Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESTROGENS, CONJUGATED SYNTHETIC A (UNII: JM2621P2LS) (ESTROGENS, CONJUGATED SYNTHETIC A - UNII:JM2621P2LS)
Physicians Total Care, Inc.
ESTROGENS, CONJUGATED SYNTHETIC A
ESTROGENS, CONJUGATED SYNTHETIC A 0.45 mg
ORAL
PRESCRIPTION DRUG
Cenestin therapy is indicated for the: 1. Treatment of moderate-to-severe vasomotor symptoms associated with the menopause. - 0.45 mg Cenestin - 0.625 mg Cenestin - 0.9 mg Cenestin - 1.25 mg Cenestin 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - 0.3 mg Cenestin Cenestin should not be used in women with any of the following conditions: - Undiagnosed abnormal genital bleeding. - Known, suspected, or history of cancer of the breast. - Known or suspected estrogen-dependent neoplasia. - Active deep vein thrombosis, pulmonary embolism or a history of these conditions. - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). - Liver dysfunction or disease. - Cenestin therapy should not be used in patients with known hypersensitivity to its ingredients. - Known or su
Cenestin (synthetic conjugated estrogens, A) Tablets are available as: Round, orange, film-coated, and are debossed with letters, dp , and number, 46. Round, red, film-coated, and are debossed with letters, dp , and number, 42. Round, blue, film-coated, and are debossed with letters, dp , and number, 44. Store at 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Dispense in tight container. Dispense in child-resistant packaging. Keep out of the reach of children. Pharmacist: Include one “Information for the patient” leaflet with each package dispensed.
New Drug Application
CENESTIN - SYNTHETIC CONJUGATED ESTROGENS, A TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- CENESTIN (SYNTHETIC CONJUGATED ESTROGENS, A) TABLETS RX ONLY REVISED SEPTEMBER 2004 11000422506 ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, MALIGNANT NEOPLASMS, _ENDOMETRIAL CANCER_.) CARDIOVASCULAR AND OTHER RISKS Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, CARDIOVASCULAR DISORDERS.) 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 equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES.) 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 oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL PHARMACOLOGY, CLINICAL STUDIES.) 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 ris Read the complete document