Generic Name: Tamoxifen 20mg
Manufacturer/Distributor: Beximco Pharmaceuticals Ltd.
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Indications
Tamoxifen is prescribed to treat breast cancer.
Pharmacology
Tamoxifen is a nonsteroidal drug that binds to estrogen receptors (ER), causing the receptor to alter its shape. This causes a blockade or alteration in the expression of estrogen-dependent genes. Tamoxifen's extended adherence to the nuclear chromatin of these cells results in decreased DNA polymerase activity, poor thymidine consumption, estradiol uptake blockage, and diminished estrogen responsiveness. Tamoxifen most likely interacts with other tissue coactivators or corepressors and binds to various estrogen receptors, ER-alpha or ER-beta, causing both estrogenic and antiestrogenic effects.
Dosage & Administration
Adults (including elderly): The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily.
Interaction
Tamoxifen may have a significantly increased anticoagulant effect when used with coumarin-type anticoagulants. When starting such co-administration, it is important to keep a close eye on the patient. When Tamoxifen is used with cytotoxic drugs, the risk of thromboembolic events increases.
Contraindications
Tamoxifen should not be used during pregnancy. Tamoxifen should not be administered to patients who have had an allergic reaction to the product or any of its components.
Side Effects
Side effects can be classified as those caused by the drug's pharmacological action, such as hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae, and tumor flare, or as more general side effects, such as gastrointestinal intolerance, headache, light-headedness, and, in rare cases, fluid retention and alopecia. When such side effects are severe, it may be feasible to reduce them with a simple dose reduction (within the approved dose range) without losing disease control.
There have been sporadic reports of skin rashes, including erythema multiforme, Stevens-Johnson syndrome, and bullous pemphigoid, as well as uncommon hypersensitivity responses, including angioedema. On the first day of treatment, a small proportion of patients with bone metastases experienced hypercalcemia.
Platelet counts have been observed to fall in patients using Tamoxifen for breast cancer, generally to 80,000-90,000 per/mm3 but sometimes lower.
A handful of incidences of visual abnormalities, including uncommon reports of corneal alterations and retinopathy, have been reported in Tamoxifen-treated individuals. The drug's administration has been linked to an increase in the occurrence of cataracts. Endometrial alterations such as hyperplasia and polyps have been observed, as have uterine fibroids. Cystic ovarian swellings have been reported on rare occasions in premenopausal women using Tamoxifen.
Tamoxifen has been associated with leucopenia, sometimes in conjunction with anemia and/or thrombocytopenia. Neutropenia has been observed in rare instances, and it can be severe. There is evidence that Tamoxifen treatment increases the risk of thromboembolic events such as deep vein thrombosis and pulmonary embolism.
Tamoxifen has been linked to changes in liver enzyme levels and, in rare cases, a range of more serious liver problems such as fatty liver, cholestasis, and hepatitis. Tamoxifen usage may be related to tooth pancreatitis in some circumstances.
Pregnancy & Lactation
Pregnancy: Tamoxifen should not be used during pregnancy. There have been a few instances of spontaneous abortions, birth abnormalities, and fetal deaths following Tamoxifen use in women, although no causative link has been proven. Reproductive toxicity investigations in rats, rabbits, and monkeys found no evidence of teratogenicity.
Women who are sexually active should be counseled not to become pregnant while taking Tamoxifen and to utilize barrier or other nonhormonal contraceptive methods if they are sexually active. Premenopausal women must be thoroughly checked before beginning therapy to rule out pregnancy. If a woman wishes to become pregnant while taking Tamoxifen or within two months of discontinuing medication, she should be advised of the potential hazards to the fetus.
Breastfeeding: Because it is unknown if Tamoxifen is secreted in human milk, the medication is not suggested during lactation. The choice to stop Tamoxifen should be made with the value of the medication to the nursing mother in mind.
Precautions & Warnings
Women who are sexually active should be counseled not to become pregnant while taking Tamoxifen and to utilize barrier or other nonhormonal contraceptive methods if they are sexually active. Premenopausal women must be thoroughly checked before beginning therapy to rule out pregnancy. Patients receiving or who have previously had Tamoxifen and report atypical gynecological symptoms, particularly vaginal bleeding, should be examined as soon as possible.
Following the treatment of breast cancer patients with Tamoxifen, a number of second primary tumors, developing at locations other than the endometrium and the opposite breast, have been documented in clinical studies. No causative relationship has been shown, and the clinical relevance of these findings is unknown.
Storage Conditions
Temperatures should be kept between 20 and 25 degrees Celsius. Keep out of direct sunlight.
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