"The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis."...
Clinical experience with acute overdosage of zoledronic acid (Reclast) solution for intravenous infusion is limited. Patients who have received doses higher than those recommended should be carefully monitored. Overdosage may cause clinically significant renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
Single doses of Reclast should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes [see DOSAGE AND ADMINISTRATION].
Reclast is contraindicated in patients with the following conditions:
- Hypocalcemia [see WARNINGS AND PRECAUTIONS]
- Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see WARNINGS AND PRECAUTIONS].
- Known hypersensitivity to zoledronic acid or any components of Reclast. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Post-Marketing Experienc].
Last reviewed on RxList: 4/25/2016
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