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Click here to download Full Prescribing Information for Actonel with Calcium.
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Actonel is indicated for the treatment of postmenopausal osteoporosis.
Actonel 5 mg and 35 mg are indicated for the prevention of postmenopausal osteoporosis.
Actonel 150 mg may be considered for use for prevention of postmenopausal osteoporosis.
Selected Safety Information for Actonel
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, including Actonel, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur. There have also been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates.
Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Actonel. Patients who develop ONJ while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan (including the consideration of discontinuation of bisphosphonate therapy) of each patient based on individual benefit/risk assessment.
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. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely.
Actonel with Calcium is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Selected Safety Information for Actonel with Calcium (risedronate sodium tablets with calcium carbonate tablets, USP)
Actonel with Calcium is contraindicated in patients with hypocalcemia and hypercalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia, hypercalcemia, and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel with Calcium therapy. Actonel with Calcium is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min). In patients with conditions causing or predisposing to hypercalcemia and in patients with a history of kidney stones, the administration of calcium should be assessed prior to prescribing and then monitored appropriately.
Bisphosphonates, including Actonel with Calcium, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcers. Actonel with Calcium should be taken according to the dosing instructions to minimize the risk of these events. Patients should discontinue use if new or worsening symptoms occur. Calcium may cause gastrointestinal adverse effects such as constipation, flatulence, nausea, abdominal pain, and bloating.
There have been reports of severe and occasionally incapacitating bone, joint and/or muscle pain in patients taking bisphosphonates. Rare occurrences of osteonecrosis, primarily of the jaw (ONJ), have been reported in patients treated with bisphosphonates. Most cases were reported in cancer patients receiving intravenous bisphosphonates, but some have been in patients treated orally for osteoporosis. Most cases were reported in patients undergoing dental procedures such as tooth extraction.
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. Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions), and eye inflammation (iritis, uveitis) have been reported rarely in patients treated with Actonel.
