Product Information
Registration Status: ActiveCLOMIPHENE TABLET 50mg is approved to be sold in Singapore with effective from 1992-09-10. It is marketed by YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD, with the registration number of SIN07181P.
This product contains Clomifene 50mg in the form of TABLET. It is approved for ORAL use.
This product is manufactured by Y S P INDUSTRIES (M) SDN BHD in MALAYSIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
A triphenyl ethylene stilbene derivative which is an estrogen agonist or antagonist depending on the target tissue.
Indication
Used mainly in female infertility due to anovulation (e.g. due to polycystic ovary syndrome) to induce ovulation.
Mechanism of Action
Clomifene has both estrogenic and anti-estrogenic properties, but its precise mechanism of action has not been determined. Clomifene appears to stumulate the release of gonadotropins, follicle-stimulating hormone (FSH), and leuteinizing hormone (LH), which leads to the development and maturation of ovarian follicle, ovulation, and subsequent development and function of the coprus luteum, thus resulting in pregnancy. Gonadotropin release may result from direct stimulation of the hypothalamic-pituitary axis or from a decreased inhibitory influence of estrogens on the hypothalamic-pituitary axis by competing with the endogenous estrogens of the uterus, pituitary, or hypothalamus. Clomifene has no apparent progestational, androgenic, or antrandrogenic effects and does not appear to interfere with pituitary-adrenal or pituitary-thyroid function.
Pharmacokinetics
- Absorption
- Based on early studies with 14 C-labeled clomifene, the drug was shown to be readily absorbed orally in humans.
- Distribution
- Metabolism
- Hepatic
- Elimination
Toxicity
The acute oral LD50 of clomifene is 1700 mg/kg in mice and 5750 mg/kg in rats. The toxic dose in humans is not known. Toxic effects accompanying acute overdosage of clomifene have not been reported. Signs and symptoms of overdosage as a result of the use of more than the recommended dose during clomifene therapy include nausea, vomiting, vasomotor flushes, visual blurring, spots or flashes, scotomata, ovarian enlargement with pelvic or abdominal pain.
Active Ingredient/Synonyms
2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-N,N-diethylethanamine | 2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine | 2-(p-(β-chloro-α-phenylstyryl)phenoxy)triethylamine | Clomifeno | Clomifenum | Clomiphene | Clomifene |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.