国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
ALENDRONATE (AS SODIUM)
美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)
M05BA04
錠劑
ALENDRONATE (AS SODIUM) (9200036540) MG
鋁箔盒裝
製 劑
須由醫師處方使用
MERCK SHARP & DOHME (ITALIA) SPA VIA EMILIA, 21 27100 PAVIA, ITALY IT
alendronic acid
停經婦女骨質疏鬆症之治療。治療男性骨質疏鬆症,以增加骨密度。
註銷日期: 2016/07/22; 註銷理由: 屆期未申請展延; 有效日期: 2016/04/24; 英文品名: FOSAMAX TABLETS 70MG
已註銷
2001-04-24
MK0217-MF-052013 MK0217-TWN-2012-004080-V1 TABLETS FOSAMAX ® 70 mg (alendronate sodium) ONCE WEEKLY THERAPEUTIC CLASS Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. FOSAMAX® (alendronate sodium) is a bisphosphonate that acts as a potent, specific inhibitor of osteoclast-mediated bone resorption. Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate INDICATIONS In postmenopausal women with osteoporosis FOSAMAX is indicated for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). FOSAMAX is indicated for the treatment of osteoporosis in men to increase bone material density. No available data in the pivotal studies indicated that the incidence of bone fractures in men is reduced. DOSAGE AND ADMINISTRATION FOSAMAX must be taken at least one-half hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX (see DRUG INTERACTIONS). To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX should only be swallowed upon arising for the day with a full glass of water and patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences (see PRECAUTIONS). Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS). No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for patients with more severe renal insufficiency (creatinine clearance < 35 mL/min, or serum creatinine > 1.6 mg/dL) due to 阅读完整的文件