Pharmacological action
A combined low-dose monophasic contraceptive with antiandrogenic activity. The mechanism of action is due to the antiandrogenic agent of steroid structure – cyproterone acetate and oral estrogen – ethinyl estradiol. Blocks androgen receptors, inhibits the secretion of gonadotropic hormones by the pituitary gland.
Cyproterone has the ability to competitively bind to receptors of natural androgens (including testosterone, dehydroepiandrosterone, androstenedione), formed in small quantities in the female body, mainly in the adrenal glands, ovaries and skin. By blocking androgen receptors in target organs, it reduces androgenization in women (due to disruption of processes mediated by hormone-receptor complexes at the level of basic intracellular mechanisms). Along with antiandrogenic properties, it has gestagenic activity, imitating the properties of the corpus luteum hormone. It inhibits the secretion of gonadotropic hormones by the pituitary gland and inhibits ovulation, which determines its contraceptive effect.
Ethinyl estradiol enhances the central and peripheral effects of cyproterone on ovulation, maintains high viscosity of cervical mucus, which complicates the penetration of sperm into the uterine cavity and helps ensure a reliable contraceptive effect.
Indications for the active ingredients of Diane-35®
Contraception in women with androgenization; treatment of androgen-dependent diseases/conditions in women (“vulgar” acne (acne papulopustulosa, acne nodulocystica); seborrhea; androgenic alopecia; hirsutism).
The method of administration and dosage regimen of a specific drug depends on its form of release and other factors. The optimal dosage regimen is determined by a doctor. It is necessary to strictly observe the correspondence of the used dosage form of a specific drug to the indications for use and dosage regimen.
Contraindications for use
Thrombosis (venous and arterial) and thromboembolism at present or in the anamnesis (including deep vein thrombosis, pulmonary embolism), ischemic heart disease, stroke; conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in the anamnesis; complicated lesions of the valvular apparatus of the heart (pulmonary hypertension, atrial fibrillation, subacute bacterial endocarditis in the anamnesis); uncontrolled arterial hypertension (systolic BP above 160 mm Hg or diastolic BP above 100 mm Hg); major surgery with prolonged immobilization; Diabetes mellitus with vascular complications; Multiple or pronounced risk factors for venous or arterial thrombosis, including cerebrovascular or coronary artery disease, arterial hypertension, advanced age; Liver failure and severe liver disease (before normalization of liver function tests); Active viral hepatitis, decompensated liver cirrhosis; Idiopathic jaundice or pruritus during a previous pregnancy; Congenital hyperbilirubinemia (Gilbert’s, Dubin-Johnson and Rotor syndromes); Liver tumors (benign or malignant), currently or in history; Migraine with focal neurological symptoms, currently or in history; Pancreatitis with severe hypertriglyceridemia, currently or in history; Detected or suspected hormone-dependent malignant diseases (including breast and endometrial cancer); Vaginal bleeding of unknown genesis; sickle cell anemia; otosclerosis worsened by pregnancy; history of herpes during pregnancy; smoking at the age over 35 years; pregnancy; lactation period; hypersensitivity to any component of the combination.
Warning: Always consult a doctor before using medications.
