Restofos-10mg

Class: Hormone/Bisphosphonates Action Inhibits bone resorption and increases bone density. Indications Treatment of osteoporosis in postmenopausal women; prevention of osteoporosis in postmenopausal women at risk of developing osteoporosis; treatment of osteoporosis in men; treatment of glucocorticoid-induced osteoporosis in men and women; treatment of Paget disease of the bone. Contraindications Hypocalcemia. Route/Dosage Osteoporosis (Postmenopausal Women) ADULTS: PO Treatment: 70 mg once weekly or 10 mg once daily. Prevention: 35 mg once weekly or 5 mg once daily. Osteoporosis (Men) ADULTS: PO 10 mg once daily. Glucocorticoid-Induced Osteoporosis ADULTS PO 5 mg once daily. For postmenopausal women not receiving estrogen, 10 mg once daily. Paget Disease ADULTS: PO 40 mg once daily for 6 mo. Retreatment may be considered for patients who relapse after a 6-mo observation period. Interactions Food: Absorption of alendronate is decreased by food. Liquids: Beverages other than water decrease absorption. Ranitidine: Increased alendronate absorption; clinical importance unknown. Calcium supplements, antacids: Decreased alendronate absorption. Aspirin: Risk of upper GI adverse effects is increased by concomitant use of aspirin and alendronate doses over 10 mg/day. Lab Test Interferences None well documented. Adverse Reactions CNS: Headache. GI: Abdominal pain; constipation; diarrhea; flatulence; esophageal ulcer; dysphagia. OTHER: Musculoskeletal pain. Precautions Pregnancy: Category C. Lactation: Undetermined. Children: Safety and efficacy not established. Renal: Not recommended for patients with CrCl < 35 mL/min. GI Disorders: Not recommended for patients with upper GI problems. Hypocalcemia: Correct before starting alendronate. Nutrition: Maintain adequate calcium and vitamin D intake during alendronate therapy. Concomitant estrogen replacement therapy: Not recommended. Absorption: Food, beverages other than water, and medication inhibit absorption. Must be taken first thing in the morning with a full glass of water ³ 30 min before any food, beverages, or medications. Must remain sitting or standing for 30 min after taking. PATIENT CARE CONSIDERATIONS Administration/Storage Divide dose if GI upset occurs. Avoid high calcium food, vitamins with mineral supplements, and antacids high in metals within 2 hr of dosing. Take 30 min before first meal, medication, or drink of the day. Take with 6 to 8 oz of plain water only. Store at room temperature in well-closed container. Assessment/Interventions Obtain patient history. Assess for hypersensitivity reaction. Assess for severe renal insufficiency prior to administration. OVERDOSAGE: SIGNS & SYMPTOMS Hypocalcemia, hypophosphatemia, upper GI adverse effects Patient/Family Education Instruct patient to take medication with plain water 30 min before the first food or drink of the day. Take medication with a full glass of water. Patient should not lie down for 30 min following administration. Instruct patient not to suck or chew on tablet; swallow whole. Have patient take supplemental calcium (1500 mg) and vitamin D (400 IU PO daily) if dietary intake is not adequate. Encourage patient to perform weight-bearing exercises and modify behaviors that promote osteoporosis (ie, avoid alcohol and cigarette smoking). Have patient read package insert before starting therapy.