Trade Names:Actonel- Tablets 5 mg- Tablets 30 mg- Tablets 35 mg- Tablets 150 mg
Inhibits normal and abnormal bone resorption.
Relatively rapid and occurs in upper GI tract (oral). T max is about 1 h. Steady state is about 57 days. Bioavailability is 0.63%.
60% of dose is distributed to bone. Protein binding is about 24%.
Steady-state Vd is 13.8 L/kg.
No evidence of system metabolism.
Eliminated in urine (about 50%) in 24 h. Mean renal Cl is 105 mL/min. Mean total Cl is 122 mL/min. Terminal exponential half-life is about 561 h.
Cl decreased about 70% with CrCl 30 mL/min. Not recommended for use in patients with severe renal function impairment.Hepatic Function Impairment
Pharmacokinetics have not been studied.
Treatment and prevention of osteoporosis in postmenopausal women; prevention and treatment of glucocorticoid-induced osteoporosis in men and women; treatment of Paget disease of the bone in men and women; treatment to increase bone mass in men with osteoporosis.
Hypocalcemia; inability to stand or sit upright for at least 30 min; hypersensitivity to any component of the product.
PO 30 mg once daily for 2 mo.Treatment and Prevention of Glucocorticoid-Induced OsteoporosisAdults
PO 5 mg daily.Treatment and Prevention of Postmenopausal OsteoporosisAdults
PO 5 mg daily, 35 mg once a week or 150 mg once a month.Treatment to Increase Bone Mass in Men With OsteoporosisAdults
PO 35 mg once weekly.
Store at controlled room temperature (68° to 77°F).
May decrease risedronate absorption, which may decrease activity.
Interferes with bone-imaging agents.
Hypertension (11%); arrhythmia (2%).
Headache (18%); depression, dizziness (7%); asthenia, insomnia (5%).
Rash (12%); bullous skin reactions, generalized rash (postmarketing).
Cataract (7%); pharyngitis (6%); iritis, uveitis (postmarketing).
Diarrhea (20%); constipation (13%); abdominal pain (12%); dyspepsia, nausea (11%); gastritis (3%); upper GI irritation including esophagitis and esophageal or gastric ulcer (postmarketing).
UTI (11%); benign prostatic hyperplasia (5%); nephrolithiasis (3%).
Allergic reactions (4%); angioedema (postmarketing).
Increased serum parathyroid hormone (less than 30%); hypocalcemia (5%); decreased serum phosphate (less than 3%).
Peripheral edema (8%).
Arthralgia (33%); back pain (28%); arthritis (10%); traumatic bone fracture (9%); joint disorder, myalgia (7%); bone pain, neck pain (5%); incapacitating bone, joint, and muscle pain; osteonecrosis of the jaw (postmarketing).
Bronchitis (10%); sinusitis (9%); increased cough, rhinitis (6%).
Infection (31%); accidental injury (17%); pain (14%); flu-syndrome (11%); chest pain (7%).
Category C .
Safety and efficacy not established.
Not recommended in patients with CrCl less than 30 mL/min.
Before beginning therapy for prevention or treatment of glucocorticoid-induced osteoporosis, determine the hormonal status and consider appropriate replacement.
Effectively treat hypocalcemia and other disturbances of bone and mineral metabolism prior to starting risedronate.
Severe and incapacitating bone, joint, and muscle pain have been reported.
Osteonecrosis, primarily of the jaw, has been reported in patients receiving bisphosphonates.
Bisphosphonates may cause upper GI disorders such as dysphagia, esophageal ulcer, esophagitis, and gastric ulcer.
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