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Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) 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 1-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%).
Actonel with Calcium is contraindicated in patients with known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Actonel® (risedronate sodium tablets) and Calcium are contraindicated, respectively, in patients with hypocalcemia and hypercalcemia. These 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 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. Calcium may cause gastrointestinal adverse effects such as constipation, flatulence, nausea, abdominal pain, and bloating.
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, Actonel was generally well tolerated. 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 1-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%).
ACTONEL is a prescription medication to treat and prevent postmenopausal osteoporosis.
You should not take ACTONEL if you are allergic to any of the ingredients, if you have low blood calcium (hypocalcemia), have kidneys that work poorly, or cannot stand or sit upright for 30 minutes. Stop taking ACTONEL and tell your doctor if you experience difficult or painful swallowing, chest pain, or severe or continuing heartburn, as these may be signs of serious upper digestive problems. Follow dosing instructions carefully to lower the chance of these events occurring. Side effects are generally mild or moderate and may include back, muscle, bone or joint pain, stomach pain or upset, or constipation. Contact your doctor if symptoms are severe. Tell all of your healthcare providers about all the medicines that you take. See Product Information. If you have questions, please talk to your doctor.
