Tamoxifen, tablets 10 mg 30 pcs

Pharmacodynamics

Antitumor agent.

The anti-estrogen.

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

Pharmacokinetics

Tamoxifen is metabolized in the liver, undergoing intestinal-hepatic recirculation. It is excreted with the bile as 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.

Pharmacological effect

Pharmacodynamics

Antitumor agent.

Antiestrogen.

Blocks estrogen receptors and thus inhibits the progression of tumor disease stimulated by estrogen.

Pharmacokinetics

Tamoxifen is metabolized in the liver and undergoes enterohepatic recirculation. Excreted in bile in the form of metabolites.

Special instructions

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

During treatment, the peripheral blood picture (especially the platelet count) should be regularly monitored; blood calcium and glucose levels; with long-term use, observation by an ophthalmologist is indicated (every 3 months).

Should not be combined with medications containing hormones, especially estrogens.

When used simultaneously with drugs that affect the blood coagulation system, a dose adjustment of tamoxifen is necessary.

Experimental studies have established the carcinogenic effect of tamoxifen.

Active ingredient

Tamoxifen

Composition

1 tablet contains:

Active ingredients:

tamoxifen 10 mg.

Excipients:

corn starch,

lactose,

povidone,

magnesium stearate,

sodium starch glycolate,

purified water.

There are 10 tablets in a blister.

There are 3 blisters in a cardboard package.

Pregnancy

Tamoxifen is contraindicated for use during 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 liver transaminases; in some cases – fatty liver infiltration, cholestasis, hepatitis.

From the side of the central nervous system: rarely – depression, dizziness, headache, retrobulbar neuritis.

From the organ of vision: rarely – retinopathy, keratopathy, cataract.

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, itching.

Other: pain in bones and lesions, increased body temperature.

Interaction

When used simultaneously with coumarin derivatives anticoagulants, the risk of increased anticoagulant action increases; with cytostatics – there may be an increased risk of thrombosis.

When used simultaneously with allopurinol, hepatotoxicity is possible; with aminoglutethimide – a decrease in the concentration of tamoxifen in plasma, apparently due to an increase in its metabolism.

In patients receiving tamoxifen, the neuromuscular blockade caused by atracurium may be prolonged.

With simultaneous use of bromocriptine, the dopaminergic effect of bromocriptine may be enhanced. 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 simultaneously with mitomycin, the risk of developing hemolytic-uremic syndrome increases.

There may be a decrease in the concentration of tamoxifen in the blood plasma, which is apparently due to the induction of the CYP3A4 isoenzyme under the influence of rifampicin.

Estrogens may reduce the therapeutic effect of tamoxifen.

Overdose

Acute overdose with tamoxifen has not 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; treatment should be symptomatic.

Storage conditions

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

Shelf life

3 years

Manufacturer

Ozon, Russia