(British Approved Name, US Adopted Name, rINN)
Pharmacopoeias. In British, Japan and US.
BP 2008 (Dydrogesterone). A white or almost white crystalline powder odourless or almost odourless. Practically insoluble in water sparingly soluble in alcohol and in methyl alcohol soluble in acetone freely soluble in chloroform slightly soluble in ether and in fixed oils. Protect from light.
The United States Pharmacopeia 31, 2008 (Dydrogesterone). A white to pale yellow crystalline powder. Practically insoluble in water soluble 1 in 40 of alcohol, 1 in 2 of chloroform, and 1 in 200 of ether.
Adverse Effects and Precautions
As for progestogens in general (see Progesterone). See also under Hormone Replacement Therapy.
Dydrogesterone has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients.
Anomalies (non-virilising) of the genito-urinary tract were found in a 4-month-old baby whose mother had taken dydrogesterone 20 mg daily from the eighth to twentieth week of pregnancy and 10 mg daily from then until term. She had also been given hydroxyprogesterone caproate 250 mg by intramuscular injection weekly from the eighth to the twentieth week.
As for progestogens in general (see Progesterone).
Uses and Administration
Dydrogesterone is a progestogen structurally related to progesterone. It does not have oestrogenic or androgenic properties.
Dydrogesterone has been given orally in the treatment of menstrual disorders such as menorrhagia, usually in a dose of 10 mg twice daily in a cyclical regimen, and for the treatment of endometriosis in a dose of 10 mg two or three times daily cyclically or continuously. It has also been given cyclically in doses of 10 mg once or twice daily, or continuously in doses of 5 mg daily, for endometrial protection during menopausal HRT.
In threatened miscarriage suggested doses have been 40 mg initially followed by 10 mg or more every 8 hours, continued for a week after symptoms cease then gradually reduced unless symptoms return. In recurrent miscarriage suggested doses have been 10 mg twice daily given cyclically until conception then continuously until week 20 of pregnancy, the dose may then be gradually reduced. However, such use is not recommended unless there is proven progesterone deficiency. Cyclical dydrogesterone has also been used in infertility in doses of 10 mg twice daily.
British Pharmacopoeia 2008: Dydrogesterone Tablets
The United States Pharmacopeia 31, 2008: Dydrogesterone Tablets.
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Israel: Biphaston Duphaston
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New Zealand: Duphaston
South Africa: Duphaston
Austria: Femoston Femoston Conti Femphascyl Femphascyl conti
Belgium: Femoston Femoston Conti
Brazil: Femoston Femoston Conti
Chile: Femoston Femoston Conti
Czech Republic: Femoston Femoston Conti
Finland: Femoston Femoston Conti
Germany: Femoston Femoston Conti
Hong Kong: Femoston
Ireland: Femoston Femoston Conti
Italy: Femoston Femoston Conti
Malaysia: Femoston Femoston Conti
The Netherlands: Climaston Continu Femoston Femoston Continu Femphascyl Continu
Poland: Femoston Femoston Conti
Portugal: Femoston Femoston 1/5 Femphascyl
Russia: Femoston Femoston 1/5
South Africa: Femoston Femoston Conti
Singapore: Femoston Femoston Conti
Switzerland: Femoston Femoston Conti
Thailand: Femoston 1/10 Femoston Conti
UK: Femapak Femoston Femoston Conti
Venezuela: Femoston Femoston Conti