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Soltamox

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Soltamox

SOLTAMOX™
(tamoxifen citrate) Oral Solution

Soltamox

WARNING

For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women).

Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women years of 0.17 for tamoxifen vs. 0.0 for placebo) *. For stroke, the incidence rate per 1,000 women years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women years was 0.75 for tamoxifen versus 0.25 for placebo **.

Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

* Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma. ** See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies.

DRUG DESCRIPTION

SOLTAMOX™ (tamoxifen citrate) solution, a nonsteroidal antiestrogen, is for oral administration. Each 5 mL solution contains 15.2 mg tamoxifen citrate, equivalent to 10 mg tamoxifen and the following inactive ingredients: ethanol, glycerol, propylene glycol, sorbitol solution, licorice flavor, aniseed flavor, purified water.

The chemical name is (Z)2-[4-(1,2-diphenyl-l-butenyl) phenoxy]-N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are:

SOLTAMOX Structural Formula Illustration

Tamoxifen citrate has a molecular weight of 563.62, the pKa' is 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.

What are the possible side effects of tamoxifen (Soltamox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tamoxifen and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate;
  • pain, swelling, warmth, or redness in one or both legs;
  • nausea, loss of...

Read All Potential Side Effects and See Pictures of Soltamox »

What are the precautions when taking tamoxifen citrate (Soltamox)?

Before taking tamoxifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have cancer limited to the milk ducts, or if you are taking this medication to prevent breast cancer, then this medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a history of blood clots (e.g., deep vein thrombosis, pulmonary embolism, stroke), conditions that require treatment with a "blood thinner" (such as warfarin).

If you have breast cancer and a history of blood clots/stroke, you may or may not be able to take...

Read All Potential Precautions of Soltamox »

Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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