MIKROGINON

Active material: Ethinylestradiol, Levonorgestrel
When ATH: G03AA07
CCF: Monophasic oral contraceptive
When CSF: 15.11.04.01
Manufacturer: SCHERING AG (Germany)

DOSAGE FORM, STRUCTURE AND PACKAGING

Drop1 drop
ethinylestradiol30 g
levonorgestrel150 g

Excipients: lactose, corn starch, polyvidone 25000, talc, magnesium stearate.

The composition of the shell: sucrose, polyvidone 700000, polyethylene glycol 6000, calcium carbonate, talc, Titanium dioxide, glycerol 85%, Mining glycol wax, dye iron oxide yellow.

21 PC. – blisters (1) – packs cardboard.

Pharmacological action

The contraceptive estrogen-progestin combination drug. If ingestion inhibits the secretion of pituitary gonadotropins. The contraceptive effect is due to several mechanisms. As a progestin component (progestin) It contains a derivative of 19-nortestosterone – levonorgestrel, surpassing the activity of the hormone progesterone luteum (and a synthetic analogue of the last – pregnin), It acts at the receptor level without preliminary metabolic transformations. Estrogen component is ethinyl estradiol. Under the influence of levonorgestrel comes blockade release releasing factor (LH and FSH) gipotalamusa, inhibition of secretion of pituitary gonadotropins, which leads to inhibition of the maturation and release ready to fertilize the egg (Ovulation). The contraceptive effect is enhanced ethinylestradiol. Retains high viscosity of cervical mucus (difficult getting sperm into the uterus). Along with the contraceptive effect with regular admission normalizes the menstrual cycle and helps to prevent the development of a number of gynecological diseases, incl. the nature of the tumor.

 

Testimony

Contraception, functional disorders of the menstrual cycle (incl. dysmenorrhea without organic cause, dysfunctional metrorrhagia, premenstrual syndrome).

 

Contraindications

Hypersensitivity, hepatic failure, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor), liver tumors (gemangioma, liver cancer). Malignant tumors (especially breast cancer or endometrial cancer). The presence or indication of a history of severe cardiovascular and cerebrovascular disease, thromboembolism and predisposition to them (ischemic or hemorrhagic stroke, widespread atherosclerosis, miokardit, decompensated chronic heart failure, heart disease, severe hypertension). Diabetes severe (accompanied by retinopathy and microangiopathy). Drepanocytemia, chronic hemolytic anemia, vaginal bleeding of unknown etiology, migraine. Otosclerosis; molar pregnancy, otosclerosis with hearing impairment, idiopathic jaundice or itching – during a previous pregnancy. Congenital hyperlipidemia, women, subject to high loads on the vocal cords (Professional Speakers, Lecturers), Marfan syndrome, older than 40 let.C caution. Diseases of the liver and gall bladder, epilepsy, depression, yazvennыy colitis, hysteromyoma, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles).

 

Side effects

Nausea, vomiting, headache, breast engorgement, weight gain, decreased libido and mood, brutalization vote, the emergence of inter-menstrual bleeding, in some cases – swelling of the eyelids, conjunctivitis, blurred vision, discomfort while wearing contact lenses (These effects are temporary and disappear after the cancellation without assigning any therapy). Chronic administration rarely may occur chloasma, hearing loss, generalized itching, jaundice, leg cramps, increase in the frequency of epileptic seizures. Rarely marked hypertriglyceridemia, giperglikemiâ, reduced glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, skin rashes, the changing nature of the vaginal secretion, vaginal candidiasis, fatigue, diarrhea.

 

Dosing and Administration

Inside, by 1 drop 1 once a day, beginning with 1 or 5 day of the menstrual cycle (depending on the type of drug: monophasic, 2- or 3-phase) during 21 day, followed by a 7-day interval. When the content of 28 pills in a calendar pack – taking in continuous mode. One package contains a calendar of different pills (two- and three-phase preparations) or the same color (monophasic). Drops accept, without chewing, washed down with a small amount of liquid. Reception time is irrelevant, However, subsequent reception should be performed in the same selected hour, preferably after breakfast or dinner (to ensure a constant concentration of hormones in plasma, interval between doses should not exceed 36 no, it should be maintained at 22-26 no). If the drug was launched in the second half of the week, first menstrual cycle can be shorter 4 Sun. After completion of the drug should be a 7-day break, after which to begin a typical menstrual bleeding. Regardless of the occurrence and duration of bleeding, following a 21-day course of the drug necessary to begin immediately after the 7-day break (ie. on 8 day). Usually the first menstrual cycle after stopping treatment extended to 1 Sun. In the case of missing the reception it is necessary to take the drug for a further 12 no. When a reception interval in 36 h can not be guaranteed reliable contraceptive effect (Despite this, Treatment should be continued, in order to prevent the premature onset of menstruation, associated with discontinuation). During this period it is recommended to use etc.. non-hormonal methods of contraception (other than the calendar method for Knaus-Ogino, and the method of temperature measurement). With therapeutic purposes dose picked individually. Usually they take on 2-3 pills a day for 10 days (or to stop bleeding).

 

Cautions

When using two-phase preparation reliable contraceptive effect occurs only in the second cycle of the drug, so you should use other. non-hormonal methods of contraception in the first half of the cycle. Adolescent girls and women younger than 35 s recommended 3-phase low-dose drug. 2-phase drugs are most appropriate for women moderate progestin phenotype, and may also be used in young nulliparous women, tk. ensure the transformation of the mucous membrane of the uterus. With therapeutic and prophylactic purposes it is advisable to use a monophasic PM. After stopping treatment, fertility is restored quickly enough, during 1-3 menstrual cycles. Appointment after childbirth or abortion (abortion) It recommended to be held not earlier than the first normal menstrual cycle. Before the start of every contraceptive 6 Months recommended general medical and gynecological examination (include studies of breast, liver function, control of blood pressure and blood cholesterol concentrations, Analysis of urine). In small amounts excreted in breast milk. Typically, use of oral contraceptives is shown only when the long period of lactation, tk. for a brief period of lactation menstrual cycle, usually, not restored. If necessary, the appointment during lactation should stop breastfeeding. Smokers, taking hormonal contraceptive drugs, have an increased risk of cardiovascular disease with serious consequences (myocardial infarction, stroke). The risk increases with age and, depending on the number of cigarettes smoked (especially in older women 35 years). When diarrhea, vomiting contraceptive effect is reduced (not stopping taking the drug, you must use an additional non-hormonal methods of contraception). Treatment must be stopped immediately if pregnancy occurs, the development of migraine headaches (if they were not previously), with the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of veins in the legs), occurrence of jaundice, visual impairment, cerebrovascular disorders, stabbing pain of unknown etiology when breathing or coughing, pain or tightness in the chest, with an increase in blood pressure, as well as 3 months before the planned pregnancy and for roughly 6 weeks before the planned surgery, during prolonged immobilization. Moderate spotting during the course do not require discontinuation of.

 

Cooperation

Barbiturates, Some antiepileptic drugs (Carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can enhance the metabolism of a part of the preparation of steroid hormones. Reduced contraceptive efficacy can be observed while the appointment with some antimicrobial drugs (Ampicillin, rifampicin, chloramphenicol, neomycin, Polymyxin B, sulьfanilamidami, Tetracycline), due to changes in the gut microflora. When you receive a progestogen-estrogen drugs may require correction dosing regimen hypoglycemic drugs, and anticoagulants.

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