Risedronic acid


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Paget's disease of bone 30 mg once daily for 2 mth, repeat if necessary after 2 mth interval. Treatment and prophylaxis of postmenopausal or corticosteroid-induced osteoporosis 5 mg/day. Increase bone mass in men w/ osteoporosis 35 mg once wkly.
Dosage Details
Oral
Treatment and prophylaxis of postmenopausal or corticosteroid-induced osteoporosis
Adult: 5 mg daily. Alternatively, for postmenopausal osteoporosis, 35 mg once wkly, or 75 mg on 2 consecutive days of each mth, or 150 mg once mthly.

Oral
Paget's disease of bone
Adult: 30 mg once daily for 2 mth, may repeat if necessary after 2 mth interval.

Oral
Increase bone mass in men with osteoporosis
Adult: 35 mg once wkly.
Renal Impairment
CrCl (mL/min) Dosage
<30 Contraindicated.
Contraindications
Hypocalcaemia, abnormalities of the oesophagus which may delay emptying (e.g. stricture or achalasia), inability to stand or sit upright for at least 30 min. Severe renal impairment (CrCl <30 mL/min). Lactation.
Special Precautions
Correct hypocalcaemia and evaluate sex steroid hormonal status prior to therapy. Mild to moderate renal impairment. Pregnancy.
Adverse Reactions
Arthralgia, back pain, GI disturbances (e.g. abdominal pain, dyspepsia), hypersensitivity reactions (e.g. angioedema, rash, bullous skin reactions), Stevens-Johnson syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis, alopecia, hepatic disorders, eye disorders (e.g. iritis, uveitis), osteonecrosis of the jaw, atypical femur fractures; bone, joint or muscle pain.
Patient Counseling Information
Ensure adequate Ca and vit D intake.
MonitoringParameters
Monitor serum Ca; biochemical markers of bone turnover; bone mineral density (osteoporosis); alkaline phosphatase (Paget's disease).
Overdosage
Symptoms: Hypocalcaemia, hypophosphatemia. Management: Admin milk or antacids to reduce absorption. Gastric lavage may be considered in cases of substantial overdose. May give IV Ca to relieve signs and symptoms of hypocalcaemia.
Drug Interactions
Decreased absorption w/ antacids or mineral supplements containing divalent cations (e.g. Al, Ca, Mg).
Food Interaction
Food reduces absorption.
Lab Interference
May interfere w/ diagnostic imaging agents (e.g. technetium-99m-diphosphonate) in bone scans.
Action
Description: Risedronic acid inhibits bone resorption via actions on osteoclast or on osteoclast precursors. It reduces bone turnover while the osteoblast activity and bone mineralisation is preserved.
Pharmacokinetics:
Absorption: Poorly absorbed from the GI tract. Decreased bioavailability when administered w/ food. Bioavailability: 0.63%. Time to peak plasma concentration: Approx 1 hr.
Distribution: Volume of distribution: 6.3 L/kg. Plasma protein binding: Approx 24%.
Metabolism: Not metabolised.
Excretion: Via urine (about half of absorbed amount); faeces (unabsorbed drug). Terminal half-life: 480 hr.
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.
ATC Classification
M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
References
Anon. Risedronate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/09/2015.

Buckingham R (ed). Risedronate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/09/2015.

McEvoy GK, Snow EK, Miller J et al (eds). Risedronate Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 04/09/2015.

Risedronate Sodium Hemi-Pentahydrate and Risedronate Sodium Monohydrate Tablet, Film-Coated (Actavis Pharma, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 04/09/2015.

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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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