risedronate sodium 30 MG Oral Tablet
1 INDICATIONS AND USAGE Risedronate sodium tablets 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 are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate reduces 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 3 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.
Mylan Pharmaceuticals Inc.
ROUND WHITE M 114
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16 HOW SUPPLIED/STORAGE AND HANDLING Risedronate Sodium Tablets, USP are available containing 5 mg, 30 mg, 35 mg or 150 mg risedronate sodium, USP. The 5 mg tablets are light beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and 44 on the other side. They are available as follows: NDC 0378-4044-93 bottles of 30 tablets NDC 0378-4044-05 bottles of 500 tablets The 30 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 114 on the other side. They are available as follows: NDC 0378-4114-93 bottles of 30 tablets NDC 0378-4114-05 bottles of 500 tablets The 35 mg tablets are light orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and 714 on the other side. They are available as follows: NDC 0378-4714-99 unit of use blister card containing 4 tablets NDC 0378-4714-92 carton of 10 cards each containing 4 tablets NDC 0378-4714-96 unit of use blister card containing 12 tablets NDC 0378-4714-78 carton of 10 cards each containing 12 tablets The 150 mg tablets are light blue, film-coated, round, unscored tablets debossed with M over RE on one side of the tablet and 150 on the other side. They are available as follows: NDC 0378-4150-32 unit of use blister card containing 1 tablet NDC 0378-4150-97 carton of 10 cards each containing 1 tablet NDC 0378-4150-53 unit of use blister card containing 3 tablets NDC 0378-4150-93 carton of 10 cards each containing 3 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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