Organometrile
Organometrile: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. For violations of liver function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Orgametril
ATX code: G03DC03
Active ingredient: linestrenol (Lynestrenol)
Manufacturer: Organon N. V. (Organon, NV) (Netherlands)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 2579 rubles.
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Orgametril is a drug with a progestogenic effect.
Release form and composition
The drug is produced in the form of tablets: white, flat-cylindrical, round, with beveled edges, on one side there is a risk, above which there is an engraving "TT", below it is "4", on the other side there is an engraving "ORGANON" with the image of a five-pointed star (30 pcs. in blisters, in a cardboard box 1 blister and instructions for use of Organometril).
The composition of 1 tablet includes:
- Active ingredient: linestrenol - 5 mg;
- Auxiliary components: talc, potato starch, alpha-tocopherol, glycerol, magnesium stearate, lactose monohydrate.
Pharmacological properties
Pharmacodynamics
The active ingredient in Orgametril is linestrenol, a synthetic progestogen with pharmacological characteristics that are similar to natural progesterone.
Organometrile has a pronounced progestogenic effect on the endometrium. When taken continuously, it can suppress menstruation and ovulation.
It is considered advisable to prescribe the drug in cases where a pronounced progestogenic effect on the body is required.
Pharmacokinetics
Once in the gastrointestinal tract, linestrenol is rapidly absorbed. In the liver, it is biotransformed into the pharmacologically active metabolite norethisterone. The maximum plasma concentration reaches 2-4 hours after taking Orgametril.
Linestrenol and its metabolites are excreted mainly by the kidneys, to a lesser extent through the intestines.
The half-life of norethisterone is approximately 8-11 hours.
Indications for use
- Polymenorrhea;
- Metrorrhagia, menorrhagia;
- Primary or secondary amenorrhea or oligomenorrhea (in some cases);
- Dysmenorrhea;
- Endometrial carcinoma (in some cases);
- Benign breast diseases;
- Endometriosis;
- Delaying normal menstruation;
- Suppression of menstruation, ovulatory pain, ovulation (not for contraception).
Orgametril is also prescribed as an adjunct to estrogen replacement therapy in postmenopausal and perimenopausal women (to prevent endometrial hyperplasia).
Contraindications
Absolute:
- Vaginal bleeding of unknown origin;
- Diabetes;
- Hepatoma, severe liver disease, including hepatitis or cholestatic jaundice (or history of severe liver disease in cases where liver function indicators have not returned to normal);
- Severe depression;
- Congenital disorders of cholesterol metabolism;
- Thromboembolism / thrombosis (deep vein thrombosis, cerebrovascular disorders, pulmonary embolism, heart attack);
- Conditions that can be aggravated by the use of sex steroid hormones, such as gestational herpes, gestational jaundice, otosclerosis, chloasma of pregnant women, severe itching, porphyria (current or history);
- Rotor, Gilbert and Dubin-Johnson syndromes;
- Blood clotting disorders;
- Pregnancy (confirmed or suspected), ectopic pregnancy (anamnestic data) and breastfeeding period;
- Hypersensitivity to drug components.
Relative (the appointment of Orgametril requires caution and regular monitoring of the condition):
- Thromboembolism (anamnestic data);
- Arterial hypertension;
- Chronic heart failure;
- Depression (anamnestic data).
Orgametril, instructions for use: method and dosage
Organometrile is taken orally with a small amount of water or other liquid. If you miss a single dose, you need to take it as early as possible, unless the delay is more than 24 hours.
Recommended dosing regimen (first day of menstrual bleeding - first day of the cycle; daily dose):
- Polymenorrhea: 1 tablet daily during the period from 14 to 25 days of the menstrual cycle;
- Metrorrhagia, menorrhagia: 2 tablets for 10 days; bleeding usually stops within a few days from the moment you start taking Organometril. In the future, during the next 3 menstrual cycles, treatment should be repeated with a daily dose reduced to 1 tablet daily from 14 to 25 days of each menstrual cycle. In case of ineffectiveness of therapy, it is recommended to carry out additional diagnostic and therapeutic measures;
- Primary or secondary amenorrhea or oligomenorrhea (in some cases): therapy should be started with estrogens (for example, 0.02-0.05 mg ethinylestradiol per day for a course of 25 days). Organometrile should be taken while taking estrogens, 1 tablet per day from 14 to 25 days of the menstrual cycle. Menstrual bleeding after the end of the drug usually begins after 3 days. The second cycle of therapy should be started from day 5, counting from the onset of bloody discharge: estrogen drug - from 5 to 25 days of the menstrual cycle, Orgametril - from 14 to 25 days. The therapeutic course must be repeated at least one more cycle;
- Endometriosis: 1-2 tablets continuously over a course of at least 6 months;
- Endometrial carcinoma (in some cases): long-term, 6-10 tablets;
- Benign breast diseases: 1 tablet from 14 to 25 days of the menstrual cycle for at least 3-4 months;
- Dysmenorrhea, suppression of menstruation, ovulatory pain, ovulation: 1 tablet from 1 day of the menstrual cycle (no later than 5 days of the menstrual cycle). Continuous therapy can be continued for many months. If, while taking the drug, breakthrough vaginal bleeding is observed, for 3-5 days it is possible to increase the daily dose to 2-3 tablets;
- Postponement of normal menstruation: 1 tablet, the reception begins 14 days before the expected date of the onset of menstruation. If therapy is started less than 7 days before the date of the onset of menstruation, the daily dose of the drug should be increased to 2-3 tablets (in this case, a delay of more than 7 days is undesirable). The likelihood of developing breakthrough bleeding from the vagina increases with late initiation of therapy. It is not recommended to start treatment if less than 3 days are left before the expected menstruation occurs;
- Addition to estrogen replacement therapy in post-menopausal and perimenopausal: daily 1 / 2 -1 tablet course of 12-15 days per month (for example, during the first 2 weeks of each month), it allows for estrogen replacement therapy continuously at the lowest effective dose …
Side effects
Possible side effects (> 10% - often, 1-10% - infrequently, <1% - rarely):
- Digestive system: often - nausea, vomiting, abdominal pain, diarrhea, constipation; infrequently or rarely - jaundice, abnormal liver function tests (increased activity of liver enzymes);
- Blood coagulation system: rarely - hypercoagulation;
- Nervous system: infrequently or rarely - headache, migraine, dizziness;
- Reproductive system: often (with prolonged therapy - more often, with cyclic administration - less often; in most cases, controlled by a temporary increase in the dose of Orgametril) - metrorrhagia; infrequently - soreness of the mammary glands; infrequently or rarely - amenorrhea, vaginal discharge, cervical discharge;
- Immune system: infrequently or rarely - hypersensitivity;
- Psyche: often - change (increase or decrease) in libido; infrequently or rarely - increased nervous irritability, depression;
- Subcutaneous tissue and skin: infrequently or rarely - increased sweating, chloasma, itching, acne, seborrhea, rash, urticaria, hirsutism;
- Metabolism: often - an increase in body weight; infrequently or rarely - fluid retention, incl. peripheral edema, decreased glucose tolerance, lipid metabolism disorders (an increase in LDL cholesterol and a decrease in HDL cholesterol).
Due to the lactose that is part of Orgametril (as an excipient), it should not be taken against the background of such rare hereditary disorders as galactose intolerance, glucose-galactose malabsorption or lapp lactase deficiency.
Overdose
In case of overdose, nausea and vomiting occur.
If necessary, symptomatic treatment is recommended.
special instructions
Against the background of the use of Orgametril, chloasma may develop, especially in women with anamnestic data on chloasma of pregnant women. If you are prone to disease, it is recommended to avoid exposure to artificial UV radiation or sunlight.
If there is evidence of the development of functional liver disorders, therapy should be interrupted.
Taking Orgametril may affect specific laboratory tests; changes in the parameters of carbohydrate metabolism, liver function, and the blood coagulation system are also possible. In many patients, during therapy, the level of LDL in the blood can increase and the level of HDL can decrease.
With prolonged therapy, systematic medical examinations, monitoring of indicators of carbohydrate and lipid metabolism, the concentration of transaminases, bilirubin, and the coagulation system are shown. Their nature and frequency are determined individually, but at least once every six months.
Linestrenol is able to exhibit some androgenic activity, which can be expressed in the form of mild signs of virilization (mainly seborrhea or acne).
With thrombosis, the reception of Organometril should be interrupted. It is also recommended to interrupt therapy with prolonged immobilization due to surgery or illness. In the presence of a history of thromboembolic diseases, the possibility of their recurrence should be considered.
In case of circulatory disorders (as well as if they are indicated in the anamnesis), it is necessary to constantly monitor the condition of patients, since against the background of taking the drug, the likelihood of the development of certain cardiovascular diseases or cerebrovascular conditions increases.
During therapy, it is recommended to limit the intake of carbohydrates and fats (especially important with an initially increased body weight).
While taking Orgametril in patients with diabetes mellitus, it is necessary to control the glycemic profile (in some cases, an increase in the dose of insulin may be required), with a predisposition to arterial hypertension - blood pressure (it is recommended to reduce the daily fluid intake to 1.5-2 liters).
In case of dysfunctional uterine bleeding in women of reproductive age, it is recommended to start therapy after carrying out a therapeutic and diagnostic curettage of the uterus.
The ineffectiveness of therapy (with recurrent bleeding and endometrial hyperplastic processes) requires additional diagnostics.
With a prolonged delay in menstruation while taking Orgametril, an ectopic pregnancy should be excluded.
Influence on the ability to drive vehicles and complex mechanisms
During therapy, it is recommended to be careful when driving vehicles or other equipment, since Orgametril can lead to the development of dizziness.
Application during pregnancy and lactation
It is contraindicated to prescribe orgametril during pregnancy.
The safety of linestrenol for children whose mothers take the drug during lactation has not yet been established.
For violations of liver function
Orgamethril is prohibited for use in severe liver diseases such as hepatoma, hepatitis and cholestatic jaundice, as well as in patients with a history of severe liver disease, until the liver function is normalized.
Drug interactions
With the combined use of Orgametril with certain substances / drugs, the following effects may occur (based on data on the interaction of combined oral contraceptives or synthetic progestogens):
- Beta-blockers, theophylline, cyclosporine, troleandomycin: an increase in their therapeutic, pharmacological or toxicological effects;
- Antibiotic drugs of the macrolide group: increasing the risk of toxic liver damage;
- Aminoglutethimide, carbamazepine, rifamycin, laxatives, hydantoin derivatives (including phenytoin), barbiturates (including primidone), activated charcoal: decreasing the effectiveness of Orgametril;
- Insulin: decrease in its effectiveness.
Analogs
Orgametril analogs are: Linestrenol, Exluton.
Terms and conditions of storage
Store in a dark, dry place out of reach of children at a temperature of 2-30 ° C.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Orgametril
Patients leave mostly positive reviews about Orgametril, which is used to treat various women's diseases. They note, if not a cure, then a significant improvement in the clinical picture after the end of the course. There are frequent reports of the development of side effects, including nausea, increased appetite, skin rash, spotting, and breakthrough uterine bleeding. But, despite the fact that adverse reactions are not always mild or moderate, most women consider the benefits of Orgametril more significant.
Price for Organometrile in pharmacies
The approximate price for Organometril is 2272–3180 rubles. per pack of 30 tablets.
Organometril: prices in online pharmacies
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Drug name Price Pharmacy |
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Organometrile 5 mg tablets 30 pcs. 2579 RUB Buy |
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Organometrile tablets 5mg 30 pcs. 2638 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
