Percocet (Oxycodone Hydrochloride / Acetaminophen) - Description and Clinical Pharmacology

DESCRIPTION

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

Oxycodone Hydrochloride         2.5 mg

Acetaminophen, USP                325 mg

2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

Oxycodone Hydrochloride            5 mg

Acetaminophen, USP                325 mg

5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.

Oxycodone Hydrochloride          7.5 mg

Acetaminophen, USP                 325 mg

7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

Oxycodone Hydrochloride          7.5 mg

Acetaminophen, USP                 500 mg

7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

Oxycodone Hydrochloride           10 mg

Acetaminophen, USP                 325 mg

10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

Oxycodone Hydrochloride           10 mg

Acetaminophen, USP                 650 mg

10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength and the 7.5 mg/500 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength and the 10 mg/650 mg strength contains D&C Yellow No. 10 Aluminum Lake.

Acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C₈H₉NO₂ and the molecular weight is 151.17. It may be represented by the following structural formula:

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic pure opioid agonist which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C₁₈H₂₁NO₄·HCl and the molecular weight 351.83. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

CLINICAL PHARMACOLOGY

The principal ingredient, oxycodone, is a semisynthetic opioid analgesic with multiple actions qualitatively similar to those of morphine; the most prominent involves the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in PERCOCET are analgesia and sedation.

Oxycodone is similar to codeine and methadone in that it retains at least one-half of its analgesic activity when administered orally.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.