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Description
The instruction for use
of medicine for experts
НОРКОЛУТ®
A trade name
of Norkolut®
the International unlicensed
name Norethisteronum Dosage Form
of the Tablet of 5 mg
Structure
One tablet contains
active agent – Norethisteronum of 5 mg,
excipients: potato starch, magnesium stearate, silicon dioxide, colloidal anhydrous, gelatin, corn starch, talc, lactose mongidrat (92.5 mg).
The description
Flat round tablets of white or almost white color with a facet, on one party of tablets an engraving of NORCOLUT, on another – +
Pharmacotherapeutic group
Sex hormones and modulators of function of genitals, Estrenum derivatives
the ATX G03DC02 Code
the Pharmacological
Pharmacokinetics Well properties is soaked up from digestive tract. As a result of intensive primary metabolism in a liver and in an intestinal wall the bioavailability is 50-77%.
In 0.5-4 h after reception of 0.5 mg of Norethisteronum the maximum concentration in serum makes 205 ng ml, at reception of 1 mg – 5-10 ng ml, at reception of 3 mg – 30 ng ml.
At a concomitant use together with ethinylestradiol the concentration of Norethisteronum in blood serum is measured in higher concentrations which at multiple dose can reach a saturation stage that is caused, mainly, by delay of metabolism as a result of the introduction in communication with the globulin connecting sex hormones.
Among metabolites of Norethisteronum there are many isomers, for example, 5α-дигидро-норэтистерон and tetragidro-Norethisteronum, removed with urine in the form of glucuronide conjugates. A part of Norethisteronum and its metabolites forms communication with 17β-гидрокси-группой.
Decrease in concentration of Norethisteronum in serum is carried out in two phases. 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 with urine.
The pharmacodynamics
Norethisteronum is progestogen. Causes secretory transformations in proliferating endometrium and blocks secretion of a gonadotrophin in a hypophysis, interfering with maturing of follicles and approach of an ovulation.
Indications
– a premenstrual syndrome
– a mastodynia
– disturbance of a menstrual cycle with shortening of a secretory phase
– dysfunctional uterine bleedings
– cystous glyandulyarnaya an endometrium hyperplasia
– endometriosis
– an adenomyosis
– prevention of a lactation
– ablactation
– disfuntsionalny bleedings in a klimakteriya
the Route of administration and doses
the Premenstrual syndrome, a mastodynia, disturbance of a menstrual cycle: during the period from 16 to 25 day of a menstrual cycle on 5-10 mg a day (1-2 tablets), it is possible to accept together with estrogen.
Dysfunctional uterine bleedings, kistoznoglyandulyarny hyperplasia of endometrium: (the dysfunctional nature of bleeding has to be confirmed with the histologic analysis no more, than 6-month) on 5-10 mg day (1-2 tablets) 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 prevention of a recurrence.
Endometriosis, adenomyosis: during the period from 5 to 25 day of a cycle on 5 mg day, within 6 months. At prolonged use of drug, since 5 in the afternoon a cycle, on 2.5 mg day (12 tablets), then each 2-3 weeks it is necessary to increase a dose by 12 tablets Duration of Treatment Is 4-6 Months.
Prevention of a lactation:
Days of administration of drug
Termination of pregnancy between
16 and 28 weeks
Termination of pregnancy between
28 and 36 weeks
1
15 mg (3 tablets)
15 mg (3 tablets)
2-3
10 mg (2 tablets)
10 mg (2 tablets)
4-7
5 mg (1 tablets)
10 mg (2 tablets)
Ablactation: in 1-3 days on 20 mg (4 tablets), for 4-7 days on 15 mg (3 tablets), for 8-10 days on 10 mg (2 tablets)
Dysfunctional bleedings in a klimakteriya: in the second half of a menstrual cycle on 5 mg day (1 tablets), within 10-20 days. Additional therapy by oestradiol can be required.
Side effects
– a headache
– nausea, vomiting
– tension of mammary glands
– gastrointestinal complaints
– disturbance of periods
– a liquid delay
– paresthesia
– change of weight
– feeling of fatigue (in rare instances)
– a hloazma, a melanoderma.
Contraindications
– awkward age
– pregnancy
– a breast cancer
– malignant tumors of female genitals.
With care: in the presence of cardiovascular, renal diseases, in bronchial asthma, epilepsy, predisposition to a thrombogenesis, hepatitis, abnormal liver functions.
Medicinal interactions
It is necessary to show care when assigning together with inductors of hepatic enzymes since the last accelerate Norethisteronum metabolism.
Special instructions
It is necessary preliminary careful gynecologic, oncological inspections and inspection of mammary glands.
Pregnancy and lactation.
During extensive epidemiological inspections of children which mothers applied the oral contraceptives containing Norethisteronum before conception, increase of disturbances of development is not revealed. According to other researches, at accidental administration of drug in the early period of pregnancy, drug did not render a teratogenic ideystviye, including disturbances of development of heart and extremities.
Drug cannot be used for the purpose of provocation of bleeding of cancellation for a pregnancy exception and also at the menacing and usual abortions.
Intake of Norethisteronum in a puerperal period reduces secretion of milk and changes its quality indicators.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Norethisteronum does not affect ability to drive the car and working cars.
Overdose
Reception by young patients of high doses of the contraceptives containing Norethisteronum did not cause development of heavy side effects.
At overdose the nausea and bleeding of cancellation are possible.
Treatment: symptomatic.
A form of release and packing
of 20 tablets in the blister from PVC and aluminum foil. One blister in a cardboard box with the enclosed instruction for use.
To Store storage conditions at a temperature from +15 to +30 Pages.
To store out of children’s reach!
An expiration date
of 5 years
Prescription status
According to the prescription
the Producer Gideon Richter A.O.
of 1103 Budapest, Djemrei St., 19-21, Hungary
Additional information
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