Generic Name and Formulations:
Alendronate (as sodium) 70mg; tabs.
Merck & Co., Inc.
Indications for FOSAMAX:
Treatment and prevention of postmenopausal osteoporosis. Treatment of osteoporosis in men. Treatment of glucocorticoid-induced osteoporosis. Paget's disease of bone. Limitations of use: optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3–5yrs.
Swallow whole. Take in the AM with plain (not mineral) water only, at least 30 mins 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 mins and until after the first food of the day. 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).
Esophageal abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30 mins. Aspiration risk (oral solution). Hypocalcemia.
Active upper GI disease; discontinue and reevaluate if signs/symptoms of esophageal reaction occur. Severe renal insufficiency (CrCl <35mL/min): not recommended. Correct preexisting hypocalcemia, other mineral (eg, Vit. D deficiency) or bone disturbances before starting. Monitor for hypocalcemia during therapy. Ensure adequate Vit. D and calcium intake. Risk of osteonecrosis of the jaw; consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, surgery). History of bisphosphonate exposure: evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reevaluate periodically. Glucocorticoid-induced osteoporosis: prior to treatment, check patients' gonadal hormonal status and consider appropriate replacement; if concomitant glucocorticoids, monitor BMD before starting and repeat after 6–12 months. Pregnancy (Cat.C). Nursing mothers.
Calcium supplements, antacids, other multivalent cations reduce absorption (separate dosing by at least 30min). 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.
Abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, nausea, musculoskeletal pain (may be severe), headache; esophagitis, esophageal ulcer, stricture, or erosion, melena, jaw osteonecrosis, atypical femur fractures; rarely: gastric or duodenal ulcer.
Tabs, Soln—contact supplier; Tabs 70mg—4; Plus D—4, 12, 100, 500