Orgametril

Orgametril – drug with progestagenny action.

Form of release and structure

Orgametril release in the form of tablets: white, ploskotsilindrichesky, round, with slanted edges, on one party – risk, above which an engraving of "TT", below – "4", on other party – an engraving of "ORGANON" with the image of a five-pointed star (on 30 pieces in blisters, on 1 blister in a cardboard pack).

Is a part of 1 tablet:

• Active agent: линэстренол – 5 mg;
• Auxiliary components: talc, potato starch, alpha tocopherol, глицерол, magnesium stearate, monohydrate of lactose.

Indications to use

• Polymenorrhea;
• Metrorrhagia, menorrhagia;
• Primary or secondary amenorrhea or oligomenorrhea (in certain cases);
• Dysmenorrhea;
• Endometria carcinoma (in certain cases);
• Benign diseases of mammary glands;
• Endometriosis;
• Delay of normal periods;
• Suppression of periods, ovulatory pains, ovulations (not for contraception).

Also Orgametril appoint as an additional tool to estrogen replacement therapy in a postmenopause and a perimenopauza (for prevention of a hyperplasia of an endometria).

Contraindications

Absolute:

• Bleedings from a vagina of not clear genesis;
• Diabetes mellitus;
• Gepatoma, liver diseases in a heavy current, including hepatitis or cholestatic jaundice (or anamnestic data on a serious illness of a liver in cases if indicators of function of a liver did not return to norm);
• Heavy depression;
• Inborn disturbances of exchange of cholesterol;
• Thromboembolism/thrombosis (deep vein thrombosis, cerebrovascular disturbances, thromboembolism of a pulmonary artery, heart attack);
• States which can be aggravated with reception of sex steroid hormones, such as gestational herpes, gestational jaundice, otosclerosis, hloazma of pregnant women, severe itch, porphyria (now or anamnestic data);
• Syndromes of the Rotor, Gilbert and Dubina-Dzhonsona;
• Disturbances of coagulability of blood;
• The pregnancy (confirmed or in the presence of suspicions on it), an extrauterine pregnancy (anamnestic data) and the breastfeeding period;
• Hypersensitivity to drug components.

Relative (Orgametril's appointment demands care and regular control of a state):

• Thromboembolism (anamnestic data);
• Arterial hypertension;
• Chronic heart failure;
• Depression (anamnestic data).

Route of administration and dosage

Orgametril accept inside, washing down with water or other liquid in a small amount. At the admission of reception of a single dose it needs to be accepted as soon as possible, except for cases if such delay makes more than 24 hours.

The recommended dosing mode (the first day of menstrual bleeding – the first day of a cycle; daily dose):

• Polymenorrhea: on 1 tablet daily during the period from 14 to 25 days of a menstrual cycle;
• Metrorrhagia, menorrhagia: on 2 tablets a course of 10 days; bleeding, as a rule, stops within several days from the moment of the beginning of reception of Orgametril. Further during the following 3 menstrual cycles treatment needs to be repeated from the daily dose lowered to 1 tablet daily from 14 to 25 days of each menstrual cycle. At inefficiency of therapy holding additional diagnostic and medical actions is recommended;
• Primary or secondary amenorrhea or oligomenorrhea (in certain cases): it is necessary to begin therapy with estrogen (for example, on 0,02-0,05 mg of ethinylestradiol a day with a course of 25 days). Orgametril it is necessary to accept against the background of reception of estrogen on 1 tablet a day from 14 to 25 day of a menstrual cycle. Menstrualnopodobny bleeding after the end of administration of drugs, as a rule, begins 3 days later. The second cycle of therapy needs to be begun from 5 in the afternoon, considering from the beginning of bloody allocations: oestrogenic drug – from 5 to 25 day of a menstrual cycle, Orgametril – from 14 to 25 day. The therapeutic course needs to be repeated, at least, in one cycle;
• Endometriosis: continuously on 1-2 tablets a course of, at least, 6 months;
• Endometria carcinoma (in certain cases): it is long, till 6-10 tablets;
• Benign diseases of mammary glands: on 1 tablet from 14 to 25 days of a menstrual cycle within, at least, 3-4 months;
• Dysmenorrhea, suppression of periods, ovulatory pains, ovulations: on 1 tablet from 1 day of a menstrual cycle (no later than the 5th day of a menstrual cycle). Continuous therapy can be continued for many months. If against the background of administration of drug breakthrough vaginal bleedings are observed, for 3-5 days increase in a daily dose up to 2-3 tablets is possible;
• Delay of normal periods: on 1 tablet, reception is begun in 14 days prior to the expected start date of periods. If therapy is begun less than in 7 days prior to start date of periods, it is necessary to increase a daily dose of drug to 2-3 tablets (in this case the delay more than for 7 days is undesirable). The probability of development of breakthrough bloody allocations from a vagina increases at the late beginning of therapy. To begin treatment if before arrival of the expected periods there are less than 3 days, it is not recommended;
• Addition to estrogen replacement therapy in a postmenopause and a perimenopauza: daily on ^1/2-1 tablet a course of 12-15 days in a month (for example, for the first 2 weeks of every month), it allows to carry out estrogen replacement therapy continuously in the smallest effective dose.

Side effects

Possible side effects (> 10% – are frequent, 1-10% – infrequently, <1% – is rare):

• Alimentary system: often – nausea, vomiting, an abdominal pain, diarrhea, a lock; infrequently or seldom – jaundice, disturbances of indicators of functional trials of a liver (increase in activity of liver enzymes);
• Coagulant system of blood: seldom – hypercoagulation;
• Nervous system: infrequently or seldom – a headache, migraine, dizziness;
• Reproductive system: often (at long therapy – is more often, at cyclic reception – is more rare; it is in most cases controlled by temporary increase in a dose of Orgametril) – a metrorrhagia; infrequently – morbidity of mammary glands; infrequently or seldom – an amenorrhea, vulval allocations, cervical allocations;
• Immune system: infrequently or seldom – hypersensitivity;
• Mentality: often – change (increase or decrease) a libido; infrequently or seldom – the increased nervous irritability, a depression;
• Hypodermic fabrics and skin: infrequently or seldom – the increased sweating, a hloazma, an itch, an acne, seborrhea, rash, urticaria, a hirsutism;
• Metabolism: often – increase in body weight; infrequently or seldom – a liquid delay, including peripheral hypostases, decrease in tolerance to glucose, disturbances of lipidic exchange (increase in LPNP cholesterol and reduction of LPVP cholesterol).

Because of the lactose which is Orgametril's part (as excipient), it should not be accepted against the background of such rare inherited disorders as intolerance of a galactose, glyukozo-galaktozny malabsorption or insufficiency of lapp lactase.

Special instructions

Against the background of Orgametril's use development of a hloazma, in particular at women with anamnestic data on a hloazma of pregnant women is possible. With tendency to a disease it is recommended to avoid impact on skin of artificial Uv-radiation or a sunlight.

If there are data on development of functional disturbances of a liver, therapy needs to be interrupted.

Administration of drug can exert impact on specific laboratory tests, changes in parameters of exchange of carbohydrates, functions of a liver, system of a blood coagulation are also possible. At many patients against the background of therapy level in LPNP blood can increase and decrease the LPVP level.

At long therapy systematic performing medical examinations, control of indicators of carbohydrate and lipidic metabolism, concentration of transaminases, bilirubin, system of coagulation is shown. Their character and frequency are defined individually, but at least 1 time in half a year.

Linestrenol is capable to show some androgenic activity that can be expressed as little signs of virilescence (preferential seborrhea or an acne).

At fibrinferment Orgametril's reception needs to be interrupted. Also therapy is recommended to be interrupted at a long immobilization because of surgical intervention or a disease. In the presence of thromboembolic diseases in the anamnesis it is necessary to consider a possibility of their recurrence.

At blood circulation disturbances (and also at the instruction on them in the anamnesis) it is necessary to control constantly a condition of patients as against the background of administration of drug the probability of development of some cardiovascular diseases or cerebrovascular states increases.

During therapy restriction in reception of carbohydrates and fats is recommended (in particular it is important at initially increased body weight).

Against the background of a diabetes mellitus it is necessary to control a glycemic profile (increase in a dose of insulin in certain cases can be required), predispositions to arterial hypertension – arterial pressure (it is recommended to reduce daily consumption of liquid to 1,5-2 l).

At dysfunctional uterine bleedings at women of reproductive age it is recommended to begin therapy after carrying out a medical and diagnostic scraping of a uterus.

Inefficiency of therapy by Orgametril (at a recurrence of bleedings and hyperplastic processes of an endometria) demands carrying out additional diagnosis.

At a long delay of periods during administration of drug it is necessary to exclude an extrauterine pregnancy.

During therapy it is recommended to be careful at control of motor transport or other equipment as Orgametril can lead to development of dizziness.

Medicinal interaction

At the combined use of Orgametril with some substances / drugs there can be following effects (on the basis of the combined oral contraceptives or synthetic progestogens given about interaction):

• Beta adrenoblockers, theophylline, cyclosporine, тролеандомицин: increase in their therapeutic, pharmacological or toxicological effects;
• Antibiotic drugs of group of macroleads: increase in risk of emergence of toxic damage of a liver;
• Aminoglutetimid, carbamazepine, Rifamycinum, purgatives, hydantoin derivatives (including Phenytoinum), barbiturates (including Primidonum), absorbent carbon: decrease in efficiency of Orgametril;
• Insulin: decrease in its efficiency.

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature of 2-30 °C.

Period of validity – 5 years.