ibandronate sodium tablet
1 INDICATIONS AND USAGE Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. (1.1) Limitations of Use The optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.2). 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium tablets increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of ibandronate sodium tablets for the treatment of osteoporosis are based on clinical data of three years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
dr. reddy's laboratories limited
OVAL WHITE R575
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
IBANDRONATE SODIUM tablets 150 mg are white, film coated and capsule shaped tablets printed with R575 on one side and plain on other side. Carton of 1 blister pack containing 3 tablets (NDC 55111-575-43). Carton of 3 packs (NDC 55111-575-03), each pack containing 1 tablet (NDC 55111-575-11) 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].
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