Product Name: Tamoxiver
Active substance: Tamoxifen Citrate
Tamoxiver is a non-steroidal anti-estrogen agent with too weak estrogenic properties. Its action is based on the ability to block estrogen receptors. Tamoxiver, as well as some of its metabolites, estradiol compete for binding sites with cytoplasmic estrogen receptors in tissues of the breast, uterus, vagina, the anterior pituitary gland tumor and with a high content of estrogen receptors. In contrast to estrogen receptor, complex receptor complex tamoxifen citrate does not stimulate DNA synthesis in the nucleus and inhibits cell division that leads to the regression of tumor cells and their death.
Estrogen-dependent breast cancer in women (especially postmenopausal) and male breasts. The drug can be used to treat ovarian cancer, endometrial cancer, kidney cancer, melanoma, soft tissue sarcoma in the presence of estrogen receptor in the tumor, as well as for the treatment of prostate cancer with resistance to other drugs.
Contraindications and Cautions:
- Increased sensitivity to tamoxifen citrate or any other ingredient of the drug.
Renal failure, diabetes, eye diseases (including cataracts), deep vein thrombosis and thromboembolic disease (including history), hyperlipidemia, leukopenia, thrombocytopenia, hypercalcemia, concomitant therapy with indirect anticoagulants. Women taking Tamoxiver should undergo regular gynecological examination. When you are bleeding from the vagina or vaginal bleeding should stop taking the drug. In patients with bone metastases from time to time during the initial period of treatment should be to determine the concentration of calcium in the blood serum. In the case of apparent violations of Tamoxiver should be suspended. If signs of venous thrombosis of the lower limbs (leg pain or swelling), pulmonary embolism (shortness of breath), the drug should be discontinued.
During therapy should periodically monitor the performance of blood clotting, blood calcium, blood count (leukocytes, platelets), liver function tests, blood pressure, conduct eye check-ups. In hyperlipidemic patients during treatment to control the concentration of cholesterol and triglycerides in blood serum. Effects on ability to drive and use machines. In the period of treatment should refrain from activities probable hazardous activities that require high concentration and speed of psychomotor reactions.
Tamoxiver in the treatment of the most common adverse reactions associated with its anti-estrogenic effect, manifested in the form of hot flashes (hot flushes), vaginal bleeding or discharge, itching in the genital area, alopecia, pain in the area of the lesion, ossalgiya, weight gain. Less frequently or rarely observed adverse reactions were: fluid retention, anorexia, nausea, vomiting, constipation, fatigue, depression, confusion, headache, dizziness, drowsiness, fever, skin rash, visual disturbances, including corneal changes, cataracts, retinopathy and optic neuritis. At the beginning of treatment may exacerbation local - to increase the size of soft tissue structures, sometimes accompanied by severe erythema, lesions and surrounding areas - which usually goes away within 2 weeks. May increase the risk of thrombosis and thrombophlebitis. Sometimes there may be transient leukopenia and thrombocytopenia, as well as increased levels of liver enzymes, rarely accompanied by a more severe hepatic impairment, such as fatty liver, cholestasis and hepatitis. In some patients with bone metastases at baseline was observed hypercalcemia. Tamoxiver causes amenorrhea or irregular onset of menstruation in women in the premenopausal and reversible development of cystic tumors of the ovary. With long-term treatment with tamoxifen citrate may experience changes in the endometrium, including hyperplasia, polyps, and in rare cases - cancer of the endometrium, and the development of uterine fibroids.
The dosage regimen is usually set individually depending on the evidence. The daily dose is 20-40 mg. As a standard dose is recommended to take 20 mg of Tamoxiver daily inside for a long time. If signs of progression of the disease the drug overturned. The tablets should be taken without chewing, with a small amount of fluid at one time in the morning, or by sharing the required dose into two doses in the morning and evening.
When concomitant administration of Tamoxiver and cytotoxic drugs increase the risk of thrombotic events. Antacids, histamine H2-receptor antagonists and other drugs of similar action by increasing the pH of the stomach can cause premature dissolution and loss of protective effect of enteric tablets. The interval between tamoxifen citrate and these drugs should be 1-2 hours. There are reports on the strengthening of the anticoagulant effect of drugs Tamoxiver coumarin (eg, warfarin). Drugs that decrease the excretion of calcium (eg, thiazide diuretics series), may increase the risk of hypercalcemia. Combined use of Tamoxiver and tegafur can promote chronic active hepatitis and cirrhosis. Concomitant use of tamoxifen citrate with other hormones (especially estrogen-contraceptives) leads to a weakening of the specific effect of both drugs.
Store in a dry place protected from light, at a temperature of 15-25 ° C. Keep out of reach of children.