Duphaston

Duphaston

dydrogesterone

Manufacturer:

Abbott

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dydrogesterone
Indications/Uses
Symptomatic relief of mild to moderate vasomotor symptoms associated w/ menopause. Prevention of postmenopausal osteoporosis if other treatments are unsuitable. Progesterone deficiencies including dysmenorrhoea, endometriosis, secondary amenorrhoea, irregular cycles, dysfunction uterine bleeding, threatened & habitual miscarriage, infertility due to luteal insufficiency. Luteal support as part of an assisted reproductive technology (ART) treatment.
Dosage/Direction for Use
Symptomatic relief of mild to moderate vasomotor symptoms associated w/ menopause; prevention of postmenopausal osteoporosis Continuous sequential therapy: Oestrogen is dosed continuously, 10 mg dydrogesterone is added for the last 14 days of every 28 day cycle. Cyclic therapy: Oestrogen 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 oestrogen therapy. Inadequate progestational response revealed by ultrasound or endometrial biopsies 20 mg dydrogesterone. Dysmenorrhoea 10 mg bd from day 5-25 of menstrual cycle. Endometriosis 10 mg bd-tds from day 5-25 of cycle or continuously. Dysfunctional bleeding To arrest bleeding: 10 mg bd w/ oestrogen for 5-7 days. To prevent bleeding: 10 mg bd w/ oestrogen from day 11-25 of cycle. Amenorrhoea Oestrogen once daily from day 1-25 of cycle together w/ 10 mg dydrogesterone bd from day 11-25 of cycle. Irregular cycles 10 mg bd from day 11-25 of cycle. Threatened miscarriage 40 mg at once then 10 mg every 8 hr until symptoms remit. Habitual miscarriage 10 mg bd until 20th wk of pregnancy. Infertility due to luteal insufficiency 10 mg daily from day 14-25 of cycle. Continue therapy for at least 6 consecutive cycles. Luteal support as part of ART treatment 10 mg tds starting at the day of oocyte retrieval & continuing for 10 wk if pregnancy is confirmed.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known or suspected progestogen dependent neoplasm (eg, meningioma). Undiagnosed vag bleeding. Discontinue treatment for luteal support as part of an ART treatment upon diagnosis of abortion/miscarriage. Use of estrogens in combination w/ dydrogesterone. Existence or history of serious liver disorders.
Special Precautions
Rule out organic cause of dysfunctional uterine bleeding before initiating treatment. Breakthrough bleeding & spotting may occur during 1st mth of treatment. Consider discontinuation in case of severe headache, migraine or symptoms which might suggest cerebral ischaemia; notable rise in BP; VTE. Determine & check the viability of the foetus during treatment of habitual & threatened miscarriage to see if pregnancy is continuing. Monitor conditions including cholestatic jaundice, herpes gestationis, severe pruritus, otosclerosis & porphyria. Carefully monitor patients w/ history of depression; discontinue treatment if severe depression recurs. Combination w/ oestrogens for HRT. Complete medical history (including family history) should be taken before initiating or reinstituting HRT. Physical (including gynaecological & mammary) exams should be guided by the history, CI & warnings for use. Increased risk of endometrial hyperplasia & carcinoma in prolonged oestrogen therapy w/o the addition of progestogen; breast cancer in combination of oestrogen-progestogen therapy or oestrogen-only HRT. Possible slightly increased risk of ovarian cancer in women taking oestrogen-only or combined oestrogen-progestogen HRT. Increased risk of VTE in patients w/ known thrombophilia. Temporarily stop HRT 4-6 wk before elective surgery; not to be restarted until woman is completely mobilized. Screen & identify for thrombophilic defects in women w/ no personal VTE history but w/ 1st degree relative w/ thrombosis history at young age. Anticoagulant treatment. Discontinue if VTE develops after initiating therapy. Risk of CAD & ischaemic stroke. Contains lactose monohydrate. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines; may cause mild somnolence &/or dizziness w/in 1st few hr after intake. Not to be used during lactation period. No relevant use before menarche. Adolescent 12-18 yr.
Adverse Reactions
Vag haemorrhage. Migraines/headache; nausea, vomiting, abdominal pain; menstrual disorders (including metrorrhagia, menorrhagia, oligo-/amenorrhoea, dysmenorrhoea & irregular menstruation), breast pain/tenderness.
Drug Interactions
May increase metabolism by anticonvulsants (eg, phenobarb, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz) & herbal prep containing St. John's wort, sage or ginkgo biloba. Ritonavir & nelfinavir when used concomitantly w/ steroid hormones. Increased metabolism may lead to decreased effect & bleeding pattern changes.
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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