Drug Information for DICLOFENAC POTASSIUM TABLETS50 mg (Mylan Pharmaceuticals Inc.): DESCRIPTION

Diclofenac, as the potassium salt, is a benzeneacetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, monopotassium salt. The structural formula, molecular formula and molecular weight are as follows:

Diclofenac, as the potassium salt, is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac potassium is soluble in water. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water.

Diclofenac Potassium Tablets, USP for oral administration, contain 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.