Risedronic acid


Generic Medicine Info
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. Patient Counselling 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.
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.
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.
CIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA07 - risedronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
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