ACTONEL® (risedronate sodium tablets)
Fast Fracture Protection
In the treatment of postmenopausal osteoporosis
Help protect her with:
- Proven fracture protection in 1 year: Actonel is the only therapy proven to significantly reduce vertebral fractures in just 1 year.1
- Proven tolerability: It has proven tolerability in real world patients.2
For more information, visit www.actonel.com
1Actonel package insert. Cincinnati, Ohio: Procter & Gamble Pharmaceuticals; August 2006.
2Taggart H, Bolognese MA, Lindsay R, et al. Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc. 2002;77:262-267.
3Hosking D, Keller M, Hooper M, et al. Risedronate is well-tolerated in postmenopausal osteoporotic women using NSAIDs or with underlying gastrointestinal disorder [abstract]. Calcif Tissue Int. 2000;66(suppl 1):S120.
Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the treatment and prevention of glucocorticoid-induced osteoporosis (GIO) in men and women who are either initiating or continuing systemic glucocorticoid treatment (> 7.5 mg/d of prednisone or equivalent) for chronic diseases.
In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
Among patients treated with bisphosphonates, there have been infrequent reports of severe and occasionally incapacitating bone, joint and/or muscle pain. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients receiving bisphosphonates. Most ONJ cases have occurred in cancer patients undergoing dental procedures. In the majority of cases reported, patients had received intravenous bisphosphonate therapy.
In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7% vs Actonel 5 mg 29.9%), back pain (23.6% vs 26.1%), and arthralgia (21.1% vs 23.7%).
In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6% vs Actonel 5 mg 19.0%), arthralgia (14.2% vs 11.5%) and constipation (12.2% vs 12.5%).
Please see Full Prescribing Information for Actonel (PDF)
Actonel is marketed by the Alliance for Better Bone Health, an alliance between P&G Pharmaceuticals and sanofi-aventis U.S LLC
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