Monograph Details
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Musculoskeletal Disorders
> Bone disorders
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FOSAMAX |
| Manufacturer |
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Merck & Co., Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Bisphosphonate. |
| Generic Name |
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Alendronate (as sodium) 5mg, 10mg, 35mg, 40mg, 70mg; tabs. |
| Also |
• FOSAMAX ORAL SOLUTION
• FOSAMAX PLUS D
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| Indications |
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Treatment and prevention of postmenopausal osteoporosis. Treatment of osteoporosis in men. Treatment of glucocorticoid-induced osteoporosis. Paget's disease of bone. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole. Take in the AM with plain (not mineral) water only, at least 30 minutes before the first food, drink, or medication of the day (6–8oz water after tabs or 2oz after oral solution); do not lie down for at least 30 minutes and until after the first food of the day. Reevaluate periodically. Osteoporosis treatment in men or postmenopausal women: 10mg tab once daily or 70mg once weekly or one 70mg/2800 IU or 70mg/5600 IU tab once weekly. Osteoporosis prevention in postmenopausal women: 5mg tab once daily or 35mg tab once weekly. Glucocorticoid-induced: 5mg tab once daily; glucocorticoid-induced in postmenopausal women not on estrogen: 10mg tab once daily. Paget's: 40mg once daily for 6 months; may retreat after a 6-month post-treatment evaluation period (based on serum alkaline phosphatase). |
| Contraindications |
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Esophageal abnormalities which delay esophageal emptying (eg, stricture). Inability to stand or sit upright for at least 30 minutes. Aspiration risk (oral solution). Hypocalcemia. |
| Precautions |
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Renal insufficiency (CrCl <35mL/min): not recommended. Upper GI disease. Treat disturbances of mineral metabolism. Ensure adequate Vit. D and calcium intake. Discontinue if esophageal reaction occurs. Monitor for hypocalcemia in disorders affecting mineral metabolism (eg, Vit. D deficiency). Not for sole treatment of Vit. D deficiency. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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Increased GI distress with aspirin and alendronate >10mg/day; caution with NSAIDs, other GI irritants. Anticonvulsants, cimetidine, thiazides, olestra, mineral oils, orlistat, bile acid sequestrants may antagonize Vit. D3. |
| Adverse Reactions |
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GI upset, abdominal pain, acid regurgitation, musculoskeletal pain (may be severe), headache, esophagitis; esophageal ulcer, stricture, or erosion; melena; rarely: gastric or duodenal ulcer. |
| How Supplied |
Tabs 5mg—30, 100
10mg—30, 100, 1000
35mg, 70mg—4
40mg—30
Soln—4 X 75mL
Plus D—4 |
| Additional Resources |
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• Related Prescribing Note |
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