HERAGEST 200MG CAPSULE (CAPSULE)

Administration Should be taken on an empty stomach: Take at bedtime. In women who experience difficulty swallowing the cap, take w/ a glass of water while in standing position. Dosage / Direction for Use Threatened/recurrent abortion w/ luteal phase defect 200-600 mg daily. Preterm delivery 400 mg every 6-8 hr depending on acute phase, then supporting dose of 600 mg/day divided into 3 doses until 36th wk of pregnancy. Progesterone challenge test in secondary amenorrhea 400 mg daily at bedtime for 10 days. Dysfunctional uterine bleeding, menstrual irregularities due to dysovulation or anovulation 200 mg once daily from 17th day of cycle for 10 days. Premenstrual syndrome, fibrocystic mastopathy, dysmenorrhea, premenopause 200 or 400 mg/day for 10 days (usually beginning from the 14th-17th day to complete 10 days). Prevention of endometrial hyperplasia in postmenopausal women w/ intact uterus who are receiving estrogen as hormone replacement therapy 200 mg at bedtime for 12 days sequentially per 28 day cycle. Contraindications Hypersensitivity. Allergy to peanuts; active liver disease especially the obstructive type; history of known or suspected estrogen-dependent or progestin-dependent malignant neoplasia (eg, breast cancer or endometrial cancer); undiagnosed abnormal genital bleeding; active or history of arterial thromboembolic disease (eg, stroke, MI, CHD); classical migraine; cerebral hemorrhage; active or history of confirmed venous thromboembolism (eg, DVT or pulmonary embolism) or active thrombophlebitis; partial or complete loss of vision due to ophth vascular disease; missed or incomplete abortion; porphyria. Not intended for pregnancy test. Enhanced metabolism & reduced activity w/ drugs inducing liver enzymes eg, carbamazepine, griseofulvin, barbiturates, hydantoins, meprobamates, phenylbutazone or rifampicin; ketoconazole. Decreased glucose tolerance & therefore dose adjustment in antidiabetics is required. Decreased action w/ bromocriptine. Increased plasma ciclosporin conc. Increased total estrone & equilin conc & decreased 17β estradiol conc. Reduced effect w/ St. John's wort. Increased sulfobromophthalein retention & other hepatic function tests, coagulation tests (increase in prothrombin factors VII, VIII, IX & X), pregnanediol determination, thyroid function (increases in PBI & butanol extractable protein bound iodine & decreases in T3 uptake values).