|
Indications & Dosage
INDICATIONS AND USAGE
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. For either osteoporosis treatment or prevention, supplemental calcium and/ or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal osteoporosis may be diagnosed by history or radiographic documentation of osteoporotic fracture, bone mineral densitometry, or physical signs of vertebral crush fractures (e. g., height loss, dorsal kyphosis). No single clinical finding or test result can quantify risk of postmenopausal osteoporosis with certainty. However, clinical assessment can help to identify women at increased risk. Widely accepted risk factors include Caucasian or Asian descent, slender body build, early estrogen deficiency, smoking, alcohol consumption, low calcium diet, sedentary lifestyle, and family history of osteoporosis. Text Continues Below
Evidence of increased bone turnover from serum and urine markers and low bone mass (e. g., at least 1 standard deviation below the mean for healthy, young adult women) as determined by densitometric techniques are also predictive. The greater the number of clinical risk factors, the greater the probability of developing postmenopausal osteoporosis. DOSAGE AND ADMINISTRATION The recommended dosage is one 60-mg EVISTA tablet daily which may be administered any time of day without regard to meals. HOW SUPPLIED EVISTA 60-mg tablets are white, elliptical, and film coated. They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink. They are available as follows: Bottle (count) NDC Number
30 (unit of use) NDC -0002-4165-30 100 (unit of use) NDC -0002-4165-02 2000 NDC -0002-4165-07 Store at controlled room temperature, 20º to 25º C (68º to 77º F) [see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25º C (68º to 77º F); that results in a mean kinetic temperature calculated to be not more than 25º C; and that allows for excursions between 15º and 30º C (59º and 86º F) that are experienced in pharmacies, hospitals, and warehouses. Literature revised July 11, 2003
Eli Lilly and Company, Indianapolis, IN 46285, USA www. lilly. com PV 3086 AMP PRINTED IN USA Copyright © 1997, 2003, Eli Lilly and Company. All rights reserved.
|
.gif)
