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Freebase Commons Common /common

  • Actonel (Warner Chilcott), manufactured drug form of Risedronate sodium, 75mg/tablet risedronate sodium film coated tablet, NDC 0149-0477

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • 43683-2
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  • ACTONEL is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis (1.1), Treatment to increase bone mass in men with osteoporosis (1.2), Treatment and prevention of glucocorticoid-induced osteoporosis (1.3), Treatment of Paget’s disease (1.4).
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  • Must be taken with plain water (6 to 8 oz) at least 30 minutes before the first food or drink of the day; do not lie down for 30 minutes (2) Treatment of Osteoporosis in Postmenopausal Women: 5 mg daily, 35 mg once a week, 75 mg taken on two consecutive days each month, or 150 mg once a month (2.1) Prevention of Osteoporosis in Postmenopausal Women: 5 mg daily, or 35 mg once a week (2.2) Men with Osteoporosis: 35 mg once a week (2.3) Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: 5 mg daily (2.4) Paget’s Disease: 30 mg daily for 2 months (2.5)
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  • Tablets: 5, 30, 35, 75, and 150 mg (3)
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  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4, 5.1) Inability to stand or sit upright for at least 30 minutes (4, 5.1) Hypocalcemia (4, 5.2) Known hypersensitivity to any component of this product (4, 6.2)
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  • Severe irritation of the upper gastrointestinal (GI) mucosa can occur. Dosing instructions should be followed and caution should be used in patients with active upper GI disease. Discontinue use if new or worsening symptoms occur (5.1). Hypocalcemia may worsen and must be corrected prior to use (5.2). Osteonecrosis of the jaw has been reported rarely (5.3). Severe bone, joint, or muscle pain may occur. Consider discontinuing use if severe symptoms develop (5.4, 6.2). Before initiating treatment in patients with glucocorticoid-induced osteoporosis, sex steroid hormonal status of both men and women should be ascertained and appropriate replacement considered (5.6). Bisphosphonates may interfere with bone-imaging agents (5.7).
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  • Most common adverse reactions reported in >10% of patients treated with ACTONEL and with a higher frequency than placebo are: back pain, arthralgia, abdominal pain, and dyspepsia (6.1). Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-836-0658 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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  • Calcium, antacids, or oral medications containing divalent cations interfere with the absorption of ACTONEL (7.1).
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  • ACTONEL is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min) (5.5, 8.6, 12.3). ACTONEL is not indicated for use in pediatric patients (8.4).
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  • 34088-5

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