risedronate sodium 35 MG Oral Tablet
1 INDICATIONS AND USAGE Risedronate sodium tablets, USP are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget's disease ( 1.4 ) 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. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets, USP reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies ( 14.1 , 14.2 ) ]. 1.2 Osteoporosis in Men Risedronate sodium tablets, USP are indicated for treatment to increase bone mass in men with osteoporosis. 1.3 Glucocorticoid-Induced Osteoporosis Risedronate sodium tablets, USP are indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage of greater than or equal to 7.5 mg of prednisone or equivalent) for chronic diseases. Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D. 1.4 Paget's Disease Risedronate sodium tablets, USP are indicated for treatment of Paget’s disease of bone in men and women. 1.5 Important Limitations of Use The optimal duration of use has not been determined. The safety and effectiveness of risedronate sodium tablets, USP 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.
apotex corp.
ROUND ORANGE APO RIS 35
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16 HOW SUPPLIED/STORAGE AND HANDLING
RISEDRONATE SODIUM Tablets, USP are available as follows: 35 mg film-coated, round, orange biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘35’ on the other side NDC 60505-3165-0 dose pack of 4 NDC 60505-3165-2 dose pack of 12 75 mg film-coated, round, dark pink biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘75’ on the other side NDC 60505-3096-2 dose pack of 2 150 mg film-coated, round, blue biconvex tablet, engraved ‘APO’ on one side, ‘RIS’ over ‘150’ on the other side NDC 60505-3097-2 dose pack of 1 NDC 60505-3097-4 dose pack of 3 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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