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Fluoxymesterone
Breast cancer
Hypogonadism
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Drug Name:

Fluoxymesterone CIII

Generic Name and Formulations:
Fluoxymesterone 10mg; tabs.

Company:
Various generic manufacturers

Therapeutic Use:

Indications for Fluoxymesterone:

Palliation of androgen responsive recurrent mammary cancer in women who are more than one year but less than five years postmenopausal, or who have been proven to have a hormone-dependent tumor as shown by previous beneficial response to castration.

Adult:

Individualize. 10–40mg/day; may be given in divided doses to ensure more stable blood levels. Continue therapy for at least 1 month for subjective response, 2–3 months for objective response.

Children:

Not applicable.

Contraindications:

Pregnancy (Cat.X). Serious cardiac, hepatic or renal disease.

Warnings/Precautions:

Discontinue if cholestatic hepatitis, jaundice, or hypercalcemia develops. Pre-existing cardiac, renal or hepatic disease. Monitor urine and serum calcium levels frequently. Obtain LFTs periodically. Long-term therapy: check hemoglobin and hematocrit levels, cholesterol. Nursing mothers: not recommended.

Interactions:

May need to reduce concomitant anticoagulant dose. May potentiate oxyphenbutazone. May alter insulin requirements.

Pharmacological Class:

Androgen.

Adverse Reactions:

Amenorrhea, inhibition of gonadotropin secretion, virilization, nausea, jaundice, altered LFTs, hirsutism, acne, headache, anxiety, depression, paresthesias, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol; rare: hepatic adenomas, hepatocellular carcinoma, peliosis hepatis.

Note:

Formerly known under the brand name Halotestin.

How Supplied:

Contact supplier.

Indications for Fluoxymesterone:

Replacement therapy in conditions associated with symptoms of testosterone deficiency or absence (eg, primary hypogonadism, hypogonadotropic hypogonadism). Delayed puberty.

Adult:

Individualize. Male hypogonadism: 5–20mg/day.

Children:

Delayed puberty: Use low dose, with appropriate skeletal monitoring. Duration of therapy: 4–6 months.

Contraindications:

Breast cancer. Prostate cancer. Pregnancy (Cat.X). Serious cardiac, hepatic or renal disease.

Warnings/Precautions:

Discontinue if cholestatic hepatitis, jaundice, or hypercalcemia develops. Pre-existing cardiac, renal or hepatic disease. BPH; urethral obstruction may develop. Virilization in women; discontinue if occurs. Monitor bone maturation in delayed puberty; periodic (every 6 months) X-ray of bone age should be made during treatment of prepubertal males. Obtain LFTs periodically. Long-term therapy: check hemoglobin and hematocrit levels, cholesterol. Elderly (possible increased risk of prostatic hypertrophy and prostate cancer). Nursing mothers: not recommended.

Interactions:

May need to reduce concomitant anticoagulant dose. May potentiate oxyphenbutazone. May alter insulin requirements.

Pharmacological Class:

Androgen.

Adverse Reactions:

Gynecomastia, priapism, oligospermia, nausea, jaundice, altered LFTs, virilization, male pattern baldness, acne, headache, anxiety, depression, paresthesias, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol; rare: hepatic adenomas, hepatocellular carcinoma, peliosis hepatis.

Note:

Formerly known under the brand name Halotestin.

How Supplied:

Contact supplier.

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