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oxandrolone 10 mg tablet generic oxandrin

In stock Manufacturer PAR PHARM. 49884030202
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Uses

Catabolic and Wasting Disorders

Oxandrolone is used as an adjunct to conventional therapy to promote weight gain in individuals who experience weight loss following extensive surgery, chronic infections (e.g., HIV-associated wasting syndrome; designated an orphan drug by the US Food and Drug Administration [FDA] for this use), or severe trauma (e.g., burns, spinal cord injury).

Oxandrolone is used as an adjunct to conventional therapy for management of unexplained weight loss.

Corticosteroid-induced Protein Catabolism

Oxandrolone is used as an adjunct to conventional therapy to offset protein catabolism (e.g., muscle wasting, muscle pain or weakness, delayed wound healing, atrophy of protein matrix of bone) associated with long-term corticosteroid therapy.

Osteoporosis

Oxandrolone is labeled for the symptomatic treatment of bone pain accompanying osteoporosis.

Misuse, Abuse, and Dependence

Androgens have been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique. Following review of data from published literature and case reports in October 2016, the FDA concluded that misuse and abuse of androgens are associated with serious adverse cardiovascular, hepatic, endocrine, and mental health effects. (See Misuse, Abuse, and Dependence under Warnings/Precautions: Warnings, in Cautions; see also

Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae. Such misuse by athletes is contrary to rules and ethical principles of athletic competition.

The manufacturer of oxandrolone states that androgens have not been shown to enhance athletic performance.

Serum testosterone concentrations should be evaluated in patients who may be misusing or abusing androgens (e.g., patients experiencing serious adverse cardiovascular or psychiatric effects); however, serum testosterone concentrations may be below or within the normal range in patients abusing synthetic derivatives of testosterone.

Dosage and Administration

General

The dosage of oxandrolone and the duration of therapy should be carefully individualized according to individual requirements, response, and tolerance. The minimum effective dosage of the drug should be used; oxandrolone is intended for intermittent use.

Administration

Oxandrolone is administered orally 2 to 4 times daily in adults. The drug usually is administered once daily in pediatric patients.

Dosage

Catabolic and Wasting Disorders

Pediatric Patients

Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily for 2-4 weeks. The course of therapy may be repeated intermittently as needed to maintain weight.

The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response (i.e., slowing or cessation of weight loss). A longer period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present.

A higher than recommended oxandrolone dosage of 0.1 mg/kg twice daily for 5 days to 12 months has been evaluated in pediatric patients with burns.

Adults

Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses for 2-4 weeks. The course of therapy may be repeated intermittently as needed to maintain weight.

The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response (i.e., slowing or cessation of weight loss). A longer period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present. Continuous administration for 3-4 months has been evaluated in patients with HIV-associated wasting syndrome.

Corticosteroid-induced Protein Catabolism

Pediatric Patients

Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Adults

Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Osteoporosis

Adults

For bone pain accompanying osteoporosis, adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Special Populations

Geriatric patients may receive oxandrolone in a dosage of 5 mg twice daily for 2-4 weeks. The course of therapy may be repeated intermittently as needed.

Cautions

Contraindications

Males with breast cancer or known or suspected prostate cancer.

Women with hypercalcemia associated with metastatic breast cancer. Women with known or suspected pregnancy.

Patients with nephrosis or hypercalcemia.

Warnings/Precautions

Warnings

Hepatic Effects

Potentially serious and/or life-threatening adverse hepatic effects (e.g., peliosis hepatis, hepatic adenomas, hepatocellular carcinoma) have been reported in patients receiving long-term therapy with high dosages of androgens.

If cholestatic hepatitis with jaundice occurs, or if liver function test results become abnormal during therapy, oxandrolone should be discontinued and the etiology of these disorders should be investigated. Drug-induced jaundice usually is reversible after discontinuance of drug.

Liver function should be monitored periodically.

Hypercalcemia

Hypercalcemia resulting from osteolysis reported in women with metastatic carcinoma of the breast receiving androgens. Urine and serum calcium concentrations should be monitored frequently during the course of androgen therapy in women with metastatic breast cancer.

If hypercalcemia occurs, discontinue the drug.

Fluid Retention

Edema, with or without congestive heart failure, may occur as a result of sodium and water retention; this may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.

Misuse, Abuse, and Dependence

Serious adverse effects (e.g., increased aggression, antisocial behavior, manic episode, hostility, depression, changes in libido, increased risk of cardiovascular events, hepatotoxicity, testicular atrophy, sperm abnormalities) are associated with misuse and abuse of androgens; oxandrolone preparations currently are subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs.

Manifestations of withdrawal (e.g., depressed mood, major depression, fatigue, cravings, restlessness, irritability, anorexia, insomnia, decreased libido, hypogonadotropic hypogonadism) may occur if androgens are discontinued abruptly or the dosage is substantially reduced in physically dependent patients or in those taking supratherapeutic dosages of the drug; withdrawal symptoms may persist for weeks or months.

Patients should be informed of the serious adverse effects associated with misuse and abuse of androgens.

General Precautions

Virilization

Virilization, including baldness, clitoral enlargement, deepening of voice, hirsutism, and menstrual irregularities, may occur in females.

Monitor women receiving oxandrolone therapy for signs of virilization. If virilization occurs, promptly discontinue therapy. Some changes may not be reversible (e.g., clitoral enlargement, voice changes) after discontinuance of the drug; concomitant use of estrogen with androgens does not prevent these effects.

Hematologic Effects

Possible polycythemia, especially in patients receiving high dosages of androgens. Perform periodic hemoglobin and hematocrit determinations in patients receiving high dosages of androgens.

Anabolic steroids may suppress clotting factors II, V, VII, and X and prolong prothrombin time.

Lipid Abnormalities

Androgens may increase LDL-cholesterol and decrease HDL-cholesterol concentrations; the increased risk for cardiovascular disease should be considered. Lipid concentrations return to baseline values approximately 1 month after discontinuance of androgen therapy.

Use with caution in patients with cardiovascular disease or risk factors for cardiovascular disease. Determine serum lipid concentrations periodically; adjust therapy accordingly.

Tests for Thyroid Function

Androgens may decrease thyroxine-binding globulin concentrations, resulting in decreased total serum thyroxine (T4) concentrations and increased resin uptake of triiodothyronine (T3) and T4.

Free thyroid hormone concentrations remain unchanged.

Protein-bound iodine (PBI) concentrations and radioactive iodine uptake may be decreased.

Specific Populations

Pregnancy

Category X.

May cause fetal harm; potential for virilization of fetus.

Fetotoxicity, embryotoxicity, infertility, and virilization of female offspring demonstrated in animals.

Lactation

Not known whether oxandrolone is distributed into milk. Discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

May accelerate bone maturation without producing compensatory gain in linear growth, possibly resulting in compromised adult stature. The younger the child, the greater the risk of the drug compromising final mature stature.

Use with extreme caution in children and only under the supervision of a specialist who is aware of the adverse effects of oxandrolone on bone maturation. Perform radiographic examination of the left hand and wrist every 6 months to determine rate of bone maturation and to assess the effect of treatment on epiphyseal centers.

Geriatric Use

Possible increased risk of developing prostatic hypertrophy and prostate cancer during androgen therapy.

Response in patients 65 years of age or older does not appear to differ from that in younger adults. Increased sensitivity to fluid retention and increases in hepatic transaminase values reported, particularly in geriatric women. Use lower dosage to minimize adverse effects.

Common Adverse Effects

Elevated aminotransferases (ALT, AST), lipid abnormalities (e.g., decreased HDL cholesterol concentrations).

Drug Interactions

Anticoagulants, Oral

May potentiate action of oral anticoagulants and decrease anticoagulant requirements. Increases in plasma concentrations and half-life of warfarin reported; minor bleeding has occurred. In one study, a substantial decrease (i.e., 80-85%) in warfarin dosage (from a mean dosage of 6.13 mg daily to a mean of 1.13 mg daily) was needed to maintain target international normalized ratio (INR) of 1.5.

Monitor prothrombin time (PT) or INR when oxandrolone therapy is initiated or discontinued in patients receiving oral anticoagulants and adjust anticoagulant dosage as needed. Initial anticoagulant dosage may be substantially lower in patients receiving oxandrolone. Signs and symptoms of occult bleeding should be monitored.

Antidiabetic Agents, Oral (Sulfonylureas)

Possible inhibition of sulfonylurea metabolism. Use concomitantly with care.

Corticotropin (ACTH) and Corticosteroids

May exacerbate edema. Consider possibility of interaction before use.

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