Norcolutum

General characteristics. Structure:

Active ingredient: Norethisteronum of 5 mg

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

Pharmacological properties:

Pharmacodynamics. Norethisteronum is progestogen. Causes transformation of a mucous membrane of a uterus from a proliferation phase in secretory, blocks secretion of a gonadotrophin in a hypophysis, interfering with maturing of follicles and approach of an ovulation.

Pharmacokinetics. Absorbability: It is well soaked up from digestive tract. As a result of intensive primary metabolism in a liver and in an intestinal wall bioavailability makes 50-77%.
Distribution: In 0,5-4 h after reception of 0,5 mg of Norethisteronum the maximum concentration in serum of 2-5 ng/ml, at reception of 1 mg – 5-10 ng/ml, at reception of 3 mg – 30 ng/ml.
Biotransformation: Metabolites of Norethisteronum are removed by kidneys in the form of conjugates with glucuronic acid.
Removal: Removal of the conjugated metabolites – through intestines (40%) and kidneys (60%). Decrease in concentration of Norethisteronum in serum is carried out in two phases. The elimination half-life in the first phase lasts 2,5 h, in a final phase – 8 h 80% of the metabolites which are formed in a liver are brought by kidneys.

Indications to use:

Premenstrual syndrome; the anovulatory metrorrhagia, a dysmenorrhea (which is followed by shortening of a secretory phase), endometriosis, myoma, a mastodynia, an endometria hyperplasia, the diagnostic progesteronovy test; termination and prevention of a lactation.

Route of administration and doses:

Route of administration – inside.
Premenstrual syndrome; mastodynia, dysmenorrhea: during the period from 16 to 25 day of a menstrual cycle on 5-10 mg a day (1-2 tab.), it is possible to accept together with estrogen.
Hysteromyoma: on 5-10 mg, from 5 to 25 day of a menstrual cycle, no more than 6 months.
Diagnostic progesteronovy test. An optimal variant is purpose of 10 mg of Norcolutum within 10 days. Reaction is regarded as natural if in 3-7 days after the end of reception of Norcolutum moderate bloody allocations appeared and remained within 3-4 days.

Anovulatory metrorrhagia, endometria hyperplasia: (the dysfunctional nature of bleeding has to be confirmed with the histologic analysis no more, than in 6 months prior to treatment) on 5-10 mg/day (1-2 tab.) within 6-12 days. After achievement of desirable effect, during the period between 16 and 25 days of a cycle on 5-10 mg/day, usually together with estrogen, for the prevention of a recurrence.

Endometriosis: during the period from 5 to 25 day of a cycle on 5 mg/day, within 6 months. Further treatment to the discretion of the doctor.

Prevention of a lactation:
In case of abortion between 16 and 28 weeks in the 1st day to accept 15 mg (3 tab.), on 2-3 – й to accept days on 10 mg (2 tab.) a day, from the 4th to the 7th day to accept 5 mg (1 tab.) a day;
In case of abortion between 28 and 36 weeks in the 1st day to accept 15 mg (3 tab.), on 2-3 – й to accept days on 10 mg (2 tab.) a day, from the 4th to the 7th day to accept 10 mg (2 tab.) a day.
For the termination of a lactation: in the 1st 3 days appoint in a daily dose 20 mg, from the 4th to the 7th day – 15 mg, from the 8th to the 10th day – 10 mg.

Features of use:

It is necessary to exclude existence of malignant new growths prior to treatment, to conduct preliminary careful gynecologic, oncological survey and inspection of mammary glands.
If the patient forgot to take the next pill, then the passed pill needs to be taken as soon as possible, and in this case it is necessary to apply additional methods of contraception.
Effect of drug on ability to drive the car and mechanisms on which work is connected with the increased risk of traumatism:
Norethisteronum does not influence ability to drive the car and mechanisms.

Side effects:

Headache, tension of mammary glands, the dispepsichesky phenomena (nausea, vomiting), acyclic bloody allocations from a vagina, paresthesia, increase in body weight, increased fatigue (does not demand additional treatment), peripheral hypostases, allergic reactions (skin rash, an itch). At prolonged use – thrombosis, a thrombembolia. Overdose.
Nausea, vomiting are possible; vaginal bleeding.
Symptomatic treatment.

Interaction with other medicines:

Inductors of liver enzymes accelerate metabolism of Norethisteronum.
With care appoint along with hypoglycemic medicines, peroral anticoagulants, glucocorticosteroids.

It is not recommended to combine with barbiturates, Phenytoinum, rifampicin, Cimetidinum and other medicines influencing a microsomal oxidation in a liver.

Contraindications:

The puberty period, hypersensitivity to drug components, a breast cancer (including the suspect), malignant tumors of female generative organs, pregnancy (including the suspect, except for use cases concerning not incubation), jaundice (including in the anamnesis), acute diseases of a liver (including high-quality and malignant new growths), an abnormal liver function and kidneys, a hyperbilirubinemia, tendency to fibrinferments, acute tromboflefit or a thrombembolia, bleeding from urinary tract of not clear genesis, bleeding from a genital tract of not clear genesis, cholestatic jaundice of pregnant women or a skin itch in the anamnesis, obesity, herpes.
With care – Bronchial asthma, chronic heart failure, epilepsy, arterial hypertension, migraine, a renal failure, spasms or other dysfunctions of the central nervous system (including in the anamnesis), a diabetes mellitus, liver diseases (in the anamnesis), a lipidemia, thrombophlebitis in the anamnesis, a thromboembolism in the anamnesis.

Pregnancy and lactation.
At pregnancy it is not used.
At accidental administration of drug in the early period of pregnancy drug had no teratogenic effect, including disturbances of development of heart and extremities.
Reception of Norethisteronum in a puerperal period reduces secretion of milk and changes its quality indicators.

Overdose:

Nausea, vomiting are possible; vaginal bleeding.

Carry out symptomatic therapy.

Storage conditions:

To store at a temperature of 15-30 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets of 5 mg.
10 tablets in the blister from PVC of a film and aluminum foil. Two blisters in a cardboard pack with the enclosed application instruction.