(medroxyprogesterone acetate)

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Description

DESCRIPTION

PROVERA® tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is:

Chemical Structure

Each PROVERA tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients:

Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc.

The 2.5 mg tablets also contain: FD&C Yellow No. 6.

The 5 mg tablets also contain: FD&C Blue No.2 – Aluminum Lake.

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