Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule III
- 2.5mg
- 10mg
Bone Pain Due to Osteoporosis
2.5-20 mg/day PO divided q6-12hr for 2-4 weeks
May repeat intermittently PRN
Weight Gain
Promote weight gain after weight loss following extensive surgery, chronic infections or severe trauma, or weight loss due to unknown etiology
2.5-20 mg/day divided q6-12hr PO for 2-4 weeks
May repeat intermittently PRN
Offset Protein Catabolism
Due to prolonged admin corticosteroids or associated with catabolic illness (off-label)
2.5-20 mg/day divided q6-12hr PO for 2-4 weeks
HIV-Wasting Syndrome (Orphan)
Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome
Orphan indication sponsor
- Bio-Technology General Corp; One Tower Center Boulevard, 12 th floor; East Brunswick, NJ 08816
Muscular Dystrophy (Orphan)
Treatment of patients with Duchenne's muscular dystrophy and Becker's muscular dystrophy
Orphan indication sponsor
- Savient Pharmaceuticals, Inc; One Tower Center Boulevard, 12th floor; East Brunswick, NJ 08816
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
Frequency Not Defined
Males
- Gynecomastia
- Inhibition of testicular function
- Impotence
- Priapism
- Bladder irritability
Females
- Hirsutism
- Male-pattern baldness
- Menstrual irregularities
- Virilism
Serious
- Neoplasm of liver, Peliosis hepatis
- Premature epiphyseal closure, Children
Edema
Increased risk of atherosclerosis
Habituation
Changes in libido
Acne
Retention of electrolytes
Serum lipid levels
Cholestatic hepatitis
Hepatic d/o
Jaundice
Warnings
Black Box Warnings
Peliosis Hepatis
- Peliosis hepatitis has been reported with androgenic anabolic steroid therapy In this condition, the liver & sometimes splenic tissue is replaced with blood-filled cysts
- These cysts sometimes present with minimal hepatic dysfunction but have been associated with liver failure
- Often not detected until life-threatening liver failure or intra-abdominal hemorrhage develops
- Discontinuing an anabolic steroid usually results in complete disappearance of lesions
Liver Cell Tumors
- Liver cell tumors have been reported
- Typically, these tumors are benign & androgen-dependent, but fatal malignant tumors have been reported
- Discontinuing anabolic steroids often result in regression or arrested progression of tumor
- Important to recognize that hepatic tumors associated w/ androgens or anabolic steroids are much more vascular than other hepatic tumors & may be silent until life-threatening intra-abdominal hemorrhage develops
Blood Lipid Changes
- May cause blood lipid changes associated w/ increased risk of atherosclerosis
- Lipid changes include decreased HDL & sometimes increased LDL; changes may be very marked & could have serious impact on risk for atherosclerosis & coronary artery disease
Contraindications
Known or suspected prostate or breast CA in males
Females: breast cancer with hypercalcemia
Pregnancy
Nephrosis or the nephrotic phase of nephritis
Hypercalcemia
Cautions
Increases risk of peliosis hepatis & liver cell tumors has been reported with anabolic steroids
Risk of cholestatic hepatitis & jaundice - discontinue if cholestatic hepatitis with jaundice appears or LFTS abnormal
Risk of hypercalcemia in breast CA patients - discontinue if hypercalcemia occurs
Increases risk of prostatic hypertrophy & prostate CA in geriatric patients
Concomitant administration with warfarin may require dose reduction of warfarin
Risk of growth retardation in children
Concurrent dosing with warfarin may result in unexpectedly high increases in INR & PT
Risk of edema with or without CHF in patients with preexisting cardiac, renal or liver disease
Does not improve athletic performance
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Discontinue drug if choosing to breastfeed or do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Anabolic steroid; promotes body tissue building, increases production of erythropoietin, increases Hgb & RBC volume
Pharamacokinetics
Half-life: 10-13 hr
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Patient Handout
Formulary
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