Risedronic acid


Generic Medicine Info
Indications and Dosage
Oral
Corticosteroid-induced osteoporosis
Adult: Treatment and prophylaxis in patients who are receiving chronic systemic corticosteroid therapy (prednisone ≥7.5 mg daily or equivalent): As conventional tab: 5 mg once daily. Re-evaluate the need for continued therapy periodically according to individual benefits and potential risks.

Oral
Paget's disease of bone
Adult: As conventional tab: 30 mg once daily for 2 months; may be repeated if necessary after at least 2 months post-treatment observation period. For retreatment, the same dose and duration of therapy may be given.

Oral
Osteoporosis in men
Adult: As conventional tab: 35 mg once weekly. Re-evaluate the need for continued therapy periodically according to individual benefits and potential risks.

Oral
Postmenopausal osteoporosis
Adult: As conventional tab: Treatment and prophylaxis: 5 mg once daily. Alternatively, 35 mg once weekly, or 75 mg taken on 2 consecutive days per month, or 150 mg once monthly. As delayed-release tab: Treatment: 35 mg once weekly. Re-evaluate the need for continued therapy periodically according to individual benefits and potential risks.
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
Contraindications
Hypocalcaemia, abnormalities of the oesophagus which may delay emptying (e.g. stricture, achalasia); inability to stand or sit upright for at least 30 minutes. Severe renal impairment (CrCl <30 mL/minute). Pregnancy and lactation.
Special Precautions
Patient with active upper gastrointestinal disease (e.g. dysphagia, known Barrett’s oesophagus or other oesophageal diseases, gastritis, duodenitis, ulcers), risk factors for developing osteonecrosis of the jaw (e.g. cancer, anaemia, coagulopathy, ill-fitting dentures, poor oral hygiene, invasive dental procedures, history of dental or periodontal disease) or external auditory canal (e.g. infection, trauma, steroid use); other disturbances affecting bone and mineral metabolism (e.g. hypovitaminosis D, parathyroid dysfunction). Mild to moderate renal impairment.
Adverse Reactions
Significant: Atypical subtrochanteric and diaphyseal femoral fractures (prolonged use); severe bone, joint or muscle pain; upper gastrointestinal mucosa irritation (e.g. dysphagia, oesophagitis, oesophageal or gastric ulcers, oesophageal erosions or stricture), ocular effects (e.g. iritis, uveitis), hypocalcaemia, osteonecrosis of the jaw and external auditory canal.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting.
Infections and infestations: Infection.
Investigations: Decreased serum phosphate levels (transient and mild).
Musculoskeletal and connective tissue disorders: Back pain, pain in the extremity.
Nervous system disorders: Headache.
Renal and urinary disorders: Urinary tract infection.
Skin and subcutaneous tissue disorders: Rash; bullous skin reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Vascular disorders: Hypertension.
Patient Counseling Information
Ensure adequate Ca and vitamin D intake; supplements may be considered if dietary intake is insufficient.
Monitoring Parameters
Correct hypocalcaemia or other disturbances of bone and mineral metabolism, and evaluate sex steroid hormonal status prior to therapy initiation. Monitor serum Ca and 25-hydroxyvitamin D; specific biochemical markers of bone turnover. Osteoporosis: Evaluate serial bone mineral density (BMD) at baseline and every 1-3 years during treatment, then every 2-4 years during a drug holiday. In patients on combined risedronate and glucocorticoid therapy: Assess BMD at the start of glucocorticoid therapy, after 6-12 months, then every 2-3 years if patient continues to have significant osteoporosis risk. Monitor height and weight yearly; signs of chronic back pain. Perform dental examination before treatment in patients at risk of osteonecrosis of the jaw. 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.
Overdosage
Symptoms: Hypocalcaemia and hypophosphataemia. Management: May give milk or antacids to reduce absorption. Gastric lavage may be considered in cases of substantial overdose. May administer IV Ca to relieve signs and symptoms of hypocalcaemia.
Drug Interactions
Decreased absorption with antacids, mineral supplements or other medicinal products containing polyvalent cations (e.g. Ca, Al, Fe, Mg). Delayed-release tab: Agents that elevate stomach pH (e.g. histamine 2 [H2] receptor blockers, PPIs) may cause rapid drug release which may increase plasma risedronic acid concentrations.
Food Interaction
Reduced absorption with food and drinks including mineral water.
Lab Interference
May interfere with diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Description: Risedronic acid, a pyridinyl bisphosphonate analogue, binds to hydroxyapatite and inhibits bone resorption via actions on osteoclast or osteoclast precursors. It reduces the increased rate of bone turnover while osteoblast activity and bone mineralisation are preserved.
Pharmacokinetics:
Absorption: Poorly absorbed from the gastrointestinal tract. Decreased absorption when administered with food, or products containing Ca or other polyvalent cations. Bioavailability: Approx 0.54-0.75%. Time to peak plasma concentration: Approx 1 hour (conventional tab); approx 3 hours (delayed-release tab).
Distribution: Volume of distribution: Approx 6.3-13.8 L/kg. Plasma protein binding: Approx 24%.
Metabolism: Not metabolised.
Excretion: Via urine (approx half of the absorbed dose); faeces (unabsorbed drug). Terminal elimination half-life: 480-561 hours.
Chemical Structure

Chemical Structure Image
Risedronic acid

Source: National Center for Biotechnology Information. PubChem Database. Risedronic acid, CID=5245, https://pubchem.ncbi.nlm.nih.gov/compound/Risedronic-acid (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
References
Actonel 35 mg Film-Coated Tablets (Zuellig Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 16/09/2021.

Actonel Tablet, Film Coated (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/05/2021.

Anon. Risedronate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/05/2021.

Anon. Risedronate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/05/2021.

Atelvia Tablet, Delayed Release (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/05/2021.

Buckingham R (ed). Risedronate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2021.

Joint Formulary Committee. Risedronate Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/05/2021.

Risedronate Sodium 30 mg Film-Coated Tablets (Milpharm Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/09/2021.

Risedronate Sodium 5 mg Film-Coated Tablets (Milpharm Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/09/2021.

Risedronate Sodium 75 mg Film-Coated Tablets (Generics [UK] Ltd. t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 04/05/2021.

Risedronate Sodium Accord Once a Week 35 mg Film-Coated Tablets (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 16/09/2021.

Disclaimer: This information is independently developed by MIMS based on Risedronic 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 © 2021 MIMS. All rights reserved. Powered by MIMS.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