Dosing & Uses
Dosage Forms & 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
Dosage Forms & 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- pexidartinib
fluoxymesterone and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pretomanid
fluoxymesterone, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- warfarin
fluoxymesterone increases effects of warfarin by anticoagulation. Avoid or Use Alternate Drug.
Monitor Closely (2)
- carbamazepine
fluoxymesterone increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.
- valoctocogene roxaparvovec
fluoxymesterone and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
Minor (37)
- acarbose
fluoxymesterone increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.
- androstenedione
androstenedione increases effects of fluoxymesterone by pharmacodynamic synergism. Minor/Significance Unknown.
- budesonide
fluoxymesterone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- chlorpropamide
fluoxymesterone increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.
- cortisone
fluoxymesterone, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- deflazacort
fluoxymesterone, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- dexamethasone
fluoxymesterone, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- epoetin alfa
fluoxymesterone increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.
- fludrocortisone
fluoxymesterone, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- glimepiride
fluoxymesterone increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.
- glipizide
fluoxymesterone increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.
- glyburide
fluoxymesterone increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.
- hydrocortisone
fluoxymesterone, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- insulin aspart
fluoxymesterone increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin detemir
fluoxymesterone increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin glargine
fluoxymesterone increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin glulisine
fluoxymesterone increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin lispro
fluoxymesterone increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin NPH
fluoxymesterone increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.
- insulin regular human
fluoxymesterone increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.
- metformin
fluoxymesterone increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.
- methylprednisolone
fluoxymesterone, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- miglitol
fluoxymesterone increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.
- nateglinide
fluoxymesterone increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.
- pioglitazone
fluoxymesterone increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.
- prednisolone
fluoxymesterone, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- prednisone
fluoxymesterone, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- repaglinide
fluoxymesterone increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.
- rosiglitazone
fluoxymesterone increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.
- saw palmetto
saw palmetto decreases effects of fluoxymesterone by pharmacodynamic antagonism. Minor/Significance Unknown.
- saxagliptin
fluoxymesterone increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
- sitagliptin
fluoxymesterone increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
- tacrolimus
fluoxymesterone increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.
- tolazamide
fluoxymesterone increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.
- tolbutamide
fluoxymesterone increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.
- triamcinolone acetonide injectable suspension
fluoxymesterone, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.
- vildagliptin
fluoxymesterone increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.
Adverse 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 & 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
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
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