Trade Names:Fluoxymesterone- Tablets 10 mg
Promotes growth and development of male reproductive organs, maintains secondary sex characteristics, increases protein anabolism, and decreases protein catabolism.
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.
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)Adults
PO 10 to 40 mg/day, in divided doses, for palliative therapy.Male HypogonadismAdults
PO 5 to 20 mg/day for complete replacement.
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.
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.
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.
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.
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