Tamoxifen, pills 10mg, 30pcs

Composition

1 tablet contains:

Active ingredients:

tamoxifen 10 mg.

Auxiliary substances:

corn starch,

lactose,

povidone,

magnesium stearate,

sodium glycolate starch,

purified water.

The blister contains 10 tablets.

There are 3 blisters in a cardboard box.

Pharmacological action

Pharmacodynamics

Antitumor agent.

Antiestrogen.

It blocks estrogen receptors and thus inhibits the progression of estrogen-stimulated tumor disease.

Pharmacokinetics

Tamoxifen is metabolized in the liver, undergoes enterohepatic recycling. It is excreted in the bile in the form of metabolites.

Indications

• Breast cancer in menopausal women;
• breast cancer in men after castration;
• kidney cancer;
• melanoma (containing estrogen receptors);
• ovarian cancer;
• prostate cancer with resistance to other drugs.

Use during pregnancy and lactation

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

Experimental studies have established the teratogenic effect of tamoxifen.

Contraindications

• Thrombophlebitis;
• pregnancy;
• hypersensitivity to tamoxifen.

Side effects

From the digestive system: nausea, vomiting, increased activity of hepatic transaminases; in some cases – fatty liver infiltration, cholestasis, hepatitis.

From the central nervous system: rarely-depression, dizziness, headache, retrobulbar neuritis.

From the side of the organ of vision: rarely-retinopathy, keratopathy, cataracts.

From the hematopoietic system: rarely-thrombocytopenia, leukopenia.

From the endocrine system: in women-endometrial hyperplasia, vaginal bleeding, hot flashes, weight gain; in men-impotence, decreased libido.

From the cardiovascular system: edema, thromboembolism, phlebitis.

Dermatological reactions: alopecia, rash, pruritus.

Other: pain in the bones and lesions, fever.

Interaction

When used concomitantly with anticoagulants coumarin derivatives, the risk of increased anticoagulant action increases; with cytostatics, the risk of thrombosis may increase.

When used concomitantly with allopurinol, a hepatotoxic effect is possible; with aminoglutetimide, a decrease in the concentration of tamoxifen in plasma, apparently due to an increase in its metabolism.

Patients receiving tamoxifen may experience prolonged neuromuscular blockage caused by atracurium.

Concomitant use of bromocriptine may increase the dopaminergic effect of bromocriptine. In patients receiving tamoxifen, when using warfarin, there is a risk of developing a threatening clinical situation: prolongation of prothrombin time, hematuria, and hematoma are possible.

When used concomitantly with mitomycin, the risk of developing hemolytic-uremic syndrome increases.

A decrease in the concentration of tamoxifen in blood plasma is possible, which is probably due to the induction of the CYP3A4 isoenzyme under the action of rifampicin.

Estrogens may reduce the therapeutic effect of tamoxifen.

How to take, course of use and dosage

The dosage regimen is set individually, depending on the indications, the patient’s condition and the antitumor therapy regimen used.

Overdose

No acute tamoxifen overdose has been observed in humans.

Symptoms:  it should be expected that an overdose may cause an increase in the above-described adverse reactions.

Treatment:  There are no specific antidotes, and treatment should be symptomatic.

Special instructions

Use with caution in leukopenia, thrombocytopenia, hypercalcemia, in patients with cataracts, hyperlipidemia.

During treatment, the picture of peripheral blood (especially the number of platelets) should be regularly monitored; the level of calcium and glucose in the blood; with prolonged use, an optometrist is indicated (every 3 months).

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

When used concomitantly with drugs that affect the blood coagulation system, it is necessary to adjust the dose of tamoxifen.

Experimental studies have established the carcinogenic effect of tamoxifen.

Form of production

Pills.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Tamoxifen

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Cancer, Breast Cancer