Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ALENDRONATE SODIUM (UNII: 2UY4M2U3RA) (ALENDRONIC ACID - UNII:X1J18R4W8P)
Preferred Pharmaceuticals Inc.
ALENDRONATE SODIUM
ALENDRONIC ACID 70 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ALENDRONATE SODIUM- ALENDRONATE SODIUM TABLET PREFERRED PHARMACEUTICALS INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALENDRONATE SODIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions (5.4) 2/2015 INDICATIONS AND USAGE Alendronate sodium tablets are a bisphosphonate indicated for: 1. 2. 3. 4. Limitations of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. (1.6) DOSAGE AND ADMINISTRATION 1. 2. 3. 4. 5. 6. 7. DOSAGE FORMS AND STRENGTHS 5 mg, 10 mg, 35 mg, 40 mg and 70 mg tablets (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (greater than or equal to 3%) are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. (6.1) Treatment and prevention of osteoporosis in postmenopausal women (1.1, 1.2) Treatment to increase bone mass in men with osteoporosis (1.3) Treatment of glucocorticoid-induced osteoporosis (1.4) Treatment of Paget's disease of bone (1.5) Treatment of osteoporosis in postmenopausal women and in men: 10 mg daily or 70 mg (tablet) once weekly. (2.1, 2.3) Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. (2.2) Glucocorticoid-induced osteoporosis: 5 mg daily; or 10 mg daily in postmenopausal women not receiving estrogen. (2.4) Paget's disease: 40 mg daily for six months. (2.5) Instruct patients to: (2.6) Swallow tablets whole with 6 to 8 ounces plain water at least 30 minutes before the first food, drink, or medication of the day. Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food. Abnormalities of the esophagus which delay emptying such as stricture or achalasia (4 Aqra d-dokument sħiħ