Etidronate disodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Paget's disease of bone Initial: 5 mg/kg/day for up to 6 mth, may give up to 10 mg/kg/day for up to 3 mth in severe cases. Max: 20 mg/kg/day. Ectopic ossification complicating hip replacement 20 mg/kg/day 1 mth before and 3 mth after the operation. For ectopic ossification due to spinal cord injury: 20 mg/kg/day for 2 wk then 10 mg/kg/day for 10 wk.
Dosage Details
Oral
Treatment and prophylaxis of ectopic ossification complicating hip replacement
Adult: 20 mg/kg daily 1 mth before and 3 mth after the operation. For ectopic ossification due to spinal cord injury: 20 mg/kg daily for 2 wk followed by 10 mg/kg daily for 10 wk.

Oral
Paget's disease of bone
Adult: Initially, 5 mg/kg daily for up to 6 mth. In severe cases, may give up to 10 mg/kg daily for up to 3 mth. Further treatment should only be given after a drug-free interval of at least 3 mth and after evidence of relapse. Subsequent treatment period should not exceed initial treatment period. Max: 20 mg/kg/day.
Contraindications
Overt osteomalacia; abnormalities of the oesophagus (e.g. stricture, achalasia) which may delay oesophagaeal emptying.
Special Precautions
Patient w/ enterocolitis. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Paraesthesia, peripheral neuropathy, confusion, amnesia, depression, hallucination; bone/joint/muscle pain, bone fracture, GI irritation, osteonecrosis of the jaw. Rarely, burning sensation of tongue, alopecia, erythema multiforme, exacerbation of asthma, agranulocytosis or pancytopenia.
Patient Counseling Information
Maintain adequate intake of Ca and vit D, good oral hygiene.
MonitoringParameters
Monitor alkaline phosphatase and serum Ca levels. Perform routine dental check up.
Overdosage
Symptoms: Hypocalcaemia, vomiting, paraesthesias of the fingers, diarrhoea, electrolyte imbalance. Management: Employ gastric lavage for acute overdosage. Parenteral admin of Ca salt (e.g. IV Ca gluconate) may be given to relieve signs and symptoms of hypocalcaemia.
Drug Interactions
May increase prothrombin time w/ warfarin. May enhance the adverse effects of deferasirox. Decreased serum concentration w/ antacids, multivitamins/minerals. Increased hypocalcaemic effect w/ aminoglycosides. Increased adverse/toxic effect w/ NSAIDs, systemic angiogenesis inhibitors. Diminished therapeutic effect w/ PPIs.
Food Interaction
Food may reduce absorption.
Lab Interference
May interfere w/ diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Description: Etidronate disodium decreases bone resorption by inhibiting the growth and dissolution of hydroxyapatite crystals in bone and may also directly impair osteoclast activity.
Onset: 1-3 mth.
Duration: Approx 12 mth w/o continuous therapy.
Pharmacokinetics:
Absorption: Variable and dose dependent (approx 1-6%). Reduced absorption w/ food.
Distribution: Almost exclusively distributed into bone (approx 50% of absorbed amount).
Metabolism: Not metabolised.
Excretion: Via urine, approx 50%. Elimination half-life: 1-6 hr.
Chemical Structure

Chemical Structure Image
Etidronate disodium

Source: National Center for Biotechnology Information. PubChem Database. Etidronate disodium, CID=23894, https://pubchem.ncbi.nlm.nih.gov/compound/Etidronate-disodium (accessed on Jan. 23, 2020)

Storage
Store below 40°C.
ATC Classification
M05BA01 - etidronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
References
Anon. Etidronate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 27/08/2015.

Buckingham R (ed). Etidronate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 27/08/2015.

Etidronate Disodium Tablet (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 27/08/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Etidronate Disodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 27/08/2015.

Disclaimer: This information is independently developed by MIMS based on Etidronate disodium 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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