Instruction for use: Tamoxifen citrate

Active substance Tamoxifen

ATX code L02BA01 Tamoxifen

Pharmacological groups

Estrogens, gestagens; Their homologues and antagonists

Antineoplastic hormonal agents and hormone antagonists

Nosological classification (ICD-10)

C50 Malignant neoplasm of breast

Cancer of the nipple and areola of the breast, Breast carcinoma, The hormone-dependent form of recurrent breast cancer in women in menopause, Hormone-dependent breast cancer, Disseminated breast carcinoma, Disseminated Breast Cancer, Malignant breast cancer, Malignant neoplasm of breast, Contralateral breast cancer, Locally advanced or metastatic breast cancer,Locally-distributed breast cancer, Locally-recurring breast cancer, Metastatic breast carcinoma, Metastasis of breast tumors, Metastatic breast carcinoma, Inoperable breast carcinoma, Incompatible breast cancer, Breast cancer in women with metastases, Breast cancer in men with metastases, Breast Cancer, Breast cancer in men, Mammary cancer, Breast cancer with distant metastases, Breast cancer in postmenopausal women, Breast cancer hormone-dependent, Breast cancer with local metastases, Breast cancer with metastases, Breast cancer with regional metastases,Breast cancer with metastases, Common hormone-dependent forms of breast cancer, Common Breast Cancer, Recurrent Breast Cancer, Recurrence of breast tumors, Breast cancer, Estrogen-dependent breast cancer, Estrogen-Dependent Breast Cancer, Disseminated breast cancer with overexpression of HER2, Tumors of the mammary glands

C75.1 Malignant neoplasm of pituitary gland

Pituitary Tumor, Aumada del Castillo Syndrome, Somatoliberinoma, Pituitary adenoma, Tumors of the pituitary and suprasellar region

D35.2 Benign neoplasm of pituitary gland

Pituitary adenoma, Prolactinomas, Macro-prolaktinoma, Microprolactinoma, Prolactinoma, Somatoliberinoma, Aumada del Castillo Syndrome, Tumors of the pituitary and suprasellar region

D44.3 Neoplasm of uncertain or unknown pituitary nature

Macro-prolaktinoma, Microprolactinoma, Prolactinoma, Somatoliberinoma, Prolactinomas

Composition and form of release

1 tablet contains tamoxifen citrate 10 or 20 mg; In a blister 10 pcs., In a box of 6 or 10 blisters.

pharmachologic effect

Pharmacological action - antitumor, antiestrogenic.

It inhibits the progression of an estrogen-dependent tumor by blocking estrogen receptors. Metabolites of tamoxifen are also antiestrogens.

Pharmacokinetics

Absorption is slow. Cmax - after 3-6 hours The stable level of tamoxifen in the serum is usually achieved after 3-4 weeks of taking the drug. Excreted as conjugates (70%) mainly with feces.

Indications

Estrogen-dependent breast cancer, pituitary tumors, anovulatory infertility.

Contraindications

Thrombophlebitis, pregnancy, lactation (stop breastfeeding).

Side effects

Effects caused by anti-estrogenic action: hot flashes, vaginal bleeding, vaginal discharge, itching in the genital area, alopecia, pain in the lesion and in the bones (with metastases).

From the gastrointestinal tract: nausea, vomiting.

From the central nervous system (central nervous system): rarely - dizziness, headache, depression.

Other: increased body temperature, skin rash; Rarely - edema, thromboembolism, phlebitis, visual impairment, thrombocytopenia.

Interaction

Cytotoxic drugs increase the risk of thrombosis. Potentiates the hypoprothrombotic effect of anticoagulants (eg, warfarin). Affects the level of thyroid hormones in the blood without affecting its function. Tamoxifen should not be given in combination with drugs containing hormones, especially estrogens.

Dosing and Administration

The average daily dose of 20-40 mg (in 1 or 2 doses). The effect of treatment usually appears after 1-3 months of therapy.

Precautionary measures

With caution appoint the drug to patients with leukopenia, thrombocytopenia, hypercalcemia. In the process of treatment, control of the peripheral blood pattern (including determination of the number of platelets), calcium concentration in the blood, observation of the ophthalmologist is necessary.

special instructions

People taking tamoxifen should refrain from studies that require increased concentration of attention, rapid mental reactions.

storage Conditions

In a dry, the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life

4 years.

Do not use after the expiry date printed on the package.