Duphaston

Duphaston

dydrogesterone

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dydrogesterone
Indications/Uses
Progesterone deficiencies eg, dysmenorrhoea, endometriosis; secondary amenorrhoea, irregular cycles, dysfunctional uterine bleeding, premenstrual syndrome. Luteal support as part of assisted reproductive technology (ART) treatment. Threatened & recurrent miscarriage, infertility due to luteal insufficiency. To counteract the effects of unopposed estrogen on the endometrium in HRT.
Dosage/Direction for Use
Dysmenorrhoea 10 mg bid from day 5-25 of cycle. Endometriosis 10 mg bid to tid from day 5-25 of cycle or continuously. Dysfunctional bleeding To arrest bleeding: 20 or 30 mg daily to be given up for 10 days. To regulate bleeding: 10 or 20 mg daily during 2nd half of the menstrual cycle. Secondary amenorrhoea 10 or 20 mg daily to be given for 14 days during the 2nd half of the menstrual cycle. Premenstrual syndrome 10 mg bid starting w/ the 2nd half of the menstrual cycle until the 1st day of the next cycle. Irregular cycles 10 or 20 mg daily starting w/ the 2nd half of the menstrual cycle until the 1st day of the next cycle. Threatened miscarriage Initially up to 40 mg, then 10 mg 8 hrly until symptoms remit. Recurrent miscarriage 10 mg bid until the 12th wk of pregnancy. Infertility due to luteal insufficiency 10 or 20 mg daily starting w/ the 2nd half of the menstrual cycle until the first day of the next cycle. Treatment should be maintained for at least 3 consecutive cycles. Luteal support as part of ART treatment 10 mg tid starting at the day of oocyte retrieval & continuing for 10 wk if pregnancy is confirmed. HRT Continuous sequential therapy: Estrogen + 10 mg dydrogesterone added for the last 14 days of every 28 day cycle, in a sequential manner. Cyclic therapy: When estrogen is dosed cyclically w/ a treatment-free interval, usually 21 days on & 7 days off. 10 mg dydrogesterone is added for the last 12-14 days of estrogen therapy. Dose can be adjusted to 20 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Progestogen dependent neoplasms (eg, meningioma), undiagnosed vag bleeding. Discontinue luteal support upon abortion/miscarriage. Concomitant use w/ estrogens.
Special Precautions
Breakthrough bleeding & spotting may occur during the 1st mth of treatment. Closely monitor patient & consider discontinuation of treatment if porphyria, depression or abnormal liver function values caused by acute or chronic liver disease recurs, or is aggravated. Risks associated w/ HRT in treatment of premature menopause. Perform complete personal & family medical history before initiating or reinstituting HRT. Risk of endometrial hyperplasia & carcinoma w/ prolonged use, & CAD. Increased risk of breast cancer. HRT is contraindicated in patients w/ known thrombophilic states & if thrombophilic defect is identified. Temporarily discontinue HRT 4-6 wk earlier if prolonged immobilization is to follow elective surgery. Discontinue if VTE develops after initiating therapy. Women on chronic anticoagulant treatment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Lactation.
Adverse Reactions
Migraines/headache; nausea; menstrual disorders & breast pain/tenderness.
Drug Interactions
Increased metabolism w/ anticonvulsants eg, phenobarb, phenytoin, carbamazepine, anti-infectives eg, rifampicin, rifabutin, nevirapine, efavirenz, & herbal prep containing St. John's wort (Hypericum perforatum), sage or Gingko biloba.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB01 - dydrogesterone ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Duphaston tab 10 mg
Packing/Price
20's
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