Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Remedica Ltd Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Pharmacotherapeutic group: Sex hormones and modulators of the genital system; Gonadotropins and other ovulation stimulants
ATC code: G03GB02
The ovulatory response to cyclic clomifene citrate tablets therapy is mediated through increased output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle.
Clomifene citrate tablets is a triarylethylene compound (related to chlorotrianisene and triparanol). It is a non-steroidal agent which stimulates ovulation in a high percentage of appropriately selected an ovulatory women.
Orally administered 14C labelled clomifene citrate was readily absorbed when administered to humans. Cumulative excretion of the 14C label by way of urine and faeces averaged about 50% of the oral dose after 5 days in 6 subjects, with mean urinary excretion of 7,8% and mean faecal excretion of 42,4%. A mean rate of excretion of 0,73% per day of the 14C dose after 31 days to 35 days and 0,45% per day of the 14C dose after 42 days to 45 days was seen in faecal and urine samples collected from 6 subjects for 14 to 53 days after clomifene citrate 14C administration. The remaining drug/metabolites may be slowly excreted from a sequestered enterohepatic recirculation pool.
When Ova-mit is administered over prolonged periods it may interfere with cholesterol synthesis. Patients on prolonged therapy may show elevated blood levels of desmosterol.
Long term carcinogenicity studies have not been performed to evaluate the carcinogenic potential clomifene citrate tablets.
Clomifene citrate did not induce gene mutations in bacteria (Ames test) or chromosome aberrations in cultured human peripheral blood lymphocytes. Clomifene citrate at oral doses up to 2000 mg/kg/day did not induce genotoxic effects in rats. At the highest dose tested of 2000 mg/kg/day in rats, the ratios of exposure ranged from 2 to 232 for Z-clomifene and E-clomifene respectively, taking into account limited PK data available in humans.
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