Select therapeutic use:

Breast cancer:

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 Dosage:

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

Children Dosage:

Not applicable.

ANDROXY Contraindications:

Pregnancy (Cat.X).

ANDROXY 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.

ANDROXY Classification:

Androgen.

ANDROXY 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.

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

Hypogonadism:

Indications for ANDROXY:

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

Adult Dosage:

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

Children Dosage:

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

ANDROXY Contraindications:

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

ANDROXY 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.

ANDROXY Classification:

Androgen.

ANDROXY 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.

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