Postinor (Postinor)

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

    Each tablet contains:

    Active ingredient: levonorgestrel 0.75, mg.

    Auxiliary substances: silicon dioxide colloid, potato starch, magnesium stearate, talc, corn starch, lactose monohydrate.

    Description:

    Flat tablets white or almost white, the shape of the disc with a bevel and with a circular engraving "I N ABOUT R - "on the same side.

    Pharmacotherapeutic group:Gestagen
    ATX: & nbsp

    G.03.A.D   Preparations for emergency contraception

    G.03.A.D.01   Levonorgestrel

    Pharmacodynamics:

    Levonorgestrel is a synthetic gestagen with a contraceptive effect, expressed by gestagenic and antiestrogenic properties. With the recommended dosing regimen, levonorgestrel. suppresses ovulation and fertilization, if sexual intercourse has occurred in the preovulatory phase, when the possibility of fertilization is greatest. It can also cause changes in the endometrium, which prevent implantation.The drug is not effective if the implantation has already occurred.

    Efficacy: with the help of Postinor tablets, pregnancy can be prevented in about 85% of cases. The more time passed between intercourse and taking the drug, the lower its effectiveness (95% within the first 24 hours, 85% from 24 to 48 hours, and 58% from 48 to 72 hours). Thus, the reception of the Postinor tablets is recommended to begin as soon as possible (but no later than 72 hours) after sexual intercourse, if no protective measures have been applied. In the recommended dose levonorgestrel does not significantly affect the clotting factors of blood, the exchange of fats and carbohydrates.

    Pharmacokinetics:

    When taken orally levonorgestrel quickly and almost completely absorbed. After taking 0.75 mg of levonorgestrel, the maximum concentration of the drug in the serum, equal to 14.1 ng / mg, is achieved after 1.6 hours. After reaching the maximum level of concentration, the content of levonorgestrel decreases, and the half-life is about 26 hours.

    Levonorgestrel is excreted approximately equally by the kidneys and through the intestine exclusively in the form of metabolites. Biotransformation of levonorgestrel corresponds to the metabolism of steroids. Levonorgestrel It is hydroxylated in the liver and metabolites are excreted in the form of conjugated glucuronides.Pharmacologically active metabolites of levonorgestrel are unknown. Levonorgestrel binds to serum albumin and with sex hormone binding globulin (SHBG). Only 1.5% of the total dose is in free form, and 65% is related to SHBG. Absolute bioavailability is almost 100% of the dose.

    Indications:

    Emergency (postcoital) contraception (after unprotected podvoy contact or unreliability of the contraceptive method used).

    Contraindications:

    Hypersensitivity to any component of the drug, use in adolescents under 16 years, severe hepatic impairment, pregnancy.

    Patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:

    Diseases of the liver or bile duct, jaundice (including history), Crohn's disease, lactation.

    Pregnancy and lactation:

    Postinor can not be used during pregnancy. If the pregnancy occurred when using an emergency method of contraception, then based on the available data, the adverse effect of the drug on the fetus is not revealed.

    Levonorgestrel penetrates into the mother's milk. After taking the drug, breast-feeding should be stopped for 24 hours.

    Dosing and Administration:

    The drug is administered orally. It is necessary to take 2 tablets in the first 72 hours after unprotected intercourse. The second tablet should be taken 12 hours later (but no later than 16 hours) after taking the first tablet.

    To achieve a more reliable effect, both tablets should be taken as soon as possible after unprotected intercourse (no later than 72 hours).

    If within three hours after 1 or 2 of the reception of the pill Postinora vomiting occurs, then another pill of Postinor should be taken.

    Postinor can be used at any time of the menstrual cycle. In the case of irregular menstrual nails, pregnancy must be excluded. After taking an emergency contraceptive before the next menstrual period, local barrier contraceptive methods should be used (eg, a condom, a cervical cap). Application of the drug with repeated unprotected sexual intercourse during one menstrual cycle is not recommended because of the increased frequency of acyclic bleedingdischarge / bleeding.

    Side effects:

    Allergic reactions are possible: hives, rash, itching, swelling of the face.

    Transient side effects that occur at different frequencies (often: ≥1 / 100, <1/10. Very often: ≥1 / 10) and do not require medication:

    Often: vomiting, diarrhea, dizziness, headache, breast tenderness, delay in menstruation (no more than 5-7 days), if menstruation is delayed for a longer period, pregnancy should be excluded.

    Very often: nausea, fatigue, pain in the lower abdomen, acyclic spotting (bleeding).

    Overdose:

    Increased severity of side effects. There is no specific antidote. Treatment - symptomatic.

    Interaction:

    At simultaneous reception of drugs-inducers of liver enzymes, the metabolism of levonorgestrel is accelerated.

    The following drugs may reduce the effectiveness of levonorgestrel: amprekavil, Lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates, including primidon, phenytoin and carbamazepine; preparations containing St. John's wort (Hypericum perforatum), and rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin. Reduces the effectiveness of hypoglycemic and anticoagulant (coumarin derivatives, fenindion) of medicinal products. Increases plasma concentrations of glucocorticosteroids. Women who take these drugs should consult a doctor. Preparations containing levonorgestrel, can increase the risk of toxicity of cyclosporine, due to the suppression of its metabolism.

    Special instructions:

    Postinor should be used only for emergency contraception! Repeated use of the drug Postinor during one menstrual cycle is not recommended! Efficacy of tablets Postinor after unprotected intercourse, which did not use contraceptives, eventually decreases:

    Time between sexual intercourse and reception Efficacy: tablets Postinor:

    24 hours or less 95%

    25-48 h 85%

    49-72 h 58%

    The drug does not replace the use of permanent methods of contraception. In most cases, Postinor does not affect the nature of the menstrual cycle. However, acyclic bleeding may occur and menstruation may be delayed for several days.If you delay menstruation for more than 5-7 days and change its nature (scanty or abundant discharge), you must exclude pregnancy. The appearance of pain in the lower abdomen, fainting can indicate ectopic (ectopic) pregnancy.

    Teenagers under the age of 16 in exceptional cases (including rape) need advice from a gynecologist to confirm pregnancy.

    After emergency contraception, a gynecologist is recommended to choose the most suitable method for permanent contraception.

    Emergency contraception does not protect against sexually transmitted diseases.

    In case of violations of the function of the gastrointestinal tract (for example, with Crohn's disease) the effectiveness of the drug may decrease.

    Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive a car and other machines has not been investigated.
    Form release / dosage:Tablets of 0.75 mg.
    Packaging:

    2 tablets in a blister pack AL/ PVC. 1 blister in a cardboard box with the attached instruction for use.

    Storage conditions:

    List B. At a temperature of 15 ° C to 25 ° C. in a place inaccessible to children.

    Shelf life:

    5 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011850 / 01
    Date of registration:05.03.2010
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp27.05.2016
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