Norcolut pills of 20 pieces
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Active ingredients
Norethisterone
Release form
Pills
Composition
1 tablet contains: Active ingredient: Norethisterone 5 mg. Excipients: potato starch, magnesium stearate, colloidal silicon dioxide, gelatin, talc, corn starch, lactose monohydrate .;
Pharmacological effect
Norethisterone is a progestogen. It causes the transformation of the uterine membrane from the proliferation phase to the secretory one, blocks the secretion of gonadotropin in the pituitary gland, preventing the maturation of follicles and the onset of ovulation.
Pharmacokinetics
Absorption; Well absorbed from the digestive tract. As a result of intensive primary metabolism in the liver and in the intestinal wall, bioavailability is 50-77%; Distribution; 0.5-4 hours after administration of 0.5 mg of norethisterone, Cmax in serum is 2-5 ng / ml, with a dose of 1 mg - 5-10 ng / ml, with a dose of 3 mg - 30 ng / ml .; Biotransformation; Norethisterone metabolites are excreted by the kidneys as conjugates with glucuronic acid .; Withdrawal of conjugated metabolites - through the intestines (40%) and kidneys (60%) .; The decrease in the concentration of norethisterone in serum is carried out in two phases. T1 / 2 in the first phase lasts 2.5 hours, in the final phase - 8 hours. 80% of the metabolites formed in the liver are excreted by the kidneys.
Indications
- Premenstrual syndrome; - Anovulatory metrorrhage; - Dysmenorrhea (accompanied by shortening of the secretory phase); - Endometriosis; - Uterine fibroids; - Mastodynia; - Hyperplasia of the endometrium; - Diagnostic progesterone test; - Termination and prevention of lactation.
Contraindications
- puberty; - Breast cancer (including the suspect); - Malignant tumors of the female genital organs; - Pregnancy (including the suspect, with the exception of cases of miscarriage); - Jaundice (including in history); - Acute liver diseases (including benign and malignant neoplasms); - Impaired liver and kidney function; - Hyperbilirubinemia; - Tendency to thrombosis; - Acute thrombophlebitis or thromboembolism; - Bleeding from the urinary tract of unknown origin; - Bleeding from the genital tract of unknown origin; - Cholestatic jaundice in pregnant women or skin itch in history; - Obesity; - Herpes; - Hypersensitivity to the components of the drug .; With care: bronchial asthma, chronic heart failure, epilepsy, arterial hypertension,migraine, renal failure, convulsions or other abnormalities in the function of the CNS (including history), diabetes, liver disease (history), hyperlipidemia, thrombophlebitis in history, thromboembolism in history.
Use during pregnancy and lactation
The drug is not used during pregnancy .; In case of accidental use of the drug in the early period of pregnancy, the drug did not have a teratogenic effect, incl. disorders of the development of the heart and extremities .; Taking the drug in the postpartum period reduces the secretion of milk and changes its quality indicators.
Dosage and administration
Inside .; Premenstrual syndrome, mastidinia, dysmenorrhea: in the period from the 16th to the 25th day of the menstrual cycle at 5-10 mg / day (1-2 tab.), Can be taken along with estrogen .; Uterine fibroids: 5-10 mg / day from the 5th to the 25th day of the menstrual cycle not more than 6 months .; Diagnostic progesterone test: the best option is the appointment of 10 mg of Norcolut for 10 days. The reaction is regarded as legitimate if moderate bleeding appeared 3-7 days after the end of taking Norcolut and persisted for 3-4 days .; Anovulatory metrorrhagia, endometrial hyperplasia (the dysfunctional nature of bleeding should be confirmed by histological analysis no more than 6 months before treatment): 5-10 mg / day (1-2 pills) for 6-12 days. After achieving the desired effect between the 16th and 25th days of the 5-10 mg / day cycle, usually with estrogen, to prevent recurrence .; Endometriosis: in the period from the 5th to the 25th day of the cycle at 5 mg / day for 6 months. Further treatment is at the discretion of the physician .; Lactation warning: in case of abortion between the 16th and 28th weeks, on the 1st day, take 15 mg (3 pills), on the 2nd and 3rd days, take 10 mg / day (2 pills) , from the 4th to the 7th day, take 5 mg / day (1 tab.). In case of termination of pregnancy between the 28th and 36th weeks on the 1st day, take 15 mg (3 tab.), From the 2nd and 7th days, take 10 mg / day (2 tab.) .; Termination of lactation: from the 1st to the 3rd day prescribed 20 mg / day, from the 4th to the 7th day - 15 mg / day, from the 8th to the 10th day - 10 mg / day.
Side effects
Headache, breast tension, dyspeptic symptoms (nausea, vomiting), acyclic bleeding from the vagina, paresthesia, weight gain, increased fatigue (does not require additional treatment), peripheral edema, allergic reactions (skin rash, itching). With prolonged use - thrombosis, thromboembolism.
Overdose
Nausea, vomiting are possible; vaginal bleeding .; Symptomatic therapy is performed.
Interaction with other drugs
Hepatic enzyme inducers accelerate the metabolism of norethisterone .; With caution prescribed 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 treatment, it is necessary to exclude the presence of malignant tumors, to conduct a preliminary thorough gynecological, oncological examination and examination of the mammary glands .; If the patient has forgotten to take another pill, then the missed pill must be taken as soon as possible, and in this case, additional contraceptive methods must be applied .; Norethisterone does not affect the ability to drive vehicles and mechanisms whose work is associated with an increased risk of injury.