Instruction for use: Mirolut

Dosage Form:substance powder; tablets

Active substance: Misoprostol*

ATX

G02AD06 Misoprostol

Pharmacotherapeutic group:

Generic activity stimulant - prostaglandin E1 analogue synthetic [Prostaglandins, thromboxanes, leukotrienes and their antagonists]

The nosological classification (ICD-10)

O04 Medical abortion: Artificial abortion; Medical abortion; Abortion artificial; Vacuum aspiration; Abortion

Composition

Tablets - 1 table.

active substance: Mirolut® or Misoprostol-HPMC (contains misoprostol -200 μg in terms of 100% substance, hypromellose) - 20 mg

Auxiliary substances: Prosolv (MCC and silicon colloidal dioxide) - 166 mg; Sodium carboxymethyl starch - 12 mg; Magnesium stearate - 2 mg

Description of dosage form

Tablets are white or white with a yellowish or grayish hue of color, a flat-cylindrical shape with a facet and a risk.

Pharmacology

Mode of action - stimulating labor activity, prostaglandin-like.

Pharmacodynamics

Misoprostol is a synthetic derivative of PGE1. Misoprostol induces contraction of smooth muscle fibers of myometrium and dilates the cervix, which facilitates the removal of the contents of the uterine cavity. Increases the frequency and strength of contractions of the myometrium, has a weak stimulating effect on the smooth muscles of the gastrointestinal tract.

Pharmacokinetics

When administered orally, it is quickly and completely absorbed (food reduces bioavailability). In the walls of the gastrointestinal tract and the liver is metabolized to pharmacologically active misoprostolic acid. Tmax misoprostol acid - 9-15 min, Cmax - 1 μg / l, T1 / 2 - 20-40 min. The connection with plasma proteins is 85%.

It is excreted by the kidneys - 64-73% during the first 24 hours (56% during the first 8 hours) and with bile (15% within the first 24 hours).

If the renal function is impaired, Cmax can increase almost 2-fold, and T1 / 2 may lengthen. Does not cumulate.

Indications or the Mirolut

Interruption of early pregnancy (up to 42 days amenorrhea) in combination with mifepristone.

Contraindications

Hypersensitivity to the components of the drug and other preparations of PG; cardiovascular diseases; Liver and kidney disease; Diseases associated with prostaglandin dependence or contraindications to the use of PG: glaucoma, bronchial asthma, arterial hypertension; Endocrinopathy and endocrine system diseases, incl. Diabetes mellitus, adrenal insufficiency; Hormone-dependent tumors; anemia; Lactation period; Use of intrauterine contraceptives (IUDs) (they must be removed before use); Suspicion of ectopic pregnancy.

Application in pregnancy and breastfeeding

Misoprostol can be used during pregnancy only for the purpose of interrupting it. Misoprostol should not be used if the uterine pregnancy is not confirmed or the woman is not sure that she wants to terminate the pregnancy. It is necessary to inform patients about the potential danger of misoprostol (teratogenic effect).

Breastfeeding should be discontinued for 7 days after medical abortion (from the moment of taking mifepristone), for 5 days from taking misoprostol.

Side effects

Pain in the lower abdomen, dizziness, headache, nausea, vomiting, flatulence, diarrhea, lethargy, fever, allergic reactions (skin rash, itching, angioedema).

Interaction

When combined with magnesium-containing antacids, an increase in diarrhea is possible.

Food intake, antacids reduce the concentration of misoprostol acid in the plasma (it is clinically insignificant).

Misoprostol does not have a clinically significant effect on absorption, blood concentration, and the antiplatelet effect of acetylsalicylic acid when administered at therapeutic doses, as well as on the pharmacokinetics of diclofenac and ibuprofen.

Dosing and Administration

Inside.

After 36-48 hours after taking 600 mg (3 tablets) of mifepristone, 400 μg (2 tablets) of Mirolut® are prescribed.

Overdose

Symptoms: drowsiness, retardation, tremor, cramps, shortness of breath, abdominal pain, diarrhea, fever, palpitations, decreased blood pressure, bradycardia.

Treatment: symptomatic, hemodialysis is ineffective.

Special instructions

In combination with mifepristone, misoprostol should be used only for the intended purpose and under the supervision of an obstetrician / gynecologist and only in specialized medical institutions that have the capacity to provide emergency surgical gynecological and blood transfusion care. The use of the drug requires the prevention of Rh-conflict and other common activities associated with abortion. Before the appointment of misoprostol, the patient should be informed in detail about the pharmacological action and possible side effects of the drug.

The patient should be observed in the conditions of the medical institution within 2-3 hours after taking the drug. After taking misoprostol, as a rule, there is a slight vaginal bleeding, in some women - very long. In case of massive bleeding or the development of other complications, the patient should be provided with timely medical assistance. In 80% of cases spontaneous abortion occurs within 6 hours, in 10% - within 1 week. At a very early gestation period, spontaneous abortion is possible after taking one mifepristone, but in this case it is still necessary to take misoprostol to optimize the drug effect.

After 10-14 days the patient must undergo a second examination in the same medical institution. If necessary, conduct an ultrasound or determine the level of HG in the blood serum. If suspicion of incomplete abortion or retention of pregnancy, assessed 10-14 days after taking mifepristone, a vacuum aspiration is performed followed by a histological examination of the aspirate.

Impact on the ability to drive vehicles and other mechanisms. Given the possible side effects of the drug (dizziness), it is advisable to use caution when driving vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form

Tablets, 200 mcg. In the outline of the cell packaging of PVC film and aluminum foil printed lacquered 4 or 10 pcs. In a polymer bank, 4, 10, 20 or 30 pcs. In the jar, place a bag (container) with silica gel granulated. 1 bank or 1, 2, 3, 4 or 10 contour mesh packages in a pack of cardboard.

Manufacturer

ZAO Obninsk Chemical-Pharmaceutical Company, Russia. 

Terms of leave from pharmacies

Leave only for specialized medical and diagnostic institutions.

Storage conditions of Mirolut

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of Mirolut

3 years.

Do not use beyond the expiration date printed on the package.