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ANDROXY
Breast cancer
Hypogonadism
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Drug Name:

ANDROXY CIII

Generic Name and Formulations:
Fluoxymesterone 10mg; tabs.

Company:
Upsher-Smith Laboratories, Inc.

Therapeutic Use:

Indications for ANDROXY:

Palliation of advancing inoperable metastatic (skeletal) mammary cancer in women who are 1–5 years postmenopausal. In premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

Adult:

Individualize. 10–40mg/day in divided doses. Continue therapy for 3 months or more for objective response.

Children:

Not applicable.

Contraindications:

Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if cholestatic hepatitis, jaundice, or hypercalcemia develops. Risk of peliosis hepatitis, hepatic neoplasms with prolonged high-dose therapy. Pre-existing cardiac, renal or hepatic disease. History of MI or coronary artery disease: monitor serum cholesterol accordingly. Virilization in women; discontinue if occurs. Monitor urine and serum calcium levels frequently. Obtain LFTs, hemoglobin, and hematocrit periodically. Elderly (possible increased risk of prostatic hypertrophy and prostate cancer). Nursing mothers: not recommended.

Interactions:

Monitor closely when concomitant oral anticoagulants. Increased risk of edema with concomitant ACTH or corticosteroids; caution. May potentiate oxyphenbutazone. May alter insulin requirements. May decrease thyroxine-binding globulin (TBG) levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Amenorrhea, menstrual irregularities, 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.

How Supplied:

Tabs—100

Indications for ANDROXY:

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

Adult:

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

Children:

Delayed puberty: 2.5–20mg/day with appropriate skeletal monitoring. Duration of therapy: 4–6 months.

Contraindications:

Breast cancer. Prostate cancer. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if cholestatic hepatitis, jaundice, or hypercalcemia develops. Risk of peliosis hepatitis, hepatic neoplasms with high-dose therapy. Pre-existing cardiac, renal or hepatic disease. History of MI or coronary artery disease: monitor serum cholesterol accordingly. Virilization in women; discontinue if occurs. Monitor urine and serum calcium levels frequently. Obtain LFTs, hemoglobin, and hematocrit periodically. Monitor bone maturation in delayed puberty; periodic (every 6 months) X-ray of bone age should be made during treatment of prepubertal males. Elderly (possible increased risk of prostatic hypertrophy and prostate cancer). Nursing mothers: not recommended.

Interactions:

Monitor closely when concomitant oral anticoagulants. Increased risk of edema with concomitant ACTH or corticosteroids; caution. May potentiate oxyphenbutazone. May alter insulin requirements. May decrease thyroxine-binding globulin (TBG) levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Gynecomastia, priapism, oligospermia, nausea, jaundice, altered LFTs, virilization, hirsutism, 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.

How Supplied:

Tabs—100

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