction to the corresponding 6-α- and 6-β-hydroxymetabolites. See OVERDOSAGE for toxicity information.

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