Generic
Risedronate Sodium (Risedronic acid)
9 brands available in the market
At a glance
Risedronate Sodium is a bisphosphonate used for the treatment and prevention of osteoporosis in postmenopausal women, to increase bone mass in men with osteoporosis, and for the treatment of Paget's disease of bone.
Description
Risedronate inhibits bone resorption by inhibiting osteoclasts. It prevents formation and dissolution of hydroxyapatite crystals and may interfere with bone mineralization. At the cellular level, it inhibits osteoclasts, which adhere normally to the bone surface but show evidence of reduced active resorption.
Indications
- Treatment and prevention of osteoporosis in postmenopausal women
- Increase bone mass in men with osteoporosis
- Prevention and treatment of corticosteroid-induced osteoporosis
- Paget's disease of bone
Therapeutic class
Bisphosphonate preparations
Pharmacological class
Bisphosphonate (Anti-resorptive)
Pharmacology
Risedronate has affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, it inhibits osteoclasts. Osteoclasts adhere normally to the bone surface but show evidence of reduced active resorption.
Mechanism of action
Prevents bone resorption by inhibiting osteoclasts.
Dosage
Adult Dose (Oral):
- Postmenopausal osteoporosis (treatment): 5 mg daily OR 35 mg once weekly OR 150 mg once monthly
- Men with osteoporosis: 35 mg once weekly
- Corticosteroid-induced osteoporosis: 5 mg daily
- Paget's disease: 30 mg daily for 2 months; may repeat after 2-month interval if needed
Administration
- Take at least 30 minutes before first food or drink of the day with 6-8 oz (180-240 mL) plain water
- Use plain water only (not coffee or juice)
- Stand or sit upright; do not lie down for 30 minutes after taking
- Do not chew, cut, or crush the tablet
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Side Effects:
- Arthralgia
- Back pain
- GI disturbances (abdominal pain, dyspepsia)
- Hypersensitivity reactions (angioedema, rash)
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Alopecia
- Iritis, uveitis
- Osteonecrosis of the jaw
- Atypical femur fractures
Precautions & warnings
- Correct hypocalcemia before therapy
- Ensure adequate calcium and vitamin D intake
- Caution in esophageal abnormalities (stricture, achalasia)
- Avoid in severe renal impairment (CrCl <30 mL/min)
- Do not use in pregnancy and lactation
Contraindications
- Hypocalcemia
- Esophageal abnormalities that may delay emptying (stricture, achalasia)
- Inability to stand or sit upright for at least 30 minutes
- Severe renal impairment (CrCl <30 mL/min)
- Pregnancy and lactation
Drug interactions
- Calcium, antacids, or oral medications containing divalent cations: May affect risedronate absorption; maintain at least 30 minutes interval
- Aminoglycosides: Additive calcium lowering effects
Food interactions
Risedronate interacts with food, calcium, and antacids; take at least 30 minutes before meals; it is not known whether it is safe to consume alcohol.
Use in pregnancy
Use in Pregnancy: Do not use during pregnancy (intended only for postmenopausal women); if accidentally taken, stop immediately and consult your doctor.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Do not use during breastfeeding; if accidentally taken, stop immediately and consult your doctor.
Pediatric use
Safety and efficacy not established in children and adolescents.
Geriatric use
Bioavailability, distribution, and elimination were similar in elderly (≥60 years) compared to younger subjects; no dose adjustment necessary.
Renal / hepatic impairment
Renal Impairment: No dose adjustment needed in mild-moderate renal impairment; contraindicated in severe renal impairment (CrCl <30 mL/min); consult your doctor.
Hepatic Impairment: Caution in liver disease; dose adjustment may be needed; consult your doctor.
Overdose effects
Overdose: Decreases in serum calcium; signs and symptoms of hypocalcemia; treatment: milk or antacids containing magnesium, calcium, or aluminum; in substantial overdose, gastric lavage may be considered.
Storage conditions
Store in a cool and dry place, protected from light and moisture; keep out of reach of children.
Chemical structure
Risedronate Sodium