Mirolut® (Mirolut)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceMisoprostolMisoprostol
Similar drugsTo uncover
  • Misoprostol
    pills inwards 
    China Resource Zizhu Pharmaceutical Co., Ltd     China
  • Mirolut®
    pills inwards 
    NIZHFARM, JSC     Russia
  • Topogin
    pills inwards 
    Exceleljin     France
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: Mirolut® or Misoprostol-HPMC (contains: 0.2 mg of misoprostol in terms of 100% substance, hypromellose) - 20 mg;

    Excipients: Prosalt (microcrystalline cellulose and colloidal silicon dioxide) 166 mg, sodium carboxymethyl starch 12 mg, magnesium stearate 2 mg.

    Description:Tablets are white or white with a yellowish or grayish hue of color, a flat-cylindrical shape with a facet and a risk.
    Pharmacotherapeutic group:Generic activity stimulant - prostaglandin E1 analogue synthetic
    ATX: & nbsp

    G.02.A.D.06   Misoprostol

    G.02.A.D.   Prostaglandins

    Pharmacodynamics:Misoprostol - synthetic prostaglandin E derivative1 Misoprostol induces contraction of smooth muscle fibers of myometrium and expands 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 (GIT).
    Pharmacokinetics:

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

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

    In cases of renal dysfunction Cmax can increase almost 2 times, lengthen T1/2. Do not cumulate.

    Indications: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 prostaglandins; cardiovascular diseases; liver and kidney disease; diseases associated with prostaglandin dependence or contraindications to the use of prostaglandins: glaucoma, bronchial asthma, arterial hypertension; endocrinopathy and endocrine system diseases, including diabetes mellitus, adrenal insufficiency; hormone-dependent tumors; anemia; lactation period; children's age till 15 years; use of intrauterine contraceptives (prior to use, remove IUD); suspicion of ectopic pregnancy.
    Pregnancy and lactation:

    Misoprostol can be used during pregnancy only for the purpose of interrupting it. Misoprostol should not be used / if 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 (starting from the moment of taking mifepristone).

    Dosing and Administration: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. Inside, 36-48 hours after taking 600 mg (3 tablets) of mifepristone, 400 μg (2 tablets) of Mirolute® are prescribed.
    Side effects:Pain in the lower abdomen, dizziness, headache, nausea, vomiting, flatulence, diarrhea, lethargy, blood flushes to the face, fever, allergic reactions (skin rash, itching, angioedema).
    Overdose:

    Symptoms: drowsiness, inhibition, tremor, cramps, shortness of breath, abdominal pain, diarrhea, fever heartbeat, lowering blood pressure, bradycardia.

    Treatment: symptomatic, hemodialysis is ineffective.

    Interaction:

    When combined with magnesium-containing antacids, it is possible to increase diarrhea. Food intake, antacids reduce the concentration of misoprostol acid in the plasma (clinically insignificant).

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

    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 needs to undergo a second examination in the same medical institution. If necessary, perform ultrasound (ultrasound) or determine the level of chorionic gonadotropin in the blood serum.

    If there is a suspicion of incomplete abortion or retention of pregnancy, assessed 10-14 days after taking mifepristone,Vacuum-voiding followed by histological examination of the aspirate.

    Effect on the ability to drive transp. cf. and fur:Given the possible side effects of the drug (dizziness), it is advisable to use caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Tablets, 200 mcg.
    Packaging:

    For 4 or 10 tablets in a contour cell packaging of polyvinyl chloride / polyvinylidene chloride films and aluminum foil printed lacquer.

    For 4, 10, 20 or 30 tablets per can of polymer. A jar is placed in the jar or a jar of silica gel is placed in the lid of the jar.

    On 1 bank or 1, 2, 3, 4 or 10 contour cellular packs together with the instruction on application place in a pack a cardboard.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001766
    Date of registration:03.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp16.05.2018
    Illustrated instructions
      Instructions
      Up