HormoPro 200

Treatment of secondary amenorrhea. Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tab; recurrent spontaneous abortions due to luteal phase defect; preterm labor.

Treatment of secondary amenorrhea Single daily dose of 400 mg at bedtime for 10 days. Prevention of endometrial hyperplasia Postmenopausal woman w/ a uterus who is receiving daily conjugated estrogen tab Single daily dose of 200 mg at bedtime for 12 days sequentially per 28-day cycle. Premenstrual syndrome, benign mastopathies, menstrual irregularities, pre-menopause Initially 200-300 mg daily, 10 days/cycle, usually from 14th day to until onset of menstruation. Threatened abortion or prevention of LPD-related recurrent spontaneous abortions 200-400 mg daily, spread over 2 doses, to be taken up until gestation wk 12. Threatened preterm delivery 400 mg every 6-8 hr, depending on the clinical results obtained during acute phase, followed by a maintenance dose (eg, 3 times 200 mg daily) to be taken up until gestation wk 36.

Should be taken on an empty stomach: Take at bedtime. For women w/ difficulty swallowing cap, take w/ glass of water in standing position.

Hypersensitivity. Thrombophlebitis, thromboembolic disorders, cerebral hemorrhage, or history of these conditions. Breast carcinoma. Suspected or confirmed breast or genital organ neoplasia. Undiagnosed vag bleeding. Severe liver disease (if results of LFTs have failed to return to normal), hepatic cell tumors, rotor syndrome & Dubin-Johnson syndrome.

Not suitable for contraceptive use. Discontinue therapy & institute appropriate diagnostic & therapeutic measures if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy. Caution in patients w/ conditions that might be aggravated by fluid retention (eg, HTN, cardiac/renal disease, epilepsy, migraine, asthma), in patients w/ history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity & in breastfeeding mothers. Perform clinical exam of the breasts & pelvic exam where clinically indicated. Assess each woman prior to taking HRT & at regular intervals thereafter. Intended to be co-prescribed w/ estrogen product as HRT; increased risk of developing DVT or pulmonary embolism is associated w/ use of HRT. Small increased risk of breast cancer w/ estrogen replacement therapy. May affect the results of lab tests of hepatic &/or endocrine functions. May cause drowsiness &/or dizziness; caution in drivers & users of machines. Prescription beyond the 1st trimester of pregnancy may reveal gravidic cholestasis. Use during the 2nd & 3rd trimesters of pregnancy can lead to the development of cholestatic jaundice of pregnancy or hepatocellular liver disease. Lactation.

Breakthrough bleeding, change in menstrual flow, amenorrhea, changes in cervical erosion & secretions, breast changes, edema, wt gain, catabolism, cholestatic jaundice, allergic reactions & rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism.

May interfere w/ the effects of bromocriptine. May raise the plasma conc of ciclosporin. Accelerated metabolism w/ rifamycin. Bioavailability may be increased w/ ketoconazole.

Oestrogens, Progesterones & Related Synthetic Drugs

G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.

Rx