DUPHASTON 10MG TABLET (TABLET)

Special Precautions: Breakthrough bleeding & spotting may occur during 1st mth of treatment. Discontinue treatment if porphyria, depression & abnormal liver function occur. Concomitant use w/ estrogen. Perform physical exam prior to treatment. Increased risk on endometrial hyperplasia & carcinoma; breast, ovarian cancer. Venous thromboembolism. CAD. Ischemic stroke. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Pregnancy & lactation. Adolescent 12-18 yr. Side Effects / Adverse Reactions: Migraines/headache, nausea, menstrual disorders (eg, metrorrhagia, menorrhagia, oligo-/amenorrhea, dysmenorrhea & irregular menstruation), breast pain/tenderness. 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 When treatment is started 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 or maintained for at least 3 cycles. Luteal support as part of an ART treatment 10 mg tid daily starting at the day of oocyte retrieval & continued for 10 wk if pregnancy is confirmed. Hormone replacement therapy Continuous sequential therapy: 1 tab of 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; 1 tab of 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.