Tamoxifen

Active material: Tamoxifen
When ATH: L02BA01
CCF: Anti-estrogen drug with antitumor activity
When CSF: 15.13.01
Manufacturer: ORION CORPORATION (Finland)

DOSAGE FORM, STRUCTURE AND PACKAGING

Pills round, lenticular, from white to yellow to white to creamy-yellowish brown color, with Figure “10” on one side.

30 PC. – plastic bottles (1) – packs cardboard.
100 PC. – plastic bottles (1) – packs cardboard.

Pills round, lenticular, from white to yellow to white to creamy-yellowish brown color, with Figure “20” on one side.

Excipients: corn starch, lactose monohydrate, povidone, sodium starch glycolate, magnesium stearate, Purified water.

30 PC. – plastic bottles (1) – packs cardboard.
100 PC. – plastic bottles (1) – packs cardboard.

DESCRIPTION OF ACTIVE SUBSTANCES

Pharmacological action

The antitumor agent. An antiestrogen. Blocks the receptors of estrogen and thus inhibits the progression of tumor diseases, stimulated with estrogen.

Pharmacokinetics

Tamoxifen is metabolized in the liver, kishechno-pechenocna recycling. Return to jelchew in the form of metabolites.

Testimony

Breast cancer in menopausal women, breast cancer in men after castration, kidney cancer, melanoma (contains estrogenic receptors), ovarian cancer; prostate cancer resistance to other drugs.

Dosage regimen

The mode set individually, depending on the evidence, the condition of the patient and the schemes of anticancer therapy.

Side effect

From the digestive system: nausea, vomiting, increase in liver transaminases; in some cases – fatty liver, cholestasis, hepatitis.

CNS: rarely – depression, dizziness, headache, optic neuritis.

On the part of the organ of vision: rarely – retinopathy, keratopathy, Cataract.

From the hematopoietic system: rarely – thrombocytopenia, leukopenia.

On the part of the endocrine system: female – endometrial hyperplasia, vaginal bleeding, tides, weight gain; males – impotence, decreased libido.

Cardio-vascular system: swelling, thromboembolism, phlebitis.

Dermatological reactions: alopecia, rash, itch.

Other: pain in the bones and hotbeds of defeat, fever.

Contraindications

Tromboflebit, pregnancy, hypersensitivity to tamoksifenu.

Pregnancy and lactation

Tamoxifen is contraindicated for use in pregnancy. If necessary, use during lactation should stop breastfeeding.

IN experimental studies teratogenic effect of tamoxifen.

Cautions

Be wary when using radiation, thrombocytopenia, hypercalcemia, in patients with cataract, hyperlipidaemia.

During treatment should regularly monitor the pattern of peripheral blood (especially the number of platelets); calcium level and blood glucose; with long-term use shows the eye observation (every 3 Months).

It should not be combined with drugs, containing hormones, especially the estrogens.

In an application with drugs, influencing svertawatuyu of blood, a correction dose of tamoxifen.

IN experimental studies established carcinogenic effect of tamoxifen.

Drug Interactions

Together with the application antikoagulyantami coumarin derivatives increased risk of strengthening antikoaguljantnogo actions; with cytostatics – possible increased risk of thrombosis.

Together with the application allopourinolom may gepatotoksicescoe; with aminoglutetimidom – reducing the concentration of tamoxifen in plasma, apparently, by raising its metabolism.

Patients, receiving tamoxifen, possible prolongation of neuromuscular blockade, caused by atrakuriem.

If you are applying to dopaminergicheskogo actions may increase bromokriptina bromokriptina.

Patients, receiving tamoxifen, When applying risk threatening development of warfarin clinical situation: possible prolongation of prothrombin time, hematuria, hematoma.

If you are applying with mitomycine increases the risk of haemolytic uraemic syndrome.

May reduce the concentration in the blood plasma of tamoxifen, what, apparently, due to the induction of CYP3A4 izofermenta under the influence of rifampicin.

Estrogens may diminish the therapeutic effect of tamoxifen.