risedronate sodium

risedronate sodium

Actonel

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, 75 mg

⊘Indications and dosages

➣ Osteoporosis

Adults: 5 mg P.O. daily. Alternatively, for men and postmenopausal women, 35 mg P.O. weekly.

➣ Prevention and treatment of postmenopausal osteoporosis

Adults: 1 (75-mg) tablet P.O. daily on 2 consecutive days for total of 2 tablets monthly

➣ Paget's disease

Adults: 30 mg 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 or other bisphosphonates
• Hypocalcemia
• Inability to stand or sit upright for at least 30 minutes

Precautions

Use cautiously in:
• renal disease, hypotension, upper GI disorders, difficulty swallowing
• pregnant or breastfeeding patients.

Administration

• Give with 6 to 8 oz of water 30 minutes before first food or beverage of day (other than 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.

Route	Onset	Peak	Duration
P.O.	Rapid	1 hr	Unknown

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

GU: urinary tract infection

Hematologic: anemia

Musculoskeletal: bone, back, or joint pain; bone fracture; bursitis; myalgia; arthritis; leg and muscle cramps

Respiratory: crackles, cough, bronchitis, pneumonia

Skin: rash, pruritus, ecchymosis, skin cancer

Other: accidental injury, infection, neck pain, flulike symptoms, allergic reactions, neoplasm

Interactions

Drug-drug. Antacids, aspirin, calcium or magnesium supplements: 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.
• Assess skin for unusual findings that may indicate skin cancer.

Patient teaching

• Advise patient to read patient information insert before starting therapy.
☞ Stress importance of taking with a full glass (6 to 8 oz) of water at least 30 minutes before first food or drink of day and staying upright for at least 30 minutes afterward.
☞ Instruct patient to stop taking drug and notify prescriber if she experiences difficulty or pain on swallowing, midline chest pain, or severe, persistent heartburn.
• Tell patient that chewing or sucking tablet may cause mouth irritation.
• Tell patient to report signs and symptoms of colitis.
• If patient must take calcium, magnesium, or aluminum supplements or antacids, tell her to take them at least 2 hours after risedronate.
• Inform patient that drug may cause leg cramps and bone or joint pain. Advise her to discuss these problems with prescriber.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.