Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Pharmacotherapeutic group: ovulation stimulants, synthetic
ATC code: G03BG02
The ovulatory response to cyclic Clomid 50 mg Tablets therapy is mediated through increased output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle.
Clomid 50 mg 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 anovulatory 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 feces averaged about 50% of the oral dose after 5 days in 6 subjects, with mean urinary excretion of 7.8% and mean fecal excretion of 42.4%.
A mean rate of excretion of 0.73% per day of the 14C dose after 31–35 days and 0.45% per day of the 14C dose after 42–45 days was seen in fecal and urine samples collected from 6 subjects for 14–53 days after Clomifene citrate 14C administration.
The remaining drug/metabolites may be slowly excreted from a sequestered enterohepatic recirculation pool.
Long-term carcinogenicity studies have not been performed to evaluate the carcinogenic potential of Clomid.
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 2–232 for Z-clomifene and E-clomifene respectively, taking into account limited PK data available in humans.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
