ibandronate sodium
ibandronate sodium is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Ibandronate Sodium. Available dosage form: injection.
Drug Details
- Generic Name
- ibandronate sodium
- Brand Names
- Ibandronate Sodium
- Application Number
- ANDA204222
- Sponsor
- Apotex Corp.
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- IBANDRONATE SODIUM
Indications and Usage
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 increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations of Use Theoptimalduration 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.