Xolnic Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Zoledronic acid

Indications/Uses

Hypercalcaemia of malignancy. Multiple myeloma & bone metastases from solid tumors in conjunction w/ standard antineoplastic therapy.

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Dosage/Direction for Use

Hypercalcaemia of malignancy 4 mg as single dose IV infusion over 15 min. Retreatment w/ 4 mg may be considered if necessary after min of 7 days has elapsed. Multiple myeloma & metastatic bone lesion of solid tumor Patient w/ CrCl >60 mL/min 4 mg infused over not <15 min every 3-4 wk, 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

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Contraindications

Hypersensitivity to zoledronic acid or other bisphosphonates.

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Warnings

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Special Precautions

Patient w/ aspirin-sensitive asthma. Monitor serum levels of Ca, phosphate & Mg after initiating inj; serum creatinine after initiating inj & prior to each dose; hematocrit/Hb. Adequately rehydrate patients w/ hypercalcemia of malignancy prior to administration. Concomitant use w/ loop diuretics & other nephrotoxic drugs. Not recommended in severe renal impairment. Hepatic impairment. Not to be used during pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Flu-like syndrome (fever, chills, bone pain &/or arthralgias & myalgias); nausea, vomiting; conjunctivitis & hypomagnesaemia. Asthenia, chest pain, leg edema, mucositis, metastases; dysphagia; granulocytopenia, thrombocytopenia, pancytopenia; non-specific infection; hypocalcemia; dehydration; arthralgias; headache, somnolence; pleural effusion.

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Drug Interactions

May have additive effect to lower serum Ca levels for prolonged periods w/ aminoglycosides. May increase risk for renal impairment w/ potentially nephrotoxic drugs. May increase risk of renal dysfunction w/ thalidomide in multiple myeloma patients.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Agents Affecting Bone Metabolism

ATC Classification

M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.

Regulatory Classification

POM

Presentation/Packing

Form

Xolnic lyo powd for inj 4 mg

Packing/Price

1's

Xolnic

zoledronic acid

Manufacturer:

Khandelwal Lab

Distributor:

Ni Lay Naing