Dosing and uses of Androxy, Halotestin (fluoxymesterone)
Adult dosage forms and strengths
tablet: Schedule III
- 2mg
- 5mg
- 10mg
Hypogonadism, Males
5-20 mg PO qd
Metastatic Breast Cancer, Females
Palliative adjunctive therapy: 10-40 mg/day PO in divided doses x3 months or longer
Other Indications & Uses
Off-label: prevention of post-partum breast engorgement (historically), angioneurotic edema
Pediatric dosage forms and strengths
tablet: Schedule III
- 2mg
- 5mg
- 10mg
Delayed Puberty, Males
2.5-20 mg PO qD x4-6 months
Hypogonadism, Males
As adults; 5-20 mg PO qd
Other Information
Androgens should be used with extreme caution in children and only by specialists who are aware of the adverse effects of these drugs on bone maturation
Androxy, Halotestin (fluoxymesterone) adverse (side) effects
>10%
Edema
Acne
Breast soreness
Priapism
Menstrual irregularities
Virilization
Frequency not defined
Gynecomastia
Suppression of clotting factors II, V, VII
Anaphylaxsis
Warnings
Contraindications
Severe cardiac, hepatic or renal disease, males with breast or prostate cancer, hypersensitivity
Pregnancy
Cautions
Benign prostatic hypertrophy, males with delayed puberty, geriatric pts, pediatric pts
Hypercalcemia may occur in breast CA or immobilized pts
Halogenated derivative of testosterone with upto 5 times activity of methyltestosterone
Pregnancy and lactation
Pregnancy category: X
Lactation: excretion in milk unknown; contraindicated
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 of Androxy, Halotestin (fluoxymesterone)
Half-Life: 9.2 hr, longer t1/2 than natural androgens
Bioavailability: PO: rapidly absorbed
Protein Bound: 98%
Metabolism: liver
Excretion: urine (90%)
Mechanism of action
Synthetic derivative of testosterone with predominantly androgenic activity; promoting growth and development of male sex organs and maintaining secondary sex characteristics in androgen-deficient males
