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:
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. | OR | calcium 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. | OR | calcium 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. | OR | calcium stearate, corn starch, lactose, mineral oil, sucrose, talc. |