Included in the formulation
АТХ:G.03.A.A.12 Drospirenone and ethinylestradiol
Pharmacodynamics:Drospirenone
Drospirenone has antiandrogenic properties due to substitution of exogenous and endogenous androgens on specific receptors. Has therapeutic activity in inflammatory forms of vulgar acne. Increases the number of high-density lipoproteins in blood plasma.
Ethinylestradiol
It blocks the release of the follicle-stimulating hormone and luteinizing hormone of the pituitary gland, interrupting the process of maturation of the oocyte - excludes ovulation, imitating the physiological hormonal cycle. Suppressing the secretion of their own sex hormones, excludes all the undesirable effects associated with the hyperfunction of estrogens and progestins: menstrual disorders, hyperplastic endometrial processes, fibrocystic changes in the mammary glands, ovulatory syndrome and premenstrual tension syndrome.
Calcium levomefolinate
The active derivative of folic acid, is involved in the synthesis of purine and pyrimidine bases, which form the basis of nucleic acids. Replenishes the reserve of folic acid in the body, prevents the development of anemia.
Pharmacokinetics:Drospirenone
After ingestion, up to 90% is absorbed. The maximum concentration in the blood plasma is reached after 1 hour. It binds to plasma proteins by 90%. Metabolised in the liver.
The half-life is 11 hours. Elimination by the kidneys in the form of metabolites.
Ethinylestradiol
After oral administration, it is absorbed completely and quickly in the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 1.5 hours. It enters the breast milk. It is metabolized in the walls of the intestine and liver.
The half-life is 28 hours. Elimination by the kidneys (40%) and with feces (60%).
Calcium levomefolinate
After ingestion, up to 98% is absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 1 hour. The connection with plasma proteins is 27%.
Metabolism in the liver.
The half-life is 6 hours. Elimination by the kidneys, up to 20% unchanged.
Indications:
It is used as a means of contraception and regulation of the menstrual cycle in the reproductive age. Eliminates manifestations of ovulatory and premenstrual syndromes.
XII.L60-L75.L70 Acne
XIV.N80-N98.N94.3 Premenstrual tension syndrome
XXI.Z30-Z39.Z30.0 General advice and advice on contraception
IV.E50-E64.E53 Insufficiency of other B vitamins
XIV.N80-N98.N94.6 Dysmenorrhea, unspecified
XXI.Z30-Z39.Z30 Monitoring the use of contraceptives
Contraindications:
Tumors of the mammary glands, endometrial and ovarian cancer, acute diseases and liver tumors, intracranial hypertension (including history), thrombophlebitis and thromboembolism in history, undiagnosed bleeding from genital organs and urinary tract, diabetes mellitus complicated by angiopathy, ischemic heart disease, pregnancy and lactation, age under 18 years, individual intolerance.
Carefully:
Diseases of the liver and bile ducts, Crohn's disease, jaundice (including history), multiple sclerosis, hypertension, epilepsy, tuberculosis, varicose veins, mastopathy, hypersensitivity.
Pregnancy and lactation:Recommendations for FDA - Category X. Contraindicated in pregnancy and lactation.
Dosing and Administration:Inside. 1 tablet once a day, regardless of the time of food intake for 21 days with a break of 7 days. The drug starts at 1 or 5 days of the cycle.After a break of seven days begins receiving the next package of the drug, regardless of the duration of menstrual like bloody discharge. If you miss a drug, take the next pill for 12 hours, or 2 tablets for the next day.
The highest daily dose: 1 dragee.
The highest single dose: 1 dragee (2 dragees after admission).
Side effects:Central and peripheral nervous system: intracranial hypertension, bulbospinal paralysis, headache, emotional lability, fast fatigue.
The cardiovascular system: thrombophilia.
Digestive system: nausea, vomiting, flatulence.
Reproductive system: metrorrhagia, stress and enlargement of the mammary glands, a change in libido.
Sense organs: intolerance to contact lenses.
Dermatological manifestations: chloasma, erythema nodosum.
Allergic reactions.
Overdose:Nausea, vomiting.
Treatment is symptomatic.
Interaction:Decrease in the effectiveness of estrogens is observed with simultaneous administration with antibiotics of the penicillin series, tetracyclines, ritonavir.
Ascorbic acid, paracetamol, atorvastatin increase the concentration of estrogens.
Reduces the effectiveness of glucocorticoids, clofibrate.
Enhances the effect of hepatotoxic drugs due to the activation of hepatic blood flow by estrogens.
When used simultaneously with cyclosporine, the risk of toxicity increases.
Drospirenone affects the effectiveness of anticoagulants and hypoglycemic drugs.
Special instructions:In the absence of a menstrual-like reaction in response to the withdrawal of the drug, it is recommended to exclude pregnancy. If the result is positive, cancel the drug. At random reception of a preparation in the beginning of pregnancy of the data on disturbance of an embryogenesis it is not revealed.