Accord Zoledronic Acid

Accord Zoledronic Acid

zoledronic acid


I & C


I & C
Concise Prescribing Info
Zoledronic acid
Prevention of skeletal related events in adult patients. Treatment of adult patients w/ tumour-induced hypercalcaemia.
Dosage/Direction for Use
Prevention of skeletal related events in patients Adult & elderly 4 mg every 3-4 wk. Treatment of tumour-induced hypercalcaemia Adult & elderly 4 mg single dose. Renal impairment CrCl >60 mL/min 4 mg, CrCl 50-60 mL/min 3.5 mg, CrCl 40-49 mL/min 3.3 mg, CrCl 30-39 mL/min 3 mg.
Hypersensitivity to zoledronic acid or to other bisphosphonates. Lactation.
Special Precautions
Patients, especially the elderly, should be appropriately hydrated before administration of zoledronic acid. Avoid overhydration. Assess serum creatinine levels prior to administration. Monitor serum levels of Ca, phosphate & Mg after initiating therapy. Osteonecrosis of the jaw & external auditory canal. Bone, joint &/or muscle pain. Atypical subtrochanteric & diaphyseal femoral fractures. Hypocalcaemia. Concomitant use w/ other bisphosphonate. Renal impairment. May affect ability to drive & use machines. Pregnancy.
Adverse Reactions
Bone pain, myalgia, arthralgia, generalised pain; fever, flu-like syndrome (fatigue, rigors, malaise & flushing); anaemia; headache; conjunctivitis; nausea, vomiting, anorexia; renal impairment; hypophosphataemia; blood creatinine & blood urea increased, hypocalcaemia.
Drug Interactions
Additive effect (lowering of serum Ca level) w/ aminoglycosides. Use w/ caution when administered concomitantly w/ medicines that could affect renal function. Increased risk of renal dysfunction w/ thalidomide in multiple myeloma patients. Increased incidence of osteonecrosis of the jaw w/ anti-angiogenic medicinal products.
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Accord Zoledronic Acid conc for soln for infusion 4 mg/5 mL
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