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Zometa

Zometa

zoledronic acid

Manufacturer:

Novartis Pharma

Distributor:

X3 Lifescience
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Prevention of skeletal-related events (pathological fractures, spinal compression, bone radiation or surgery, or tumour-induced hypercalcaemia) in patients w/ advanced bone malignancies. Hypercalcaemia of malignancy (HCM).
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Dosage/Direction for Use
Adult & elderly Prevention of skeletal-related events in patient w/ advanced bone malignancies 4 mg as single IV infusion in no <15 min every 3-4 wk w/ PO Ca supplement 500 mg & vit D 400 IU daily. HCM 4 mg as single IV infusion in no <15 min. 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.
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Overdosage
View Zometa overdosage for action to be taken in the event of an overdose.
Contraindications
Hypersensitivity to zoledronic acid or other bisphosphonates. Pregnancy & lactation.
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Special Precautions
Osteonecrosis of the jaw (ONJ), external auditory canal & other anatomical sites eg, hip & femur; atypical subtrochanteric & diaphyseal femoral fractures; bone, joint &/or muscle pain. Avoid overhydration in patients at risk of cardiac failure. Correct hypocalcaemia prior to therapy; ensure adequate Ca & vit D supplementation during therapy. Monitor serum Ca, phosphate, Mg & creatinine levels during therapy; renal function in untreated hypercalcemia patients. Ensure adequate hydration prior to administration. Avoid invasive dental procedures during treatment. Maintain good oral hygiene & perform dental exam w/ preventive dentistry prior to treatment. Not to be given concomitantly w/ other bisphosphonates. Concomitant use w/ chemotherapy, corticosteroids, other hypocalcaemia-causing drugs. Not recommended in severe renal impairment. Hepatic impairment. Avoid pregnancy in women of childbearing potential. Not to be used during pregnancy & lactation.
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Adverse Reactions
Hypophosphataemia. Anaemia; headache, paraesthesia; sleep disorder; conjunctivitis; nausea, vomiting, decreased appetite, constipation; hyperhidrosis; bone pain, myalgia, arthralgia, generalized body pain, joint stiffness; HTN; renal impairment; acute phase reaction, pyrexia, flu-like illness, peripheral oedema, asthenia; increased blood creatinine & urea, hypocalcaemia.
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Drug Interactions
Additive effect w/ aminoglycosides, calcitonin, loop diuretics. Increased incidence of ONJ w/ anti-angiogenic drugs. Other potentially nephrotoxic drugs, thalidomide. Not to be mixed w/ Ca, other infusion soln or other divalent cation-containing infusion soln eg, lactated Ringer's soln.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Zometa detailed prescribing information
Storage
View Zometa storage conditions for details to ensure optimal shelf-life.
Description
View Zometa description for details of the chemical structure and excipients (inactive components).
Action
View Zometa mechanism of action for pharmacodynamics and pharmacokinetics details.
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 infusion conc 4 mg/5 mL
Packing/Price
10 × 1's;1's;4 × 1's
Form
Zometa soln for infusion 4 mg/100 mL
Packing/Price
1's
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