Universal reference book for medicines
Product name: ORGAMETRIL ® (ORGAMETRIL)

Active substance: lynestrenol

Type: Gestagen

Manufacturer: NV ORGANON (The Netherlands)
Composition, form of production and packaging
Tablets of
white color, round, flat-cylindrical, with bevelled edges, with a risk on one side of the tablet, with engraving "TT" higher risks and "4" lower risks, and engraving "ORGANON" with a five-pointed star on the other side of the tablet.

1 tab.

lynestrenol 5 mg

Auxiliary substances: potato starch,? -tocopherol, glycerol, magnesium stearate, talc, lactose monohydrate.

30 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Synthetic progestogen for oral administration.
Linestrenol has pharmacological characteristics similar to natural progesterone. Organometrie ® has a pronounced progestogenic effect on the endometrium. With continuous use of the drug, lentestrone is able to suppress ovulation and menstruation.
Organometrium ® is suitable for use in cases where a pronounced progestogenic effect is required.

PHARMACOKINETICS

After oral administration, the linestrenol is rapidly absorbed and is converted into a pharmacologically active norethisterone in the liver.
C max of norethisterone in the blood plasma is observed 2-4 hours after the administration of the drug. T 1/2 from norethisterone plasma 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

- polymenorrhea;

- Menorrhagia and metrorrhagia;

- Some cases of primary or secondary amenorrhea or oligomenorrhoea;

- endometriosis;

- Some cases of endometrial carcinoma;

- benign diseases of mammary glands;

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

- dysmenorrhea;

- to delay normal menstruation;

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

DOSING MODE

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

Polymenorea: 5 mg (1 tab.) / Day from 14 to 25 days of the menstrual cycle.

Menorrhagia and metrorrhagia: 10 mg (2 tab.) / Day for 10 days.
Usually bleeding stops within a few days after starting the drug. The course of treatment should be repeated during the next 3 menstrual cycles of 5 mg (1 tab.) Every day 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 oligomenorrhea: treatment should be initiated with the appointment of estrogens, for example, 20-50 μg ethinyl estradiol daily for 25 days.
On the background of taking estrogen, Organometr ® is prescribed 5 mg (1 tab.) / 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. The treatment continues (the second cycle), starting from the 5th day, counting from the beginning of bloody discharge: the estrogen preparation is prescribed from the 5th to the 25th day of the menstrual cycle, and the Organometr ® is administered from 14 to 25 days. The course of treatment should be repeated, at least in one more cycle.
Endometriosis: 5-10 mg (1-2 tablets) per day for at least 6 months in continuous mode.

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

Benign breast diseases: 5 mg (1 tab.) Per day from 14 to 25 days of the menstrual cycle for at least 3-4 months.

To suppress ovulation, ovulatory pain and menstruation;
dysmenorrhea: administration of the preparation of Ormetil® in a dose of 5 mg (1 tab.) per day should be started from the 1st day of the menstrual cycle, but no later than the 5th 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 10-15 mg (2-3 tablets) per day for 3-5 days.
To delay normal menstruation: taking the drug at 5 mg (1 tab.) A day should begin 2 weeks before the expected date of the onset of menstruation.
If treatment is started less than 1 week before the date of menstruation, the 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 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.
Addition to estrogen replacement therapy in perimenopause and postmenopause for the purpose of preventing endometrial hyperplasia: Orgometriol ® is prescribed 2.5-5 mg (1 / 2-1 tab.) Daily for 12-15 days per month (for example, during the first 2 weeks of each month), in this case, estrogen-replacement therapy can be performed continuously in the lowest effective dose.

SIDE EFFECT

Adverse reactions reported in the literature and post-marketing surveillance

Adverse Reactions Frequency *

From the coagulation system of the blood

hypercoagulability rarely

From the immune system

hypersensitivity infrequent or infrequent

From the side of metabolism

weight gain is often

fluid retention, incl.
peripheral edema decreased glucose tolerance disorders of lipid metabolism ** infrequently or rarely
From the side of the psyche

increased libido decrease libido Often

Increased nervous excitability Depression Uncommon or rare

From the nervous system

headache migraine dizziness infrequently or rarely

From the digestive system

nausea vomiting abdominal pain diarrhea constipation Often

jaundice, disturbances in liver function tests (increase in hepatic enzyme activity) Infrequently or rarely

From the skin and subcutaneous tissues

increased sweating chloasma itching acne seborrhea rash hives hirsutism infrequently or rarely

From the side of the reproductive system

metrorrhagia *** often

tenderness of the mammary gland infrequent

amenorrhea vaginal discharge cervical discharge infrequent or infrequent

* - incidence of adverse reactions: often (> 10%), infrequently (1-10%), rarely (<1%).

** Increase in LDL cholesterol and decrease in HDL cholesterol.

*** With prolonged use of the drug Metmetil ® often metrorrhagia (bloody spotting or breakthrough bleeding from the vagina).
During the cyclic administration of the preparation of Metametil ® , metrorrhagia may also occur, but more rarely. Basically, the frequency of metrorrhagia is greatest during the first 2 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.
CONTRAINDICATIONS

- Pregnancy or suspected pregnancy;

- the period of breastfeeding;

- ectopic pregnancy (in history);

- 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;

- Dubin-Johnson syndrome;

- Gilbert's syndrome;

bleeding from the vagina of an unclear etiology;

- conditions (at present or in the anamnesis), which 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;

- Coagulation disorder;

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

- Hypersensitivity to the components of the drug.

Carefully

Patients should be monitored regularly for any of the following conditions: chronic heart failure;
arterial hypertension; thromboembolism (in the anamnesis);depression (in the anamnesis).
PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy.

The safety of the use of the preparation of Organometr ® during the lactation period has not been established to date.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

It is forbidden to use the drug for liver diseases (jaundice), liver tumors.

SPECIAL INSTRUCTIONS

Treatment should be discontinued if the 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 UV radiation.

Admission of sex hormones can affect specific laboratory tests.
In many patients, during treatment with the preparation of Organometr ®, it is possible to raise the level in the blood of LDL and decrease the level of HDL. 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.
Due to the influence of linestrenol on the level of globulin that binds sex hormones, it can exhibit some androgenic activity.
This can be expressed 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, stop taking the drug Organometr. 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.
It is necessary to constantly monitor the condition of patients with circulatory disorders (and also, if they have a history), since the risk of certain cardiovascular diseases or cerebrovascular conditions is slightly increased when taking oral estrogen / progestin contraceptives.

When taking the drug, Organometr ® is recommended to limit the intake of fats and carbohydrates (which is especially important for women with initially high body weight).

With diabetes, the glycemic profile should be monitored (an increase in the insulin dose may be required).

If you are predisposed to hypertension, you need to monitor 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 preparation of Organometr ® , ectopic pregnancy should be excluded.

Organometr ® contains in its composition lactose as an auxiliary substance.
Therefore, this drug should not be given to patients with rare hereditary disorders, such as galactose intolerance, lactase deficiency lapp or glucose-galactose malabsorption.
Impact on the ability to drive vehicles and manage mechanisms

Because the drug may cause dizziness, patients should be careful when driving vehicles or other equipment.

OVERDOSE

Symptoms: nausea, vomiting.

Treatment: symptomatic therapy.

DRUG INTERACTION

Although there is insufficient data, it is possible to interact with the drug Medimetil ® with other drugs.
The following interaction was described with the use of synthetic progestogens or combined oral contraceptives, also relates to the preparation of Organometr.
Rifamycin, hydantoin derivatives (including phenytoin), barbiturates (including primidone), carbamazepine and aminoglutethimide, laxatives, activated charcoal can reduce the effectiveness of the preparation Organometr.
Conversely, Orgmetryl ® may increase the therapeutic, pharmacological or toxicological effects of cyclosporine, theophylline, trolleandomycin and beta-blockers.
Organometr ® can reduce the effectiveness of insulin.

With the simultaneous use of macrolides with antibiotics, an increased risk of developing toxic liver damage is possible.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of 2 ° to 30 ° C.
Shelf life - 5 years.
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