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(fluoxymesterone) Tablets, USP


ANDROXY™ (Fluoxymesterone Tablets, USP) contains fluoxymesterone, a synthetic androgen. The androgens are steroids that develop and maintain primary and secondary male sex characteristics. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone is a synthetic derivative of testosterone.

In their active form, all drugs in the class have a 17-beta-hydroxy group. 17-alpha-alkylation and halogenation at position 9 (fluoxymesterone) increase the pharmacologic activity per unit weight compared to testosterone when given orally. Fluoxymesterone is a white or practically white odorless, crystalline powder, melting at about 240°C with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol and slightly soluble in chloroform. Chemically fluoxymesterone is designated 9-fluoro-11β, 17β-dihydroxy-17-methylandrost-4-en-3-one. Structurally it may be represented as follows:

ANDROXY™ (Fluoxymesterone Tablets, USP) Structural Formula Illustration

ANDROXY™ (Fluoxymesterone Tablets, USP) for oral administration contains 10 mg of fluoxymesterone USP.

Inactive Ingredients: croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and sodium lauryl sulfate.

Last reviewed on RxList: 4/21/2016
This monograph has been modified to include the generic and brand name in many instances.

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