ANAVAR 50

Oxandrolone Tablets

PRODUCT NAME & PACKAGING

Brand Name: ANAVAR 50
Generic Name: Oxandrolone
Strength & Packaging: 50 tablets per tub | 50 mg per tablet

Oxandrolone is an oral anabolic steroid. In current U.S. DailyMed labeling, oxandrolone tablets are listed in 2.5 mg and 10 mg strengths; a 50 mg tablet should therefore be treated as a manufacturer-specific presentation rather than a standard U.S.-labeled strength. Oxandrolone is also classified in the U.S. as a Schedule III controlled substance.

DESCRIPTION

ANAVAR 50 contains oxandrolone, a synthetic anabolic steroid derived from testosterone. The current DailyMed monograph describes oxandrolone tablets as oral tablets containing the anabolic steroid oxandrolone, with the chemical name 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one. As a class, anabolic steroids have both anabolic and androgenic effects.

INDICATIONS

In current U.S. labeling, oxandrolone is indicated as adjunctive therapy to offset the protein catabolism associated with prolonged administration of corticosteroids and for the relief of bone pain frequently accompanying osteoporosis. For this brand-specific 50 mg tablet presentation, use should follow the manufacturer’s labeling, local regulations, and licensed-prescriber judgment.

DOSAGE & ADMINISTRATION

Route: Oral administration

For the current U.S.-labeled oxandrolone reference products, the adult dosage is 2.5 mg to 20 mg daily in 2 to 4 divided doses, with therapy typically used intermittently and a usual course of 2 to 4 weeks; pediatric dosing is listed as less than 0.1 mg/kg/day. Because your listed product is a 50 mg tablet, which is not a standard U.S.-labeled strength, a fixed dose for this specific presentation should be stated as:

“Administer only under the direction of a licensed healthcare professional and in accordance with the manufacturer’s labeling and patient-specific clinical judgment.”

MECHANISM OF ACTION

Oxandrolone belongs to the anabolic steroid class. Current labeling states that anabolic steroids are synthetic derivatives of testosterone, may suppress pituitary gonadotropic function, may inhibit luteinizing hormone (LH) release during exogenous administration, and at higher doses may suppress follicle-stimulating hormone (FSH) and spermatogenesis.

PRECAUTIONS

Use requires careful medical oversight. Current labeling warns about cholestatic hepatitis/jaundice, edema that may be serious in patients with cardiac, renal, or hepatic disease, lipid changes associated with atherosclerotic risk, and important interaction risk with warfarin, which can markedly increase INR/PT and bleeding risk. Women should be monitored for virilization, and the drug is contraindicated in pregnancy because of possible masculinization of the fetus. It is also contraindicated in known or suspected prostate or male breast carcinoma, hypercalcemia, and nephrosis/nephritic nephrosis.

SIDE EFFECTS

Adverse effects reported in the current label include cholestatic jaundice, liver-function abnormalities, peliosis hepatis, hepatic tumors with long-term use, acne, gynecomastia, edema, nausea, vomiting, insomnia, depression, libido changes, and in females clitoral enlargement, menstrual irregularities, deepening of the voice, hirsutism, and other virilizing effects. In males, post-pubertal effects can include testicular atrophy, oligospermia, and changes in sexual function.