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 详细处方信息以本药内容附件PDF文件（201252721512039.pdf,201252721511630.pdf）的“原文Priscribing Information”为准
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 部分中文FOSAMAX PLUS D处方资料（仅供参考）

默克骨质疏松新药ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ获美国ＦＤＡ批准
    默克公司４月８日宣布，美国ＦＤＡ已经批准了该公司新药ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ的上市申请ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ骨质疏松治疗药物，含有７０ｍｇ福善美（ＦＯＳＡＭＡＸ，阿仑膦酸钠）和２８００ ＩＵ维生素Ｄ３，每周只需服用次。福善美主要于绝经后患有骨质疏松症的妇女，能够降低髋部和脊柱骨折的发生率，是目唯一一和一周用量的维生素Ｄ３配伍的双磷酸化合物类药物。

英文藥名: Fosamax Plus D (Alendronate/Cholecalciferol Tablets)

中文藥名: 福善美 加D（阿侖膦酸鈉膽骨化醇片）

藥品名稱
通用名：阿侖膦酸鈉
英文名：ALENDRONATE SODIUM
主要成份: 阿侖膦酸鈉，

規格
阿侖膦酸鈉溶液: 70mg/75ml;
阿侖膦酸鈉-膽骨化醇片: 70mg/70mcg

藥理毒理
本品是骨代謝調節劑，為氨基二膦酸鹽，與骨內羥磷灰石有強親和力。能進入骨基質羥磷灰石晶體中，當破骨細胞溶解晶體，藥物被釋放，能抑製破骨細胞活性，並通過成骨細胞間接起抑製骨吸收作用。其特點是抗骨吸收活性強，無骨礦化抑製作用。

藥代動力學
據文獻報道，本品口服吸收後主要在小腸內吸收，但吸收程度很差，生物利用度約為0.7%，且食物和礦物質等可顯著減少其吸收。本品血漿結合率約80%，血清半衰期短，吸收後的藥物大約20%～60%被骨組織迅速攝取，骨中達峰時間約為用藥後2小時，其餘部分能迅速以原形經腎排泄消除，服藥後24小時內99%以上的體內存留藥物集中於骨，本品在骨內的半衰期較長，與藥的半衰期相仿，約為10年以上。

適應症
用於治療絕經後婦女的骨質疏鬆症。

用法用量
口服每日早餐前至少30分鍾空腹用200ml溫開水送服，一次10mg，一日1次。
任何疑問，請遵醫囑！

不良反應
腹痛，腹瀉，惡心，便秘，消化不良，如不按規定服用方法者可有食道潰瘍，偶有血鈣降低，短暫白細胞升高，尿紅細胞、白細胞升高。
 
禁忌
食道動力障礙，如食道遲緩不能，食道狹窄者禁用，嚴重腎損害者、骨軟化症患者禁用。

注意事項
1．早餐前至少30分鍾用200ml溫開水送服，用藥後至少30分鍾方可進食。
2．與桔子汁和咖啡同時服用會顯著影響本品的吸收。
3．在服用本品前後30分鍾內不宜飲用牛奶、奶製品和含較高鈣的飲料。服藥後即臥床有可能引起食道刺激或潰瘍性食管炎。
4．胃腸道功能紊亂、胃炎、食道不適、十二指腸炎、潰瘍病患者慎用。嬰幼兒、青少年慎用。
5．輕、中度腎功能異常患者慎用。
6．開始使用本品治療前，必須糾正鈣代謝和礦物質代謝紊亂、維生素D缺乏和低鈣血症。補鈣劑、抗酸劑和一些口服藥劑很可能妨礙本品的吸收，因此，服用本品後應至少推遲半小時再服用其他藥物。
7．男性骨質疏鬆症用藥的安全性和有效性尚未驗證，不推薦使用。

孕婦及哺乳期婦女用藥
安全性不明確，不宜使用。

兒童用藥
長期用藥可能影響骨代謝，應慎用。

藥物相互作用
1．抗酸藥和導瀉劑因常含鈣或其他金屬離子如鎂、鐵等而會影響本藥吸收。
2．與氨基糖　類合用會誘發低鈣血症。

How Do I Know FOSAMAX or FOSAMAX PLUS D is Working?
You will not feel it working, but you and your doctor can monitor your progress with a bone mineral density test prescribed by your doctor. Ninety-six percent of patients, on either a once-daily or once-weekly schedule, increased or maintained bone mass.

How Long Do I Take FOSAMAX or FOSAMAX PLUS D?
Only your doctor can determine how long you should keep taking FOSAMAX or FOSAMAX PLUS D. The effects will continue as long as you continue treatment. For most patients, that means your bone density will be maintained or increased and your bones will be less likely to fracture.

If you experience side effects, call your doctor right away.

Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX or FOSAMAX PLUS D. Before use, talk to your doctor if you have or have had stomach or digestive problems or problems with swallowing. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, lymphoma).

Stop taking FOSAMAX or FOSAMAX PLUS D and call your doctor right away if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems, which can include irritation, inflammation, or ulceration of the esophagus. (See the Patient Product Information for more details.) If you develop severe bone, joint, and/or muscle pain at any time, contact your doctor. FOSAMAX AND FOSAMAX PLUS D may cause jawbone problems in some people. Jawbone problems may include infection, and delayed healing after teeth are pulled. Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea.

How to Take FOSAMAX 35-mg or 70-mg Once-Weekly Tablets, FOSAMAX 70-mg Once-Weekly Oral Solution, and FOSAMAX PLUS D 70-mg/2,800 IU Once-Weekly Tablets
Choose a day of the week that best fits your schedule. Take 1 FOSAMAX or FOSAMAX PLUS D dose on your chosen day, every week.

Tablets: Swallow 1 FOSAMAX or FOSAMAX PLUS D tablet with 6 to 8 ounces of plain water first thing in the morning before you have anything to eat or drink.

OR

Oral Solution: Drink 1 entire bottle of solution followed by at least 2 ounces (a quarter of a cup) of plain water.

Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

If you miss a dose, take only 1 dose of FOSAMAX or FOSAMAX PLUS D on the morning after you remember. Do not take 2 doses on the same day.

Continue your usual schedule of 1 dose once a week on your chosen day.

How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX. Before use, talk to your doctor if you have stomach or digestive problems. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, and lymphoma).

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 详细处方信息以本药内容附件PDF文件（201252721512039.pdf,201252721511630.pdf）的“原文Priscribing Information”为准
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