Pharmacological Class:
Bisphosphonate.

Active Ingredient(s):
Alendronate (as sodium) 70mg; effervescent tabs for oral soln; strawberry-flavor; contains 650mg sodium/tab.

Indication(s):
Treatment of postmenopausal osteoporosis. To increase bone mass in men with osteoporosis.

Pharmacology:
Alendronate binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. It reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Clinical Trials:
Binosto (alendronate sodium) effervescent tablet 70mg is bioequivalent to alendronate sodium tablet 70mg. The fracture reduction efficacy and bone mineral density changes attributed to Binosto are based on clinical trial data of alendronate sodium 10mg daily and alendronate sodium 70mg weekly.

Legal Classification:
Rx

Adults:
Dissolve one tab in 4oz plain (not mineral) water only; after effervescence stops, wait 5mins and stir soln for 10secs. Take in the AM at least 30 minutes before the first food, drink, or medication of the day. Do not lie down for at least 30 minutes and until after the first food of the day. 70mg once weekly.

Children:
Not recommended.

Contraindication(s):
Esophagus abnormalities which delay esophageal emptying (eg, stricture, achalasia). Inability to stand or sit upright for at least 30 minutes. Increased risk of aspiration. Hypocalcemia.

Warnings/Precautions:
Active upper GI disease; discontinue and reeva luate if signs/symptoms of esophageal reaction occur. Severe renal impairment (CrCl <35mL/min): not recommended. Correct preexisting hypocalcemia or other mineral metabolism disorders (eg, Vit. D deficiency) before starting. Monitor for hypocalcemia during therapy. Ensure adequate Vit. D and calcium intake. Sodium restriction (including heart failure, hypertension, or other cardiovascular diseases). Consider discontinuing therapy during invasive dental procedures (eg, tooth extraction, implants, boney surgery). History of bisphosphonate exposure: eva luate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Reeva luate periodically. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):
Calcium supplements, antacids, other multivalent cations reduce absorption (separate dosing by at least 30min). Increased upper GI events with aspirin-containing products and alendronate >10mg/day; caution with NSAIDs.

Adverse Reaction(s):
Abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain (may be severe), nausea; esophagitis, esophageal ulcers or erosions; jaw osteonecrosis, atypical femur fractures; rarely: gastric or duodenal ulcer.

How Supplied:
Tabs—4, 12

Last Updated:
10/31/2012

制造商：
任务医药品公司

药理分类：
双膦酸盐。

“活性成分”（词）：
阿仑膦酸钠（钠）70毫克，口服SOLN;草莓味泡腾片标签包含650mg钠/标签。

指示（S）：
绝经后骨质疏松症的治疗。男性骨质疏松患者骨量的增加。

药理作用：
阿仑膦酸钠绑定到骨的羟基磷灰石，并特异性地抑制破骨细胞的活性，骨吸收的细胞。它可减少骨吸收与骨形成没有直接的影响，尽管后者最终降低骨转换过程中，因为骨吸收和骨形成耦合。

临床试验：
Binosto泡腾片70毫克（阿仑膦酸钠）是具有生物等效性阿仑膦酸钠片剂70毫克。骨折复位疗效和骨密度变化归因于Binosto 10mg，每日阿仑膦酸钠和阿仑膦酸钠70毫克每周的临床试验数据的基础上，。

法律分类：
接收

成人：
一个选项卡4盎司平原（矿物质）水溶解;在泡腾停止后，等待5分钟，搅拌SOLN 10secs。以在上午前至少30分钟，第一食品，饮料或药物的一天。请勿躺下休息至少30分钟，直到后第一食品的一天。 70毫克，每周一次。

儿童：
不推荐。

禁忌（S）：
延迟的食管异常的食管排空（例如，狭窄，贲门失弛缓症）。无法站立或坐直至少30分钟。风险增加的愿望。低钙血症。

警告/注意事项：
活动上消化道疾病，停止和重新评估，如果出现的食管反应的症状/体征。严重肾功能不全（肌酐清除率<35mL/min）：不推荐使用。纠正已经存在的低钙血症或其他矿物质代谢疾病（如维生素D缺乏症），然后再开始。在治疗过程中发生低血钙的监测。确保有足够的维生素。 D和钙的摄入量。限钠（包括心脏衰竭，高血压或其他心血管疾病）。在侵入性牙科手术（如拔牙，植入物，骨多的手术）考虑停止治疗。双膦酸盐暴露评估非典型骨折，如果大腿/腹股沟疼痛的发展，考虑风险/效益评估的预扣税治疗，直到史。重新评估定期。怀孕（Cat.C）。哺乳期的母亲。

互动（补）：
钙补充剂，抗酸剂，其他多价阳离子的吸收减少（单独给药至少30分钟）。含阿司匹林的产品和阿仑膦酸钠> 10mg/day增加上消化道事件的谨慎使用非甾体抗炎药。

不良反应（S）：
腹部疼痛，反酸，便秘，腹泻，消化不良，肌肉骨骼疼痛（可能是严重的），恶心，食管炎，食管溃疡或糜烂;颚骨坏死，非典型股骨骨折;很少：胃或十二指肠球部溃疡。

如何提供：
标签-4，12

最后更新：
2012年10月31号