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Dydrogesterone

Drug Approvals

(British Approved Name, US Adopted Name, rINN)

DydrogesteroneSynonyms: 6-Dehydro-9β,10α-progesterone; 6-Dehydro-retro-progesterone; Dehydroprogesterone; Didrogesteron; Didrogesterona; Dydrogesteron; Dydrogesteroni; Dydrogesteronum; Isopregnenone; NSC-92336
BAN: Dydrogesterone
USAN: Dydrogesterone
INN: Dydrogesterone [rINN (en)]
INN: Didrogesterona [rINN (es)]
INN: Dydrogestérone [rINN (fr)]
INN: Dydrogesteronum [rINN (la)]
INN: Дидрогестерон [rINN (ru)]
Chemical name: 9β,10α-Pregna-4,6-diene-3,20-dione
Molecular formula: C21H28O2 =312.4
CAS: 152-62-5
ATC code: G03DB01
Read code: y02b7

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.

Porphyria. Dydrogesterone has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients.

Pregnancy. 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.

Interactions

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.

Preparations

British Pharmacopoeia 2008: Dydrogesterone Tablets

The United States Pharmacopeia 31, 2008: Dydrogesterone Tablets.

Proprietary Preparations

Australia: Duphaston

Austria: Duphaston

Belgium: Duphaston

Brazil: Duphaston

Chile: Duphaston

Czech Republic: Duphaston

Finland: Terolut

France: Duphaston

Germany: Duphaston

Greece: Duphaston

Hong Kong: Duphaston

Hungary: Duphaston

India: Duphaston

Indonesia: Duphaston

Ireland: Duphaston

Israel: Biphaston Duphaston

Italy: Dufaston

Malaysia: Duphaston

The Netherlands: Duphaston

New Zealand: Duphaston

Philippines: Duphaston

Poland: Duphaston

Portugal: Duphaston

Russia: Duphaston

South Africa: Duphaston

Singapore Duphaston

Sweden: Duphaston

Switzerland: Duphaston

Thailand: Duphaston

Turkey: Duphaston

UK: Duphaston

Venezuela: Duphaston.

 

Multi-ingredient

Australia: Femoston

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

France: Climaston

Germany: Femoston Femoston Conti

Greece: Femaston

Hong Kong: Femoston

Hungary: Femoston

Ireland: Femoston Femoston Conti

Italy: Femoston Femoston Conti

Malaysia: Femoston Femoston Conti

Mexico: Lutalmin

The Netherlands: Climaston Continu Femoston Femoston Continu Femphascyl Continu

Philippines: Femoston

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

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