Country: Индонезија
Језик: Индонежански
Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PROGESTERONE
NUFARINDO - Indonesia
PROGESTERONE
100 Mg
KAPSUL LUNAK
DUS, 2 BLISTER @ 15 KAPSUL LUNAK
LABORATORIOS LEON FARMA, S.A. - Spain
2022-03-21
GYNPROGEST PROGESTERONE Soft Capsules COMPOSITION Each capsule contains 100 mg micronized Progesterone. Each capsule contains 200 mg micronized Progesterone. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group (ATC Code: G03DA04: Genito-urinary system and sex hormones). Progesterone is a natural progesterone, the main hormone of the corpus luteum and the placenta. It acts on the endometrium by converting the proliferating phase to the secretatory phase. Gynprogest capsules have all the properties of endogenous progesterone with induction of a full secretory endometrium and in particular gestagenic, antiestrogenic, slightly anti- androgenic and antialdosterone effects. PHARMACOKINETICS PROPERTIES _Absorption _ Micronised progesterone is absorbed by the digestive tract. Pharmacokinetic studies conducted in healthy volunteers have shown that oral adminstration of 2 capsules (200 mg), plasma progesterone levels increased to reach the Cmax of 13.8 ng/ml +/- 2.9 ng/ml in 2.2 +/-1.4 hours. The elimination half-life observed was 16.8 +/-2.3 hours. Although there were inter-individual variations, the individual pharmacokinetic characteristics were maintained over several months, indicating predictable responses to the drug. _Distribution _ Progesterone is approximately 96%-99% bound to serum proteins, primarily to serum albumin (50%- 54%) and transcortin (43%-48%). _Elimination _ Urinary elimination is observed for 95% in the form of glycuroconjugated metabolites, mainly 3a, 5 B- pregnadiol (pregnadiol). _Metabolism _ Progesterone is metabolised primarily by the liver. The main plasma metabolites are 20 a hydroxy- 4a-prenolone and 5 a-dihydroprogesterone. Some progesterone metabolites are excreted in the bile and these may be deconjugated and further metabolized in the gut via reduction, dehydroxylation and epimerization. The main plasma and urinary metabolites are similar to those found during the physiological secretion of the corpus luteum. INDICATIONS Gynprogest is prescribed for disorder r Прочитајте комплетан документ