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Indications:

Adjuvant treatment of breast carcinoma in women; metastatic breast carcinoma in men and women; reduction in risk of breast cancer in high-risk women; lower risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS). Unlabeled Uses Ovulation stimulation in specially selected anovulatory women desiring pregnancy; management and treatment of some types of mastalgia (eg, cyclical); malignant carcinoid tumor and carcinoid syndrome; migraine associated with menstruation; metastatic malignant melanoma; oligozoospermia; McCune-Albright syndrome in female pediatric patients (in combination with other agents); metastatic melanoma; desmoid tumors; symptomatic gynecomastia.

Contraindications:

Hypersensitivity to drug; women who require concomitant coumarin-type anticoagulant therapy; women with a history of deep vein thrombosis or pulmonary embolus.

Adverse reactions:

Cardiovascular Vasodilation (41%); hypertension (11%); ischemic cerebrovascular events, ischemic CV disease (3%). CNS Asthenia/fatigue, mood disturbances (18%); depression (12%); insomnia (9%); dizziness, headache (8%); anxiety (6%); paresthesia (5%); fatigue (4%). Dermatologic Flushing (80%); skin changes (19%); rash (13%); sweating (6%); alopecia (5%); bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome. EENT Pharyngitis (14%); cataract (7%). GI Nausea (26%); vomiting (12%); constipation (8%); diarrhea (7%); dyspepsia (6%); GI disorder (5%); anorexia (1%). Genitourinary Vaginal discharge (55%); irregular menses (25%); amenorrhea, vaginal bleeding (23%); altered menses (13%); UTI (10%); leucorrhea, oligomenorrhea (9%); breast pain, menstrual disorder, vaginal hemorrhage (6%); breast neoplasm, vaginitis, vulvovaginitis (5%); ovarian cysts (3%), endometrial cancer (1%). Hematologic-Lymphatic Lymphedema (11%); anemia, venous thromboembolic events (5%); deep venous thromboembolic events, thrombocytopenia (2%). Lab Tests Increased AST (5%); increased bilirubin, increased creatinine (2%); elevated triglycerides in some cases with pancreatitis. Metabolic-Nutritional Fluid retention (32%); weight loss (23%); peripheral edema (11%); weight gain (9%); hypercholesterolemia (4%). Musculoskeletal Arthritis (14%); arthralgia (11%); back pain (10%); fracture, osteoporosis (7%); bone pain (6%); arthrosis, joint disorder, myalgia (5%); musculoskeletal pain (3%). Respiratory Cough (9%); dyspnea (8%), bronchitis, sinusitis (5%); interstitial pneumonitis. Miscellaneous Pain (16%); accidental injury (10%); abdominal pain, infection (9%); flu syndrome (6%); chest pain, cyst, neoplasm (5%); edema (4%); abdominal cramps (1%); hypersensitivity, including angioedema.

Interactions:

Aminoglutethimide, phenobarbital Tamoxifen concentrations may be reduced. Anastrozole Plasma concentrations of anastrozole may be decreased. Do not coadminister. Bromocriptine Tamoxifen concentrations may be increased. Cytotoxic agents Increased risk of thromboembolic events. Letrozole Plasma concentrations may be decreased by tamoxifen, reducing the therapeutic effect. Rifamycins (eg, rifampin) Tamoxifen plasma levels may be reduced, decreasing the antiestrogenic effect. Warfarin Increased hypoprothrombinemic effect.

Warnings:

Pregnancy Category D . Lactation Undetermined. Children Safety and efficacy in children have not been established. Amenorrhea May occur. Disease of bone Increased bone pain, tumor pain, and local disease flare are sometimes associated with a good tumor response shortly after starting tamoxifen, and generally subside rapidly. Hematologic effects Thrombocytopenia, leukopenia, and neutropenia and/or pancytopenia have occurred. Hepatic effects Changes in liver enzyme levels may occur. Hypercalcemia If occurs, institute appropriate measures and, if severe, discontinue use. Nonmalignant uterine effects An increased incidence of endometrial changes, including hyperplasia and polyps, have been reported. Endometriosis and uterine fibroids have been reported. Secondary tumors Secondary primary tumors, occurring at sites other than the endometrium, were reported following treatment of breast cancer with tamoxifen. Thromboembolic effects Deep vein thrombosis and pulmonary embolism have occurred. Visual disturbances Visual disturbances, including corneal changes, cataracts, the need for cataract surgery, decrement in color vision perception, retinal vein thrombosis, and retinopathy, have occurred with use.

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