Orgametril, tablets 5 mg 30 pcs

Orgametril is progestagenic.

Binds to specific cytoplasmic receptors, forming a complex that interacts with the chromatin of target cells.

Causes the transition of the uterine mucosa from the proliferation phase to the secretory phase.

Pharmacodynamics

It has a pronounced atrophic effect on the myometrium; suppresses ovulation and menstruation (with prolonged continuous administration).

Indications

Active ingredient

Composition

Active ingredient:

linestrenol 5 mg;

Associates:

Potato starch,

α-tocopherol,

Glycerol,

How to take, the dosage

The drug should be taken orally with a small amount of water or other liquid. If there is a delay in taking the next pill, the woman should take the pill as soon as she remembers it, unless there is a delay of more than 24 hours.

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

Polymenorrhea: 5 mg (1 tablet)/day on days 14 to 25 of the menstrual cycle.

Menorrhagia and metrorrhagia: 10 mg (2 tablets)/day for 10 days. Usually bleeding stops within a few days after initiation of the drug. The treatment course should be repeated for the next 3 menstrual cycles with 5 mg (1 tablet) daily from 14 to 25 days of each menstrual cycle. If the therapy proves to be ineffective it is necessary to carry out additional diagnostic and therapeutic measures.

Some cases of primary or secondary amenorrhea or oligomenorrhea: treatment should be started with the prescription of estrogens, for example, on 20-50 mcg ethinylestradiol per day for 25 days. On a background of reception of estrogens Orgametril it is appointed on 5 mg (1 tablet) day with 14 to 25 day of a menstrual cycle. After the end of medication menstrual-like bleeding usually begins after 3 days. The treatment proceeds (the second cycle), starting from the 5th day, counting from the beginning of the menstrual bleeding: the estrogenic preparation is prescribed from the 5th to the 25th day of the menstrual cycle, Orgametril is prescribed from the 14th to the 25th day. The course of treatment should be repeated in at least one more cycle.

Endometriosis: 5-10 mg (1-2 tablets) per day for at least 6 months continuously.

Some cases of endometrial carcinoma: 30-50 mg (6-10 tablets) per day for long periods.

Benign breast disease: 5 mg (1 tablet) per day from days 14 to 25 of the menstrual cycle for at least 3 to 4 months.

For suppression of ovulation, ovulatory pain, and menstruation; dysmenorrhea: Orgametril at a dose of 5 mg (1 tablet) per day should be started from day 1 of the menstrual cycle, but no later than day 5 of the menstrual cycle. Treatment may be continued for many months (without interruptions). If breakthrough vaginal bleeding occurs during treatment, the dose of the drug may be increased to 10-15 mg (2-3 tablets) per day for 3-5 days.

To delay normal menstruation: the use of 5 mg (1 tablet) per day should be started 2 weeks before the expected date of menstruation. If treatment is started less than 1 week before the date of menstruation, the drug dose should be increased to 10-15 (2-3 tablets) per day. However in this case a delay of more than 1 week is undesirable. The probability of breakthrough bloody discharge from the vagina increases when treatment is started late. For this reason, it is not recommended to start treatment if there are less than 3 days before the arrival of the expected menstruation.

Addition to estrogen replacement therapy in the perimenopause and postmenopause to prevent endometrial hyperplasia: Orgametril is given 2.5-5 mg (1/2-1 tablet) daily for 12-15 days per month (for example, during the first 2 weeks of each month) in which case estrogen replacement therapy may be given continuously at the lowest effective dose.

Interaction

While there are insufficient data, there may be interactions between Orgametril and other medications. The following interaction has been described with synthetic progestagens or combined oral contraceptives, also relevant to the drug Orgametril.

Refamycin, hydantoin derivatives (including phenytoin), barbiturates (including primidone), carbamazepine and aminoglutethimide, laxatives, activated charcoal can decrease the effectiveness of Orgametril. Conversely, Orgametril may increase the therapeutic, pharmacological or toxicological effects of cyclosporine, theophylline, troleandomycin and beta-adrenoblockers.

Orgametril may decrease the effectiveness of insulin.

Concomitant use with antibiotics of the macrolide group may increase the risk of toxic liver damage.

Special Instructions

The treatment should be interrupted if the results of the tests indicate a liver dysfunction.

When taking medications containing estrogen and/or progestogen, especially in women with a history of pregnancy chloasma, sometimes chloasma is observed. Women who are prone to chloasma should avoid exposing their skin to sunlight or artificial UV radiation.

The administration of sex hormones may affect specific laboratory tests. In many patients, during treatment with Orgametril, there may be an increase in LDL blood levels and a decrease in HDL levels. There may be changes in the parameters of liver function, carbohydrate metabolism, blood clotting system.

With long-term treatment systematic medical examination is indicated; control of lipid and carbohydrate metabolism parameters, bilirubin concentration, transaminases, clotting system. The frequency and nature of systematic medical examinations depend on the circumstances of each individual case and should be determined in accordance with the clinical report, but at least once every 6 months.

Orgametril may exhibit some androgenic activity due to the effect of linestrenol on sex hormone-binding globulin levels. This may manifest as mild signs of virilization (mostly acne or seborrhea).

Epidemiologic studies have found an association between progestagen use in combination with estrogens and an increased incidence of venous thromboembolism (deep vein thrombosis and pulmonary embolism). Although the clinical significance of these data for linestrone without the estrogen component is unknown. Orgametril should be discontinued if thrombosis occurs. Consideration should also be given to discontinuing Orgametril if prolonged immobilization due to surgery or disease. Women with a history of thromboembolic disease should be informed about the possibility of recurrence.

Patients with a history of bleeding disorders should be monitored on an ongoing basis, since taking oral estrogen/gestagen contraceptives slightly increases the risk of some cardiovascular events or cerebrovascular conditions.

When taking Orgametril, it is recommended to limit intake of fats and carbohydrates (this is especially important for women with a baseline increase in body weight).

In case of diabetes, the glycemic profile should be monitored (it may be necessary to increase the dose of insulin).

In case of predisposition to arterial hypertension it is necessary to control BP (reduce fluid intake to 1.5-2 liters per day).

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

The ineffectiveness of therapy (recurrent bleeding and endometrial hyperplastic processes) requires specification of the causes of bleeding.

In case of prolonged menstrual delay during therapy with Orgametril, ectopic pregnancy should be excluded.

Orgametril contains lactose as an excipient. Therefore, this drug should not be administered to patients with rare hereditary disorders, such as galactose intolerance, lactase lapp deficiency or glucose-galactose malabsorption.

Impact on driving and operating machinery

As the drug may cause dizziness, patients should exercise caution when driving motor vehicles or other machinery.

Contraindications

Side effects

When using Orgametril as a therapeutic agent, breakthrough bleeding or smeary discharge from the genital tract, increased or decreased libido, nausea, diarrhea, headache, dizziness, increased body weight may occur; rarely – nervousness, depression, increased sweating, acne, hirsutism, chloasma, rash, itching, jaundice, altered liver function tests, decreased glucose tolerance, altered lipoprotein spectrum, breast pain, increased blood clotting.

. When using Orgametril as a means for oral contraception intermenstrual bleeding, shortened menstrual cycle (less than 25 days) or oligomenorrhea (more than 45 days), nausea, headaches, mammary gland engorgement, weight gain, fluid retention in the body, decreased libido, arterial hypertension, acne, decreased glucose tolerance, pigmentation are possible.

Overdose

Symptoms: nausea, vomiting.

Treatment: conducting symptomatic therapy.