Misoprostol (Mizoprostol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceMisoprostolMisoprostol
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    • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active substance: Powder misoprostol HPMC (1:99) contains 0.2 mg of misoprostol and 19.8 mg of hypromellose;

    Excipients: carboxymethyl starch sodium salt 10 mg, castor 1 oil 2 mg, cellulose microcrystalline 160 mg, silicon dioxide colloid 8 mg.

    Description:Biconvex round white tablets.
    Pharmacotherapeutic group:Generic activity stimulant - prostaglandin E1 analogue synthetic
    ATX: & nbsp

    G.02.A.D.06   Misoprostol

    G.02.A.D.   Prostaglandins

    Pharmacodynamics:

    Misoprostol is a synthetic derivative of prostaglandin E1.

    It induces contraction of smooth muscle fibers of myometrium and expansion of the cervix. The ability of misoprostol to stimulate uterine contractions facilitates the opening of the cervix and the removal of the contents of the uterine cavity.

    After taking mifepristone misoprostol can induce or enhance the frequency and strength of spontaneous contractions of the uterus.

    The drug has a weak stimulating effect on the smooth muscles of the gastrointestinal tract.Large doses of misoprostol inhibit the secretion of gastric juice.

    Pharmacokinetics:The drug is rapidly absorbed when taken orally, completely absorbed after 1.5 hours. The maximum concentration of the active metabolite (misoprostol acid) in the blood plasma is reached after 15 minutes at a dosage of 200 mg, its average value is 0.309 μg / l. The active metabolite is excreted mainly by the kidneys, the half-life is 36-40 minutes.
    Indications:Interruption of uterine pregnancy of early terms (up to 42 days amenorrhea) in combination with mifepristone.
    Contraindications:Hypersensitivity to the components of the drug; 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 dysfunction; hormone sensitive tumors; anemia; lactation period; use of intrauterine contraceptives (prior to use, remove IUD); suspicion of ectopic pregnancy.
    Pregnancy and lactation:The drug can be used by pregnant women only for its interruption, otherwise it is categorically contraindicated in pregnancy. When establishing pregnancy in women taking misoprostol, therapy with this drug should be discontinued. It is necessary to inform patients about the teratogenic effect of misoprostol. Breastfeeding should be discontinued for 7 days from taking mifepristone in a method of medical abortion (for 5 days after taking Misoprostol).
    Dosing and Administration:

    For abortion with a drug mifepristonemisoprostol should be used in institutions that have appropriately trained medical staff.

    Inside, 36-48 hours after taking 200 mg (1 tablet) or 600 mg (3 tablets) of the drug mifepristone prescribe 400 mcg (2 tablets) of the drug misoprostol.

    Side effects:When used in the early stages of pregnancy, nausea, vomiting, dizziness, lethargy, and pain in the lower abdomen are possible. There are extremely cases (1 out of 10,000) of the "tide" of blood to the face, an increase in body temperature, itching, allergic reactions.
    Overdose:The toxicity of misoprostol in humans is not revealed. Clinical signs that may indicate over dosage are drowsiness, tremor, cramps, abdominal pain, fever, increased heart rate, hypotension or bradycardia.
    Interaction:

    The use of rifampicin, isoniazid, anticonvulsants, antidepressants, cimetidine, acetylsalicylic acid, indomethacin and barbiturates for a long time, smoking more than 10 cigarettes a day stimulates the metabolism of misoprostol, reducing its concentration in the blood serum.

    Within 1 week after using misoprostol, you should stop taking acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.

    Special instructions:

    1. When used for early termination of pregnancy misoprostol should be used only in combination with mifepristone.

    2. In combination with mifepristone misoprostol should be used only for the purpose and under the supervision of a doctor and only in specialized medical institutions that have the capacity to provide emergency surgical gynecological and hemotransfusion care.

    3.Before the appointment of misoprostol, the patient should be informed in detail about the effect and possible side effects of the drug. The patient should be observed in the conditions of the medical institution for 4-6 hours before taking the drug. During and after taking the drug, the patient should receive timely medical attention in the event of massive bleeding or other complications.

    4. After taking the drug in patients, as a rule, there is a slight vaginal bleeding, a part of women is very long. At a very early gestation period, miscarriage is possible after taking mifepristone, but in this case, also taking the misoprostol tablets is necessary to optimize the results of the drug exposure. After taking misoprostol, about 80% of women miscarriage occurs within 6 hours and about 10% of women - within 1 week.

    5. Patients should undergo a second examination in the same medical institution 8-15 days after taking the drug. If necessary, an ultrasound or a level of chorionic gonadotropin in the blood serum should be performed.If there is a suspicion of incomplete abortion or the maintenance of pregnancy, a comprehensive medical examination should be conducted in a timely manner.

    6. In case of incomplete abortion or continuing pregnancy, estimated on the 10-14th day after taking mifepristone, it is necessary to carry out vacuum emptying with the subsequent. histological examination of aspirates, since it is possible to form congenital malformations in the fetus.

    Effect on the ability to drive transp. cf. and fur:After taking the drug, special care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.
    Form release / dosage:Tablets 0.2 mg.
    Packaging:For 3 or 4 tablets are packed in an aluminum blister with an aluminum coating. Blister and instructions for use are placed in a paper box.
    Storage conditions:Store in a sealed package in a dry and cool place, protected from light and out of reach of children, at a temperature of no higher than 25 ° C.
    Shelf life:2 years.Do not use after the expiration date.
    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002019
    Date of registration:22.09.2011 / 12.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:China Resource Zizhu Pharmaceutical Co., LtdChina Resource Zizhu Pharmaceutical Co., Ltd China
    Manufacturer: & nbsp
    Information update date: & nbsp24.04.2018
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