Description
Tablets are white, square-shaped, flat on both sides and chamfered, scored and engraved "BP" on one side, with rounded edges. Dosage form Tablets. PHARMACOTHERAPEUTIC GROUP and ATC code: Antitumor agent, L02B A01. PHARMACOLOGICAL PROPERTIES: Pharmacodynamic properties Tamoxifen is an antimetabolite (antiestrogen) that competes with estrogen receptors in the cytoplasm of estrogen-dependent tumor cells. Together with them, it penetrates into the nucleus, where it blocks the interaction of estrogen with its receptors. pharmacokinetic properties. After oral administration, the drug is rapidly absorbed and maximum serum concentrations are reached within 4-7 hours. Steady-state concentrations (approximately 300 ng/mL) are achieved after four weeks of treatment with a daily dose of 40 mg. Tamoxifen binds well to serum albumin (>99%). As a result of metabolism, in the process of hydroxylation, demethylation and conjugation, a number of metabolites are formed that have pharmacological profiles similar to the parent chemical compound, which thus contributes to the achievement of a therapeutic effect. The half-life is 7 days. Excretion occurs mainly through feces. INDICATIONS: Metastatic breast cancer, especially in menopausal patients, endometrial cancer, kidney cancer, soft tissue sarcoma, anovulatory infertility, postpartum agalactia, oligospermia, pituitary tumors.It has been observed that the prophylactic administration of tamoxifen to women at risk of breast cancer reduces their incidence by 45% compared to women of the same risk who did not take the drug. METHOD OF APPLICATION AND DOSES: In case of breast, endometrial or kidney cancer, 10-20 mg 2-3 times a day. The course dose is 2.4-9.6 g, treatment continues until the process regresses and for the next 1-2 months. With anovulatory infertility, 10 mg 2 times a day for 4 days, starting from the 2nd day of menstruation, then 20 mg 2 times a day, and if necessary, 40 mg 2 times a day. With postpartum agalactia, 10 mg 4 times a day for 5 days. With oligospermia, 10 mg 2 times a day. SIDE EFFECTS: Lack of appetite, nausea, vomiting. Feeling tired, drowsiness, dizziness, erythema, hypercalcemia, moderate metrorrhagia. Pulmonary embolism, thrombosis. Endometrial hyperplasia, polyposis or endometrial carcinoma, uterine fibroids, cystic ovarian swellings in women, retinopathy, corneal clouding, hot flashes, weight gain, genital itching, changes in the menstrual cycle. Headaches. Rarely fever, leukopenia, sometimes with anemia and / or thrombocytopenia, neutropenia. Changes in the levels of liver enzymes, and in rare cases, with more serious disorders, including fatty liver, cholestasis and hepatitis. CONTRAINDICATIONS: Absolute – pregnancy, thrombophlebitis, hypersensitivity to tamoxifen. Relative – leukopenia, thrombocytopenia, hyperlipidemia, hypercalcemia, cataracts. OVERDOSE: increased antiestrogenic side effects. There is no specific antidote and treatment should be symptomatic. PRECAUTIONS AND PECULIARITIES OF APPLICATION: In the process of treatment, it is necessary to control the number of leukocytes, platelets, calcium levels, indicators of the blood coagulation system. Little effective in the treatment of patients with metastases (especially in the liver). A number of women taking tamoxifen for the treatment of pre-menopausal breast cancer do not have periods. it is recommended to carefully monitor patients while using coumarin-type anticoagulants. Lactation: There are no data on the excretion of tamoxifen into breast milk in women, so its use during lactation is not recommended. INTERACTION WITH OTHER DRUGS: Antacids and secretolytics should not be administered simultaneously with tamoxifen, but with an interval of 2 hours. Estrogens weaken the effect of tamoxifen, and progestogens enhance it. Cytostatics increase the risk of thrombosis. The use of the drug in combination with coumarin-type anticoagulants can cause a significant increase in the anticoagulant effect. NAME AND ADDRESS of the manufacturer: SC Balkan Pharmaceuticals SRL Republic of Moldova mun. Chisinau, st. Gradescu, 4.
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