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SOLTAMOX ORAL SOLUTION
Breast cancer
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Drug Name:

SOLTAMOX ORAL SOLUTION Rx

Generic Name and Formulations:
Tamoxifen (as citrate) 10mg/5mL; licorice and aniseed flavors; sugar-free; contains alcohol.

Company:
Midatech Pharma US Inc.

Therapeutic Use:

Indications for SOLTAMOX ORAL SOLUTION:

Treatment of estrogen receptor (+) metastatic breast cancer in adult patients. Adjuvant treatment of adult patients with early stage estrogen receptor (+) breast cancer. Reduction of contralateral breast cancer occurrence in adult patients when used as adjuvant therapy for breast cancer. 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:

Metastatic treatment: 20–40mg/day; give doses >20mg in divided doses (AM and PM). Adjuvant treatment: 20mg daily for 5–10yrs. Doses >20mg daily yield no additional benefit. Reduction of incidence in high-risk women or DCIS: 20mg once daily for 5yrs.

Children:

Not established.

Contraindications:

For reduction in incidence in high-risk women and women with DCIS: concomitant coumarin anticoagulants, history of deep vein thrombosis or pulmonary embolism.

Boxed Warning:

Uterine malignancies. Thromboembolic events.

Warnings/Precautions:

See full labeling. Women with DCIS and at high-risk for breast cancer: consider serious risk of uterine malignancies (endometrial adenocarcinoma, uterine sarcoma), stroke and pulmonary embolism. 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. Do gynecological exam at least annually. Breast cancer treatment: history of thromboembolic events. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Females of reproductive potential should use effective non-hormonal contraception during and for 9 months after last dose. Males (w. female partners) should use effective contraception during and for 6 months after last dose. Nursing mothers: not recommended (during and for 3 months after last dose).

Pharmacological Class:

Antiestrogen.

Interactions:

See Contraindications. May potentiate oral anticoagulants; if co-administered, monitor PT. Concomitant anastrozole: not recommended. Antagonizes letrozole. Plasma levels reduced by CYP3A4 inducers (eg, rifampin, aminoglutethimide). Cytotoxic drugs increase risk of thrombotic events.

Adverse Reactions:

Hot flashes, mood disturbances, vaginal discharge/bleeding, altered menses, oligomenorrhea, nausea, fluid bleeding, 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, liver abnormalities, hypertriglyceridemia, blood dyscrasias, hair loss.

Metabolism:

Hepatic (CYP3A, 2C9, 2D6).

Elimination:

Fecal.

Generic Availability:

NO

How Supplied:

Soln—150mL

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