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Pharmacologic class: Bisphosphonate
Therapeutic class: Calcium regulator
Pregnancy risk category C
Inhibits osteoclast-mediated bone resorption. Also exerts antiresorptive effect, probably by directly inhibiting mature osteoclast activity or indirectly inhibiting osteoblasts.
Tablets: 5 mg, 30 mg, 35 mg, 150 mg
Tablets (delayed-release): 35 mg
⊘Indications and dosages
➣ Prevention of postmenopausal osteoporosis
Adults: 5 mg P.O. daily or 35 mg P.O. weekly (immediate-release)
➣ Treatment of postmenopausal osteoporosis
Adults: 5 mg P.O. daily, or 35 mg P.O. weekly, or 150 mg P.O. monthly (immediate-release). Or, 35 mg P.O. weekly (delayed-release).
➣ Osteoporosis in men
Adults: 35 mg (immediate-release) P.O. weekly
➣ Glucocorticoid-induced osteoporosis
Adults: 5 mg (immediate-release) P.O. daily
➣ Paget's disease
Adults: 30 mg (immediate-release) P.O. daily for 2 months. If indicated, may retreat with same dosage after post-treatment observation period of at least 2 months.
• Hypercalcemia of malignancy
• Primary hyperparathyroidism
• Hypersensitivity to drug, its components, or other bisphosphonates
• Inability to stand or sit upright for at least 30 minutes
• Esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia
Use cautiously in:
• hypotension, upper GI disorders, difficulty swallowing
• severe renal impairment with creatinine clearance less than 30 ml/minute (not recommended)
• pregnant or breastfeeding patients
• children (use not indicated)
• Be aware that hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting drug.
• Give immediate-release tablets with 6 to 8 oz of water 30 minutes before first food or beverage of day (other than water).
• Give delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water.
☞ Make sure patient stays upright for at least 30 minutes after taking.
• Be aware that patient with poor dietary intake may need calcium and vitamin D supplements.
• Give calcium, magnesium, or aluminum supplements or antacids at different time of day so they don't interfere with risedronate absorption.
CNS: headache, anxiety, depression, dizziness, vertigo, syncope, asthenia
CV: hypertension, vasodilation, angina, chest pain, cardiovascular disorder, peripheral edema
EENT: cataract, conjunctivitis, dry eyes, otitis media, rhinitis, sinusitis, pharyngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, gastroenteritis, colitis, esophageal irritation, dry mouth, anorexia, esophageal stricture or perforation (rare)
GU: urinary tract infection
Musculoskeletal: bone, back, or joint pain; bone fracture; bursitis; myalgia; arthritis; leg and muscle cramps; jaw osteonecrosis
Respiratory: crackles, cough, bronchitis, pneumonia
Skin: rash, pruritus, ecchymosis, skin cancer
Other: accidental injury, infection, neck pain, flulike symptoms, allergic reactions, neoplasm, hypersensitivity reactions including angioedema (rare)
Drug-drug.Antacids, aspirin, calcium-or magnesium-based supplements or laxatives, iron preparations: decreased risedronate absorption
Nonsteroidal anti-inflammatory drugs, salicylates: increased GI irritation
Drug-diagnostic tests.Bone-imaging diagnostic agents: interference with test agents
Calcium, phosphorus: decreased levels
Drug-food.Any food: decreased drug absorption
• Watch for difficulty swallowing and signs and symptoms of esophageal irritation. Discontinue drug if new or worsening symptoms occur.
• Assess skin for unusual findings that may indicate skin cancer.
• Monitor patient for severe bone, joint, or muscle pain; consider discontinuing drug if symptoms are severe
• Advise patient to read patient information insert before starting therapy.
☞ Stress importance of taking immediate-release tablets with a full glass (6 to 8 oz) of water at least 30 minutes before first food or drink of day and delayed-release tablets in the morning immediately after breakfast with at least 4 oz of plain water. Tell patient to stay upright for at least 30 minutes afterward.
☞ Instruct patient to stop drug and notify prescriber if difficulty or pain on swallowing, midline chest pain, or severe, persistent heartburn occurs.
• Tell patient that chewing or sucking tablet may cause mouth irritation.
• Tell patient to report signs and symptoms of colitis.
• Advise patient taking calcium-, magnesium-, or aluminum-based supplements or antacids to take them at least 2 hours after risedronate.
• Advise patient to promptly report leg cramps or bone, joint, or jaw pain.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.