Reclast (Zoledronic Acid Injection) Drug Information: Overdosage and Contraindications

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May 27, 2012

Reclast

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Osteoporosis is a condition of increased susceptibility to fracture due to fragile bone.
Osteoporosis weakens bone and increases risk of bone fracture.
Bone mass (bone density) decreases after 35 years of age and decreases more rapidly in women after menopause.
Key risk factors for osteoporosis include genetics, lack of exercise, lack of calcium and vitamin D, personal history of fracture as an adult, cigarette smoking, excessive alcohol consumption, history of rheumatoid arthritis, low body weight, and family history of osteoporosis.
Patients with osteoporosis have no symptoms until bone fractures occur.
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OVERDOSE

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].

CONTRAINDICATIONS

Hypocalcemia

[See WARNINGS AND PRECAUTIONS]

Renal Failure

Reclast is contraindicated in patients with creatinine clearance < 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see WARNINGS AND PRECAUTIONS]

Hypersensitivity to Zoledronic Acid or Any Components of Reclast

Hypersensitivity reactions including rare cases of urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Post-Marketing Experience].

Last reviewed on RxList: 9/12/2011
This monograph has been modified to include the generic and brand name in many instances.