risedronate sodium

risedronate sodium

Pharmacologic class: Bisphosphonate

Therapeutic class: Calcium regulator

Pregnancy risk category C

Action

Inhibits osteoclast-mediated bone resorption. Also exerts antiresorptive effect, probably by directly inhibiting mature osteoclast activity or indirectly inhibiting osteoblasts.

Availability

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.

Off-label uses

• Hypercalcemia of malignancy
• Primary hyperparathyroidism

Contraindications

• Hypersensitivity to drug, its components, or other bisphosphonates
• Hypocalcemia
• Inability to stand or sit upright for at least 30 minutes
• Esophageal abnormalities that delay esophageal emptying, such as stricture or achalasia

Precautions

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)

Administration

• 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.

Adverse reactions

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

Hematologic: anemia

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)

Interactions

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

Patient monitoring

• 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

Patient teaching

• 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.