Миролют®

General characteristics. Structure:

Active agent: Mirolt (contains 0,2 mg of a mizoprostol in terms of 100% substance, a gipromelloza) - 20 mg. Excipients Cellulose microcrystallic, silicon dioxide colloid (aerosil), sodium carboxymethylstarch (sodium glikolit starch), magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Mizoprostol - synthetic derivative E1 prostaglandin. Mizoprostol induces reduction of smooth muscle fibers of a myometrium and expansion of a neck of uterus. Ability of a mizoprostol to stimulate reductions of a uterus facilitates disclosure of a neck and removal of contents of a cavity of the uterus. Drug has a weak promoting effect on smooth muscles of digestive tract. High doses of a mizoprostol inhibit secretion of a gastric juice. Mizoprostol has no clinically significant action on prolactin, level of gonadotrophins, thyritropic hormone, a growth hormone, thyroxine, cortisol, creatinine, on aggregation of thrombocytes, function of lungs and cardiovascular system.

Pharmacokinetics. At oral administration it is quickly absorbed. The concomitant use with food - reduces bioavailability of a mizoprostol (greasy food considerably reduces absorption, without exerting impacts on absorption duration). In walls of digestive tract and liver it is metabolized to pharmacological active diesterified metabolite - mizoprostolovy acid. Time of achievement of the maximum concentration of a metabolite - 15-30 min. The maximum concentration of a mizoprostol makes 6,08=1,64 pg/ml, mizoprostolovy acid of-499±15 pg/ml. An elimination half-life of mizoprostolovy acid - less than 30 min. Does not kumulirut. Increase in a dose of a mizoprostol from 200 mkg to 400 mkg leads to increase in concentration in plasma of mizoprostolovy acid twice. It is removed preferential through intestines and kidneys (less than 1%).

Indications to use:

Abortion of early terms (up to 42 days of an amenorrhea) in combination with mifepristone.

Route of administration and doses:

For abortion together with mifepristone drug has to be used in institutions which have appropriately prepared medical shots. Inside, in 36-48 hours after reception of 600 mg (3 tablets) of mifepristone appoint 400 mkg (2 tablets) of the drug Mirolyut®.

Features of use:

At use to abortion on early terms мизопростол it has to be applied only in combination with mifepristone. In combination with mifepristone мизопростол it has to be applied only to destination and under observation of the doctor and only in the specialized medical institutions having opportunities of rendering the emergency surgical gynecologic and hemotransfusionic help.

Use of drug demands the prevention a Rhesus factor conflict and other general actions accompanying abortion. Before purpose of a mizoprostol the patient has to be it is in detail informed on action and possible side effects of drug. The patient has to be observed in the conditions of medical institution within 4 — 6 hours before administration of drug. In time and after administration of drug timely medical care in case of massive bleeding or development of other complications has to be provided to the patient. After administration of drug patients, as a rule, have a small vaginal bleeding, at a part of women very long. At very early duration of gestation abortion after mifepristone reception is possible, however in this case reception of tablets of a mizoprostol is also necessary for optimization of results of medicamentous abortion. After reception of a mizoprostol approximately at 80% of women abortion is done within 6 hours and approximately at 10% of women - within 1 week. Patients need to undergo repeated inspection in the same medical institution in 8-15 days after administration of drug. Ultrasonography or determination of level of a chorionic gonadotrophin in blood serum has to be in case of need carried out. At suspicion on incomplete abortion or preservation of pregnancy it is necessary to conduct comprehensive medical examination timely. At incomplete abortion or the continuing pregnancy estimated for 10-14 day after mifepristone reception surely carry out a vakuumaspiration with the subsequent histologic research of aspirate as drug impact assessment on formation of inborn malformations at a fruit is necessary.

Side effects:

Colicy pains in the bottom of a stomach, dizziness, a headache, nausea, vomiting, a meteorism, diarrhea, skin rash, a hyperthermia. The recommended doses of a mizoprostol do not cause side reactions from cardiovascular system, a liver or kidneys.

Interaction with other medicines:

Reception throughout a long time of rifampicin, an isoniazid, anticonvulsant drugs, antidepressants, Cimetidinum, acetylsalicylic acid, indometacin and drugs of group of phenobarbital, smoking more than 10 cigarettes a day stimulates metabolism of a mizoprostol, reducing its level in blood serum. Within 1 week after use of a mizoprostol it is necessary to refuse reception of aspirin and other non-steroidal anti-inflammatory drugs.

Contraindications:

Hypersensitivity to drug components;

Cardiovascular diseases;

Diseases of a liver and kidneys;

The diseases connected with prostaglandinovy dependence or contraindications to use of prostaglandins: glaucoma, bronchial asthma, arterial hypertension;

Endocrinopathies and diseases of endocrine system, including diabetes mellitus, dysfunction of adrenal glands;

Gormonalnozavis

imy tumors; Anemia;

Lactation period;

Use of intrauterine contraceptives (before use it is necessary to remove VMK);

Suspicion on an extrauterine pregnancy.

Overdose:

Toxicity of a mizoprostol at people is not revealed. Clinical signs which can demonstrate exceeding of a dosage are drowsiness, a tremor, spasms, an abdominal pain, fever, the strengthened heartbeat, hypotension or bradycardia.

Storage conditions:

List B. In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets of 200 mkg. On 4 or 10 tablets in planimetric strip or bezjyacheykovy packaging. On 4, 10, 20 or 30 tablets in banks polymeric. In bank place a package (container) with silikagsly granulated. After 1 bank or 1, 2, 3, 4, 10 planimetric strip or bezjyacheykovy packagings together with the application instruction place in a pack from a cardboard.