Organometr® (Orgametril®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLinestrenolLinestrenol
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  • Organometr®
    pills inwards 
    Organon, N.V.     Netherlands
  • Eksluton®
    pills inwards 
    Organon, N.V.     Netherlands
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: lynestrenol 5 mg;

    Excipients: potato starch 17.94 mg, alpha-tocopherol 0.2 mg, glycerol 1,794 mg, magnesium stearate 0.75 mg, talc 4 mg, lactose monohydrate 70.3 mg.

    Description:White, round, flat cylindrical tablets with bevelled edges; with a risk on one side of the tablet, with engraving "TT" above the risks and "4" lower risks, and engraving "ORGANON" with a five-pointed star on the other side of the tablet.
    Pharmacotherapeutic group:Derivatives of estrene (gestagen)
    ATX: & nbsp

    G.03.A.C.02   Linestrone

    G.03.A.C   Progestogens

    Pharmacodynamics:

    Organometr® is a drug for oral use. It contains a synthetic progestogen linestrone, which has pharmacological characteristics similar to natural progesterone. Organometr® has a pronounced progestogenic effect on the endometrium. With continuous reception of the drug linestrone has the ability to suppress ovulation and menstruation. Organometr® is suitable for use in those cases where a pronounced progestogenic effect is required.

    Pharmacokinetics:

    After oral administration linestrone It is rapidly absorbed and is converted into a pharmacologically active liver norethisterone. Maximum the level of norethisterone in the blood plasma is observed after 2-4 hours after taking the drug. The half-life of plasma from norethisterone after taking linestrenol is approximately 8-11 hours. Linestrenol and its metabolites are mainly excreted by the kidneys, and to a lesser extent through the intestine.

    Indications:

    - Polymenoray.

    - Menorrhagia and metrorrhagia.

    - Some cases of primary or secondary amenorrhea or oligomenorrhoea.

    - Endometriosis.

    - Some cases of endometrial carcinoma.

    - Benign breast diseases.

    - To suppress ovulation (not for the purpose of contraception), ovulatory pain and menstruation; dysmenorrhea.

    - To delay normal menstruation.

    - Supplement to estrogen replacement therapy in perimenopause and postmenopause for the purpose of preventing endometrial hyperplasia.

    Contraindications:

    - Increased individual sensitivity to any component of the drug Organometr®

    - Pregnancy or suspected pregnancy.

    - The period of breastfeeding.

    - Ectopic pregnancy (in anamnesis).

    - Severe liver disease, such as cholestatic jaundice or hepatitis (or having a history of severe liver disease, if liver function tests have not returned to normal), hepatoma.

    - Rotor Syndrome.

    - Syndrome Dubin-Johnson.

    - Gilbert's syndrome.

    - Bleeding from the vagina of an unclear 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 disorders of cholesterol metabolism.

    - Violation of blood clotting.

    - Thrombosis / thromboembolism (deep vein thrombosis, pulmonary embolism, pulmonary infarction, cerebrovascular disorders).

    Carefully:

    Regular examination of patients with any of the following conditions should be performed: chronic heart failure; arterial hypertension; thromboembolism (in the anamnesis); depression (in the anamnesis).

    Pregnancy and lactation:

    The drug Organometr® is contraindicated for use during pregnancy. The safety of the use of the preparation of Organometr® during lactation has not been established to date.

    Dosing and Administration:

    Orgometri® tablets should be taken orally, with a small amount of water or other liquid. If the next pill is delayed, the woman should take the pill as soon as she remembers it, except when the delay in admission is more than 24 hours.

    Indication for use

    Dosage*

    Polymenorea:

    One tablet a day from 14 to 25 days of menstrual flow cycle.

    Menorrhagia and metrorrhagia:

    2 tablets a day for 10 days. Usually bleeding stops within a few days after starting the drug. The course of treatment should be repeated in the next three menstrual cycles, taking 1 tablet daily from 14 to 25 days of each menstrual cycle. If the therapy is ineffective, additional diagnostic and treatment measures should be taken.

    Some cases of primary or secondary amenorrhea or oligomenorrhoea:

    Treatment should be started with the appointment of estrogens, for example, 0.02-0.05 mg of ethinylestradiol per day for 25 days. On the background of taking estrogens, Orgometri® is prescribed one tablet a day from the 14th to the 25th day of the menstrual cycle.After the end of the medication, menstrual bleeding usually begins after 3 days. Treatment continues (the second cycle), starting from the 5th day, counting from the beginning of bloody discharge: the estrogen drug is prescribed from the 5th to the 25th day of the menstrual cycle, and the preparation of Organometr® is prescribed from 14 to 25 days. The course of treatment should be repeated, at least in one more cycle.

    Endometriosis:

    1-2 tablets per day for at least 6 months in continuous mode.

    Some cases of endometrial carcinoma:

    for 6-10 tablets a day for extended periods.

    Benign breast diseases:

    one tablet a day from 14 to 25 days of the menstrual cycle for at least 3-4 months.

    To suppress ovulation, ovulatory pain and menstruation: dysmenorrhea:

    Reception of the drug Orgometil® in a dose of 1 tablet per day should be started preferably from the 1st day of the menstrual cycle, but not later than the fifth day of the menstrual cycle. Treatment can last for many months (without interruptions). If breakthrough vaginal bleeding occurs against the background of treatment, the dose of the drug can be increased to 2 or 3 tablets per day for 3-5 days.

    To delay normal menstruation:

    Taking the drug 1 tablet a day should be started preferably two weeks before the expected date of the onset of menstruation. If treatment is started less than one week before the required date of menstruation, the dose should be increased to 2-3 tablets per day. However, in this case, a delay of more than 1 week is undesirable. The likelihood of breakthrough bleeding from the vagina increases with the late start of treatment. For this reason, it is not recommended to begin treatment if less than 3 days remain before the expected menstruation.

    Supplement to estrogen replacement therapy in perimenopause and postmenopause for the purpose of preventing endometrial hyperplasia:

    Organometril® is taken by 1/2 tablet or whole tablet daily for 12-15 days per month (for example, during the first two weeks of each month) in which case estrogen replacement therapy can be performed continuously in the lowest effective dosage.

    * The first day of the cycle is the first day of menstrual bleeding.

    Side effects:

    In the literature and post-registration observation, the following adverse reactions were reported:

    System-Organ Class

    Adverse events

    Frequency*

    Violations of the blood and lymphatic system

    Hypercoagulation

    Rarely

    Immune system disorders

    Hypersensitivity

    Infrequently or rarely

    Disorders from the metabolism and nutrition

    Weight gain

    Often

    Fluid retention, incl. peripheral edema, decreased glucose tolerance, lipid abnormalities **

    Infrequently or rarely

    Psychiatric

    disorders

    Increased libido, decreased libido

    Often

    Increased nervous excitability, depression

    Infrequently or rarely

    Disturbances from the nervous system

    Headache, migraine, dizziness

    Infrequently or rarely

    Disorders from the gastrointestinal tract

    Nausea, vomiting, abdominal pain, diarrhea, constipation

    Often

    Disturbances from the liver and bile ducts

    Jaundice, abnormalities in hepatic functional tests (increase in hepatic enzyme activity)

    Infrequently or rarely

    Disturbances from the skin and subcutaneous tissues

    Increased sweating, chloasma, itching, acne, seborrhea, rash, hives, hirsutism

    Infrequently or rarely

    Violations of the reproductive system and breast

    Metrorrhagia ***

    Often

    Soreness of the mammary glands

    Infrequently

    Amenorrhea, vaginal discharge, cervical discharge

    Infrequently or rarely

    * The incidence of adverse events is indicated in terms of "often" (> 10%), "infrequently" (1-10%) and "rarely" (<1%).

    ** Increase in low density lipoprotein cholesterol and decrease in high-density lipoprotein cholesterol (see section "Special instructions").

    *** With prolonged use of the drug, Metmetil®, metrorrhagia is often met (spotting spots or breakthrough bleeding from the vagina). During the cyclic administration of the drug, Metmethyl ®, it is also possible the appearance of metrorrhagia, but more rare. Basically the frequency of appearance of metrorrhagia the greatest during the first two months of treatment. In the future, its frequency progressively decreases. A temporary increase in the dose of the drug allows you to control bleeding in most cases.

    Overdose:

    Symptoms of an overdose: nausea, vomiting. Symptomatic therapy is performed.

    Interaction:

    Although there is insufficient data, it is possible to interact with the drug Medimetil® with other drugs.The following interactions that have been described with the use of synthetic progestogens or combined oral contraceptives are also relevant to the preparation of Organometr. Rifampicin, hydantoin derivatives (including phenytoin), barbiturates (including primidon), carbamazepine and aminoglutethimide, laxatives, Activated carbon can reduce the effectiveness of the drug Organometr. Conversely, the administration of the drug Organometr® can enhance the therapeutic, pharmacological or toxicological effects of cyclosporine, theophylline, troleandomycin, and beta-blockers. Organometr® can reduce the effectiveness of insulin. Macrolides may increase the risk of developing toxic liver damage.

    Special instructions:

    - Organometr® contains lactose in its composition as an auxiliary substance. Therefore, this drug should not be taken by patients with rare hereditary conditions, such as galactose intolerance, Lappease lactase deficiency or glucose-galactose malabsorption.

    - Treatment should be discontinued if test results indicate a violation of liver function.

    - When taking medications containing estrogen and / or progestogen, especially in women with a history of pregnant chloasma, chloasma is sometimes observed. Women prone to the emergence of chloasma, should avoid exposure to the skin of sunlight or artificial ultraviolet radiation.

    - Admission of sex hormones can affect specific laboratory tests. In many patients, during treatment with the preparation of Organometr®, it is possible to increase the level of low-density lipoprotein in the blood and to lower the level of high-density lipoproteins. There are changes in the parameters of liver function, carbohydrate metabolism, blood coagulation system.

    - With prolonged treatment, systematic medical examinations are shown; control of lipid and carbohydrate metabolism, bilirubin concentration, transaminase, coagulation system. The frequency and nature of systematic medical examinations depend on the circumstances in each individual case and should be determined in accordance with the clinical conclusion, but not less than once in 6 months.

    - In connection with the effect of the preparation of Organometr® on the level of globulin that binds sex hormones (SHBG), Organometr® can exhibit some androgenic activity.This can manifest in the lung signs of virilization (mainly acne or seborrhea).

    - Epidemiological studies have revealed a link between the use of progestogen in combination with estrogens with an increase in the incidence of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Despite the fact that the clinical significance of these data for linestrenol without an estrogen component is unknown, in the case of thrombosis, the administration of the drug Metmethyl® should be discontinued. Consideration should also be given to the need to discontinue administration of the drug Metmethyl® in the case of prolonged immobilization due to surgery or disease. Women with thromboembolic disease in a history should be informed about the possibility of their recurrence.

    - Constant monitoring of the condition of patients with circulatory disorders (and also, if there is an anamnesis) is necessary, since the risk of certain cardiovascular diseases or cerebrovascular conditions is slightly increased when taking oral estrogen / progestational contraceptives.

    - It is recommended to limit the intake of fats and carbohydrates during the administration of the preparation Metametil® (which is especially important for women with initially high body weight),in diabetes mellitus, the glycemic profile should be monitored (an increase in the insulin dose may be required).

    - If you are predisposed to hypertension, you need to control blood pressure (reduce fluid intake to 1.5-2 l / day).

    - In the case of dysfunctional uterine bleeding in women of reproductive age, it is recommended to start therapy after treatment and diagnostic curettage of the uterus.

    - Inefficiency of therapy (relapse of bleeding and hyperplastic processes of the endometrium) requires clarification of the causes of bleeding.

    - With prolonged delay of menstruation against the background of therapy with the drug Organometr®, ectopic pregnancy should be excluded.

    Effect on the ability to drive transp. cf. and fur:

    Since dizziness occurs in some patients, caution should be exercised when driving or using other equipment.

    Form release / dosage:Tablets 5 mg.
    Packaging:

    For 30 tablets in a blister of PVC / PVDC / Al. One blister along with the instructions for use are placed in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature of 2-30 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014810 / 01
    Date of registration:19.12.2008 / 25.04.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Organon, N.V.Organon, N.V. Netherlands
    Manufacturer: & nbsp
    ORGANON, N.V. Netherlands
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp11.06.2017
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