Monograph Details
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Musculoskeletal Disorders
> Bone disorders
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ACTONEL |
| Manufacturer |
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Procter & Gamble Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Bisphosphonate. |
| Generic Name |
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Risedronate (as sodium) 5mg, 30mg, 35mg, 75mg; 150mg; tabs. |
| Also |
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• ACTONEL WITH CALCIUM
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| Indications |
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Prevention and treatment of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis (men & women). Treatment to increase bone mass in men with osteoporosis. Treatment of Paget's disease of bone. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole; take in the AM with a full glass (6–8 oz) plain (not mineral) water at least 30 minutes before other food or drink; take in upright position; do not lie down for at least 30 minutes afterwards. Postmenopausal: 5mg once daily or 35mg once weekly or one 75mg tablet taken on 2 consecutive days per month or one 150mg tablet once monthly. Glucocorticoid-induced: 5mg once daily. Osteoporosis in men: 35mg once weekly. Paget's: 30mg once daily for 2 months; may retreat after a 2-month post-treatment evaluation period. |
| Contraindications |
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Inability to stand or sit upright for at least 30 minutes. Hypocalcemia. Calcium: also hypercalcemia. |
| Precautions |
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Upper GI disease. Severe renal impairment (CrCl <30mL/min): not recommended. Correct preexisting hypocalcemia, other mineral or bone disturbances before starting. Obtain and correct sex steroid hormonal status before initiating therapy in glucocorticoid-induced osteoporosis. Ensure adequate Vit. D and calcium intake. Reevaluate if esophageal reaction occurs. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Risedronate: calcium, aluminum, magnesium, other divalent cations reduce absorption (separate dosing). Caution with other GI irritants. May interfere with bone-imaging agents. Calcium: blocks tetracycline, levothyroxine, fluoroquinolone absorption. Calcium absorption decreased by glucocorticoids. |
| Adverse Reactions |
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GI upset, abdominal pain, musculoskeletal pain (may be severe), others; rarely: dysphagia, esophagitis, gastric ulcer, jaw osteonecrosis. Calcium: also hypercalciuria, hypercalcemia. |
| How Supplied |
Tabs 5mg, 30mg—30
35mg—4, 12
75mg—2
150mg—1, 3
Actonel w. Calcium—1 pack (4 week supply) |
| Additional Resources |
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• Related Prescribing Note |
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