Mirolt

Миролют Drug photo

The description is actual on 07.10.2014

  • Latin name: Mirolut
  • ATH code: G02AD06
  • Active ingredient: Mizoprostol (Misoprostol)
  • Producer: CJSC Obninsk Chemical and Pharmaceutical Company, Russia

Structure

Drug contains 20 mg of active agent – a mizoprostol.

The excipients which are a part of drug – sodium carboxymethylstarch, prosolv (silicon dioxide colloid and MKTs), magnesium stearate.

Release form

Mirolt let out in the form of ploskotsilindrichesky white tablets (can sometimes have a yellow or gray shade) with risky and a facet. In blisters or polymeric banks there can be 4, 10, 20 or 30 tablets.

Pharmacological action

Mirolt is the prostaglandinopodobny means stimulating patrimonial activity.

Pharmacodynamics and pharmacokinetics

Mizoprostol is to synthetic derivatives of E1 prostaglandin. It causes expansion of a uterus and reduction of muscle fibers of a myometrium. Disclosure of a neck of uterus and, respectively, removal of contents of her cavity, becomes simpler thanks to ability of a mizoprostol to stimulate reduction of a uterus.

Mirolt it is capable to have in weak degree a promoting effect on muscles of a gastrointestinal tract. In high doses mizoprostol inhibits allocation of a gastric juice.

Does not make clinically significant impact on the level of a growth hormone, gonadotrophins, cortisol, thyritropic hormone, thyroxine, creatinine, on prolactin, function of lungs, aggregation of thrombocytes and cardiovascular system.

It is absorbed quickly. Bioavailability of substance decreases at a concomitant use with food (absorption decreases because of greasy food, absorption duration at the same time does not change).

It is metabolized in a liver and walls of a gastrointestinal tract to mizoprostolovy acid. The maximum concentration of a metabolite comes in 15-30 minutes. The period through how many medicine – begins to work 30 minutes, effect duration – 3-6 hours. Does not kumulirut. An elimination half-life – 30 minutes.

It is removed through kidneys and intestines.

Indications to use

Drug is appointed for implementation of medicamentous abortion in combination with Mifepristone. It is intended for abortion – till 42 days of an amenorrhea.

Contraindications

Reception of medicine is prohibited in the following cases:

  • diseases of kidneys and liver;
  • anemia;
  • sensitivity to drug components;
  • endocrinopathies, diseases of endocrine system (including dysfunction of adrenal glands and a diabetes mellitus);
  • feeding period breast;
  • cardiovascular diseases;
  • use of intrauterine contraceptives (it is necessary to remove VMK before reception);
  • hormonal tumors;
  • diseases at which reception of prostaglandins is contraindicated: bronchial asthma, glaucoma, arterial hypertension;
  • diseases which are connected with a prostaglandinovy illness;
  • probability of an extrauterine pregnancy.

Side effects

During reception of medicine of Mirolyut there can be following side effects:

At reception of a mizoprostol in the doses recommended by the instruction side reactions from kidneys, a liver or cardiovascular system are not shown.

The instruction to Mirolyut (A way and a dosage)

Pill of Mirolyut is taken inside. In combination with Mifepristone it is necessary to accept only at appointment as the doctor and under continuous supervision in medical institutions of the obstetrician-gynecologist that if necessary specialists could give the emergency surgical gynecologic and hemotransfusionic help. Demands carrying out all actions which accompany abortion.

Therapy begins with reception of 3 tablets (600 mg) of mifepristone, in 3-4 days appoint 2 tablets (400 mkg) of means of Mirolyut.

Overdose

At people toxicity of active agent was not revealed. When exceeding a dose clinical signs can be shown: epigastric pains, drowsiness, hypotension, bradycardia, tremor, tachycardia, convulsive reactions, fever, delay of a cordial rhythm.

Interaction

The metabolism of a mizoprostol is stimulated at reception for an appreciable length of time of the Isoniazid, antidepressants, Rifampicin, anticonvulsants, Indometacin, acetylsalicylic acid, drugs from group of phenobarbital, Tsimedin, nicotine therefore the level of its content in blood decreases.

It is not necessary to take Aspirin and other nonsteroid antiinflammatory drugs within a week after administration of drug of Mirolyut.

Antacids break absorption of active agent of medicine of Mirolyut. The combination of magniysoderzhashchy antacids and a mizoprostol can lead to strengthening of diarrhea.

Terms of sale

It is possible to get Mirolyut in a drugstore only in the presence of the recipe.

Storage conditions

Optimum temperature for storage – 25 °C to store in the dark not wet place.

Period of validity

To store no more than 3 years.

Special instructions

When using drug for abortion to 42 days it is necessary to combine drugs of Mirolyut and Mifepristone. At the same time such therapy has to be carried out exclusively to destination, under supervision of the specialist doctor in specialized medical institution where there is an opportunity to give the emergency surgical gynecologic and hemotransfusionic help.

Administration of drug demands carrying out all actions which accompany abortion, including the prevention of a Rhesus factor.

It is necessary to inform the patient on action and side effects of drug before its appointment. In 4-6 hours prior to drug intake the patient has to be observed in medical institution. When developing massive bleeding or other complications in time or after drug use, it is necessary to provide medical care urgently.

Developing of small vaginal bleeding after Mifepristone reception (at some women long time can last) is possible. On very early term abortion is possible after administration of drug, but in that case for optimization of its results it is necessary to take a pill of Mirolyut. After its reception abortion happens within 6 hours at 80% of patients, within a week – at 10% of patients.

In 8-15 days after taking the medicine it is necessary to pass repeated inspection in medical institution. If necessary it is necessary to carry out ultrasonography or to determine the level of a chorionic gonadotrophin in blood. At emergence of suspicions on preservation of pregnancy or incomplete abortion, it is necessary to conduct full medical examination.

At the detection of incomplete abortion or the remained pregnancy estimated in 2 weeks after mifepristone use it is necessary to carry out vacuum aspiration with histologic research of aspirate as it is necessary to estimate influence of funds for forming of inborn defects at a fruit.

Analogs

Coincidence on the ATH code of the 4th level:

Mizotab and Mizoprost carry to the means having similar pharmacological action.

Miropriston and Mirolyut

Drugs of Mirolyut and Miropriston cannot be considered as analogs as they are accepted in a complex for implementation of medicamentous abortion on early terms. These drugs are used in complex therapy and are not interchangeable.

About Mirolyuta and Miropristona demonstrate that at accurate observance of the instruction and recommendation of the doctor, efficiency of drugs is quite high. However at their use after 42 days of pregnancy there is a probability of emergence of complications, such as incomplete abortion.

Zdravzona

  • Mirolt 0,2mg No. 4 tabletkiobninsky HFK
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Section: Gynecologic
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