Zoledronic acid


Full Generic Medicine Info
Dosage/Direction for Use

Intravenous
Hypercalcaemia of malignancy
Adult: 4 mg as a single infusion over at least 15 min. Re-treatment: 4 mg after at least 7 days if necessary. Co-admin oral Ca 500 mg and vit D 400 IU daily.
Renal impairment: Serum creatinine >400 mcmol/L or >4.5 mg/dL: Evaluate risk versus benefit.
Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Bone metastases associated with solid tumours
Adult: 4 mg by infusion over at least 15 min 3-4 wkly. Co-admin oral Ca 500 mg and vit D 400 IU daily.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Not recommended.
30-393 mg 3-4 wkly.
40-493.3 mg 3-4 wkly.
50-603.5 mg 3-4 wkly.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Osteolytic lesions associated with multiple myeloma
Adult: 4 mg by infusion over at least 15 min 3-4 wkly. Co-admin oral Ca 500 mg and vit D 400 IU daily.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<30Not recommended.
30-393 mg 3-4 wkly.
40-493.3 mg 3-4 wkly.
50-603.5 mg 3-4 wkly.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Paget's disease of bone
Adult: 5 mg as a single infusion over 15 min. Patients should receive elemental Ca 1,500 mg and vit D 800 IU daily particularly w/in 2 wk after admin. Patients who have relapsed: May be given an additional infusion of 5 mg after an interval of at least 1 yr from the initial dose.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<35Contraindicated.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Osteoporosis in postmenopausal women
Adult: 5 mg as a single infusion over at least 15 min, once yrly, w/ adequate Ca and vit D intake. Patients w/ low-trauma hip fracture: Start 2 or more wk after hip fracture repair w/ a loading dose of vit D 50,000-125,000 IU given orally or by IM route prior to 1st infusion.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<35Contraindicated.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Increase bone mass in men with osteoporosis
Adult: 5 mg as a single infusion over at least 15 min, once yrly, w/ adequate Ca and vit D intake. Patients w/ low-trauma hip fracture: Start 2 or more wk after hip fracture repair w/ a loading dose of vit D 50,000-125,000 IU given orally or by IM route prior to 1st infusion.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<35Contraindicated.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Corticosteroid-induced osteoporosis
Adult: 5 mg as a single infusion over at least 15 min, once yrly, w/ adequate Ca and vit D intake. Patients w/ low-trauma hip fracture: Start 2 or more wk after hip fracture repair w/ a loading dose of vit D 50,000-125,000 IU given orally or by IM route prior to 1st infusion.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<35Contraindicated.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).

Intravenous
Prophylaxis of postmenopausal osteoporosis
Adult: 5 mg as a single infusion once every 2 yr.
Renal impairment:
CrCl (ml/min)Dosage Recommendation
<35Contraindicated.

Reconstitution: Dilute the required amount in 100 mL of NaCl 0.9% or dextrose 5%.
Incompatibility: Ca- or other divalent cation-containing infusion soln (e.g. lactated Ringer's soln).
Contraindications
Hypocalcaemia, severe renal impairment (CrCl <35 mL/min) and those w/ evidence of acute renal impairment due to an increased risk of renal failure. Lactation.
Special Precautions
Patient w/ aspirin-sensitive asthma. Mild to moderate renal impairment. Pregnancy. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Adequately hydrate patients prior to admin. Ensure adequate Ca and vit D intake. Monitoring Parameters Monitor serum Ca, Mg, phosphate and electrolytes; haematocrit/Hb (oncology use); biochemical markers of bone turnover (non-oncology use). Prior to therapy, perform dental exam and preventive dentistry in patients at risk of osteonecrosis.
Adverse Reactions
Arthralgia, fever, flu-like symptoms, myalgia, headache, pain in extremity, nausea, vomiting, diarrhoea, eye inflammation; alopecia, hyperhidrosis, bone/joint/muscle pain, osteonecrosis of the jaw, femoral fracture, hypersensitivity reactions (e.g. urticaria, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis, hypotension.
Potentially Fatal: Severe hypocalcaemia, severe kidney problems.
Overdosage
Symptoms: Renal impairment, hypocalcaemia, hypophosphatemia, hypomagnesaemia. Management: Admin IV Ca gluconate, K or Na phosphate, and Mg sulfate, respectively.
Drug Interactions
Increased exposure of concomitant drugs eliminated by renal excretion (e.g. digoxin). Increased risk of hypocalcaemia w/ loop diuretics. Lowered serum Ca concentrations for prolonged periods w/ aminoglycosides. Increased risk of renal dysfunction w/ nephrotoxic agents.
Lab Interference
May interfere w/ diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Zoledronic acid inhibits osteoclast activity and skeletal Ca release induced by tumours. It decreases serum Ca and phosphorus, and increases their elimination. In osteoporosis, it inhibits osteoclast-mediated resorption, thus reducing bone turnover.
Distribution: Plasma protein binding: 28-56%.
Metabolism: Not metabolised.
Excretion: Via urine (approx 23-55% of the dose) as unchanged drug. Terminal elimination half-life: Approx 146 hr.
Storage
Intravenous: Store between 15-30°C. After opening, stable for 24 hr at 2-8°C. Allow refrigerated soln to reach room temp before admin.
CIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA08 - zoledronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Disclaimer: This information is independently developed by CIMS based on zoledronic acid from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in