RISEDRONATE SODIUM

RISEDRONATE SODIUM
(ri-se-dron'ate)
Actonel
Classifications: bisphosphonate; regulator, bone metabolism;
Therapeutic: bone resorption inhibitor
; osteoporosis treatment
Prototype: Etidronate disodium
Pregnancy Category: C

Availability

5 mg, 30 mg, 35 mg, 75 mg tablets

Action

Diphosphate preparation with primary action on bone. Mechanism of action not fully understood. Lowers serum alkaline phosphatase, presumably by decreasing release of phosphate from bone and increasing excretion of parathyroid hormone. Slows rate of bone resorption and new bone formation in pagetic bone lesions and in normal remodeling process.

Therapeutic Effect

Effectiveness indicated by decreased bone and joint pain and improved bone density.

Uses

Paget's disease, prevention and treatment of postmenopausal osteoporosis and steroid-induced osteoporosis.

Contraindications

Hypersensitivity to risedronate or other bisphosphonates; hypocalcemia, vitamin D deficiency; severe renal impairment (CLcr <30 mL/min); pregnancy (category C); lactation.

Cautious Use

Renal impairment; CHF; hyperphosphatemia; hepatic disease; fever related to infection or other causes. Safety and efficacy in children <18 y are not established.

Route & Dosage

Paget's Disease
Adult: PO 30 mg q.d. for 2 mo, may repeat after 2 mo rest if necessary

Prevention & Treatment of Osteoporosis
Adult: PO 5 mg q.d. OR 35 mg once weekly OR 75 mg x 2 consecutive days each month

Administration

Oral
  • Give on an empty stomach (before first food or drink of the day) with at least 6–8 oz plain water.
  • Note: Patient should be upright. Maintain upright position and empty stomach for at least 30 min after administration.
  • Space calcium supplements and antacids as far as possible from risedronate.
  • Store at 15°–30° C (59°–86° F) in a tightly closed container and protect from light.

Adverse Effects (≥1%)

Body as a Whole: Flu-like syndrome, asthenia, arthralgia, bone pain, leg cramps, myasthenia. CNS: Headache, dizziness. CV: Chest pain, peripheral edema. GI: Diarrhea, abdominal pain, nausea, constipation, belching, colitis. Respiratory: Bronchitis, sinusitis. Skin: Rash. Special Senses: Amblyopia, tinnitus, dry eyes.

Diagnostic Test Interference

May interfere with the use of bone-imaging agents.

Interactions

Drug: Calcium, antacids significantly decrease absorption, use with nonsteroidal antiinflammatories may increase risk of gastric ulcer.

Pharmacokinetics

Absorption: Minimally absorbed from GI tract, bioavailability 0.63%. Peak: 1 h. Distribution: Approximately 60% of dose is distributed to bone. Metabolism: Not metabolized. Elimination: In urine; unabsorbed drug excreted in feces. Half-Life: 220 h.

Nursing Implications

Assessment & Drug Effects

  • Lab tests: Baseline and periodic serum calcium, phosphorus, and alkaline phosphatase.
  • Monitor carefully for and immediately report S&S of GI bleeding and hypocalcemia.

Patient & Family Education

  • Learn administration guidelines regarding upright position, empty stomach, and spacing relative to calcium supplements and antacids must be strictly followed.
  • Report any of the following to physician: eye irritation, significant GI upset, or flu-like symptoms.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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