Tamoxifen 20 mg №30 pills / Ozone /
Composition and release form1 tablet contains:
active ingredients: tamoxifen citrate 10, 20, 30 or 40 mg;
in a package of 10, 20, 30, 40, 50, 60, 90, 100, 120, 150 pills.
pharmachologic effectTamoxifen is a non-steroidal anti-estrogen agent, possessing also poor estrogenic properties. Its action is based on the ability to block estrogen receptors. Tamoxifen, and also some of its metabolites compete with estradiol at the site of binding to the cytoplasmic estrogen receptors in the tissues of the mammary gland, the wedge, the womb, the anterior pituitary gland in tumors with a high content of estrogen receptors. In contrast to the estrogen receptor complex, the receptor complex of tamoxifene does not stimulate DNA synthesis in the nucleus, but inhibits cell division, which leads to regression of tumor cells as a result of their death.
PharmacokineticsAfter oral administration, tamoxifen is well absorbed. Cmax in serum is achieved within 4 to 7 hours after a single dose. The equilibrium concentration of tamoxifen in the serum is usually achieved after 3-4 weeks of intake. Communication with plasma proteins - 99%.
Metabolized in the liver to form metabolites.
Removal of tamoxifen from the body is biphasic in nature with an initial T1 / 2 from 7 to 14 h and with subsequent slow terminal T1 / 2 for 7 days. It is excreted mainly in the form of conjugates, mainly with feces and only small amounts are excreted in the urine.
Tamoxifen, indications for useEstrogen-dependent breast cancer in women (especially in menopause) and in men.
The drug can be used for the treatment of ovarian cancer, endometrial cancer, kidney cancer, melanoma, soft tissue tissue in the presence of estrogen receptors in the tumor, and also for the treatment of prostate cancer with other lectures.
Hypersensitivity to tamoxifen and / or any other ingredient of the drug Tamoxifen.
With care: renal failure, diabetes mellitus, eye diseases (including cataracts), deep vein thrombosis and thromboembolic disease (including history), hyperlipidemia, leukopenia, thrombocytopenia, hypercalcemia, concomitant therapy with indirect anticoagulants.
Dosage and administrationThe dosage regimen is usually set individually depending on the situation. The daily dose is 20-40 mg.As a standard dose, it is recommended to take 20 mg of tamoxifene orally daily for a long time until signs of disease progression appear.
pills should be taken unzipped, zapivaya by a small amount of liquid, with food in a single dose in the morning, or by dividing the required dose into two in the morning and evening.
Side effectsIn the treatment of Tamoxifen, the most common adverse reactions associated with its anti-estrogenic effect, manifested in the form of paroxysmal sensations of heat (tides), vaginal bleeding or discharge, itching in the genital area, alopecia, pain in the lesion, ossalgia, weight gain.
The following adverse reactions were less frequently or rarely observed: fluid retention, anorexia, nausea, vomiting, constipation, fatigue, depression, confusion, headache, dizziness, drowsiness, fever, skin rash, blurred vision, including changes in the cornea, cataract , retinopathy and retrobulbar neuritis.
At the beginning of treatment, a local exacerbation of the disease is possible - an increase in the size of soft-tissue formations, sometimes accompanied by severe erythema of the affected areas and surrounding areas - which usually passes within 2 weeks. The likelihood of thrombophlebitis and thromboembolism may increase. Sometimes transient leukopenia and thrombocytopenia can occur, as well as an increase in the level of liver enzymes, very rarely accompanied by more severe disorders of liver function, such as fatty infiltration of the liver, cholestasis and hepatitis.
In some patients with bone metastases, hypercalcemia was observed at the beginning of treatment.
Tamoxifen causes amenorrhea or irregular menstruation in women in the premenopausal period, as well as the reversible development of ovarian cystic tumors.
With long-term treatment with Tamoxifen, changes in the endometrium can be observed, including hyperplasia, polyps, and in rare cases endometrial cancer, as well as the development of uterine fibroids.
special instructionsWomen receiving tamoxifen should undergo regular gynecological examination. When a bloody discharge from the vagina or vaginal bleeding occurs, the drug should be stopped.
In patients with bone metastases, the concentration of calcium in the serum should be determined periodically during the initial period of treatment. In case of marked violations, tamoxifen should be temporarily stopped.
If there are signs of venous thrombosis of the lower extremities (pain in the legs or their swelling), pulmonary embolism (shortness of breath), the drug should be stopped.
During the period of therapy, it is necessary to periodically monitor blood coagulation parameters, calcium content in the blood, blood picture (leukocytes, platelets), liver function indicators, blood pressure, to be examined by an ophthalmologist.
In patients with hyperlipidemia in the process of treatment it is necessary to control the concentration of cholesterol and TG in the serum.
Influence on ability to drive motor transport and control mechanismsDuring the period of treatment, it is necessary to refrain from practicing potentially dangerous activities that require increased concentration of attention and psychomotor speed.
Interaction with other drugsWith the simultaneous appointment of tamoksifena and cytostatics increases the risk of thrombosis.
There are reports of the potentiation of the anticoagulant effect of the coumarin series by drugs (eg, parpharin).
Medicines that reduce the renal excretion of calcium, such as diuretics of the thiazide series, may increase the risk of hypercalcemia.
The simultaneous use of tamoxifen with other hormonal preparations (especially estrogen-containing counter-receptacles) leads to the weakening of the specific action of both drugs.
OverdoseAcute overdose of tamoxifen was not observed in humans. It should be expected that overdose may cause an increase in the above described adverse reactions. There are no specific antidotes, treatment should be symptomatic.
Storage conditionsB. List: In a dry, the dark place at a temperature below 25 ° C.
It is a pharmaceutical drug. Use only as directed by your doctor.