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阿仑膦酸钠片|Fosamax(Alendronate Tablets)

2010-01-19 01:18:36  作者:新特药房  来源:中国新特药网  浏览次数:277  文字大小:【】【】【
简介: 【简述】 福善美片用于治疗绝经后妇女的骨质疏松症,以预防髋部和脊柱等引起骨折症状. 【福善美药理作用】 福善美(阿仑膦酸钠.默沙东)是一种氨基一二磷酸盐,是对破骨细胞所介导的骨质再吸收的一种有 ...

英文药名: Fosamax (Alendronate Tablets)

中文药名: 福善美(阿仑膦酸钠片)

生产品牌药厂家: Merck Frosst

药品名称和成分

阿仑膦酸钠片
【英文名】Alendronate Sodium Tablets
【成份】阿仑膦酸钠
【性状】白色片
药理毒理

阿仑膦酸钠为氨基二膦酸盐骨吸收抑制剂,与骨内羟磷灰石有强亲和力。本品是通过抑制破骨细胞的活性而发挥抗骨吸收作用。其特点是抗骨吸收活性强,无骨矿化抑制作用。
适应症

适应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。
如果您有任何疑问,请遵医嘱。
不良反应

服用后耐受性良好,少数病人可见胃肠道反应,如恶心、腹胀、腹痛等,偶有头痛、骨胳肌痉痛等,罕见皮疹或红斑。
禁忌

1 对本品过敏者禁用。
2 低钙血症患者禁用。
3 孕妇、哺乳期妇女禁用。
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地减少本品的吸收。
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。
4 服药后即卧床有可能引起食道刺激或溃疡性食管炎。
5 胃肠道紊乱、胃炎、食道不适、十二指肠炎、溃疡病患者慎用。
6 婴幼儿、青少年不宜服用。
7 中、重度肾功能不全患者不宜服用。
8 开始使用本品治疗前,必须治愈钙代谢和矿物质代谢紊乱、维生素D缺乏及低钙血症。
9 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它药物。
10 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。
贮藏

密闭保存。

Fosamax

Generic Name: alendronate (a LEN dro nate)
Brand Names: Fosamax

What is Fosamax?

Fosamax (alendronate) is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Fosamax slows bone loss while increasing bone mass, which may prevent bone fractures.

Fosamax is used in men and women to treat or prevent osteoporosis that is caused by menopause or by taking steroids. Fosamax is also used to increase bone mass in men who have osteoporosis, and to treat Paget's disease of bone in men and women.

Fosamax may also be used for other purposes not listed in this medication guide.

Important information about Fosamax

Do not take a Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking Fosamax.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.

Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water, coffee, tea, or juice) when taking a Fosamax tablet.

For at least the first 30 minutes after taking a Fosamax tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Fosamax. You may need to stop using the medicine for a short time.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Before taking Fosamax

Do not take a Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

You should not take Fosamax if you are allergic to alendronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

To make sure you can safely take Fosamax, tell your doctor if you have any of these other conditions:

  • trouble swallowing;
  • a vitamin D deficiency;
  • a dental problem;
  • kidney disease; or
  • an ulcer or other problem in your stomach or esophagus.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category C. It is not known whether Fosamax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Do not use Fosamax without telling your doctor if you are breast-feeding a baby.

How should I take Fosamax?

Take Fosamax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Fosamax tablets are taken either once each day or once each week.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take a Fosamax tablet only once a week, take it on the same day each week and always first thing in the morning.

Take each Fosamax tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a tablet. Do not crush, chew, or suck the Fosamax tablet. Swallow the pill whole.

After taking a Fosamax tablet, carefully follow these instructions:

  • Do not lie down or recline for at least 30 minutes after taking Fosamax.
  • Do not eat or drink anything other than plain water.
  • Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking Fosamax. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure Fosamax is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take Fosamax tablets once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take Fosamax tablets once a week: If you forget to take Fosamax on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking Fosamax?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a Fosamax tablet. Some medicines can make it harder for your body to absorb Fosamax. Do not lie down for at least 30 minutes after you take a tablet.

Fosamax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Fosamax: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • severe heartburn, burning pain in your upper stomach, or coughing up blood;
  • new or worsening heartburn;
  • fever, body aches, flu symptoms;
  • severe joint, bone, or muscle pain;
  • new or unusual pain in your thigh or hip;
  • jaw pain, numbness, or swelling.

Less serious Fosamax side effects may include:

  • mild heartburn, bloating;
  • mild nausea, vomiting, or stomach pain;
  • diarrhea, gas, or constipation;
  • mild joint pain or swelling;
  • swelling in your hands or feet; or
  • dizziness, eye pain, headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Fosamax?

Tell your doctor about all other medicines you use, especially aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as:

  • celecoxib (Celebrex);
  • diclofenac (Voltaren);
  • diflunisal (Dolobid);
  • ibuprofen (Motrin, Advil);
  • indomethacin (Indocin);
  • ketoprofen (Orudis)
  • ketorolac (Toradol);
  • naproxen (Aleve, Naprosyn); or
  • piroxicam (Feldene), and others.

This list is not complete and other drugs may interact with Fosamax. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

药品中文名称  阿仑膦酸钠片 
药品名称说明  
药品英文名称  Alendronate Sodium Tablets 
药品中文商品名  福善美 
药品英文商品名  Fosamax 
中文剂型  片剂 
英文剂型  
药品规格  70mg 
包装规格  1片,2片/盒 
注册证号  H20080172 
原注册证号  
注册证号说明  
分包装文号  
公司中文名称  
公司英文名称  Merck Sharp & Dohme(Australia) Pty.Ltd 
公司中文地址  
公司英文地址  54-68 Ferndell Street SOUTH GRANVILLE NSW 2142 AUSTRALIA 
公司中文国别  澳大利亚 
公司英文国别  AUSTRALIA 
生产厂商中文名  
生产厂商英文名  Merck Sharp & Dohme Italia SPA 
生产厂国内地址  
生产厂国内地址  Via Emilia 21,Pavia 27100 
生产厂中文国别  意大利 
生产厂英文国别  Italy 
批准日期  2008-04-21 
注册证效期  2013-04-20 
分包装企业  Merck Sharp & Dohme(Australia)Pty.Ltd. 
分包装地址  54-68 Ferndell Street SOUTH GRANVILLE NSW 2142 AUSTRALIA 
分包批准日  
分包截止日  
产品类别  化学药品 
分包装企业国别  澳大利亚,Australia 

フォサマックス (Fosamax ) の商品情報
・商品名: フォサマックス錠 70mg
・英名: Fosamax Tablets 70mg
・一般名: アレンドロン酸
・成分: Alendronate Sodium 70mg
・メーカー: メルク (MERCK)
・製造国: メキシコ
・規格: 70mg
 
フォサマックス (Fosamax ) の注意事項
 
<注意>「薬監証明」なしで簡易通関だけで輸入できる処方箋薬の量は「一か月分」です(外用剤なら標準サイズで1品目24個以内)。規定量を守って注文を申し込んでください。なお、こちらの判断で商品を分割発送することがあります(送料の追加請求はありません)。
 
<注意>このサイトで扱っている医薬品は、主に医者の処方箋が必要な処方箋薬です。かかりつけの医師とよく相談し、その必要性を十分に検討してから、医薬品の個人輸入代行をお申し込みください。また、サイト上での商品に関する説明は、主に商品に添付の説明書を簡単翻訳したものや、「イーファーマ」、「goo ヘルスケア」、「おくすり110」などのサイトから一部を引用したものです。実際に服用するときには、成分、内容量、規格を確認した上、医者や薬剤師の指導の下で服用してください。医薬品の個人輸入と服用はすべて自己責任であることを予めご了承ください。 
 フォサマック錠

欧文商標名
FOSAMAC Tablets

組成

**有効成分の名称
日本薬局方 アレンドロン酸ナトリウム水和物

含量: 1錠中アレンドロン酸として
有効成分に関する理化学的知見

一般名
アレンドロン酸ナトリウム水和物
(Alendronate Sodium Hydrate)

**化学名
Monosodium trihydrogen 4-amino-1-hydroxybutane-1, 1-diyldiphosphonate trihydrate

分子式
C4H12NNaO7P2・3H2O

分子量
325.12

融点
約252℃ (分解、ただし乾燥後)

**性状
白色の結晶性の粉末である。水にやや溶けにくく、エタノール(99.5)にほとんど溶けない。0.1mol/Lクエン酸三ナトリウム試液に溶ける。

**構造式
包装

フォサマック錠5: PTP 28錠 (14錠×2)
               100錠 (10錠×10)
               140錠 (14錠×10)
               500錠 (10錠×50)
               700錠 (14錠×50)
フォサマック錠5: 瓶   500錠

*製造販売元
MSD株式会社

责任编辑:admin


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