Didrogesteron
Producer: SC Balkan Pharmaceuticals SRL (Balkans Pharmasyyutikals) Republic of Moldova
Code of automatic telephone exchange: G03DB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 10 mg of a didrogesteron in 1 tablet.
Gestagenny drug.
Pharmacological properties:
Pharmacodynamics. Has the selection effect on an endometria, promotes formation of a normal secretory endometria at women after preliminary therapy by estrogen. Provides approach of a phase of secretion in an endometria, reducing thereby the risk of a hyperplasia and/or carcinogenesis in an endometria increased under the influence of estrogen. Reduces excitability and contractility of a uterus and pipes. Does not cause a masculinization of a fruit and virilescence of mother.
Pharmacokinetics. Absorption is high, time of approach of Cmax after intake — 2 h, contacts proteins for 97%. It is metabolized in a liver by a hydroxylation. It is excreted by kidneys (60–80% in the form of metabolites), during 24 h 85% are removed, in 72 h it is removed completely. Against the background of a renal failure the pharmacokinetics does not change.
Indications to use:
Progesteronovy insufficiency, including infertility, abortion (usual, menacing), endometriosis, a dysmenorrhea, irregular periods, a secondary amenorrhea, dysfunctional uterine bleedings; premenstrual syndrome; for neutralization of proliferative effect of estrogen on an endometria when performing replacement hormonal therapy in a menopause.
Route of administration and doses:
Inside, the mode of dosing is selected individually, depending on character and severity of a disease. Usually single dose — 10 mg, reception frequency — 1–3 times a day.
Features of use:
Use at pregnancy and feeding by a breast. It can be applied during pregnancy. It is allocated with maternal milk. Breastfeeding during treatment of mother is not recommended.
It is necessary to consider that replacement hormonal therapy is not appointed without preliminary general medical examination, including gynecologic survey. Regular carrying out mammography is recommended. The abnormal bleedings and pathological changes revealed at gynecologic survey can serve as the indication to an endometria research.
Side effects:
From system of a hemopoiesis: in isolated cases — hemolitic anemia.
From immune system: seldom or never — hypersensitivity reactions.
From TsNS: head pain / migraine.
From gepatobiliarny system: seldom — an abnormal liver function (followed by weakness or an indisposition, jaundice and pain in a stomach).
From reproductive system: in rare instances — the breakthrough bleedings which are stopped increase in a dose; hypersensitivity of mammary glands.
From skin and hypodermic cellulose: seldom — skin rash, an itch, a small tortoiseshell; very seldom — a Quincke's disease.
Others: peripheral hypostases.
Interaction with other medicines:
Inductors of microsomal enzymes of a liver (including phenobarbital, rifampicin) can accelerate biotransformation of a didrogesteron and weaken effect.
Contraindications:
Hypersensitivity, syndrome the Cudgel — Johnson, the Rotor syndrome.
Restrictions to use. At the combined use with estrogen: renal failure, cardiovascular diseases, diabetes mellitus, epilepsy, migraine.
Overdose:
Treatment: symptomatic, gastric lavage.
Storage conditions:
To store at a temperature of 15-25 °C, in dry, protected from light and the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets of 10 mg, 20 tablets in each blister, on one, two or three blisters together with the application instruction in cardboard packaging.