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Alendronate Tablets 70mg(Alendronate 阿仑膦酸片片)
药店国别  
产地国家 加拿大 
处 方 药: 是 
所属类别 70毫克/片 100片/盒  
包装规格 70毫克/片 100片/盒  
计价单位: 盒 
生产厂家中文参考译名:
Apotex
生产厂家英文名:
Apotex
该药品相关信息网址1:
https://www.drugs.com/pro/alendronate.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
ALENDRONATE 70mg/tab 100tabs/box
原产地英文药品名:
ALENDRONATE
中文参考商品译名:
阿仑唑奈 70毫克/片 100片/盒
中文参考药品译名:
阿仑膦酸
曾用名:
简介:

 

部份中文阿仑膦酸钠处方资料(仅供参考)
药品英文名
Alendronate Sodium
药品别名
阿仑磷酸钠、阿屈膦酸酸、福善美、天可、SodiumAlendronate、Fosamax
药物剂型
1.片剂:13.05mg;
2.胶囊:5mg,10mg。
药理作用
本品为第3代磷酸盐烃骨吸收抑制剂,主要沉积在骨吸收部位的破骨细胞内,被摄取到破骨细胞表面的量比在成骨细胞表面的量大10倍。药物与骨中的羟磷灰石结合,不干扰破骨细胞的聚集和附着,但抑制破骨细胞的活性和释放H+能力。另一方面,本品作用于破骨细胞,抑制其产生破骨细胞活化因子,使活性破骨细胞的数量减少。由于破骨细胞活性受到抑制,使骨转换降低,骨重建点的数量减少,并在重建点骨的形成大于骨的吸收,阻止骨质溶解,使骨密度增加。本品口服可吸收,作用持久,可长期应用。无骨矿化抑制作用。
药动学
口服吸收很差,生物利用度平均为0.7%,单剂量10mg顿服,男性的生物利用度为0.59%,女性为0.78%,且食物和矿物质影响其吸收,使吸收率更低,因此要餐前吞服,不能与牛奶或饮料同服。口服后在血浆中迅速消除,有60%~70%被骨组织摄取,2h后达峰值,在骨中的半衰期为10年以上,血浆蛋白结合率为78%。本品部分由肝脏代谢,主要以原形药物由尿液中排出。
适应证
用于骨质疏松,恶性肿瘤并发的高钙血症,溶骨性癌转移引起的骨痛及佩古特病。
禁忌证
1.高钙血症患者禁用。
2.对二磷酸盐类药物过敏者禁用。
注意事项
1.严重肾功能不全者、心血管疾病者慎用。
2.儿童、驾驶员慎用。
3.孕妇及哺乳妇女慎用。
4.为便于吸收,避免对食管和胃的刺激,本品应于空腹给药,并建议用足量水送服,口服后30min内不宜进食和卧床,不宜喝牛奶、咖啡、茶、矿泉水、果汁和含钙的饮料。
5.如在治疗中发生咽痛、进食困难、吞咽疼痛和胸骨后疼痛,应及时治疗。
6.使用过程中应注意监测血浆钙、磷等电解质水平和血小板计数。
不良反应
1.常见有胃刺激症状,如恶心、呕吐、腹痛、胸骨后疼痛、消化不良、咽痛、吞咽疼痛、胸闷、头晕及轻微肝肾功能改变。
2.少见的不良反应有低血钙现象及听力丧失。长期应用未见在体内蓄积。
用法用量
口服:用于绝经期骨质疏松和预防骨折,每次10mg,每天1次。用于预防骨质疏松,每次5mg,每天1次。用于变形性骨炎,每次40mg,每天1次,早餐前30min服用。
药物相应作用
不得与其他种类二膦酸盐类药物合并使用。
临床研究
对骨矿物质密度的影响在四项为期2年或3年疗程的双盲、安慰剂对照的临床研究中,证明了每天给予10mg本品对绝经后骨质疏松症妇女的疗效。因此,不论患者以前是否出现过脊椎骨折,本药均能降低其骨折发生率。在骨折干预试验研究中,对髋部和腕部骨折的累积发生率的3年研究结果显示,本品治疗患者的这些类型的骨折发生率在各时间点均低于安慰剂治疗的患者。本品将髋部骨折妇女的比例降低了51%,而腕部骨折降低了48%。在五项合并的骨质疏松症治疗研究中观察到的髋部和腕部骨折降低比例相近。
总的来说,这些结果表明,本药能有效的降低包括脊椎和髋部在内的骨质疏松性骨折发病率最高的部位的骨折发生率。270名用本品剂量每天1~20mg,治疗一、二或三年的绝经后骨质疏松症患者的骨组织学检查表明,与安慰剂比较,治疗组出现了正常的骨钙化和结构,以及所希望的骨转换率降低。连同在长期给予阿仑膦酸钠的大鼠和狒狒所观察到的正常骨组织学和骨强度增加的结果,这些数据表明,本药治疗期间形成的骨骼是正常的。
Alendronate
INDICATIONS
Fosamax 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.
INSTRUCTIONS
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.
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.
DOSAGE
Treatment of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 70 mg tablet once weekly
one bottle of 70 mg oral solution once weekly
one 10 mg tablet once daily
Prevention of Osteoporosis in Postmenopausal Women
The recommended dosage is:
one 35 mg tablet once weekly
one 5 mg tablet once daily
Treatment to Increase Bone Mass in Men with Osteoporosis
The recommended dosage is:
one 70 mg tablet once weekly
one bottle of 70 mg oral solution once weekly
one 10 mg tablet once daily
Treatment of Glucocorticoid-Induced Osteoporosis
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Treatment of Paget's Disease of Bone
The recommended treatment regimen is 40 mg once a day for six months.
STORAGE
Store at room temperature away from moisture and heat.
SAFETY INFORMATION
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.
Talk with your doctor about the risks and benefits of using Fosamax.
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.
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. 

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