risedronate sodium


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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.

References in periodicals archive ?
Material and Methods: Eighty-five postmenopausal women with primer osteoporosis who had uninterrupted risedronate sodium (A) (35 mg/week), strontium ranelate (P) (2 g/day) and calcium (1000 mg/day)--vitamin D (880 IU/day) supplementation for 3 years were included in our retrospective study.
Key words: Osteoporosis, treatment, bone mineral density, risedronate sodium, strontium ranelate
Risedronate sodium hydrate is a bisphosphonate antiosteoporotic agent, which was originally synthesized by Norwich Eaton Pharmaceuticals, Inc.
The once-weekly formulation of risedronate sodium hydrate was approved in 2002 in the United States and now are being approved in more than 80 countries around the world.
Teva's AB-rated Risedronate Sodium Tablets are indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget's disease.
Food and Drug Administration has granted tentative approval for the Company's ANDA for Risedronate Sodium Tablets, 5 mg, 30 mg and 35 mg.
Teva's Risedronate Sodium Tablets are the AB-rated generic equivalent of Procter and Gamble's Actonel(R) Tablets, a product indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget's disease.
Food and Drug Administration (FDA) seeking approval to market Risedronate Sodium Delayed-release Tablets, 35 mg.