| RISEDRONATE SODIUM
Classifications: bisphosphonate; regulator, bone metabolism; Therapeutic: bone resorption inhibitor; osteoporosis treatment
Prototype: Etidronate disodium
Pregnancy Category: C
5 mg, 30 mg, 35 mg, 75 mg tablets
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.
Effectiveness indicated by decreased bone and joint pain and improved bone density.
Paget's disease, prevention and treatment of postmenopausal osteoporosis and steroid-induced osteoporosis.
Hypersensitivity to risedronate or other bisphosphonates; hypocalcemia, vitamin D deficiency; severe renal impairment (CLcr <30 mL/min); pregnancy (category C); lactation.
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
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
- Give on an empty stomach (before first food or drink of the day) with at least 68 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
Rash. Special Senses:
Amblyopia, tinnitus, dry eyes.
Diagnostic Test Interference
May interfere with the use of bone-imaging agents.
InteractionsDrug: Calcium, antacids
significantly decrease absorption, use with nonsteroidal antiinflammatories
may increase risk of gastric ulcer.
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:
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.