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  药店国别: 德国药房
产地国家: 德国
所属类别: 骨科药物->治疗骨质疏松药物
处方药:处方药
包装规格: 10毫克/片 28片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
MSD Sharp & Dohme GmbH
生产厂家英文名:
MSD Sharp & Dohme GmbH
该药品相关信息网址1:
www.drugs.com/fosamax.html
该药品相关信息网址2:
www.rxlist.com/fosamax-drug.htm
该药品相关信息网址3:
http://www.medicinenet.com/alendronate/article.htm
原产地英文商品名:
FOSAMAX 10mg/tab 28Tabs/box
原产地英文药品名:
Alendronic Acid
中文参考商品译名:
福善美 10毫克/片 28片/盒
中文参考药品译名:
阿仑磷酸
原产地国家批准上市年份:
1995/09/29
英文适应病症1:
Osteoporosis
临床试验期:
完成
中文适应病症参考翻译1:
骨质疏松症
药品信息:

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 详细处方信息以本药内容附件PDF文件(201252722260925.PDF)的“原文Priscribing Information”为准
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 部分中文阿仑膦酸钠处方资料(仅供参考)

【性状】本品为白色片。

【药理作用】本品是骨代谢调节剂,为氨基二膦酸盐,与骨内羟磷灰石有强亲和力。能进入骨基质羟磷灰石晶体中,当破骨细胞溶解晶体,药物被释放,能抑制破骨细胞活性,并通过成骨细胞间接起抑制骨吸收作用。其特点是抗骨吸收活性强,无骨矿化抑制作用。

【药代动力学】据文献报道,本品口服吸收后主要在小肠内吸收,但吸收程度很差,生物利用度约为0.7%,且食物和矿物质等可显著减少其吸收。本品血浆结合率约80%,血清半衰期短,吸收后的药物大约20%~60%被骨组织迅速摄取,骨中达峰时间约为用药后2小时,其余部分能迅速以原形经肾排泄消除,服药后24小时内99%以上的体内存留药物集中于骨,本品在骨内的半衰期较长,与药的半衰期相仿,约为10年以上。

【适应证】用于治疗绝经后妇女的骨质疏松症。

【用法用量】口服每日早餐前至少30分钟空腹用200ml温开水送服,一次10mg,一日1次。

【不良反应】腹痛,腹泻,恶心,便秘,消化不良,如不按规定服用方法者可有食道溃疡,偶有血钙降低,短暂白细胞升高,尿红细胞、白细胞升高。

【禁忌】食道动力障碍,如食道迟缓不能,食道狭窄者禁用,严重肾损害者、骨软化症患者禁用。

【注意事项】
1.早餐前至少30分钟用200ml温开水送服,用药后至少30分钟方可进食。
2.与桔子汁和咖啡同时服用会显著影响本品的吸收。
3.在服用本品前后30分钟内不宜饮用牛奶、奶制品和含较高钙的饮料。服药后即卧床有可能引起食道刺激或溃疡性食管炎。
4.胃肠道功能紊乱、胃炎、食道不适、十二指肠炎、溃疡病患者慎用。婴幼儿、青少年慎用。
5.轻、中度肾功能异常患者慎用。
6.开始使用本品治疗前,必须纠正钙代谢和矿物质代谢紊乱、维生素D缺乏和低钙血症。补钙剂、抗酸剂和一些口服药剂很可能妨碍本品的吸收,因此,服用本品后应至少推迟半小时再服用其他药物。
7.男性骨质疏松症用药的安全性和有效性尚未验证,不推荐使用。
 
【相互作用】
1.抗酸药和导泻剂因常含钙或其他金属离子如镁、铁等而会影响本药吸收。
2.与氨基糖苷类合用会诱发低钙血症。

【孕妇及哺乳期妇女用药】安全性不明确,不宜使用。

【儿童用药】长期用药可能影响骨代谢,应慎用。

【剂型】片剂

GENERIC NAME: alendronate

BRAND NAME: Fosamax

DRUG CLASS AND MECHANISM: Alendronate is in a class of medications called bisphosphonates. The bisphosphonate class includes etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), and tiludronate (Skelid). Bisphosphonates are used for treating osteoporosis (reduced density of bone that leads to fractures) and bone pain from diseases such as metastatic breast cancer, multiple myeloma, and Paget's disease. Bone is in a constant state of remodeling. New bone is laid down by cells called osteoblasts while old bone is removed by cells called osteoclasts. Bisphosphonates strengthen bone by inhibiting bone removal (resorption) by osteoclasts. After menopause, there is an increased rate of bone loss leading to osteoporosis, and alendronate has been shown to increase bone density and decrease fractures of bones. The FDA approved alendronate in September 1995.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Tablets: 5, 10, 35, 40, 70 mg. Solution: 70 mg

STORAGE: Tablets and solution should be stored at room temperature, 15-30 C (59-86 F) and not frozen.

PRESCRIBED FOR: Alendronate is used for treating osteoporosis in men and postmenopausal women. It also is used for Paget's disease of bone and osteoporosis caused by steroid treatment. Non-FDA approved (off-label) uses include vitamin D overdose and osteoporosis caused by spinal injury.

DOSING: The recommended dose for treatment of osteoporosis is 5-10 mg daily or 35-70 mg weekly. Paget's disease is treated with 40 mg once daily for six months.

Since food, other medications, and vitamins can interfere with the absorption of alendronate, they should be taken at least 30 minutes before alendronate. In order to avoid chemical irritation of the esophagus (the swallowing tube that connects the mouth with the stomach), alendronate should be taken with a full glass of plain water immediately upon arising in the morning and never chewed or sucked. It should be avoided by patients with abnormalities of the esophagus which delay esophageal emptying, such as scarring (stricture) or poor motility (achalasia). Patients should also not lie down for 30 minutes after swallowing the tablets. Those patients who are unable to remain upright for at least 30 minutes after taking alendronate should not take it.

DRUG INTERACTIONS: Calcium supplements and antacids reduce the absorption of alendronate. Therefore, alendronate should be taken at least 30 minutes before calcium and antacids.

Intravenous ranitidine (Zantac) increases blood levels of alendronate. The importance of this reaction is unknown.

The risk of stomach and intestinal side effects may increase when alendronate is combined with aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs).

PREGNANCY: Alendronate has not been studied in pregnant women.

NURSING MOTHERS: It is not known whether alendronate is secreted in breast milk.

SIDE EFFECTS: The most common side effect of alendronate is stomach pain. It also may cause nausea, vomiting, bloating, constipation, diarrhea, gas, black stool (due to intestinal bleeding), change in taste perception, and muscle or joint pain. Alendronate may irritate the esophagus, causing ulcers and bleeding. This occurs more often when patients do not drink enough water with alendronate, wait 30 minutes before lying down, or take alendronate before the first meal of the day. Rarely, patients may experience jaw problems (osteonecrosis of the jaw) associated with delayed healing and infection after tooth extraction.

Bone, joint, and muscle pain also can occur as can femoral fractures.

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 详细处方信息以本药内容附件PDF文件(201252722260925.PDF)的“原文Priscribing Information”为准
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更新日期: 2013-10-09
附件:


201252722260925.PDF    

 
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