Fluoxymesterone

Trade Names:Fluoxymesterone- Tablets 10 mg

Pharmacology

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).

Contraindications

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 Administration

PO Titrate dose utilizing a low dose, appropriate skeletal monitoring, and by limiting the duration of therapy to 4 to 6 mo.

PO 10 to 40 mg/day, in divided doses, for palliative therapy.

PO 5 to 20 mg/day for complete replacement.

General Advice

• Administer without regard to meals. Administer with food if GI upset occurs.

Storage/Stability

Store tablets at controlled room temperature (68° to 77°F).

Drug Interactions

Blood glucose levels may be reduced by fluoxymesterone, decreasing insulin requirements.

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.

Adverse Reactions

CNS

Increased or decreased libido; headache; anxiety; depression; generalized paresthesia.

Dermatologic

Hirsutism; male pattern baldness; seborrhea; acne.

GI

Nausea.

Genitourinary

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).

Hematologic

Suppression of clotting factors II, V, VII, and X; polycythemia.

Hepatic

Cholestatic jaundice; altered LFTs; hepatocellular neoplasms, peliosis hepatitis.

Metabolic

Sodium, chloride, water, potassium, calcium, and inorganic phosphate retention.

Miscellaneous

Allergic hypersensitivity (including skin manifestations and anaphylactoid reactions).

Precautions

Pregnancy

Category X . Ensure that X-ray examinations of bone age are made every 6 mo during treatment of prepubertal male.

Lactation

Undetermined.

Children

Use with caution and only by specialists aware of the adverse effects on bone maturation.

Elderly

Elderly men may be at increased risk of developing prostatic hypertrophy or carcinoma.

Athletic performance

Abuse of this agent to enhance athletic performance has potential risk of serious adverse reactions.

Breast cancer and immobilized patients

May cause hypercalcemia.

Delayed puberty

Because bone maturation without compensatory linear growth can occur, use with caution in males with delayed puberty.

Edema

Use with caution in patients with conditions that might be affected by fluid retention (eg, renal, hepatic, or cardiac disease).

Gynecomastia

May occur and persist in patients being treated for hypogonadism.

Hepatic effects

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.

Priapism

May be indicative of excessive dosage.

Urethral obstruction

May develop in patients with benign prostatic hypertrophy.

Virilization

May occur in women using high-dose androgens.

Patient Information

• 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.

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