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1 Indications And Usage Actonel 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 Actonel Is Indicated For The Treatment And Prevention Of Osteoporosis In Postmenopausal Women. In Postmenopausal Women With Osteoporosis, Actonel 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 Actonel Is Indicated For Treatment To Increase Bone Mass In Men With Osteoporosis. 1.3 Glucocorticoid-Induced Osteoporosis Actonel Is 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 Actonel Is 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 Actonel 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.
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