risedronate sodium
risedronate sodium is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including risedronate sodium, Atelvia, Risedronate Sodium. Available dosage forms: tablet, film coated, tablet, delayed release.
Drug Details
- Generic Name
- risedronate sodium
- Brand Names
- risedronate sodium, Atelvia, Risedronate Sodium
- Application Number
- ANDA090886
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- NDC Codes
- 8
- Dosage Forms
- TABLET, FILM COATED, TABLET, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- RISEDRONATE SODIUM HEMI-PENTAHYDRATE, RISEDRONATE SODIUM MONOHYDRATE, RISEDRONATE SODIUM HEMIPENTAHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Risedronate sodium delayed-release tablets are bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis (1.1) Limitations of Use 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 Postmenopausal Osteoporosis Risedronate sodium delayed-release tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies (14.1) ]. 1.2 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium delayed-release tablets for the treatment of osteoporosis are based on clinical data of one year 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.