Risedronate

Risedronate
Brands

DEA Class;  Rx

Common Brand Names; Actonel, Atelvia, Actonel with Calcium

  • Calcium Metabolism Modifiers; 
  • Bisphosphonate Derivatives

Potent oral second-generation pyridinyl bisphosphonate; monthly, weekly, or daily regimens available for selected conditions
Used primarily for treatment and prevention of osteoporosis in both men and postmenopausal women; also used to treat and prevent corticosteroid-induced osteoporosis
Also used for the management of Paget’s disease

Indicated For

  • Postmenopausal Osteoporosis
  • Glucocorticoid-Induced Osteoporosis
  • Paget Disease
  • Osteoporosis in Men
  • Osteogenesis Imperfecta (Orphan)

Hypersensitivity; angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported

Hypocalcemia

Hypercalcemia from any cause including, but not limited to, hyperparathyroidism, hypercalcemia of malignancy, or sarcoidosis

Inability to stand or sit upright for at least 30 minutes

Esophagus abnormalities (eg, stricture, achalasia) that delay esophageal emptying

  • Arthralgia (7-33%)
  • Diarrhea (5-20%)
  • Headache (3-18%)
  • Nausea (4-13%)
  • Constipation (3-13%)
  • Rash (8-12%)
  • Abdominal pain (2-12%)
  • Hypertension (11%)
  • Dyspepsia (4-11%)
  • Flulike syndrome (10%)
  • Depression (7%)
  • Chest pain (5-7%)
  • Dizziness (3-7%)
  • Pharyngitis (6%)
  • Rhinitis (6%)
  • Prostatic hyperplasia (5%)
  • Hypocalcemia (<5%)
  • Dyspnea (4%)
  • Gastritis (3%)
  • Nephrolithiasis (3%)
  • Hypophosphatemia (<3%)
  • Arrhythmia (2%)

Ensure adequate intake of calcium and vitamin D; correct hypocalcemia, if present, before initiating therapy

Avoid concomitant polyvalent cation-containing medications

May cause upper GI disorders (eg, dysphagia, esophagitis, esophageal or gastric ulcer); instruct patients to follow dosing instructions; discontinue use if new or worsening symptoms occur

Severe irritation of upper GI mucosa; discontinue if new or worsening symptoms occur in patients with active upper GI disease

Available data on use in pregnant women are insufficient to inform a drug- associated risk of adverse maternal or fetal outcomes; discontinue therapy when pregnancy recognized

Adults

5 mg/day PO, 35 mg/week PO, or 150 mg/month PO for osteoporosis. For Paget’s disease 30 mg/day PO for 2 months.

Geriatric

5 mg/day PO, 35 mg/week PO, or 150 mg/month PO for osteoporosis. For Paget’s disease 30 mg/day PO for 2 months.

Adolescents

Weighing 40 kg or more: Safety and efficacy have not been established; however, 5 mg/day PO or 30 mg/week PO has been used off-label for osteogenesis imperfecta.
Weighing 31 to 39 kg: Safety and efficacy have not been established; however, 5 mg/day PO or 15 mg/week PO has been used off-label for osteogenesis imperfecta.
Weighing 10 to 30 kg: Safety and efficacy have not been established; however, 2.5 mg/day PO or 15 mg/week PO has been used off-label for osteogenesis imperfecta.

Children

4 to 12 years weighing 40 kg or more: Safety and efficacy have not been established; however, 5 mg/day PO or 30 mg/week PO has been used off-label for osteogenesis imperfecta.
4 to 12 years weighing 31 to 39 kg: Safety and efficacy have not been established; however, 5 mg/day PO or 15 mg/week PO has been used off-label for osteogenesis imperfecta.
4 to 12 years weighing 10 to 30 kg: Safety and efficacy have not been established; however, 2.5 mg/day PO or 15 mg/week PO has been used off-label for osteogenesis imperfecta.
1 to 3 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

risedronate sodium

tablet

  • 5mg

  • 30mg

  • 35mg

  • 150mg

tablet, delayed release

  • 35mg

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