Universal reference book for medicines
Product name: TAMOXIFEN HEXAL (TAMOXIFEN HEXAL)

Active substance: tamoxifen

Type: Antiestrogenic drug with antitumor effect

Manufacturer: HEXAL (Germany) manufactured by SALUTAS PHARMA (Germany)
Composition, form of production and packaging
The tablets covered with a cover of
white or slightly yellowish color, round, biconcave, with a homogeneous smooth surface.

1 tab.

tamoxifen citrate 15.2 mg,

which corresponds to the content of tamoxifen 10 mg

[PRING] lactose monohydrate 71.3 mg, sodium starch glycolate 10 mg, povidone 2.5 mg, microcrystalline cellulose 24.8 mg, magnesium stearate 1.2 mg.

The composition of the shell: dye white opadray - 2.5 mg (lactose - 0.9 mg, titanium dioxide - 0.65 mg, hypromellose - 0.7 mg, polyethylene glycol 4000 - 0.25 mg).

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (10) - packs cardboard.
The tablets covered with a cover of white or slightly yellowish color, round, biconcave, with a notch on one side, with a homogeneous smooth surface.

1 tab.

tamoxifen citrate 30.4 mg,

which corresponds to the content of tamoxifen 20 mg

[PRING] lactose monohydrate 142.6 mg, sodium starch glycolate 20 mg, povidone 5 mg, microcrystalline cellulose 49.6 mg, magnesium stearate 2.4 mg.

The composition of the coating: dye white opadray - 5 mg (lactose - 1.8 mg, titanium dioxide - 1.3 mg, hypromellose - 1.4 mg, polyethylene glycol 4000 - 0.5 mg).

10 pieces.
- Packings contour mesh (3) - packs cardboard.
10 pieces.
- Packings contour mesh (10) - packs cardboard.
The tablets covered with a cover of white or slightly yellowish color, round, biconcave, with a homogeneous smooth surface.

1 tab.

tamoxifen citrate 45.6 mg,

which corresponds to the content of tamoxifen 30 mg

[PRING] lactose monohydrate - 213.9 mg, sodium starch glycolate - 30 mg, povidone - 7.5 mg, microcrystalline cellulose - 74.4 mg, magnesium stearate - 3.6 mg.

The composition of the shell: dye white opadray - 7.5 mg (lactose - 2.7 mg, titanium dioxide - 1.95 mg, hypromellose - 2.1 mg, polyethylene glycol 4000 - 0.75 mg).

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (10) - packs cardboard.
The tablets covered with a cover of white or slightly yellowish color, round, biconcave, with a notch on one side, with a homogeneous smooth surface.

1 tab.

tamoxifen citrate 60.8 mg,

which corresponds to the content of tamoxifen 40 mg

[PRING] lactose monohydrate - 285.2 mg, sodium starch glycolate - 40 mg, povidone - 10 mg, microcrystalline cellulose - 99.2 mg, magnesium stearate - 4.8 mg.

The composition of the shell: dye white opadray - 10 mg (lactose - 3.6 mg, titanium dioxide - 2.6 mg, hypromellose - 2.8 mg, polyethylene glycol 4000 - 1 mg).

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

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 to the cytoplasmic estrogen receptors in the tissues of the mammary gland, uterus, vagina, anterior pituitary gland and tumors with a high estrogen receptor content. In contrast to the receptor complex of estrogen, the receptor complex of tamoxifen 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

Suction and distribution

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.
The equilibrium concentration of tamoxifen in the blood serum is usually achieved after 3-4 weeks of administration.
The connection with plasma proteins is 99%.
Metabolism and excretion

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, in 1 morning, or by dividing the required dose into 2 doses in the morning and 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.

Occasionally, transient leukopenia and thrombocytopaedy may occur, as well as an increase in the level of hepatic enzymes, very rarely accompanied by more severe liver function abnormalities such as fatty liver, cholestasis and hepatitis.

In some patients with bone metastases, hypercalcaemia was observed at the beginning of 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, changes in the endometrium, including hyperplasia, polyps, and in some cases - endometrial cancer, as well as the development of uterine fibroids, can be observed.

CONTRAINDICATIONS

- Pregnancy;

- the period of lactation (breastfeeding);

- 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, thrombocytoenia, hypercalcemia, concomitant therapy with indirect anticoagulants.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy.

There is insufficient evidence as to whether tamoxifen penetrates into breast milk, so do not use the drug during lactation or decide whether to stop breastfeeding.

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 triglycerides 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

An 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, histamine H 2 receptor blockers and other drugs of similar action, 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.

Joint use of tamoxifen and tegafur can promote the development of active chronic hepatitis and 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

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 5 years.
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