Active substanceNorethisteroneNorethisterone
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  • Norkolut
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Dosage form: & nbsppills
    Composition:

    Active substance: norethisterone 5 mg

    Excipients: potato starch, magnesium stearate, silicon dioxide colloid, gelatin, talc, corn starch, lactose monohydrate.

    Description:

    Flat round tablets white or almost white with chamfer, on one side of tablets - marking "NORCOLUT", on the other - "+".

    Pharmacotherapeutic group:progestogen
    ATX: & nbsp

    G.03.D.C.02   Norethisterone

    Pharmacodynamics:

    Norethisterone is a progestogen. Causes transformation of the mucous membrane of the uterus from the proliferation phase to the secretory, blocks the secretion of gonadotropin in the pituitary gland, preventing the maturation of follicles and the onset of ovulation.

    Pharmacokinetics:

    Absorbability: Well absorbed from the gastrointestinal tract. As a result of intensive primary metabolism in the liver and in the intestinal wall, bioavailability is 50-77%.

    Distribution: After 0.5-4 hours after taking 0.5 mg of norethisterone, the maximum concentration in serum is 2-5 ng / ml, with the intake of 1 mg - 5-10 ng / ml, with the intake of 3 mg - 30 ng / ml.

    Biotransformation: Metabolites of norethisterone are excreted by the kidneys in the form of conjugates with glucuronic acid.

    Excretion: Excretion of conjugated metabolites through the intestine (40%) and kidneys (60%). Reduction in the concentration of norethisterone in the serum is carried out in two phases.The half-life in the first phase lasts 2.5 h, in the final phase-8 h. 80% of the metabolites formed in the liver are excreted by the kidneys.

    Indications:

    Premenstrual syndrome; anovulatory metrorrhagia, dysmenorrhea (accompanied by a shortening of the secretory phase), endometriosis, fibroids, mastodinia, endometrial hyperplasia, diagnostic progesterone test; cessation and prevention of lactation.

    Contraindications:Period of puberty, hypersensitivity to the components of the drug, breast cancer (including suspected), malignant tumors of the female genital organs, pregnancy (including the suspect, except for the cases of miscarriage), jaundice (including in history), acute liver disease (including benign and malignant neoplasms), impaired liver and kidney function, hyperbilirubinemia, a tendency to thrombosis, acute thrombophlebitis or thromboembolism, bleeding from urinary tract of unknown origin, bleeding from the genital tract of unknown origin, cholestatic jaundice of pregnant women or skin pruritus in the anamnesis, obesity, herpes.

    Carefully:Bronchial asthma, chronic heart failure, epilepsy, arterial hypertension, migraine, renal failure, seizures, or other disorders of the central nervous system (including history), diabetes mellitus, liver disease (in history), hyperlipidemia, thrombophlebitis in anamnesis, thromboembolism in the anamnesis.
    Pregnancy and lactation:

    When pregnancy is not used.

    At random reception of a preparation in the early period of pregnancy the preparation did not render teratogenic action, including disturbances of development of heart and extremities.

    The intake of norethisterone in the puerperium reduces the secretion of milk and changes its quality.

    Dosing and Administration:

    Method of application - inside.

    Premenstrual syndrome; mastodynia, dysmenorrhea: in the period from 16 to 25 days of the menstrual cycle of 5-10 mg per day (1-2 tablets), can be taken together with estrogen.

    Myoma of the uterus: 5-10 mg, from 5 to 25 days of the menstrual cycle, no more than 6 months.

    Diagnostic progesterone test. The best option is to administer 10 mg of Norcolut for 10 days. The reaction is regarded as regular,if after 3-7 days after the end of reception of the Norcolut there appeared moderate bloody discharge and persisted for 3-4 days.

    Anovulatory metrorrhagia, endometrial hyperplasia: (dysfunctional character of the bleeding should be confirmed by histological analysis no more than 6 months before the treatment) at 5-10 mg / day (1-2 tablets) for 6-12 days. After achieving the desired effect, between 16 and 25 days of the cycle, 5-10 mg / day, usually along with estrogen, to prevent recurrence.

    Endometriosis: in the period from 5 to 25 day of the cycle at 5 mg / day, for 6 months. Further treatment at the discretion of the doctor.

    Prevention of lactation:

    In case of termination of pregnancy between 16 and 28 weeks on day 1, take 15 mg (3 tablets), on days 2-3 take 10 mg (2 tablets) per day, from the 4th to the 7th day to take 5 mg (1 tablet) per day;

    In the event of termination of pregnancy between 28 and 36 weeks on day 1, take 15 mg (3 tablets), on days 2-3 take 10 mg (2 tablets) per day, from the 4th to the 7th day to take 10 mg (2 tablespoons) per day.

    To stop lactation: in the first 3 days, appoint a daily dose of 20 mg, from the 4th to the 7th day - 15 mg, from the 8th to the 10th day - 10 mg.
    Side effects:

    Headache, stress of the mammary glands, dyspeptic phenomena (nausea, vomiting), acyclic spotting from the vagina,paresthesia, weight gain, fatigue (does not require additional treatment), peripheral edema, allergic reactions (skin rash, itching). With prolonged use - thrombosis, thromboembolism.

    Overdose:

    Possible nausea, vomiting; vaginal bleeding.

    Treatment is symptomatic.

    Interaction:

    Inducers of liver enzymes accelerate the metabolism of norethisterone.

    With caution appoint simultaneously with hypoglycemic drugs, oral anticoagulants, glucocorticosteroids.

    It is not recommended to combine with barbiturates, phenytoin, rifampicin, cimetidine and other drugs that affect microsomal oxidation in the liver.

    Special instructions:

    Before the start of treatment, it is necessary to exclude the presence of malignant neoplasms, to conduct preliminary careful gynecological, oncological examination and examination of the mammary glands.

    If the patient has forgotten to take the next pill, then the missed tablet should be taken as soon as possible, in which case additional methods of contraception should be applied.

    Effect on the ability to drive transp. cf. and fur:

    Norethisterone does not affect the ability to drive and machines.

    Form release / dosage:

    Tablets 5 mg.

    Packaging:10 tablets in a blister of PVC film and aluminum foil. Two blisters in a cardboard box with the attached instruction for use.
    Storage conditions:

    Store at a temperature of 15-30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014881 / 01
    Date of registration:24.03.2009
    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: & nbsp07.08.2015
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