Oledron

Oledron

zoledronic acid

Manufacturer:

Gland Pharma

Distributor:

Unimed
Concise Prescribing Info
Contents
Zoledronic acid
Indications/Uses
Hypercalcemia of malignancy. Prevention of skeletal-related events (pathological fractures, spinal compression, bone radiation or surgery, or tumour-induced hypercalcaemia) in patients w/ advanced bone malignancies.
Dosage/Direction for Use
Adult & elderly Tumour-induced hypercalcaemia 4 mg single dose. Prevention of skeletal-related events in patient w/ advanced bone malignancies 4 mg every 3-4 wk.
Contraindications
Hypersensitivity to zoledronic acid or other biphosphonates. Pregnancy & lactation.
Special Precautions
Osteonecrosis of the jaw (ONJ) & external auditory canal; bone, joint &/or muscle pain; atypical subtrochanteric & diaphyseal femoral fractures. Avoid overhydration in patients at risk of cardiac failure. Correct hypocalcaemia prior to therapy. Adequate Ca & vit D supplementation during therapy. Monitor standard hypercalcaemia-related metabolic parameters eg, serum Ca, phosphate, Mg & creatinine levels during therapy. Perform dental exam w/ appropriate preventive dentistry prior to therapy. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Ensure adequate hydration prior to & following administration. Concomitant use w/ nephrotoxic drugs; medicines causing hypocalcaemia. May affect ability to drive & use machines. Not recommended in severe renal impairment. Hepatic impairment. Avoid pregnancy in women of childbearing potential. Not to be used during pregnancy. Childn 1-17 yr.
Adverse Reactions
Hypophosphataemia. Anaemia; headache; conjunctivitis; nausea, vomiting, decreased appetite, bone pain, myalgia, arthralgia, generalized pain; renal impairment; fever, flu-like syndrome; increased blood creatinine & urea, hypocalcaemia.
Drug Interactions
Additive effect w/ aminoglycosides, calcitonin, loop diuretics. Possible hypomagnesaemia w/ other potentially nephrotoxic drugs. Increased risk of renal dysfunction w/ thalidomide. Increased incidence of ONJ w/ anti-angiogenic medicines.
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
Oledron infusion conc 4 mg/5 mL
Packing/Price
1's
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