Percodan (Oxycodone Hydrochloride / Oxycodone Terephthalate / Aspirin) - Description and Clinical Pharmacology

DESCRIPTION

Each tablet of PERCODAN contains:

  Oxycodone Hydrochloride,                                                 USP4.5 mg *

  Oxycodone Terephthalate,                                               USP0.38 mg **

  Aspirin, USP 325 mg

*4.5 mg oxycodone HCl is equivalent to 4.0338 mg of oxycodone.

**0.38 mg oxycodone terephthalate is equivalent to 0.3008 mg of oxycodone.

PERCODAN Tablets also contain: D&C Yellow 10, FD&C Yellow 6, microcrystalline cellulose and starch.

The oxycodone component is 14-hydroxydihydrocodeinone, a white odorless crystalline powder which 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 of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in PERCODAN 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.

PERCODAN also contains the non-opioid antipyretic-analgesic, aspirin.