Clodronic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Osteolytic bone metastases Initial: 1,600 mg/day, increase as needed. Max: 3,200 mg/day. Hypercalcemia of malignancy Maintenance following IV therapy: 1,600-2,400 mg/day. Max: 3,200 mg/day. IV Hypercalcaemia of malignancy 300 mg/day for up to 7 days, or 1,500 mg as a single infusion.
Dosage Details
Intravenous
Hypercalcaemia of malignancy
Adult: 300 mg daily via infusion over at least 2 hr until normocalcaemia is achieved. Max duration of treatment: 7 days. Alternatively, 1,500 mg as a single infusion over at least 4 hr.

Oral
Osteolytic bone metastases
Adult: Initially, 1,600 mg daily as a single or in 2 divided doses, increased as necessary. Max: 3,200 mg daily.

Oral
Hypercalcaemia of malignancy
Adult: Maintenance following Ca normalisation w/ IV therapy: 1,600-2,400 mg as a single or in 2 divided doses. Max: 3,200 mg daily.
Renal Impairment
Oral
Daily doses >1,600 mg should not be used continuously.
CrCl (mL/min)  Dosage
 <10 Contraindicated.
 10-<30 Reduce dose by 50%.
 30-<50 Reduce dose by 25%.
Intravenous
CrCl (mL/min)  Dosage
 <10 Contraindicated.
 10-49 Reduce dose by 25-50%.
 50-80 Reduce dose by up to 25%.
Administration
Should be taken on an empty stomach. Take w/ a glass of plain water at least 1 hr before or after food. Remain in an upright position for at least 30 min. Do not take w/ milk, food or products containing Ca or other polyvalent cations. Tab may be divided only along the score-line. Swallow cap/tab whole or divided halves of tab, do not chew/crush.
Reconstitution
Dilute dose in 500 mL of NaCl 0.9% or glucose 5%.
Incompatibility
Incompatible w/ Ca-containing soln (e.g. Ringer’s soln).
Contraindications
Acute GI inflammatory conditions. Severe renal failure (CrCl <10mL/min). Pregnancy and lactation. Patients receiving other bisphosphonates.
Special Precautions
Renal impairment.
Adverse Reactions
Osteonecrosis of the jaw and external auditory canal, skin reactions (e.g. pruritus, urticaria, exfoliative dermatitis), bronchospasm, diarrhoea, nausea, vomiting, moderate leucopenia, renal dysfunction (including renal failure), hypocalcaemia; elevated serum creatinine, lactic acid dehydrogenase, parathyroid hormone, transaminase and alkaline phosphatase; transient proteinuria (IV). Rarely, atypical femoral fractures.
Patient Counseling Information
Maintain adequate fluid intake.
MonitoringParameters
Monitor hepatic and renal function, CBC; serum Ca, K, Mg, and phosphate levels.
Overdosage
Symptoms: Increased serum creatinine, renal dysfunction. Acute renal failure and liver injury may occur. Theoretically, hypocalcaemia may develop up to 2-3 days following the overdose. Management: Symptomatic treatment. Ensure adequate hydration. Oral or parenteral Ca supplementation may be needed.
Drug Interactions
Decreased effect and absorption w/ antacids or iron preparations. Increased risk of severe hypocalcaemia w/ aminoglycosides. Increases serum level of estamustine phosphate. May potentiate the hypocalcaemic effect w/ corticosteroids, phosphate, calcitonin, mithramycin and loop diuretics. Risk of renal dysfunction w/ NSAIDs.
Food Interaction
Food, beverage and dairy products may interfere w/ absorption.
Lab Interference
May interfere w/ diagnostic imaging agent such as technetium-99m-diphosphonate in bone scans.
Action
Description: Clodronic acid lowers serum Ca through inhibition of bone resorption via actions on osteoclasts or osteoclast precursors.
Onset: Ca-lowering effect: W/in 48 hr (IV).
Duration: Ca-lowering effect: 5 days to 3 wk following discontinuation.
Pharmacokinetics:
Absorption: Poorly absorbed (oral). Decreased absorption when given w/ food, esp Ca-containing products. Bioavailability: 1-4% (oral). Time to peak plasma concentration: 30 min (oral).
Distribution: Volume of distribution: Approx 20 L. Plasma protein binding: Low; strongly bound to bone.
Excretion: Via urine (60-80% as unchanged drug) and faeces (as unabsorbed drug). Terminal elimination half-life: Oral: Approx 6 hr. IV 13 hr (serum).
Chemical Structure

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Storage
Store between 15-30˚C.
ATC Classification
M05BA02 - clodronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Disclaimer: This information is independently developed by MIMS based on Clodronic 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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