- Tablets 10 mg
Promotes growth and development of male reproductive organs, maintains secondary sex characteristics, increases protein anabolism, and decreases protein catabolism.
Indications and Usage
Replacement therapy in conditions associated with symptoms of deficiency or absence of endogenous testosterone; delayed puberty (men); palliation of androgen-responsive recurrent mammary cancer in women who are more than 1 yr but less than 5 yr postmenopausal (women).
Men with carcinoma of the breast; men with known or suspected carcinoma of the prostate gland; women known or suspected to be pregnant; patients with serious cardiac, hepatic, or renal disease; hypersensitivity to any component of the product.
Dosage and AdministrationDelayed Puberty (Men)
PO Titrate dose utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to 4 to 6 mo.Inoperable Carcinoma of the Breast (Women)
PO 10 to 40 mg/day, in divided doses, for palliative therapy.Male Hypogonadism
PO 5 to 20 mg/day for complete replacement.
- Administer without regard to meals. Administer with food if GI upset occurs.
Store tablets at controlled room temperature (68° to 77°F).
Blood glucose levels may be reduced by fluoxymesterone, decreasing insulin requirements.Oral anticoagulants (eg, warfarin)
Effects of oral anticoagulant may be increased. Dosage reduction may be required.
Laboratory Test Interactions
Thyroxine-binding globulin levels may be decreased; however, thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.
Increased or decreased libido; headache; anxiety; depression; generalized paresthesia.
Hirsutism; male pattern baldness; seborrhea; acne.
Amenorrhea and other menstrual irregularities, inhibition of gonadotropin secretion, virilization including deepening of voice, clitoral enlargement (women); gynecomastia, excessive frequency and duration of penile erection, oligospermia (men).
Suppression of clotting factors II, V, VII, and X; polycythemia.
Cholestatic jaundice; altered LFTs; hepatocellular neoplasms, peliosis hepatitis.
Sodium, chloride, water, potassium, calcium, and inorganic phosphate retention.
Allergic hypersensitivity (including skin manifestations and anaphylactoid reactions).
Determine liver enzymes, lipid profile, and hemoglobin and hematocrit levels before starting and periodically during treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.
Category X . Ensure that X-ray examinations of bone age are made every 6 mo during treatment of prepubertal male.
Use with caution and only by specialists aware of the adverse effects on bone maturation.
Elderly men may be at increased risk of developing prostatic hypertrophy or carcinoma.
Abuse of this agent to enhance athletic performance has potential risk of serious adverse reactions.
Breast cancer and immobilized patients
May cause hypercalcemia.
Because bone maturation without compensatory linear growth can occur, use with caution in males with delayed puberty.
Use with caution in patients with conditions that might be affected by fluid retention (eg, renal, hepatic, or cardiac disease).
May occur and persist in patients being treated for hypogonadism.
Cholestatic hepatitis and jaundice may occur. Prolonged use of high doses may result in hepatic adenomas, hepatocellular carcinoma, and peliosis hepatitis.
Oligospermia and reduced ejaculatory volume
May occur after prolonged use or excessive dosage.
May be indicative of excessive dosage.
May develop in patients with benign prostatic hypertrophy.
May occur in women using high-dose androgens.
- Instruct patient, family, or caregiver to take (give) exactly as prescribed and to not change the dose or discontinue therapy unless advised by health care provider.
- Advise patient, family, or caregiver that each dose may be taken without regard to meals but to take with food if stomach upset occurs.
- Instruct patient, family, or caregiver that if a dose is missed to skip that dose and not to double the next dose.
- Advise patient that medication does not enhance athletic performance and not to use for this purpose because of potential serious adverse health risks.
- Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
- Instruct patient, family, or caregiver to discontinue therapy and immediately contact health care provider if any of the following occur: persistent nausea or vomiting, yellowing of skin or eyes, swelling of feet or ankles.
- Instruct men to report too frequent or persistent erections to health care provider.
- Instruct women to report hoarseness, acne, changes in menstrual periods, or increase in facial hair to health care provider.
- Caution women of childbearing potential to avoid becoming pregnant while being treated.
Copyright © 2009 Wolters Kluwer Health.
More about fluoxymesterone
- Other brands: Halotestin