Nolvadex (Tamoxifen Citrate) Drug Information: Overdosage and Contraindications

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May 27, 2012

Nolvadex

Uterine Cancer »

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 ...

Read the Uterine Cancer article »

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OVERDOSE

Signs observed at the highest doses following studies to determine ^LD50 in animals were respiratory difficulties and convulsions.

Acute overdosage in humans has not been reported. In a study of advanced metastatic cancer patients which specifically determined the maximum tolerated dose of NOLVADEX (tamoxifen citrate) in evaluating the use of very high doses to reverse multidrug resistance, acute neurotoxicity manifested by tremor, hyperreflexia, unsteady gait and dizziness were noted. These symptoms occurred within 3-5 days of beginning NOLVADEX (tamoxifen citrate) and cleared within 2-5 days after stopping therapy. No permanent neurologic toxicity was noted. One patient experienced a seizure several days after NOLVADEX (tamoxifen citrate) was discontinued and neurotoxic symptoms had resolved. The causal relationship of the seizure to NOLVADEX (tamoxifen citrate) therapy is unknown. Doses given in these patients were all greater than 400 mg/m² loading dose, followed by maintenance doses of 150 mg/m² of NOLVADEX (tamoxifen citrate) given twice a day.

In the same study, prolongation of the QT interval on the electrocardiogram was noted when patients were given doses higher than 250 mg/m² loading dose, followed by maintenance doses of 80 mg/m² of NOLVADEX (tamoxifen citrate) given twice a day. For a woman with a body surface area of 1.5 m² the minimal loading dose and maintenance doses given at which neurological symptoms and QT changes occurred were at least 6 fold higher in respect to the maximum recommended dose.

No specific treatment for overdosage is known; treatment must be symptomatic.

CONTRAINDICATIONS

NOLVADEX (tamoxifen citrate) is contraindicated in patients with known hypersensitivity to the drug or any of its ingredients.

Reduction in Breast Cancer Incidence in High Risk Women and Women with DCIS

NOLVADEX (tamoxifen citrate) is contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus.

Last reviewed on RxList: 4/10/2008
This monograph has been modified to include the generic and brand name in many instances.