fluoxymesterone (Rx)

Brand and Other Names:Androxy, Halotestin
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and fluoxymesterone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            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 levels of warfarin by decreasing metabolism. Avoid or Use Alternate Drug.

              Monitor Closely (1)

              • carbamazepine

                fluoxymesterone increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.

              Minor (38)

              • 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.

              • clobetasone

                fluoxymesterone, clobetasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • 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.

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              Adverse Effects

              >10%

              Edema

              Acne

              Breast soreness

              Priapism

              Menstrual irregularities

              Virilization

              Frequency Not Defined

              Gynecomastia

              Suppression of clotting factors II, V, VII

              Anaphylaxsis

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              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

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              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.

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              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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              Formulary

              FormularyPatient Discounts

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              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.