Tamoxifen and/or Equivalent Nolvadex Prescription Information
Tamoxifen is a prescription Estrogen Receptor Antagonistused for the treatment of Breast Cancer. Anticancer properties are effected via tamoxifen's active metabolite, hydroxytamoxifen. By demonstrating agonistic properties at the endometrium, tamoxifen may be typically characterized as a mixed agonist/antagonist. Tamoxifen is also a standard Anti-Estrogen therapy for the treatment of Hormone Receptor Positive Breast Cancer in menopausal women.
Tamoxifen is primarily used in the treatment of early and advanced Estrogen Receptor Positive (ER+) Breast Cancer in both pre- and post-menopausal females. It is also the most commonly used hormone treatment to control breast cancer in males. Tamoxifen is approved by the U.S. FDA as a prevention therapy in women who are at high risk of developing breast cancer and for the suppression of contralateral cancer. Tamoxifen is also indicated for the following:
McCune-Albright syndrome: Treatment of premature puberty and its consequences.
Bipolar disorder: Tamoxifen has shown great results in manic bipolar disorder.
Infertility: Treatment of infertility in women with anovulatory disorders.
Gynecomastia: Tamoxifen is used to prevent estrogen related gynecomastia.
Riedel's thyroiditis treatment.
Ductal Carcinoma in Situ (DCIS).
Dose, Administration and Dosage Forms:
Tamoxifen is available in orally administered tablets in 10mg and 20mg strengths. Dosage is dependent on the indication for which it is prescribed. For the treatment of breast cancer, the recommended dose is 20mg once per day to 20mg twice per day. For the treatment of ductal carcinoma and prevention of breast cancer in high risk women, the recommended dose is 20 mg per day for up to 5 years. Tamoxifen tablets should be stored at room temperature between 20 C to 25 C in a tightly closed, light resistant container.
Mechanism of Action:
Tamoxifen is a prodrug which is metabolized in the liver by the cytochrome P450 into active metabolites such as 4-hydroxytamoxifen and N-desmethyl-4-hydroxytamoxifen. These active metabolites have 30-100 times more affinity than tamoxifen toward estrogen receptors and thereby competitively inhibit and prevent the binding of estrogen to the estrogen receptors. Since various breast cancer cells require estrogen for their normal growth, this lack of estrogen at the cellular level blocks breast cancer cell growth by decreasing DNA synthesis.
Side-effects and Safety Profile:
Side-effects of moderate severity reported with tamoxifen usage include: hair thinning, tumor related pain, depression, hot flashes, headache, fever, chills, body aches, bone and joint pain, dizziness, numbness, purple or red pinpoint spots under the skin, restlessness, weakness, hands or feet swelling, nausea, increased thirst, loss of appetite, upper stomach pain, vaginal dryness and itching, suppressed sexual drive, impotence and difficulty in reaching orgasm, etc.
Tamoxifen is contraindicated in patients who are allergic to it.
Tamoxifen is contraindicated for those patients who need concomitant warfarin anticoagulation treatment because of deep vein thrombosis (DVT) and/or pulmonary embolus.
Tamoxifen may cause uterine cancer, strokes, and blood clotting with a serious or fatal outcome. Patients must discuss any history of stroke, heart attack and blood clotting with their physician.
Patients should tell their doctor if they smoke or have high blood pressure, diabetes, or impaired walking ability before taking tamoxifen.
Genital organs should be regularly monitored and examined for early signs of uterine cancer.
Tamoxifen is classified as a pregnancy category D drug, meaning it may cause fetal harm; therefore, it should not be prescribed to pregnant women.
Studies have not been performed on nursing mothers to determine whether tamoxifen excretes in breast milk. Therefore, tamoxifen should be prescribed in nursing women only if the potential benefit justifies the risk to the baby.
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