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Duphaston

Duphaston

dydrogesterone

Manufacturer:

Abbott

Distributor:

Abbott
Concise Prescribing Info
Contents
Dydrogesterone
Indications/Uses
Progesterone deficiencies eg, dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened & habitual miscarriage & infertility due to luteal insufficiency. Luteal support as part of an assisted reproductive technology (ART) treatment. To counteract the effects of unopposed estrogen on the endometrium in HRT for women w/ disorders due to natural or surgical induced menopause w/ an intact uterus.
Dosage/Direction for Use
Dysmenorrhea 10 or 20 mg daily from day 5-25 of the menstrual cycle. Endometriosis 10-30 mg daily from day 5-25 of the cycle or continuously. Dysfunctional uterine bleeding To arrest a bleeding episode: 20 or 30 mg daily for up to 10 days. Continuous treatment: 10 or 20 mg daily given during the 2nd ½ of the menstrual cycle. Secondary amenorrhea 10 or 20 mg daily for 14 days during the 2nd ½ of the theoretical menstrual cycle. Premenstrual syndrome 10 mg bid starting w/ the 2nd ½ of the menstrual cycle until the 1st day of the next cycle. Irregular cycles 10 or 20 mg daily starting w/ the 2nd ½ of the menstrual cycle until the 1st day of the next cycle. Threatened miscarriage Initially up to 40 mg followed by 20 or 30 mg daily until symptoms remit. Habitual miscarriage 10 mg bid until the 12th wk of pregnancy. Infertility due to luteal insufficiency 10 or 20 mg daily starting w/ the 2nd ½ of the menstrual cycle until the 1st day of the next cycle. Treatment should be maintained for at least 3 consecutive cycles. Luteal support as part of an ART treatment 10 mg tid starting at the day of oocyte retrieval & continued for 10 wk if pregnancy is confirmed. HRT Continuous sequential therapy: Dydrogesterone 10 mg added to continuous estrogen dose for the last 14 days of every 28 day cycle in a sequential manner. Cyclic therapy: When an estrogen is dosed cyclically w/ a treatment-free interval, usually 21 days on & 7 days off; dydrogesterone 10 mg is added for the last 12-14 days of estrogen therapy. Can subsequently be adjusted to dydrogesterone 20 mg daily depending on clinical response.
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. Used in combination w/ estrogens.
Special Precautions
Breakthrough bleeding & spotting may occur during the 1st mth of treatment. Closely monitor if porphyria, depression, or abnormal liver function values caused by acute or chronic liver disease recurs or is aggravated. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Complete personal & family medical history should be taken before initiating or reinstituting HRT. Increased risk of endometrial hyperplasia & carcinoma; breast cancer; ovarian cancer. Discontinue if VTE develops after initiating therapy. Women on chronic anticoagulant treatment. CAD. Ischemic stroke. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Adolescent 12-18 yr.
Adverse Reactions
Vag hemorrhage. Migraines/headache; nausea, vomiting, abdominal pain; menstrual disorders (including metrorrhagia, menorrhagia, oligo-/amenorrhea, dysmenorrhea & irregular menstruation), breast pain/tenderness.
Drug Interactions
Increased metabolism w/ anticonvulsants (eg, phenobarb, phenytoin, carbamazepine), anti-infectives (eg, rifampicin, rifabutin, nevirapine, efavirenz) & herbal prep containing eg, St. John's wort, sage or Gingko biloba. 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 tab 10 mg
Packing/Price
20's (P1,790/pack)
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