Tamoxifen-Zdorovye tablets are used for the following indications:
breast cancer and endometrial cancer in women; adjuvant chemotherapy of breast cancer with lymph node involvement in women, treatment of metastatic breast cancer in women and men.
Composition
One tablet contains (active ingredient) tamoxifen 20 mg.
Excipients: potato starch; lactose, monohydrate; calcium stearate; povidone; colloidal anhydrous silicon dioxide.
Contraindication
hypersensitivity to the components of the drug; severe thrombocytopenia, leukopenia; severe hypercalcemia; simultaneous use of anastrazole and tamoxifen.
Method of application
The recommended daily dose of tamoxifen for adults is 20 mg. In cases of advanced cancer, doses may be increased to 30 mg or 40 mg per day.
The maximum daily dose of tamoxifen is 40 mg. An objective therapeutic effect is usually observed after 4-10 weeks of treatment, however, in the presence of bone metastases, a positive effect can be achieved only after several months of therapy.
The tablets should be swallowed without chewing, with sufficient liquid.
If two or more tablets of the drug are prescribed per day, they can be taken in 1 or 2 doses.
The duration of treatment depends on the severity of the disease. Treatment is usually long-term.
Application features
Pregnant women
Tamoxifen is contraindicated during pregnancy or breastfeeding.
Children
Recommendations for tamoxifen treatment of children have not yet been developed.
Drivers
Tamoxifen is unlikely to affect the ability to drive or use machines. However, fatigue, drowsiness, and blurred vision have been reported during tamoxifen treatment. Patients experiencing these symptoms should be cautious when driving or using machines.
Overdose
Symptoms
Tamoxifen has been shown to have estrogenic effects in animals at high doses. In theory, overdose would be expected to lead to increased antiestrogenic side effects.
There have been no reports of acute overdose in humans. Little is known about overdose in humans. At doses of 160 mg/m2 and above, ECG changes (prolonged QT interval) occurred, and at doses of 300 mg/m2 daily, neurotoxicity (tremor, hyperreflexia, unsteady gait, and vertigo) occurred.
Treatment
There is no specific antidote. In case of overdose, symptomatic treatment should be carried out.
Side effects
Most of the side effects listed below are reversible, often resolving after dose reduction.
Benign and malignant neoplasms (including cysts and polyps): Cases of exacerbation of the disease have been reported. A small number of patients with bone metastases develop hypercalcemia at the beginning of tamoxifen therapy. During this initial period, bone pain and swelling may increase, as may erythema around skin lesions, indicating a response to therapy. Existing skin lesions may also enlarge or new ones may appear.
Tamoxifen therapy is associated with an increased incidence of endometrial proliferative changes, including polyps and endometrial cancer. The risk of endometrial cancer increases with duration of tamoxifen therapy and is approximately 2-3 times greater than that of women who have not taken the drug. There is also a slightly increased incidence of uterine sarcoma (predominantly malignant mixed Müllerian tumors). However, the clinical benefit of tamoxifen treatment of breast cancer outweighs the potential risk of endometrial neoplasms.
From the blood and lymphatic system: transient anemia, leukopenia, thrombocytopenia (the platelet count usually decreases to 80,000-90,000/mm3). Cases of agranulocytosis, neutropenia, sometimes severe neutropenia, pancytopenia have been reported.
Endocrine system: hypercalcemia in patients with bone metastases, particularly at the beginning of treatment.
Metabolic: fluid retention, increased serum triglyceride levels, anorexia. There have been isolated reports of severe hypertriglyceridemia, sometimes accompanied by pancreatitis.
Mental: depression, loss of libido in men.
From the nervous system: dizziness, headache, drowsiness, sensory disturbances (paresthesia, dysgeusia).
From the organs of vision: decreased visual acuity, corneal opacity, development of cataracts and retinopathy. These effects probably depend on the doses of tamoxifen and the duration of therapy. They may be partially reversible after discontinuation of tamoxifen treatment. Cases of optic neuropathy, optic neuritis have been noted (rarely, loss of vision was observed).
Vascular disorders: facial flushing, ischemic cerebrovascular events, lower limb cramps, thrombosis, stroke. Tamoxifen therapy in combination with other cytotoxic drugs may increase the risk of thromboembolic events, including venous thromboembolism: deep vein thrombosis and pulmonary embolism.
Respiratory, thoracic and mediastinal disorders: interstitial pneumonitis.
Hepatobiliary system: changes in liver enzymes, fatty infiltration of the liver, cirrhosis, fatty hepatosis. There have been isolated reports of cholestasis, hepatitis, jaundice, necrotizing hepatitis, hepatocellular lesions, liver failure. Sometimes more severe liver disorders have led to death.
Skin and subcutaneous tissue disorders: skin rashes (including isolated cases of erythema multiforme, Stevens-Johnson syndrome or bullous pemphigoid); alopecia, hypersensitivity reactions, including isolated cases of angioedema; cutaneous vasculitis, cases of cutaneous lupus erythematosus have also been reported.
Musculoskeletal and connective tissue disorders: myalgia.
Reproductive system and breast disorders: vaginal discharge, menstrual irregularities and suppression of menstruation in the premenopausal period, vaginal bleeding; genital itching, increase in the size of uterine fibroids, proliferative changes in the endometrium (endometrial neoplasia, hyperplasia and polyps, rarely endometriosis). Cases of impotence in men, cystic ovarian edema, vaginal polyps have been reported.
Congenital, hereditary and genetic disorders: chronic hematoporphyria.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
