Clinical and pharmacological group: & nbsp

"Estrogens, gestagens, their homologues and antagonists"

Included in the formulation
  • Belara®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • АТХ:

    G.03.A.A   Progestogens and estrogens (fixed combinations)

    Pharmacodynamics:

    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.

    Chlormadinone has antiandrogenic properties due to substitution of exogenous and endogenous androgens on specific receptors.

    Pharmacokinetics:

    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%).

    Chlormadinone

    After oral administration, it is completely absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is achieved in 1-2 hours. The connection with plasma proteins is 95%.

    Metabolism in the liver.

    The half-life is 34 hours. Elimination by the kidneys (50%) and with feces (50%).

    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.

    XIV.N80-N98.N94.3   Premenstrual tension syndrome

    XIV.N80-N98.N94.6   Dysmenorrhea, unspecified

    XXI.Z30-Z39.Z30.4   Monitoring the use of contraceptive medicines

    XXI.Z30-Z39.Z30.0   General advice and advice on contraception

    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, individual intolerance, children under 18 years of age.

    Carefully:

    Diseases of the liver and bile ducts, Crohn's disease, jaundice, including in history, multiple sclerosis, hypertension, epilepsy, tuberculosis, varicose veins, mastopathy, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - Category C. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Inside. 1 tablet 1 time per day, regardless of the time of eating 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 tablet (2 tablets after admission).

    The highest single dose: 1 tablet (2 tablets 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.

    Chlormadinone 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.

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