Combunox (Oxycodone Hydrochloride / Ibuprofen) - Description

FOREST LABORATORIES       CII       Rx only

DESCRIPTION

Each combination Combunox™ tablet contains:

Oxycodone HCl, USP 5 mg

Ibuprofen, USP 400 mg

Combunox is supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone HCl, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Oxycodone HCl is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5α-Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its chemical formula is C₁₈H₂₁NO₄ HCl and molecular weight is 351.83. Its structural formula is:

Ibuprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. Its chemical name is (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is C₁₃H₁₈O₂ and molecular weight is 206.29. Its structural formula is:

Inactive ingredients in Combunox tablets include: sodium starch glycolate, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, calcium stearate, carboxymethylcellulose, povidone, Opadry® II White, Y-22 7719 coloring agent. Opadry® II White, Y-22 7719 coloring agent consists of titanium dioxide, polydextrose, hypromellose, triacetin and polyethylene glycol 8000.