ANDROXY- fluoxymesterone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluoxymesterone (UNII: 9JU12S4YFY) (fluoxymesterone - UNII:9JU12S4YFY)

Available from:

Upsher-Smith Laboratories, LLC

INN (International Name):

fluoxymesterone

Composition:

fluoxymesterone 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ANDROXY™ Tablets are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. ANDROXY™ (Fluoxymesterone Tablets, USP) may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patient

Product summary:

ANDROXY™ (Fluoxymesterone Tablets, USP) 10 mg are round, green, scored compressed tablets debossed with 832 and 86 and are available in bottles of 100. Dispense in a tight, light-resistant container as defined in the USP. Store at controlled room temperature 15 – 30°C (59 – 86°F). Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ANDROXY- FLUOXYMESTERONE TABLET
UPSHER-SMITH LABORATORIES, LLC
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ANDROXY™ (FLUOXYMESTERONE TABLETS, USP)
CIII
RX ONLY
DESCRIPTION
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) 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.
CLINICAL PHARMACOLOGY
Endogenous androgens are responsible for the normal growth and
development of the male sex organs
and for maintenance of secondary sex characteristics. These effects
include growth and maturation of
prostate, seminal vesicles, penis, and scrotum; development of male
hair distribution, such as beard,
pubic, chest, and axillary hair; laryngeal enlargement; vocal cord
thickening; alterations in body
musculature; and fat distribution.
Androg