02 Details
Halotestion (fluoxymesterone)
Halotestin (fluoxymesterone) 20mg/tab 100 tabs
Halotestin, Ora-Testryl, Ultandren, others
Androfluorene; NSC-12165; 9α-Fluoro-11β-hydroxy-17α-methyltestosterone; 9α-Fluoro-17α-methylandrost-4-en-11β,17β-diol-3-one
Pharmacopoeias. In US. USP 31(Oxandrolone). A white odourless crystalline powder. Soluble 1 in 5200 of water, 1 in 57 of alcohol, 1 in 69 of acetone, 1 in less than 5 of chloroform, and 1 in 860 of ether. Protect from light.
Pharmacologic Category
Dosing: Adult
Weight gain (adjunct): Oral: 10-40 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: 10-40 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.
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
Storage/Stability
Store at 20°C to 25°C (68°F to 77°F).
Medication Patient Education with HCAHPS Considerations
- Patient may experience insomnia or sexual dysfunction. Have patient report immediately to prescriber priapism, acne vulgaris, urinary retention, oliguria, asthenia, considerable anxiety, signs of hepatic impairment, ecchymosis, hemorrhaging, signs of virilization, dyspnea, excessive weight gain, or edema of extremities (HCAHPS).
Contraindications
Nephrosis; carcinoma of breast (women with hypercalcemia or men) or prostate; hypercalcemia; pregnancy
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.
Pregnancy Risk Factor
X
Category X: Studies in animals or human beings have demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
Pregnancy Considerations
Use is contraindicated in women who are or may become pregnant; masculinization of the fetus has been reported.
Lactation
Excretion in breast milk unknown/not recommended
Breast-Feeding Considerations
It is not known if oxandrolone is excreted in breast milk. Due to the potential for serious adverse reactions in the nursing infant, breast-feeding is not recommended.
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 inhibited
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: Hepatotoxicity (idiosyncratic) (Chalasani, 2014)
Metabolism/Transport Effects
None known.
Drug Interactions
Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Risk C: Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy
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
Test Interactions
May suppress factors II, V, VII, and X; may increase PT; may decrease thyroxine-binding globulin and radioactive iodine uptake
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
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral: 10 mg, 20 mg
Anatomic Therapeutic Chemical (ATC) Classification
- A14AA08
Mechanism of Action
Synthetic testosterone derivative with similar androgenic and anabolic actions.
Pharmacodynamics/Kinetics
Half-life elimination: 10-13 hours
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions