Mizoprostol

General characteristics. Structure:

Active agent: powder мизопростол contains GPMTs (1:99) 0,2 mg of a mizoprostol and 19,8 mg of a gipromelloza.

Excipients: sodium carboxymethylstarch, castor oil, cellulose microcrystallic, silicon dioxide colloid.

Pharmacological properties:

Mizoprostol – synthetic derivative E1 prostaglandin.

Induces reduction of smooth muscle fibers of a myometrium and expansion of a neck of uterus. Mizoprostol's ability to stimulate reductions of a uterus facilitates disclosure of a neck and removal of contents of a cavity of the uterus.

After mifepristone reception Mizoprostol can induce or strengthen the frequency and force of spontaneous reductions of a uterus.

Drug has a weak promoting effect on smooth muscles of digestive tract. High doses of a mizoprostol inhibit secretion of a gastric juice.

Pharmacokinetics. Drug is quickly absorbed at oral administration, being completely soaked up in 1,5 hours. The maximum concentration of an active metabolite (mizoprostolovy acid) in a blood plasma is reached in 15 minutes; at a dosage of 200 mg its average size makes 0,309 mkg/l. The active metabolite is brought out of an organism preferential with urine, the elimination half-life makes 36–40 minutes.

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 Mizoprostol.

 

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.

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 the 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 influence. After reception of a mizoprostol approximately at 80% the abortion of women occurs 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 from mifepristone reception surely carry out a vakuumaspiration with the subsequent histologic research of aspirate as formation of inborn malformations at a fruit is possible.

Side effects:

At use on early durations of gestation nausea, vomiting, dizziness, slackness, pains in the lower part of a stomach is possible. Extremely exceptional cases of rush of blood to the person, fervescences, an itch, allergic reactions are celebrated.

Interaction with other medicines:

Reception throughout a long time of rifampicin, an isoniazid, anticonvulsant drugs, antidepressants, Cimetidinum, acetylsalicylic acid, indometacin and barbiturates, 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

- gormonalnozavisimy 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:

To store in the sealed packaging in dry and cool, protected from light and the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Tablets of 0.2 mg. On 3 tablets pack into the aluminum blister with an aluminum covering. The blister and the application instruction are placed in a paper box.