Duphaston

Duphaston

dydrogesterone

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dydrogesterone
Indications/Uses
Dysmenorrhoea, endometriosis, secondary amenorrhoea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened & habitual abortion associated w/ proven progesterone deficiency, infertility due to luteal insufficiency, HRT. Luteal support as part of assisted reproductive technology (ART) treatment.
Dosage/Direction for Use
Dysmenorrhoea 1 tab bd from day 5-25 of cycle. Endometriosis 1 tab bd-tds from day 5-25 of cycle or continuously. Dysfunctional bleeding (to stop bleeding) 1 tab bd for 5-7 days, (to prevent bleeding) 1 tab bd from day 11-25 of cycle. Amenorrhoea 1 tab bd from day 11-25 of cycle w/ oestrogen once daily from day 1-25 of cycle. Premenstrual syndrome/irregular cycles 1 tab bd from day 11-25 of cycle. Threatened abortion 4 tab at once, then 1 tab every 8 hr until reduced symptoms. Habitual abortion 1 tab bd until 20th wk of pregnancy. Infertility due to luteal insufficiency 1 tab daily from day 14-25 of cycle for at least 6 consecutive cycles. Luteal support as part of ART treatment 1 tab tds starting at oocyte retrieval day & continue for 10 wk in confirmed pregnancy. HRT In combination w/ continuous oestrogen therapy: 1 tab daily for 14 consecutive days of 28-day cycle. In combination w/ cyclical oestrogen therapy: 1 tab daily during last 12-14 days of oestrogen therapy.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known or suspected progestogen-dependent neoplasms eg, meningioma; undiagnosed vag bleeding. Conditions related to use in combination w/ estrogen. Discontinue luteal support as part of ART treatment upon abortion or miscarriage diagnosis.
Special Precautions
Discontinue use if VTE develops. Determine bleeding etiology prior to treatment. Increased risk of endometrial hyperplasia & carcinoma; breast & ovarian cancer. Porphyria, depression, abnormal liver function values by acute & chronic liver disease occurred during pregnancy or previous hormone treatment; known thrombophilic states, use of estrogens, older age, major surgery, prolonged immobilization, obesity (BMI >30 kg/m2), postpartum period, SLE, cancer; CAD; ischaemic stroke. Temporarily withhold treatment for 4-6 wk if prolonged immobilisation is to follow elective surgery & not to be restarted until completely mobilised. Perform complete personal & family medical history & physical exam eg, pelvic & breast exam prior to therapy. Concomitant use w/ anticoagulants. Prolonged use. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not to be used during lactation. Not recommended in childn <18 yr.
Adverse Reactions
Vag haemorrhage. Migraine/headache; nausea, vomiting, abdominal pain; menstrual disorders (eg, metrorrhagia, menorrhagia, oligo-/amenorrhoea, dysmenorrhoea & irregular menstruation), breast pain/tenderness.
Drug Interactions
Increased metabolism w/ anticonvulsants (eg, phenobarb, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz), St. John's wort-, sage- or gingko biloba-containing herbal prep; ritonavir, nelfinavir.
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 FC tab 10 mg
Packing/Price
20's
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