Alendronic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Postmenopausal osteoporosis; Increase bone mass in men w/ osteoporosis 10 mg/day or 70 mg once wkly. Prophylaxis of postmenopausal osteoporosis 5 mg/day or 35 mg once wkly. Paget's disease of bone 40 mg/day for 6 mth. Corticosteroid-induced osteoporosis 5 mg/day, or 10 mg/day in postmenopausal women not receiving oestrogen.
Dosage Details
Oral
Paget's disease of bone
Adult: 40 mg once daily for 6 mth; may be repeated if necessary after 6-mth post-treatment evaluation period.

Oral
Prophylaxis of postmenopausal osteoporosis
Adult: 5 mg once daily or 35 mg once wkly.

Oral
Corticosteroid-induced osteoporosis
Adult: 5 mg once daily, or 10 mg once daily in postmenopausal women not receiving oestrogen.

Oral
Increase bone mass in men with osteoporosis, Postmenopausal osteoporosis
Adult: 10 mg once daily or 70 mg once wkly.
Renal Impairment
CrCl (mL/min)
Dosage
<35 Not recommended.
Administration
Should be taken on an empty stomach. Take w/ a full glass of plain water at least 30 min before the 1st food/drink/medication of the day & remain in sitting/upright position for at least 30 min. Swallow whole, do not chew/crush.
Reconstitution
Effervescent tab: Dissolve in 120 mL of room temp plain water; wait for at least 5 min after effervescence stops, then stir for 10 seconds and administer.
Contraindications
Oesophageal abnormalities which may delay oesophageal emptying (e.g. stricture, achalasia); inability to stand or sit upright for at least 30 min; hypocalcaemia; risk of aspiration (oral soln/effervescent tab); difficulty swallowing liquids (oral soln).
Special Precautions
Patient w/ active upper GI abnormalities; history of major GI disease (e.g. peptic ulcer, GI bleeding), or surgery of the upper GI tract other than pyloroplasty. Renal impairment. Pregnancy and lactation.
Adverse Reactions
GI symptoms (e.g. abdominal pain, dyspepsia, diarrhoea, constipation), severe oesophageal reactions (e.g. oesophagitis, erosions, ulceration, stricture), peptic ulceration, osteonecrosis of the jaw, bone/joint/muscle pain, femoral fracture, hypocalcaemia, nausea. Rarely, Stevens Johnson syndrome, toxic epidermal necrolysis.
Patient Counseling Information
Maintain good oral hygiene.
MonitoringParameters
Monitor alkaline phosphatase, serum Ca and 25(OH)D levels. Re-evaluate bone density every 2 yr; height/wt measurement (annual). Perform routine dental check-ups.
Overdosage
Symptoms: Hypocalcaemia, hypophosphataemia, upper GI adverse events (e.g. upset stomach, heartburn, oesophagitis, gastritis, ulcer). Management: May give milk or antacids to bind alendronate. Patient should remain in upright position.
Drug Interactions
Reduced absorption w/ antacids, Ca supplements or oral medications containing multivalent cations. Increased risk of GI irritation w/ aspirin, NSAIDs.
Food Interaction
Food and beverages reduce absorption.
Lab Interference
May interfere w/ diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Description: Alendronic acid inhibits bone resorption by binding to bone hydroxyapatite and specifically inhibiting the activity of osteoclasts, the bone-resorbing cells.
Pharmacokinetics:
Absorption: Poorly absorbed from the GI tract. Reduced absorption w/ food and beverages. Bioavailability: Approx 0.4%.
Distribution: Plasma protein binding: Approx 78%.
Metabolism: Not metabolised.
Excretion: Via urine (approx 50% of absorbed amount).
Chemical Structure

Chemical Structure Image
Alendronic acid

Source: National Center for Biotechnology Information. PubChem Database. Alendronic acid, CID=2088, https://pubchem.ncbi.nlm.nih.gov/compound/Alendronic-acid (accessed on Jan. 20, 2020)

Storage
Store between 20-25°C. Protect from moisture.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
References
Anon. Alendronate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 28/08/2015.

Binosto Effervescent Tablet (Mission Pharmacal Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/08/2015.

Buckingham R (ed). Alendronate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 28/08/2015.

Fosamax Tablet (Merck Sharp & Dohme Corp.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 28/08/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Alendronate Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 28/08/2015.

Disclaimer: This information is independently developed by MIMS based on Alendronic 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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