Dosage and administration
- Metastatic breast cancer: For patients with breast cancer, the recommended daily dose of SOLTAMOX is 20 to 40 mg. Doses greater than 20 mg per day should be given in divided doses (morning and evening).
- Adjuvant treatment of breast cancer: For use in the adjuvant setting, the recommended dose of SOLTAMOX is 20 mg daily for 5-10 years. Doses greater than 20 mg daily yield no additional clinical benefit.
- Ductal Carcinoma in Situ: For patients with DCIS, the recommended dose of SOLTAMOX is 20 mg daily for 5 years.
- Reduction in Breast Cancer Incidence in Women at High Risk: In the risk reduction setting, the recommended dose of SOLTAMOX is 20 mg daily for 5 years.
Dosage FOrms AND Strengths
SOLTAMOX oral solution: Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate.
HOW SUPPLIED/STORAGE AND HANDLING
SOLTAMOX oral solution is a sugar-free, clear colorless liquid, with licorice and aniseed odor and taste. It is supplied in a 150 mL bottle with a dosing cup intended for the measurement of SOLTAMOX oral solution only. Each 10 mL of solution contains 20 mg tamoxifen, equivalent to 30.4 mg tamoxifen citrate.
Store at room temperatures 20° to 25°C (68° – 77°F); excursions permitted between 15° to 30°C (59° – 86°F) [see USP Controlled Room Temperature].
DO NOT freeze or refrigerate.
Store in original packaging in order to protect from light. Discard any unused portion after 3 months of first opening of the bottle.