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Oxandrolone

Pronunciation

Pronunciation

(oks AN droe lone)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Oxandrin: 2.5 mg [scored]

Oxandrin: 10 mg

Generic: 2.5 mg, 10 mg

Brand Names: U.S.

  • Oxandrin

Pharmacologic Category

  • Androgen

Pharmacology

Synthetic testosterone derivative with similar androgenic and anabolic actions

Absorption

Oral: Well absorbed (Orr 2004)

Excretion

Urine (28% as unchanged drug) (Orr 2004)

Time to Peak

Concentration: ~1 hour (Orr 2004)

Half-Life Elimination

10 to 13 hours

Protein Binding

95% (Orr 2004)

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

Contraindications

Nephrosis; carcinoma of breast (women with hypercalcemia or men) or prostate; hypercalcemia; pregnancy

Dosing: Adult

Weight gain (adjunct): Oral: 2.5-20 mg in divided doses 2-4 times daily based on individual response; a course of therapy of 2-4 weeks is usually adequate. This may be repeated intermittently as needed.

Dosing: Geriatric

Weight gain (adjunct): Oral: 5 mg twice daily

Dosing: Pediatric

Weight gain (adjunct): Oral: Children: Total daily dose: ≤0.1 mg/kg; may be repeated intermittently as needed

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling; use with caution due to propensity to cause edema.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling; use with caution.

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):519-21.21378300

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy

Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy

CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification

Test Interactions

May suppress factors II, V, VII, and X; may increase PT; may decrease thyroxine-binding globulin and radioactive iodine uptake

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, libido changes

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

Hematologic: Prothrombin time increased, suppression of clotting factors

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)

Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014)

ALERT: U.S. Boxed Warning

Peliosis hepatis:

Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.

Liver cell tumors:

Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.

Blood lipid changes:

Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.

Warnings/Precautions

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. Use with caution in patients with hepatic impairment.

Disease-related concerns:

• Breast cancer: Use with caution in patients with breast cancer; may cause hypercalcemia by stimulating osteolysis. Discontinue use if hypercalcemia occurs.

• Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in patients with diabetes.

• COPD: Use with caution in patients with COPD.

• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.

Concurrent drug therapy issues:

• Warfarin: Use caution with concomitant warfarin therapy; warfarin dose may need to be significantly decreased.

Special populations:

• Elderly: Use with caution in elderly patients, they may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and transaminase elevations.

• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children; effect may continue for 6 months after the drug is stopped; in prepubertal children perform radiographic examination of the left hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.

• Females: May cause mild virilization in females; monitor for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinue with evidence of mild virilization in female patients; early discontinuation may prevent irreversible virilization.

Other warnings/precautions:

• Appropriate use: Anabolic steroids have not been shown to improve athletic ability.

Monitoring Parameters

Liver function tests, cholesterol profile, hemoglobin/hematocrit; INR/PT in patients on anticoagulant therapy

Children: Radiographs of left wrist and hand 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

Pregnancy Risk Factor

X

Pregnancy Considerations

Use is contraindicated in women who are or may become pregnant; masculinization of the fetus has been reported.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience insomnia or sexual dysfunction. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), priapism, acne, urinary retention, change in amount of urine passed, muscle weakness, severe anxiety, bruising, bleeding, signs of virilization (in females a deep voice, facial hair, pimples, or period changes), shortness of breath, excessive weight gain, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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