TAMOTREX – 5mg – 100 Tab.

TAMOTREX – 5mg – 100 Tab.

Tamoxifen Citrate 10 mg/tab 100 Tablets

For oral use

Therapeutic Class: Antiestrogen

Composition:

Each tablet of TAMOTREX contains:

• 10 mg Tamoxifen Citrate

Indications:

Treatment of metastatic breast cancer in men and women. Axillary node-positive breast cancer in postmenopausal women after surgery + irradiation. Axillary node-negative breast cancer in women after surgery + irradiation. Reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS) after surgery+ radiation. Reduction in breast cancer incidence in high-risk women.

Adult:

Treatment: 20-40 mg/day; give doses >20 mg in divided doses (AM and PM). Reduction of incidence in high-risk women or DCIS: 20 mg once daily for 5 years.

Children:

McCune-Albright Syndrome, precocious puberty: see literature.

Contraindications:

For risk reduction: concomitant coumarin anticoagulants, history of deep vein thrombosis or pulmonary embolism, planned pregnancy. Pregnancy (Cat.D). Nursing mothers.

Warnings/Precautions:

See literature. Do gynecological exam at least annually. DCIS and risk reduction: consider increased risk of uterine cancer (endometrial adenocarcinoma, uterine sarcoma) and thrombotic events. Women with advanced disease: discontinue if severe hypercalcemia occurs. Monitor blood, lipids, liver function, for thromboembolism symptoms (eg, leg swelling, unexplained shortness of breath), and for uterine changes/ cancer (eg, pelvic pain or pressure); promptly investigate any abnormal vaginal bleeding. Breast cancer treatment: history of thromboembolic events. Premenopausal: use effective non-hormonal contraception during and within 2 months of discontinuing therapy; begin therapy during menses or, if irregular menses, obtain (-) 8-hCGpregnancy test first.

Interactions:

May potentiate oral anticoagulants (see Contraindications). Antagonizes anastrozole (avoid concomitant use); letrozole. Plasma levels reduced by CYP3A4 inducers (eg, rifampin). Cytotoxic drugs increase risk of thrombotic events. Potentiated by bromocriptine.
Adverse Reactions:
Hot flashes, vaginal discharge, altered menses, rash, headache, nausea, cough, edema, fatigue, abdominal cramps, bone and tumor pain (in advanced disease), local disease flare, hypercalcemia, thrombotic events, ovarian cysts, uterine fibroids or cancer (endometrial adenocarcinoma, uterine sarcoma), endometrial or visual changes, jaundice, hypertriglyceridemia, blood dyscrasias, hair loss.

Storage:

Store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat, moisture, and light.
Do not store in the bathroom. Keep out of the reach of children and away from pets.