Osteoporosis in postmenopausal women to reduce incidence of hip, vertebral & non-vertebral fractures & to increase bone mineral density; & in men. Prevention of postmenopausal osteoporosis; clinical fractures after hip fracture in men & women. Treatment & prevention of glucocorticoid-induced osteoporosis. Paget's disease of bone.
Infusion time should not be <15 min. Postmenopausal osteoporosis, osteoporosis in men, prevention of clinical fractures after hip fracture, treatment & prevention of glucocorticoid-induced osteoporosis 5 mg as a single IV infusion once a yr. Prevention of postmenopausal osteoporosis 5 mg as a single IV infusion. Paget's disease of bone 5 mg as a single IV infusion. Re-treatment of Paget's disease Additional 5 mg IV infusion after an interval of ≥1 yr from initial treatment. Do not administer 2nd IV infusion earlier than 12 mth following initial treatment in the absence of worsening of clinical symptoms &/or bone scan consistent w/ relapse of Paget's disease of bone.
Not to be treated in patient being treated w/ zoledronic acid used for oncology indications. Hydrate patients especially in elderly & for patients receiving diuretic therapy appropriately prior to administration. Treat pre-existing hypocalcemia by adequate intake of Ca & vit D before initiating therapy. Patients w/ pre-existing renal impairment or other risk factors including advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration occurring after administration. Musculoskeletal pain. Osteonecrosis of the jaw. Avoid invasive dental procedures while in treatment in patients w/ concomitant risk factors (eg, cancer, chemotherapy, anti-angiogenic drugs, corticosteroids, poor oral hygiene). Osteonecrosis of other bones. Atypical fractures of the femur. Consider discontinuation of therapy in patients suspected to have atypical femur fracture. Not recommended for use in childn & adolescents <18 yr.
Concomitant use w/ drugs that can significantly impact renal function (eg, aminoglycosides or diuretics that may cause dehydration). May increase systemic exposure to concomitant drugs primarily excreted via kidneys in patients w/ renal impairment.
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