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PROVERA®Description (medroxyprogesterone acetate)

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.

Inactive ingredients:

2.5 mg tablets
calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc, FD&C Yellow No. 6.ORcalcium stearate, corn starch, lactose, mineral oil, sucrose, talc, FD&C Yellow No. 6.
5 mg tablets
calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc.ORcalcium stearate, corn starch, lactose, mineral oil, sucrose, talc, FD&C Blue No.2 – Aluminum Lake.
10 mg tablets
calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc.ORcalcium stearate, corn starch, lactose, mineral oil, sucrose, talc.
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