risedronate 75 mg
1 INDICATIONS AND USAGE Risedronate sodium is 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 are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets 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 are indicated for treatment to increase bone mass in men with osteoporosis. 1.3 Glucocorticoid-Induced Osteoporosis Risedronate sodium tablets 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 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 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.
sun pharmaceutical industries, inc.
ROUND PINK S 727
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16 HOW SUPPLIED/STORAGE AND HANDLING
RISEDRONATE SODIUM tablets, USP are available as follows: 5 mg film-coated, round, yellow tablets debossed ‘5’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant cap, NDC 47335-666-83 Bottles of 100 with Child-resistant cap, NDC 47335-666-88 Bottles of 100, NDC 47335-666-08 Bottles of 1000, NDC 47335-666-18 30 mg film-coated, round, white tablets debossed ‘667’ on one side and ‘S’ on other side. Bottles of 30 with Child-resistant cap, NDC 47335-667-83 Bottles of 100 with Child-resistant cap, NDC 47335-667-88 Bottles of 100, NDC 47335-667-08 Bottles of 1000, NDC 47335-667-18 35 mg film-coated, round, brown tablets debossed ‘668’ on one side and ‘S’ on other side. Unit-dose blister package of 4……………………..… NDC 47335-668-68 Unit-dose blister package of 12……………………… NDC 47335-668-62 75 mg film-coated, round, pink tablets debossed ‘727’ on one side and ‘S’ on other side. Unit-dose blister package of 2…………………..…… NDC 47335-727-98 150 mg film-coated, round, blue tablets debossed ‘928’ on one side and ‘S’ on other side. Unit-dose blister package of 1..……………………… NDC 47335-928-60 Unit-dose blister package of 3..……………………… NDC 47335-928-67 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers as defined in USP.
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