Zometa

Zometa

zoledronic acid

Manufacturer:

SciGen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients w/ advanced bone malignancies. Treatment of adult patients w/ tumour-induced hypercalcaemia.
Dosage/Direction for Use
Prevention of skeletal-related events in patient w/ advanced bone malignancies Adult & elderly Recommended dose: 4 mg IV infusion for not <15 min every 3-4 wk. Dilute the conc w/ 100 mL NaCl 0.9% or glucose soln 5%. Patient should also take oral Ca supplement 500 mg & vit D 400 IU daily. Hydrate patient prior to & following administration of Zometa. Renal impairment CrCl >60 mL/min 4 mg; 50-60 mL/min 3.5 mg; 40-49 mL/min 3.3 mg; 30-39 mL/min 3 mg. Treatment of tumour-induced hypercalcaemia Adult & elderly 4 mg single dose.
Contraindications
Hypersensitivity to zoledronic acid, or to other bisphosphonates. Lactation.
Special Precautions
Assess patients prior to administration to ensure adequate hydration. Avoid overhydration in patients at risk of cardiac failure. Monitor serum levels of Ca, phosphate & Mg after initiation of treatment. Monitor renal function carefully in patients w/ untreated hypercalcemia. Patients w/ tumor-induced hypercalcemia w/ evidence of renal function deterioration. Assess serum creatinine levels prior to each dose of Zometa. Withhold use if renal deterioration during treatment occurs. Concomitant use w/ drug that could affect renal function & drugs known to cause hypocalcemia. Osteonecrosis of the jaw or the external auditory canal. Discontinue if atypical femur fracture is suspected. Measure serum Ca & correct hypocalcemia prior to therapy. Adequately supplement w/ Ca & vit D. May affect ability to drive or operate machinery. Not recommended in patients w/ severe renal impairment. Severe hepatic impairment. Not to be used during pregnancy. Childn 1-17 yr.
Adverse Reactions
Hypophosphataemia. Anaemia; headache; conjunctivitis; nausea, vomiting, decreased appetite; bone pain, myalgia, arthralgia, generalised pain; renal impairment; fever, flu-like syndrome (including fatigue, rigors, malaise, flushing); increased blood creatinine & blood urea, hypocalcaemia.
Drug Interactions
Lower serum Ca level w/ aminoglycosides, calcitonin or loop diuretics. Possibility of hypomagnesaemia w/ potential nephrotoxic agents. Increased risk of renal dysfunction w/ thalidomide. Increased incidence of osteonecrosis of the jaw w/ anti-angiogenic agents.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Zometa concentrate for soln for infusion 4 mg/5 mL
Packing/Price
1's
Form
Zometa soln for infusion 4 mg/100 mL
Packing/Price
1's
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