Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E), LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)
Physicians Total Care, Inc.
ESTRADIOL
ESTRADIOL 4.4 mg
TRANSDERMAL
PRESCRIPTION DRUG
In women with an intact uterus, Climara Pro is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with menopause. - Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered. The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women. Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, pre
Climara Pro (Estradiol/Levonorgestrel Transdermal System) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm2 system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel. NDC 54868-5570-0 Individual Carton of 4 systems Storage Conditions: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled Room Temperature]. Do not store unpouched.
New Drug Application
CLIMARA PRO - ESTRADIOL AND LEVONORGESTREL PATCH PHYSICIANS TOTAL CARE, INC. ---------- CLIMARA PRO PRESCRIBING INFORMATION CLIMARA PRO (ESTRADIOL/LEVONORGESTREL TRANSDERMAL SYSTEM) RX ONLY WARNINGS Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.) The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer.) The WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with oral conjugated estrogens (CE 0.625 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders.) The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg and during 5.2 years of treatment with CE 0.625 mg alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES, WARNINGS, Dementia and PRECAUTIONS, Geriatric Use.) Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the indi Baca dokumen lengkap