OXANDROLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

oxandrolone (UNII: 7H6TM3CT4L) (oxandrolone - UNII:7H6TM3CT4L)

Available from:

Upsher-Smith Laboratories, LLC

INN (International Name):

oxandrolone

Composition:

oxandrolone 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxandrolone Tablets, USP are indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (see DOSAGE AND ADMINISTRATION ). Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic). - Known or suspected carcinoma of the prostate or the male breast. - Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption). - Pregnancy, because of possible masculinization of the fetus. Oxandrolone has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when

Product summary:

Oxandrolone Tablets, USP 10 mg are capsule-shaped, white, unscored, uncoated tablets, debossed with “10” on one side and “US” on the other side. Oxandrolone Tablets, USP are available in bottles of 60 tablets (NDC 0245-0272-06), bottles of 180 tablets (NDC 0245-0272-18) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0245-0272-01). Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Keep out of reach of children. Manufactured for UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 by: Pharmaceutics International, Inc. Hunt Valley, MD 21031 Revised6/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXANDROLONE- OXANDROLONE TABLET
UPSHER-SMITH LABORATORIES, LLC
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OXANDROLONE TABLETS, USP CIII
RX ONLY
DESCRIPTION
Oxandrolone Tablets, USP, oral tablets, contain 10 mg of the anabolic
steroid oxandrolone.
Oxandrolone is 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one with
the following structural
formula:
Inactive ingredients include anhydrous lactose, hypromellose,
magnesium stearate, and pregelatinized
starch.
MEETS USP DISSOLUTION TEST 3
CLINICAL PHARMACOLOGY
Anabolic steroids are synthetic derivatives of testosterone. Certain
clinical effects and adverse
reactions demonstrate the androgenic properties of this class of
drugs. Complete dissociation of
anabolic and androgenic effects has not been achieved. The actions of
anabolic steroids are therefore
similar to those of male sex hormones with the possibility of causing
serious disturbances of growth
and sexual development if given to young children. Anabolic steroids
suppress the gonadotropic
functions of the pituitary and may exert a direct effect upon the
testes.
During exogenous administration of anabolic androgens, endogenous
testosterone release is inhibited
through inhibition of pituitary luteinizing hormone (LH). At large
doses, spermatogenesis may be
suppressed through feedback inhibition of pituitary
follicle-stimulating hormone (FSH).
Anabolic steroids have been reported to increase low-density
lipoproteins and decrease high-density
lipoproteins. These levels revert to normal on discontinuation of
treatment.
In a single dose pharmacokinetic study of oxandrolone in elderly
subjects, the mean elimination half-life
was 13.3 hours. In a previous single dose pharmacokinetic study in
younger volunteers, the mean
elimination half-life was 10.4 hours. No significant differences
between younger and elderly
volunteers were found for time to peak, peak plasma concentration or
AUC after a single dose of
oxandrolone. The correlation between plasma level and therapeutic
effect has not been defined.
INDICATIONS AND USAGE
Oxandrolone Tablets, USP are in