英文药名: Sanctura XR(Trospium XR)

中文药名: 曲司氯铵缓释片

药品名称

这个药通常也叫: Trosec in Canada.
通用名：曲司氯铵片
英文名：Trospium　Chloride　Tablets
主要成分: 本品主要成分及其化学名称为：氯化－3－二苯乙醇酰基去甲莨菪烷－8－螺－1－吡咯烷。
性状: 本品为光滑的黄棕色包衣片。
药理毒理
本品为人工合成的具有四个铵基结构的托品酸衍生物，属副交感神经的阻滞药，作用类似于阿托品，主要通过与内源性神经递质乙酰胆碱竞争性结合突触后膜M-受体而起作用，对有副交感神经支配的器官起着降低副交感神经张力、去除因副交感神经引起的平滑肌痉挛的作用，对胃肠、胆道和泌尿道也有一定作用。本品脂溶性低而不易通过血脑屏障，不会产生中枢神经系统副作用。两种啮齿动物的急性和慢性毒性实验显示：可观察到的副作用是由于药效活性的提高所致，而不是特异性的靶器官毒性，且没有性别间的差异。在最大耐受剂量下无生殖毒性，体内体外实验显示无致基因突变效应和致癌效应。
药代动力学

口服本品20-60mg,药代动力学参数Cmax 和AUC0-inf与剂量成比例；当与高脂肪含量的早餐同服时，其生物利用度明显减少。　单剂量口服时，本品药代动力学参数个体差异很大，有关吸收和排泄参数的变异系数高达45%-65%；静脉给予时，药代动力学参数个体差异明显变小。　年轻男性受试者空腹单剂量口服20mg本品后，平均绝对生物利用度为9.6±4.5%。　
老年人药代动力学参数无明显变化。由于本品主要通过肾脏排泄，因此肾损害时会影响本品的药代动力学，肌酐清除率小于40ml/min的慢性肾衰患者应适当减少剂量。　
体外试验提示本品蛋白结合率很高，大约50%以上。　静脉给予同位素标记的本品，90%通过尿液和粪便排泄，大约分别为70%和20%。
适应症

膀胱过度活动症；尿频，夜尿症，非激素或器质病变所致膀胱功能紊乱（ 膀胱刺激、尿急）。
 
规格

60mg毫克/片* 28片

60mg毫克/片* 100片

Sanctura XR Description
Sanctura Xr 60mg is an antispasmodic and an antimuscarinic agent used to treat overactive bladder with symptoms such as incontinence, urgency, and frequency. Sanctura Xr 60mg may be used to treat other conditions as determined by your doctor.

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SANCTURA XR® (trospium chloride extended release capsules)
SANCTURA XR® (trospium chloride extended release capsules), approved by the U.S. Food and Drug Administration in August 2007, is a once daily medication for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

OAB is the most common cause of urinary incontinence or loss of bladder control in adults and affects approximately 33 million Americans.1 SANCTURA XR® belongs to a drug class of anticholinergic agents known as muscarinic receptor antagonists, which work by relaxing smooth muscle tissue found in the bladder, thus decreasing bladder contractions that are thought to be a cause of OAB.2 In clinical studies, SANCTURA XR® was shown to be effective and well tolerated by patients, demonstrating significant improvements in OAB symptoms. Dry mouth is a common side effect in this drug class, and SANCTURA XR® has a low incidence of dry mouth – just 10.7 percent. This is significant because as many as 70 percent of idiopathic OAB patients, the most common form of OAB, discontinue medication due to insufficient relief of symptoms or intolerable side effects (e.g., dry mouth, dry eyes, constipation, headache).3 Talk with your urologist about whether SANCTURA XR® is right for you.

Important Safety Information
SANCTURA XR® is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. It is also contraindicated in patients who have demonstrated hypersensitivity to the drug or any of its ingredients.

SANCTURA XR® should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. SANCTURA XR®, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis. In patients being treated for narrow-angle glaucoma, SANCTURA XR® should be used only if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring. SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute). Alcohol should not be consumed within two hours of SANCTURA XR® administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents. The most common adverse reactions with SANCTURA XR® were dry mouth (10.7 percent) and constipation (8.5 percent).

Sanctura XR Cautions
DO NOT TAKE SANCTURA XR 60mg if you have had an allergic reaction to it or are allergic to any ingredient in this product. Sanctura Xr 60mg may cause drowsiness or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to Sanctura Xr 60mg. Using Sanctura Xr 60mg alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT DRINK ALCOHOL WITHIN 2 HOURS before or after you take Sanctura Xr 60mg. DO NOT USE MEDICINES THAT MAY CAUSE DROWSINESS (eg, sleep aids, muscle relaxers) while you are using Sanctura Xr 60mg; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using Sanctura Xr 60mg. Sanctura Xr 60mg may cause dry mouth. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute. Sanctura Xr 60mg may reduce your ability to sweat. DO NOT BECOME OVERHEATED in hot weather or during exercise or other activities since heatstroke may occur. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING SANCTURA XR 60mg IN THE ELDERLY because they may be more sensitive to the effects of Sanctura Xr 60mg, especially dry mouth, constipation, stomach pain or upset, and trouble urinating. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Sanctura Xr 60mg during pregnancy. IT IS UNKNOWN IF SANCTURA XR 60mg IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using Sanctura Xr 60mg, check with your doctor or pharmacist to discuss the risks to your baby.

Sanctura XR Side Effects
SIDE EFFECTS that may occur while taking Sanctura Xr 60mg include constipation, dry mouth or eyes, gas, nasal dryness, nausea, or upset stomach. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR AS SOON AS POSSIBLE if you experience difficulty urinating or vision changes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; dark urine; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; or red, swollen, peeling, or blistered skin. AN ALLERGIC REACTION to Sanctura Xr 60mg is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects.

Sanctura XR Active Ingredients
Trospium