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home > drugs a-z list > nolvadex (tamoxifen citrate) drug center > nolvadex (tamoxifen citrate) drug
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Nolvadex
The uterus
The uterus is part of a woman's reproductive system. It's a hollow organ in the pelvis.
The uterus has three parts:
- Top: The top (fundus) of your uterus is shaped like a dome. From the top of your uterus, the fallopian tubes extend to the ovaries.
- Middle: The middle part of your uterus is the body (corpus). This is where a baby grows.
- Bottom: The narrow, lower part of your uterus is the cervix. The cervix is a passageway to the vagina.
The wall of the uterus has two layers of tissue:
- Inner layer: The inner layer (lining) of the uterus is the endometrium. In women of childbearing age, the lining grows and thickens each month to prepare for pregnancy. If a woman does not become pregnant, the thick, bloody lining flows out of the body. This flow is a menstrual period.
- Outer layer: The outer layer of muscle ...
Nolvadex
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NOLVADEX
(tamoxifen citrate) Tablets
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with NOLVADEX (tamoxifen citrate) 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 NOLVADEX (tamoxifen citrate) vs 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for NOLVADEX (tamoxifen citrate) vs 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for NOLVADEX (tamoxifen citrate) vs 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for NOLVADEX (tamoxifen citrate) 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 NOLVADEX (tamoxifen citrate) to reduce their risk of developing breast cancer.
The benefits of NOLVADEX (tamoxifen citrate) outweigh its risks in women already diagnosed with breast cancer.
What are the precautions when taking tamoxifen citrate (Nolvadex)?
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...
REFERENCES
What are the precautions when taking tamoxifen citrate (Nolvadex)?
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...
*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.
What are the precautions when taking tamoxifen citrate (Nolvadex)?
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...
**See Table 3 under CLINICAL PHARMACOLOGY-Clinical Studies.
DRUG DESCRIPTION
NOLVADEX® (tamoxifen citrate) Tablets, a nonsteroidal antiestrogen, are for oral administration. NOLVADEX (tamoxifen citrate) Tablets are available as:
10 mg Tablets
Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
20 mg Tablets
Each tablet contains 30.4 mg of tamoxifen citrate which is equivalent to 20 mg of tamoxifen.
Inactive Ingredients: carboxymethylcellulose calcium, magnesium stearate, mannitol and starch.
Chemically, NOLVADEX (tamoxifen citrate) is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl) phenoxy]-N, N-dimethylethanamine 2 hydroxy-1,2,3- propanetricarboxylate (1:1). The structural and empirical formulas are:
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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 precautions when taking tamoxifen citrate (Nolvadex)?
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...
Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.
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