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Active ingredients
Linestrenol
Release form
Pills
Composition
Active ingredient: Linestrenol (Lynestrenol) Active ingredient concentration (mg): 5
Pharmacological effect
Synthetic progestogen for oral administration. Linestrenol has pharmacological characteristics similar to natural progesterone. Orgametril has a pronounced progestogenic effect on the endometrium. With continuous intake of the drug, linestrenol can suppress ovulation and menstruation. It is advisable to use orgamer in cases where pronounced progestogenic effects are required.
Pharmacokinetics
After oral administration, linestrenol is rapidly absorbed and undergoes transformation in the liver into pharmacologically active norethisterone. Cmax of norethisterone in blood plasma is noted 2-4 hours after taking the drug. T1 / 2 from plasma norethisterone after administration of linestrenol is approximately 8-11 hours. Linestrenol and its metabolites are mainly excreted by the kidneys, and to a lesser extent through the intestines.
Indications
Polymenorrhea; menorrhagia and metrorrhagia; some cases of primary or secondary amenorrhea or oligomenorrhea; endometriosis; some cases of endometrial carcinoma; benign diseases of the mammary glands - to delay normal menstruation; - addition to estrogen replacement therapy in perimenopause and postmenopause in order to prevent endometrial hyperplasia.
Contraindications
Pregnancy or suspected pregnancy; - breastfeeding period; - ectopic pregnancy (in history); severe liver diseases such as cholestatic jaundice or hepatitis (or a history of severe liver disease, if liver function indicators did not return to normal), hepatoma; - Rotor syndrome; - Dubin-Johnson syndrome; - Gilbert's syndrome; - bleeding from the vagina of unknown etiology; - conditions (currently or in history) that can be aggravated by taking sex steroid hormones (including gestational herpes, gestational jaundice, otosclerosis, pregnant chloasma, severe itching, porphyria); - severe depression; - diabetes; - congenital cholesterol metabolic disorders; - blood clotting; cerebrovascular disorders); - hypersensitivity to the drug.
Precautionary measures
Do not exceed the recommended dose. With care It is necessary to regularly monitor the condition of patients in any of the following conditions: chronic heart failure; arterial hypertension; thromboembolism (in history); depression (in history).
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy. The safety of the drug use Orgametril during lactation has not yet been established.
Dosage and administration
Inside With endometriosis, dysmenorrhea, to suppress menstruation - 1-3 pills. per day for at least 6 months; with endometrial carcinoma - 6-10 pills. in a day; for delaying normal menstruation - 1-2 tables. a day 1-2 weeks before the onset of the expected menstruation. In addition to estrogen therapy, 1 / 2–1 tab. per day for 12–15 days of each month in the second phase of the cycle. In the case of amenorrhea or oligomenorrhea after estrogen preparation of the endometrium and for other indications - 1-2 tables. per day, from 14–25 days.
Side effects
Nausea, weight gain, “breakthrough” bleeding, spotting; rarely - headache, dizziness, migraine, nervousness, depression, chest pain, jaundice, changes in liver function and lipoprotein profile, decreased tolerance to glucose, acne, chloasma, hirsutism, skin rashes and itching; after the end of treatment - swelling and amenorrhea.
Overdose
Symptoms: nausea, vomiting. Treatment: symptomatic therapy.
Interaction with other drugs
Although there is insufficient data, it is possible the interaction of the drug Orgametril with other drugs. The following interaction has been described with the use of synthetic progestogens or combined oral contraceptives, also related to the drug Orgametril. Rifamycin, hydantoin derivatives (including phenytoin), barbiturates (including primidone), carbamazepine and aminoglutethimide, laxatives, activated carbon can reduce the effectiveness of the drug Orgametril. Conversely, Orgametril can increase the therapeutic, pharmacological or toxicological effects of cyclosporine, theophylline, troleandomycin and beta-blockers. Orgametryl can reduce the effectiveness of insulin. If used simultaneously with macrolide antibiotics, the risk of toxic liver damage may be increased.
special instructions
Treatment should be interrupted if test results indicate abnormal liver function. When taking drugs containing estrogen and / or progestogen, especially in women with a history of pregnant chloasma, chloasma is sometimes observed. Women who are prone to chloasma should avoid exposure of the skin to sunlight or artificial UV radiation. Acceptance of sex hormones can affect specific laboratory tests. In many patients during the treatment with Orgametril, it is possible to increase the level of LDL in the blood and lower the level of HDL. Changes in the parameters of liver function, carbohydrate metabolism, blood clotting system are possible. With prolonged treatment, systematic medical examinations are indicated; monitoring of lipid and carbohydrate metabolism, bilirubin concentrations, transaminases, coagulation systems. The frequency and nature of systematic medical examinations depend on the circumstances in each individual case and should be determined in accordance with clinical evidence, but not less than 1 time in 6 months. Due to the influence of linestrenol on the level of sex hormone-binding globulin, it can show some androgenic activity . This can be expressed in the lung signs of virilization (mainly acne or seborrhea). Epidemiological studies have found a connection between the use of progestogen in combination with estrogen and an increased incidence of venous thromboembolism (deep venous thrombosis and pulmonary thromboembolism). Although the clinical significance of this data for linestrenol without an estrogen component is unknown. In the case of thrombosis, you should stop taking the drug Orgametril. You should also consider the need to stop taking the drug Orgametril in case of prolonged immobilization due to surgery or disease. Women with a history of thromboembolic disease should be informed about the possibility of their recurrence. It is necessary to constantly monitor the condition of patients with circulatory disorders (and also, if they are in history), because when taking oral estrogen / progestin contraceptives,the risk of certain cardiovascular diseases or cerebrovascular conditions increases slightly. While taking the drug Orgametril, it is recommended to limit the intake of fats and carbohydrates (which is especially important for women with initially high body mass). In diabetes, the glycemic profile should be monitored (an increase in insulin dose may be required) In case of susceptibility to arterial hypertension, it is necessary to control blood pressure (reduce fluid intake to 1.5-2 l / day). In case of dysfunctional uterine cavities In women of reproductive age, it is recommended to begin therapy after therapeutic and diagnostic curettage of the uterus. Ineffective therapy (recurrence of bleeding and endometrial hyperplastic processes) requires clarification of the causes of bleeding. lactose as an excipient. Therefore, this drug should not be prescribed to patients with rare hereditary disorders, such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. Effect on ability to drive vehicles and control mechanisms. Since the drug can cause dizziness, patients should be careful when driving or using other equipment .