Norcolut® [Norethisterone]
Gedeon Richter
1392 Items
2019-09-19
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Clinical Pharmacology
The active ingredient of Norcolut - norethisterone is primarily a progestin-type norsteroid. Compared with other known progestogens, the drug, although not among the most active progestogens, its properties are still unusually favorable for therapy.
In the so-called "delay of mensis" test (delayed menstruation), used to determine the effectiveness of gestagens, the drug shows the properties of weak gestagens. The compound turned out to be a progestive medium-intensity steroid when tested by Hammerstein, as well as in a Clauberg test that measures the dose required for endometrial transformation.
In contrast to many progestin compounds, norethisterone has a pronounced anti-estrogenic character, and unlike other derivatives of nortestosterone in the body, only a small part of the compound is converted into estrogen.
At the same time, Paulsen observed gynecomastia in men and increased mammary glands in women under the influence of norethisterone. In addition to the main progestogenic effect, the weak androgenic property of the compound was also determined. According to clinical and pharmacological studies, norethisterone blocks the production of follicle-stimulating hormone (FSH) and hormone of the corpus luteum (LH), reduces the synthesis of steroids by the corpus luteum.
Norethisterone, which possesses mainly a gestagenic property, exhibits a significant antiestrogenic and minimal estrogenic and androgenic effect, can be very widely used in the field of obstetrics and gynecology.
Indications
Premenstrual syndrome, mastodinia, cycle disorders, accompanied by shortening of the secretion period, dysfunctional uterine bleeding, cystic glandular endometrial hyperplasia, endometriosis, adenomyosis, termination and prevention of lactation, postponement of menstruation, menopause, in case of individual need oral contraception.
Composition
1 tablet contains:
Active substance: 5 mg of norethisterone.
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Dosage and Administration
In case of premenstrual syndrome, mastodynia, and also disordered cycles 1-2 pills are prescribed from the 16th day of the cycle to the 25th day of the cycle; this dosage may be supplemented with estrogen.
With dysfunctional uterine bleeding, cystic glandular hyperplasia of the endometrium (if the functional origin of the bleeding is confirmed by a histological analysis performed in a 6-month period), 1-2 pills per day are given for 6-12 days to stop the bleeding. To prevent relapse from the 16th day of the cycle to the 25th day of the cycle, 1-2 pills per day are prescribed, usually together with estrogen. In the case of a malignant process, norcolut therapy is not used.
In case of endometriosis, adenomyosis starting from the 5th day and ending on the 25th day of the cycle, 1 tablet per day is applied for 6 months or continuously from the 5th day of the cycle 1/2 tablet per day, increasing the dose by 1/2 tablet every 2— 3 weeks, for 4-6 months.
To stop lactation in 1-3 days, 4 pills, in 4-7 days, 3 pills, in 8-10 days, 2 pills. When menopausal symptoms are prescribed for a long time (months), 1 tablet per day, or, in case of failure, is used in combination with 25-50 μg of ethinyl estradiol. For oral contraceptive use, 1 / 4–1 / 2 pills of Norcolut and 0.05 mg of ethinyl estradiol are used starting from the 5th day of the cycle for 21 days, then after a 7-day break, the course is repeated. If necessary, 2-phase contraceptive dosage is prescribed from the 5th day of the cycle for 10 days to 1/4 of Norcolut®'s tablet, then for 11 days 1/2 of the pills of Norcolut and 0.05 mg of ethinyl estradiol.
For postponing menstruation treatment begins 8 days before the expected menstruation and lasts for 12 days: with this, 2 pills of Norcolut are prescribed per day, this dosage provides approximately 7–8 days delay in menstruation.
Adverse reactions
Rarely encountered and further passing cycles: nausea, gastrointestinal complaints, extraordinary bleeding, sometimes edema, allergic skin reaction, paresthesia, weight change, fatigue.
Contraindications
Predisposition to thrombosis, hepatitis, disorders of the hepatic function, malignant tumors of the breast and genital organs.
Drug interactions
Drugs that activate microsomal liver enzymes (barbiturates, etc.) accelerate the metabolism and weaken the effect; on the contrary, inhibitors (cimetidine and others) strengthen it.
- Brand name: Norcolut
- Active ingredient: Norethysterone
- Norethisterone acetate (SH420) in advanced breast cancer
- Do the dose or route of administration of norethisterone acetate as a part of hormone therapy play a role in risk of breast cancer: National-wide case-control study from Finland
- Molecular mechanisms of the antihormonal and antiimplantation effects of norethisterone and its a-ring reduced metabolites
- Quantitative determination of norethisterone acetate in human plasma by capillary gas chromatography with mass-selective detection
- Simultaneous determination of norethisterone and six metabolites in human plasma by capillary gas chromatography with mass-selective detection
- Synthesis of (6,7-3H) norethisterone oxime acetate and its application
- Electrochemical immunosensor for norethisterone based on signal amplification strategy of graphene sheets and multienzyme functionalized mesoporous silica nanoparticles
- Intermittent progestin administration as part of hormone replacement therapy: long-term comparison between estradiol 1 mg combined with intermittent norgestimate and estradiol2 mg combined with constant norethisterone acetate
- Allergic contact dermatitis from estradiol and norethisterone acetate in a transdermal hormonal patch
- Norethisterone therapy for bleeding due to gastrointestinal telangiectases in Glanzmann's thrombasthenia
- Potential of norethisterone enanthate for male contraception: pharmacokinetics and suppression of pituitary and gonadal function
- Effect of norethisterone and its A-ring reduced metabolites on the acrosome reaction in porcine spermatozoa
- Lipoproteins and low-dose estradiol replacement therapy in post-menopausal Type 2 diabetic patients: the effect of addition of norethisterone acetate
- A multicentre randomised trial to compare uterine safety of raloxifene with a continuous combined hormone replacement therapy containing oestradiol and norethisterone acetate
- Effects of low-dose 17-β-estradiol plus norethisterone acetate and tibolone on fasting plasma homocysteine levels in postmenopausal women
- Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: a randomized controlled trial
- The effect of rifampicin on norethisterone pharmacokinetics
- Effect of norethisterone-acetate on salt excretion and on the renin-aldosterone system in man
- Preparation and pharmacokinetic evaluation of a modified long-acting injectable norethisterone microsphere
- Effects of oral contraceptive steroids (norethisterone/mestranol) on the activities of hepatic drug-metabolizing enzymes in iron-deficient anemic rats
- Determination of ethinyloestradiol in the presence of norethisterone by derivative-difference spectrophotometry
- Lipid and carbohydrate metabolism studies in oophorectomized women: Effects produced by the addition of norethisterone acetate to two estrogen preparations
- The photochemical decomposition of the progestogenic 19-norsteroid, norethisterone, in aqueous medium
- Structure elucidation of two isomeric steroids: Photolytical and thermal reaction products from norethisterone studied by two-dimensional nuclear magnetic resonance
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