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

Rx only

DESCRIPTION

Each capsule, for oral administration, contains:

Oxycodone Hydrochloride+............................................. 5 mg

Acetaminophen................................................................. 500 mg

(+5 mg Oxycodone HCl is equivalent to 4.4815 mg Oxycodone)

In addition, each capsule contains the following inactive ingredients: hard gelatin capsule (which contains FD&C Red #40, D&C Red #28, D&C Yellow #10, titanium dioxide, sodium lauryl sulfate, sodium propionate, edetate calcium disodium, benzyl alcohol, butylparaben, propylparaben, methylparaben, gelatin), starch (corn), croscarmellose sodium, colloidal silicon dioxide, sodium lauryl sulfate, stearic acid, magnesium stearate and printing ink (pharmaceutical glaze, synthetic black iron oxide, lecithin, SDA-3A alcohol, deionized water, ethylene glycol monoethyl ether, simethicone).

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. Its structural formula is:

C₆H₉NO₂ M.W. 151.16

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:

C₁₈H₂₁NO₄. HCl M.W. 351.83

CLINICAL PHARMACOLOGY

The principal ingredient, oxycodone, is a semi-synthetic narcotic 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 oxycodone 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.