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SUPREP清肠套装RECONST口服液

2011-03-14 21:21:07  作者:新特药房  来源:中国新特药网天津分站  浏览次数:591  文字大小:【】【】【
简介: SUPREP是一种有效SUPREP灌肠(硫酸钠,硫酸钾和硫酸镁)口服液 美国初步批准:08/2010 适应症 SUPREP灌肠准备工具包是一个渗透在筹备泻药清洁的结肠的结肠镜检查在成人表示 剂量和用法 稀溶液后使 ...

SUPREP是一种有效灌肠(硫酸钠,硫酸钾和硫酸镁)口服液

美国初步批准:08/2010

适应症
SUPREP灌肠准备工具包是一个渗透在筹备泻药清洁的结肠的结肠镜检查在成人表示


剂量和用法
稀溶液后使用。

分割剂量(2天)养生

结肠镜检查前一天晚上:稀释1瓶16水和饮料全部金额盎司。
饮料在未来32小时盎司的水。
第二天早上:重复这两个步骤使用第二瓶。
编制完成结肠镜检查前至少1小时。


剂型和优势
两个6口服溶液盎司瓶


禁忌
肠胃道阻塞
肠穿孔
胃内滞留
肠梗阻
有毒或毒性巨结肠结肠炎
众所周知,该工具包组件过敏


注意事项:
流体和电解质异常,心律失常,癫痫发作和肾功能损害的风险,同时药物评估,并考虑在一些病人测试
肾功能不全,患者谨慎使用,确保有足够的水化,并考虑测试(5.4)
消化道阻塞或穿孔怀疑 - 给药前诊断出规则
在误吸风险的病人 - 观察期间的管理
不直接摄入 - 稀释,并采取额外的水


不良反应
最常见(≥3%)的不良反应有:总体不适,腹胀,恶心,腹部绞痛,呕吐


药物相互作用
有些药物的风险增加,由于水,电解​​质的变化
采取口服药物后1小时各剂量开始可能不被吸收好 


 
【产地英文商品名】:SUPREP BOWEL PREP KIT RECONST ORAL SOLN 354mls/bottle
【原产地英文药品名】:SODIUM SULFATE/POTASSIUM SULFATE/MAGNESIUM SULFATE
【中文参考商品译名】:SUPREP清肠套装RECONST口服液 354毫升/瓶
【中文参考药品译名】:硫酸钠/硫酸钾/无水硫酸镁
【生产厂家中文参考译名】:BRAINTREE LABS
【生产厂家英文名】:BRAINTREE LABS

What to Expect with SUPREP Bowel Prep Kit

 
Be sure to follow your doctor’s instructions and carefully read the information that comes with SUPREP Bowel Prep Kit. Your doctor will tell you when it is time to begin taking SUPREP Bowel Prep Kit.

SUPREP is a low-volume bowel preparation that is taken as a split-dose regimen. A split-dose regimen means that you take two 6-ounce bottles of SUPREP Bowel Prep Kit. The first 6-ounce bottle is taken the evening before your colonoscopy and the second 6-ounce bottle is taken the morning of your colonoscopy.

The evening before your colonoscopy, pour the 6-ounce bottle of SUPREP liquid into the mixing container that comes with the kit. Then add cool water to the 16-ounce line on the container and mix. Drink all the liquid in the container. You MUST drink two more 16-ounce containers of water over the next hour.

Follow these same directions for preparing and taking the second 6-ounce bottle of SUPREP Bowel Prep Kit on the morning of your colonoscopy. You MUST finish drinking the final glass of water at least 1 hour before your colonoscopy.

In clinical studies, the most common side effects that people experienced with SUPREP Bowel Prep Kit were overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache.


Call your doctor if you have any questions about taking SUPREP Bowel Prep Kit.

SUPREP® Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

Suprep Bowel Prep Kit
Suprep (Soo-prěp)
(sodium sulfate, potassium sulfate and magnesium sulfate)
Oral Solution

What is the most important information I should know about Suprep Bowel Prep Kit?
Suprep Bowel Prep Kit and other osmotic bowel preparations can cause serious side effects, including:
Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood.
These changes can cause:
• abnormal heartbeats that can cause death
• seizures. This can happen even if you have never had a seizure.
• kidney problems

Your chance of having fluid loss and changes in body salts with Suprep Bowel Prep Kit is higher if you:
• have heart problems
• have kidney problems
• take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Suprep Bowel Prep Kit:
• vomiting that prevents you from keeping down the additional prescribed amount of water listed in the Instructions for Use in the Patient Instructions for Use Booklet
• dizziness
• urinating less often than normal
• headache

See Section “What are the possible side effects of Suprep Bowel Prep Kit?” for more information about side effects.

What is Suprep Bowel Prep Kit?
Suprep Bowel Prep Kit is a prescription medicine used by adults to clean the colon before a colonoscopy. Suprep Bowel Prep Kit cleans your colon by causing you to have diarrhea. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

It is not known if Suprep Bowel Prep Kit is safe and effective in children.

Who should not take Suprep Bowel Prep Kit?
Do not take Suprep Bowel Prep Kit if your heathcare provider has told you that you have:
• a blockage in your bowel (obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (bowel)
• an allergy to any of the ingredients in Suprep Bowel Prep Kit. See the end of this leaflet for a complete list of ingredients in Suprep Bowel Prep Kit.

What should I tell my healthcare provider before taking Suprep Bowel Prep Kit?
Before you take Suprep Bowel Prep Kit, tell your healthcare provider if you:
• have heart problems
• have stomach or bowel problems
• have ulcerative colitis
• have problems with swallowing or gastric reflux
• have gout
• have a history of seizures
• are withdrawing from drinking alcohol
• have a low blood salt (sodium) level
• have kidney problems
• any other medical conditions
• are pregnant. It is not known if Suprep Bowel Prep Kit will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Suprep Bowel Prep Kit passes into your breast milk. You and your healthcare provider should decide if you will take Suprep Bowel Prep Kit while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Suprep Bowel Prep Kit may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of each dose of Suprep Bowel Prep Kit.

Especially tell your healthcare provider if you take:
medicines for blood pressure or heart problems
medicines for kidney problems
medicines for seizures
water pills (diuretics)
non-steroidal anti-inflammatory medicines (NSAID) pain medicines
laxatives
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Suprep Bowel Prep Kit?
See the Instructions for Use in the Patient Instructions for Use Booklet for dosing instructions. You must read, understand, and follow these instructions to take Suprep Bowel Prep Kit the right way.
• Take Suprep Bowel Prep Kit exactly as your healthcare provider tells you to take it.
• Do not drink Suprep Bowel Prep Kit solution that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Each bottle of Suprep Bowel Prep Kit must be mixed with water (diluted) before drinking.
• It is important for you to drink the additional prescribed amount of water listed in the Instructions for Use to prevent fluid loss (dehydration).
• Do not take other laxatives while taking Suprep Bowel Prep Kit.
• Do not eat solid foods while taking Suprep Bowel Prep Kit. Only clear liquids are allowed while taking Suprep Bowel Prep Kit.

What are the possible side effects of Suprep Bowel Prep Kit?
Suprep Bowel Prep Kit can cause serious side effects, including:
• See Section “What is the most important information I should know about Suprep Bowel Prep Kit?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take Suprep Bowel Prep Kit to check your blood for changes. Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
• vomiting
• nausea
• bloating
• dizziness
• stomach (abdominal) cramping
• headache
• urinate less than usual
• trouble drinking clear liquid
• heart problems. Suprep Bowel Prep Kit may cause irregular heartbeats.
• seizures
• ulcers of the bowel or bowel problems
• worsening gout

The most common side effects of Suprep Bowel Prep Kit include:
• discomfort
• bloating
• stomach (abdominal) cramping
• nausea
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Suprep Bowel Prep Kit. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Suprep Bowel Prep Kit?
• Store Suprep Bowel Prep Kit at room temperature, between 59°F to 86°F (15°Cto 30°C).

Keep Suprep Bowel Prep Kit and all medicines out of the reach of children.

General information about the safe and effective use of Suprep Bowel Prep Kit.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Suprep Bowel Prep Kit for a condition for which it was not prescribed. Do not give Suprep Bowel Prep Kit to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes important information about Suprep Bowel Prep Kit. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

What are the ingredients in Suprep Bowel Prep Kit?
Active ingredients: sodium sulfate, potassium sulfate and magnesium sulfate

Inactive ingredients: sodium benzoate, sucraiose, malic acid, citric acid, flavoring ingredients, purified water

Braintree Laboratories, Inc.

Braintree, MA 02185, USA

责任编辑:admin


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