Alendronic acid


Generic Medicine Info
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.
Contraindications
Hypocalcaemia, abnormalities of the oesophagus which delay oesophageal emptying (e.g. stricture, achalasia); increased risk of aspiration (effervescent tab, oral solution). Patient who is unable to stand or sit upright for at least 30 minutes.
Special Precautions
Patient with active upper gastrointestinal problems (e.g. dysphagia, other oesophageal disease, ulcers, duodenitis, gastritis, recent history of major gastrointestinal disease, known Barrett's oesophagus), risk factors for developing osteonecrosis of the jaw (e.g. cancer, history of dental disease, periodontal disease) or external auditory canal (e.g. infection, trauma); other disorders affecting mineral metabolism (e.g. hypoparathyroidism, vitamin D deficiency). Renal impairment CrCl <35 mL/min. Pregnancy and lactation. Patient Counselling Ensure adequate intake of Ca and vitamin D; take supplements if dietary intake is insufficient. Monitoring Parameters Assess serum Ca (prior to and during treatment) and 25-hydroxyvitamin D for all indications; correct hypocalcaemia before initiation of therapy. Osteoporosis: Evaluate serial BMD at baseline and every 1-3 years during treatment then every 2-4 years during a drug holiday. In patients on combined alendronate and glucocorticoid therapy: Assess BMD at the beginning of glucocorticoid therapy then after 6-12 months; then every 2-3 years if patient continues to have significant osteoporosis risk. Monitor height and weight (annually), biochemical markers of bone turnover (e.g. fasting serum C-terminal cross-linked telopeptide [CTX] or urinary N-terminal telopeptide [NTX]) at baseline, 3 months, and 6 months; signs of chronic back pain. Monitor possible malabsorption. Perform routine dental check-ups. Paget's disease: Monitor serum total alkaline phosphatase at 6-12 weeks and potentially at 6 months; then at approx 6-12-month intervals following treatment completion; symptoms of pain. Monitor specific biochemical markers of bone turnover (e.g. NTX, serum β-CTX, serum procollagen type 1 N-terminal propeptide [P1NP]) in patients with abnormal liver or biliary tract function or when early assessment of treatment is needed.
Adverse Reactions
Significant: Local irritation of the upper gastrointestinal mucosa, oesophageal reactions (e.g. oesophageal ulcers, oesophagitis, oesophageal erosions); decreased serum Ca and phosphate; severe bone, joint and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures (prolonged use), osteonecrosis of the jaw and external auditory canal. Rarely, gastric and duodenal ulcers, Stevens-Johnson syndrome, toxic epidermal necrolysis. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Abdominal pain, abdominal distension, acid regurgitation, constipation, diarrhoea, dyspepsia, flatulence. General disorders and administration site conditions: Asthenia, peripheral oedema. Musculoskeletal and connective tissue disorders: Joint swelling. Nervous system disorders: Dizziness, headache. Skin and subcutaneous tissue disorders: Alopecia, pruritus.
Drug Interactions
Antacids, Ca supplements or other oral medications containing multivalent cations may interfere with the absorption of alendronic acid. Increased risk of gastrointestinal irritation with aspirin or NSAIDs. Decreased bioavailability with levothyroxine.
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Disclaimer: This information is independently developed by CIMS 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 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 © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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