Tamoksifen-Zdorovye, the tab. on 10 mg No. 60

General characteristics. Structure:

International and chemical names: Tamoxifenum (tamoxifen); ((Z)-2-[4-(1,2-difenilbut-1-enil) of a fenoksa] ethyldimethine citrate); main physical and chemical properties: tablets of white color; structure: 1 tablet contains Tamoxifenum of citrate 0,01530 g (0,01 g of Tamoxifenum are equivalent); excipients: starch potato or corn, sugar milk, calcium stearate, polyvinylpirrolidone low-molecular medical, aerosil.

Pharmacological properties:

Tamoxifenum – antineoplastic drug which shows anti-oestrogenic action. Action of Tamoxifenum is caused by its ability to contact competitively oestrogenic receptors in target organs and to interfere with their interaction with an endogenous ligand - 17 - oestradiol. It slows down development of the tumoral process stimulated by estrogen. Drug has no androgenic activity.

Pharmacokinetics. At reception of tablets Tamoxifenum is well soaked up from a digestive tract; the maximum concentration in blood is observed approximately in 3-7 h after a single dose. Equilibrium concentration in blood is established in 4 weeks after an initiation of treatment. It is metabolized in a liver by a hydroxylation and demethylation. It is removed slowly, preferential with a stake, in the form of metabolites. An elimination half-life of the main metabolite - N-dezmetiltamoksifena - 14 days, not changed Tamoxifenum - about 7 days.

Indications to use:

Breast cancer, especially at women in a menopause, cancer of chest gland at men, endometrial cancer and ovaries, cancer of kidneys, the melanoma (containing oestrogenic receptors), a prostate cancer at resistance to other medicines, hypophysis tumors, sarcoma of soft tissues, postoperative therapy for the purpose of correction of the hormonal status, and also in cases if surgical intervention or radiation therapy, anovulatory infertility, an oligospermatism is not shown.

Route of administration and doses:

The mode of dosing is set individually, depending on indications, by conditions of the patient and the applied scheme of antineoplastic therapy. Appoint only the adult. At a breast cancer, an endometria, kidneys the initial dose of drug makes 10-20 mg (on 10 mg 1-2 times a day), then, if necessary, it is possible to increase a dose to 30 mg, and in 7-10 days - to 40 mg a day (on 20 mg 2 times a day), by a course - 2,4-9,6 g. If necessary and lack of by-effects the daily dose can be increased to 60 mg (3 times on 20 mg). Treatment is carried out it is long, usually 2,5-3 months, sometimes - 2-3 years, before emergence of signs of regression of process and within the next 1-2 months. Repeated courses are conducted after 1-2 months of a break.
At patients with cancer of a mammary gland after an operative measure for the purpose of correction of the hormonal status Tamoxifenum apply in a dose 20 mg (on 10 mg 2 times a day). At anovulatory infertility accept 10 mg 2 times a day, within 4 days in a row, since 2nd day of periods; at the subsequent 4-day cycles it is possible to increase a dose to 20-40 mg 2 times a day. At an oligospermatism - on 10 mg 2 times a day.

Features of use:

Prior to treatment female patients have to pass careful gynecologic (for a pregnancy exception) and therapeutic inspection; women of childbearing age should use well-tried contraceptive remedies (not peroral), and contraception has to continue within 3 months after the termination of a course. In the course of treatment control of number of leukocytes, thrombocytes, level of calcium, indicators of system of a blood coagulation is necessary. Extra care and careful observation is required at treatment of patients with pathology of kidneys, a diabetes mellitus, ophthalmologic diseases and thromboembolic disturbances in the anamnesis. Tamoxifenum is ineffective for treatment of patients with metastasises in a liver. In need of use of drug in the period of a lactation it is necessary to stop breastfeeding. At development of vaginal bleedings, metrorrhagias and hypostases of legs the dose of Tamoxifenum should be reduced.
At reception of Tamoxifenum it is recommended to abstain from the activity demanding the increased concentration of attention or bystry mental reactions.

Side effects:

From the alimentary system: loss of appetite, nausea, vomiting, gastrointestinal frustration, increase in activity of hepatic transaminases; in some cases - fatty infiltration of a liver, a cholestasia, hepatitis. From the central nervous system: a depression, dizziness, a headache, at long therapy by high doses - a retinopathy, a keratopathy, a cataract, retrobulbar neuritis. From system of a hemopoiesis: seldom - thrombocytopenia, a leukopenia, anemia. From endocrine system: women have an endometria hyperplasia, vaginal bleedings, inflows, suppression of a menstrual cycle, increase in body weight; men have импотенцèprom-rus.com/admin/preparat_edit.phpя, decrease in a libido. From cardiovascular system: hypostases, thrombembolia, phlebitis. Dermatological reactions: seldom - weak skin rashes on a face, a neck, breasts, an itch, an alopecia. Other: hypercalcemia, ostealgias, fervescence.

Interaction with other medicines:

The combination to radio - and cytostatic therapy is allowed, but it is necessary to consider that the combined use with cytostatics increases risk of a thrombogenesis. At simultaneous use of Tamoxifenum and Allopyrinolum disturbance of functions of a liver is possible. It is not recommended to combine with hormonal drugs, especially with estrogen because the last reduce therapeutic effect of Tamoxifenum.

Contraindications:

Individual intolerance, thrombophlebitis, heavy thrombocytopenia, leukopenia, hypercalcemia, pregnancy.

Overdose:

It is shown in strengthening of side effects. Treatment - symptomatic.

Storage conditions:

To store in dry, protected from light and the place, unavailable to children, at a temperature not above 25 °C.
Period of storage - 2 years.

Issue conditions:

According to the recipe

Packaging:

On 20 or 30 tablets in a blister strip packaging or on 60 tablets in a container.