Zuellig Pharma
Concise Prescribing Info
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, hormone replacement therapy (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.
Hypersensitivity. Known or suspected progestogen-dependent neoplasms eg, meningioma; undiagnosed vag bleeding. Discontinue luteal support as part of ART treatment upon abortion or miscarriage diagnosis.
Special Precautions
Determine bleeding etiology prior to treatment. Increased risk of endometrial hyperplasia & carcinoma; breast & ovarian cancer. Porphyria; depression; known thrombophilic states, use of estrogens, older age, major surgery, prolonged immobilization, obesity (BMI >30 kg/m2), SLE, potential thromboembolic symptom (eg, painful leg swelling, sudden chest pain, dyspnea; CAD; ischaemic stroke. Perform complete personal & family medical history & physical exam eg, pelvic & breast exam prior to therapy. Concomitant use w/ anticoagulants. Prolonged use. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Abnormal liver function values by acute & chronic hepatic disease. Pregnancy. 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.
Duphaston FC tab 10 mg
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