Product Information
Registration Status: ActiveSIN11255P
DUPHASTON TABLET 10mg (FILM-COATED) is approved to be sold in Singapore with effective from 2000-10-01. It is marketed by ABBOTT LABORATORIES (SINGAPORE ) PTE LTD, with the registration number of SIN11255P.
This product contains Dydrogesterone 10mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by ABBOTT BIOLOGICALS B.V. in NETHERLANDS.
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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit ovulation. [PubChem]
Indication
Used to treat irregular duration of cycles and irregular occurrence and duration of periods caused by progesterone deficiency. Also used to prevent natural abortion in patients who have a history of habitual abortions.
Mechanism of Action
Dydrogesterone is a progestogen that works by regulating the healthy growth and normal shedding of the womb lining by acting on progesterone receptors in the uterus.
Pharmacokinetics
- Absorption
- Rapidly absorbed in the gastrointestinal tract with a bioavailability of 28%.
- Distribution
- Metabolism
- Metabolism is complete to a 20-dihydrodydrogesterone (DHD) metabolite.
- Elimination
Toxicity
No serious or unexpected toxicity has been observed with dydrogesterone. In acute toxicity studies, the LD50 doses in rats exceeded 4,640mg/kg for the oral route.
Active Ingredient/Synonyms
(9β,10α)-pregna-4,6-diene-3,20-dione | 10alpha-Isopregnenone | 6-Dehydro-retro-progesterone | 9β,10α-pregna-4,6-diene-3,20-dione | delta(6)-Retroprogesterone | delta(Sup 6)-retroprogesterone | Didrogesterona | Didrogesterone | Dydrogesterona | Dydrogestérone | Dydrogesterone | Dydrogesteronum | Gestatron | Hydrogesterone | Hydrogestrone | Isopregnenone | Retro-6-dehydroprogesterone | Dydrogesterone |
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.