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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(oks AN droe lone)
Generic Available (U.S.)
Yes
Controlled Substance
C-III
Brand Names: U.S.
Pharmacologic Category
Use: Labeled Indications
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 protein catabolism with prolonged corticosteroid administration; relief of bone pain associated with osteoporosis
Pregnancy Risk Factor
X
Pregnancy Considerations
Masculinization of the fetus has been reported.
Lactation
Excretion in breast milk unknown/not recommended
Contraindications
Hypersensitivity to oxandrolone or any component of the formulation; nephrosis; carcinoma of breast or prostate; hypercalcemia; pregnancy
Warnings/Precautions
Boxed warnings:
• Blood lipid changes: See “Concerns related to adverse effects” below.
• Hepatic effects: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Blood lipid changes: [U.S. Boxed Warning]: May cause blood lipid changes with increased risk of arteriosclerosis.
• Hepatic effects: [U.S. Boxed Warning]: Anabolic steroids may cause peliosis hepatis or liver cell tumors which may not be apparent until liver failure or intra-abdominal hemorrhage develops. Discontinue in case of cholestatic hepatitis with jaundice or abnormal liver function tests.
Disease-related concerns:
• Breast cancer: Use with caution in patients with breast cancer; may cause hypercalcemia by stimulating osteolysis.
• COPD: Use with caution in patients with COPD.
• Diabetes: Use with caution in patients with diabetes mellitus; monitor carefully.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
Concurrent drug therapy issues:
• Warfarin: Use caution with concomitant warfarin therapy; warfarin dose may need significantly decreased.
Special populations:
• Elderly: Use with caution in elderly patients, they may be at greater risk for prostatic hyperplasia, fluid retention, and transaminase elevations.
• Pediatrics: May accelerate bone maturation without producing compensatory gain in linear growth in children; in prepubertal children perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.
• Women: Discontinue with evidence of mild virilization in women.
Adverse Reactions
Frequency not defined.
Cardiovascular: Edema
Central nervous system: Depression, excitation, insomnia
Dermatologic: Acne (females and prepubertal males)
Also reported in females: Hirsutism, male-pattern baldness
Endocrine & metabolic: Electrolyte imbalances, glucose intolerance, gonadotropin secretion inhibited, gynecomastia, HDL decreased, LDL increased
Also reported in females: Clitoral enlargement, menstrual irregularities
Genitourinary:
Prepubertal males: Increased or persistent erections, penile enlargement
Postpubertal males: Bladder irritation, epididymitis, impotence, oligospermia, priapism (chronic), testicular atrophy, testicular function inhibited
Hepatic: Alkaline phosphatase increased, ALT increased, AST increased, bilirubin increased, cholestatic jaundice, hepatic necrosis (rare), hepatocellular neoplasms, peliosis hepatis (with long-term therapy)
Neuromuscular & skeletal: CPK increased, premature closure of epiphyses (in children)
Renal: Creatinine excretion increased
Miscellaneous: Bromsulfophthalein retention, habituation, voice alteration (deepening, in females)
Metabolism/Transport Effects
None known.
Drug Interactions
CycloSPORINE: Androgens may enhance the hepatotoxic effect of CycloSPORINE. Androgens may increase the serum concentration of CycloSPORINE. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Risk D: Consider therapy modification
Mechanism of Action
Synthetic testosterone derivative with similar androgenic and anabolic actions
Pharmacodynamics/Kinetics
Half-life elimination: 10-13 hours
Dosage
Children: Total daily dose: ≤0.1 mg/kg or ≤0.045 mg/lb
Adults: 2.5-20 mg in divided doses 2-4 times/day based on individual response; a course of therapy of 2-4 weeks is usually adequate. This may be repeated intermittently as needed.
Elderly: 5 mg twice daily
Dosing adjustment in renal impairment: Caution is recommended because of the propensity of oxandrolone to cause edema and water retention
Dosing adjustment in hepatic impairment: Caution is advised but there are not specific guidelines for dosage reduction
Monitoring Parameters
Liver function tests, cholesterol profile, hemoglobin/hematocrit; INR/PT in patients on anticoagulant therapy
Children: Radiographs of left wrist every 6 months (to assess bone maturation)
Adult females: Signs of virilization (deepening voice, hirsutism, acne, clitoromegaly); urine and serum calcium in women with breast cancer
Test Interactions
May suppress factors II, V, VII, and X; may increase PT; may decrease thyroxine-binding globulin and radioactive iodine uptake
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause insomnia
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, oral: 2.5 mg, 10 mg
Oxandrin®: 2.5 mg [scored]
Oxandrin®: 10 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Oxandrin)
2.5 mg (30): $249.24
10 mg (30): $822.73
Tablets (Oxandrolone)
10 mg (30): $545.98
Extemporaneously Prepared
A 1 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet® and Ora-Plus®, or a 1:1 mixture of Ora-Sweet® SF and Ora-Plus®. Crush twenty-four 2.5 mg tablets in a mortar to a fine powder. Add small portions of chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Thoroughly mix the suspension by shaking. Label “shake well” and “protect from light”. Stable for 90 days at room temperature (Johnson, 2011).
Johnson CE, Cober MP, Hawkins KA, et al, “Stability of Extemporaneously Prepared Oxandrolone Oral Suspensions,” Am J Health-Syst Pharm, 2011, 68(6):519-21.
International Brand Names
Lexi-Comp.com
Last full review/revision October 2011
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