zoledronic acid Full Prescribing Information, Dosage & Side Effects | CIMS India

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zoledronic acid
> Indication & Dosage > Contraindications > Special Precautions > Adverse Drug Reactions > Drug Interactions > Pregnancy Category (US FDA) > Storage > Mechanism of Action > CIMS Class > ATC Classification

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CIMS Abbreviation Index MIMS Abbreviation Index

Indication & Dosage

Intravenous Hypercalcaemia of malignancy Adult: 4 mg as a single dose by infusion over at least 15 minutes. Retreatment in patients who relapse or who are refractory to initial treatment: 4 mg as an infusion over at least 15 minutes, after at least 1 wk from initial dose. Renal impairment: Serum creatinine >400 micromol/L: Avoid. Intravenous Bone metastases associated with solid tumours Adult: 4 mg infusion over at least 15 minutes every 3-4 wk, in conjunction with 500 mg calcium and 400 IU vitamin D oral supplement. CrCl (ml/min) Dosage Recommendation 50-60 40-49 30-39 <30 3.5 mg every 3-4 wk 3.3 mg every 3-4 wk 3 mg every 3-4 wk Not recommended.

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Intravenous Osteolytic lesions associated with multiple myeloma Adult: 4 mg infusion over at least 15 minutes every 3-4 wk, in conjunction with 500 mg calcium and 400 IU vitamin D oral supplement. CrCl (ml/min) Dosage Recommendation 50-60 40-49 30-39 <30 3.5 mg every 3-4 wk 3.3 mg every 3-4 wk 3 mg every 3-4 wk Not recommended.
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Intravenous Paget's disease of bone Adult: Single 5 mg IV infusion over 15 minutes, in conjunction with 1500 mg elemental calcium daily in divided doses and 800 IU vitamin D daily, especially in the 2 wk following zoledronic acid admin. CrCl (ml/min) Dosage Recommendation <40 Not recommended.

Intravenous Osteoporosis in postmenopausal women Adult: Single 5 mg IV infusion over at least 15 minutes, once a year. CrCl (ml/min) Dosage Recommendation <40 Not recommended.

Reconstitution: Dilute the required amount in 100 ml of 0.9% sodium chloride or 5% dextrose. Incompatibility: Incompatible with calcium containing solutions (e.g. lactated Ringer's solution) and other divalent cation containing solutions. Contraindications Special Precautions Pregnancy; lactation; children. Cardiac disease (avoid fluid overload). Renal impairment. Monitor serum electrolytes, calcium, phosphate and magnesium. Assess renal function before each dose. Withhold treatment if there is worsening of renal function (increase of 44 micromoles/l in patients with normal baseline creatinine or increase in 88 micromoles/l in those with abnormal baseline creatinine); restart treatment at precious dose when creatinine return to within 10% of baseline. Ensure adequate hydration throughout therapy and maintain urinary output of 2 L/day. Increased risk of renal impairment with small infusion volume and rapid infusion. Increased risk of bronchoconstriction in aspirin-sensitive patients. Consider dental examination with appropriate corrective action before initiating treatment in patients at risk of osteomyelitis and osteonecrosis of the jaws (e.g. infection, anaemia, pre-existing viral disease, trauma,

http://www.mims.com/India/drug/info/zoledronic%20acid/?type=full&mtype=generic

04/08/2011

zoledronic acid Full Prescribing Information, Dosage & Side Effects | CIMS India

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influenza-like symptoms; myalgia; arthralgia; fever; rigors; renal impairment; taste disturbance; dry mouth; stomatitis; chest pain; cough; CNS effects; pruritus; rash; sweating; asthenia; peripheral oedema; hypertension; bradycardia. Drug Interactions Pregnancy Category (US FDA) Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a lifethreatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Storage Mechanism of Action Intravenous: Store at 15-30 C(59-86 F). Zoledronic acid, an aminobiphosphonate, is a potent inhibitor of bone resorption. It inhibits osteoclastic activity and skeletal calcium release caused by tumours. Distribution: Protein binding: Low (22-56%) Metabolism: Not metabolised. Excretion: Excreted unchanged in urine (23-55%), the rest sequestered to bone and eliminated very slowly. Agents Affecting Bone Metabolism M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases. Increased risk of hypocalcaemia with aminoglycosides and loop diuretics. Increased risk renal dysfunction with nephrotoxic agents.

CIMS Class ATC Classification

Related zoledronic acid information: Drugs interacting with zoledronic acid Find zoledronic acid in other countries Search zoledronic acid in Google Search zoledronic acid in PubMed

Search related pubmed documents for zoledronic acid by indication/synonym: Hypercalcaemia of malignancy Paget's disease of bone Osteoporosis in postmenopausal women Bone metastases associated with solid tumours Osteolytic lesions associated with multiple myeloma

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04/08/2011

zoledronic acid Full Prescribing Information, Dosage & Side Effects | CIMS India

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04/08/2011