Halotestin (Fluoxymesterone) 20mg/tab 100 tabs – Medical Pharma Steroid in USA

Halotestin (Fluoxymesterone) pharmacologic category

Androgen.

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

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