Dosing & Administration

Bioequivalent to tamoxifen tablets.

Same indications, side effects, and safety profile as
tamoxifen tablets.

Colorless, gluten-free, lactose-free, sugar-free liquid.

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.

NDC# 89141-123-01

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.

Related Links

Healthcare ProfessionalsPrescribing InformationClinical OverviewSafety & TolerabilityPatient CounselingPatient AccessRisk ToolEAT-10 Tool

SOLTAMOX® Important Safety Information - WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

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WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

  • Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. (5.1, 5.2)
  • Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. (5.1, 5.2)
  • For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. (5.1, 5.2)

See full prescribing information for complete boxed warning.

SOLTAMOX® Important Safety Information

  • Tamoxifen citrate is contraindicated in patients who require concomitant warfarin therapy, or a history of deep vein thrombosis or pulmonary embolus, and in patients with known hypersensitivity to the drug or any of its ingredients.
  • Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use.
  • Thromboembolic events: Risk increases with coadministered chemotherapy. For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events.
  • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • Effects on the liver: Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing.
  • The most common adverse reactions (≥20% incidence) associated with tamoxifen are hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention.
  • Anastrozole and letrozole: Should not be used in combination with tamoxifen.
  • Warfarin: Do not use in patients taking tamoxifen for DCIS and for reduction in breast cancer incidence in women at high risk. Closely monitor coagulation indices for increased anticoagulant effect when used with tamoxifen for metastatic breast cancer or as adjuvant therapy.
  • Do not use tamoxifen in lactating women.
  • Verify pregnancy status of females prior to initiation of tamoxifen.
  • Advise females and males to use effective contraception.

Please see full Prescribing Information for SOLTAMOX®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.