Universal reference book for medicines
Product name: TAMOXIFEN-EBEVE (TAMOXIFEN-EBEWE)

Active substance: tamoxifen

Type: Antiestrogenic drug with antitumor effect

Manufacturer: EBEWE PHARMA (Austria)
Composition, form of production and packaging
Tablets are
round, almost white in color, with a cross-shaped separation groove on one side.

1 tab.

tamoxifen citrate 15.2 mg,

which corresponds to the content of tamoxifen 10 mg

[PRING] lactose, cellulose, starch, silicon dioxide colloid, magnesium stearate.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
30 pcs.
- polypropylene white bottles (1) - cardboard packs.
Tablets are round, almost white in color, with a cross-shaped separation groove on one side.

1 tab.

tamoxifen citrate 30.4 mg,

which corresponds to the content of tamoxifen 20 mg

[PRING] lactose, cellulose, starch, silicon dioxide colloid, magnesium stearate.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
30 pcs.
- polypropylene white bottles (1) - cardboard packs.
Tablets are round, almost white in color, with a separating groove on one side.

1 tab.

tamoxifen citrate 45.6 mg,

which corresponds to the content of tamoxifen 30 mg

[PRING] lactose, cellulose, starch, silicon dioxide colloid, magnesium stearate.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
30 pcs.
- polypropylene white bottles (1) - cardboard packs.
The tablets are oblong, almost white in color, with a separating groove on both sides.

1 tab.

tamoxifen citrate 60.8 mg,

which corresponds to the content of tamoxifen 40 mg

[PRING] lactose, cellulose, starch, silicon dioxide colloid, magnesium stearate.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
30 pcs.
- polypropylene white bottles (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Tamoxifen is a non-steroidal antiestrogenic agent that also has weak estrogenic properties.
Its action is based on the ability to block estrogen receptors. Tamoxifen, as well as some of its metabolites, compete with estradiol for binding sites with cytoplasmic estrogen receptors in the tissues of the mammary gland, uterus, vagina, anterior pituitary and tumors with a high estrogen receptor content. In contrast to the receptor complex of estrogen receptor the tamoxifen complex does not stimulate the synthesis of DNA in the nucleus, but inhibits cell division, which leads to regression of tumor cells and their death.
PHARMACOKINETICS

After oral administration, tamoxifen is absorbed well.
C max in the serum is achieved within the range of 4 to 7 hours after administration of a single dose. C ss oftamoxifen in serum is usually achieved after 3-4 weeks of administration.
Metabolized in the liver with the formation of several metabolites.
The excretion of tamoxifen from the body has a two-phase character with an initial T 1/2 of 7 to 14 hours and a subsequent slow terminal T 1/2 for 7 days. It is allocated mainly in the form of conjugates, mainly with fecal masses and only small amounts are excreted in the urine.
INDICATIONS

- Estrogen-dependent breast cancer in women (especially menopause) and mammary glands in men.

The drug can be used for the treatment of ovarian cancer, endometrial cancer, kidney cancer, melanoma, soft tissue sarcomas in the presence of estrogen receptors in the tumor, as well as for the treatment of prostate cancer in the resistance to other medicines.

DOSING MODE

The dosage regimen is usually set individually, depending on the indications.
The daily dose is 20-40 mg. As a standard dose, taking 20 mg of tamoxifen inside daily for a long time is recommended. When there are signs of progression of the disease, taking the drug is canceled.
Tablets should be taken without chewing, squeezed a small amount of liquid, at 1 in the morning or, dividing the required dose into 2 doses, in the morning and in the evening.

SIDE EFFECT

In the treatment of tamoxifen, the most frequent adverse reactions associated with its anti-estrogenic effect, manifested in the form of paroxysmal sensations of heat (tides), vaginal bleeding or discharge, itching in the genital area, alopecia, pain in the area of ​​the lesion, ossalgia, weight gain.
Less frequently or rarely, the following adverse reactions were observed: fluid retention, anorexia, nausea, vomiting, constipation, fatigue, depression, confusion, headache, dizziness, drowsiness, fever, skin rash, visual impairment, including corneal changes, cataracts , retinopathy and retrobulbar neuritis.
At the beginning of treatment, local exacerbation of the disease is possible - an increase in the size of soft tissue formations, sometimes accompanied by a pronounced erythema of the affected areas and adjacent areas - which usually occurs within 2 weeks.

The likelihood of thrombophlebitis and thromboembolism may increase.

Sometimes transient leukopenia and thrombocytopenia can occur, as well as an increase in the level of hepatic enzymes, very rarely accompanied by more severe impairment of liver function, such as fatty liver infiltration, cholestasis and hepatitis.

In some patients with bone metastases, gipekalcia was observed at the beginning of the treatment.

Tamoxifen causes amenorrhea or irregularity of menstrual periods in premenopausal women, as well as reversible development of ovarian cystic tumors.

With long-term treatment with tamoxifen, there may be changes in the endometrium, including hyperplasia, polyps and in single cases
- endometrial cancer, as well as the development of uterine fibroids.
CONTRAINDICATIONS

- Pregnancy and lactation;

- Hypersensitivity to tamoxifen and / or any other ingredient in the drug.

With caution - renal failure, diabetes, eye diseases (including cataracts), deep vein thrombosis and thromboembolic disease (including in the history), hyperlipidemia, leukopenia, thrombocytopenia, hypercalcemia.

PREGNANCY AND LACTATION

Contraindication: pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution - kidney failure.

SPECIAL INSTRUCTIONS

Women receiving tamoxifen should undergo regular gynecological examinations.
When bloody discharge from the vagina or vaginal bleeding occurs, the drug should be discontinued. In patients with metastases in the bone, periodically during the initial period of treatment should determine the concentration of calcium in the blood serum. In case of severe disorders, tamoxifen should be temporarily discontinued.
When signs of thrombosis of the veins of the lower extremities (pain in the legs or their swelling), pulmonary embolism (dyspnea), the drug should be stopped.Tamoxifen can cause ovulation, which increases the risk of pregnancy, and therefore women who have an active sexual life during (and within about 3 months after) treatment with tamoxifen recommended the use of a mechanical or non-hormonal contraceptive.

During the period of therapy, it is necessary to periodically monitor the blood clotting parameters, the calcium content in the blood, the blood picture (leukocytes, platelets), liver function indicators, blood pressure, and check with the oculist.

In patients with hyperlipidemia, the concentration of cholesterol and TG in serum should be monitored during treatment.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

OVERDOSE

Acute overdose of tamoxifen in humans was not observed.
It should be expected that an overdose can cause an increase in the above-described adverse reactions.
Specific antidotes do not exist, treatment should be symptomatic.

DRUG INTERACTION

With the simultaneous administration of tamoxifen and cytostatics, the risk of thrombosis increases.

Antacids, H 2 -gistamine receptor blockers and other drugs of similar effect, increasing the pH value in the stomach, can cause premature dissolution and loss of protective effect of the enteric-soluble tablet.
The interval between taking tamoxifen and these drugs should be 1-2 hours.
There are reports of increased tamoxifen anticoagulant effect of coumarin drugs (eg, warfarin).

Drugs that reduce the excretion of calcium (eg, thiazide diuretics) may increase the risk of hypercalcemia.

The combined use of tamoxifen and tegafur can promote the development of active chronic hepatitis to cirrhosis of the liver.

The simultaneous use of tamoxifen with other hormonal drugs (especially estrogen-containing contraceptives) leads to a weakening of the specific effects of both drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Store in a dry, protected
from the light at a temperature of no higher than 25 ° C.
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