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  药店国别: 美国药房
产地国家: 美国
所属类别: 作用于消化系统药物->治疗肠道疾病
处方药:处方药
包装规格: 1000毫克/栓剂 30栓剂/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
Allergan, Inc.
生产厂家英文名:
Allergan, Inc.
该药品相关信息网址1:
www.canasa.com/
该药品相关信息网址2:
www.rxlist.com/canasa-drug.htm
该药品相关信息网址3:
www.drugs.com/cdi/canasa-suppositories.html
原产地英文商品名:
CANASA 1000MG/SUPPOSITORY 30SUPPOSITORIES/BOX
原产地英文药品名:
MESALAMINE
中文参考商品译名:
CANASA 1000毫克/栓剂 30栓剂/盒
中文参考药品译名:
美沙拉嗪
中文参考化合物名称:
5-氨基水杨酸栓剂
原产地国家批准上市年份:
2001/01/05
英文适应病症1:
Ulcerative Colitis
英文适应病症2:
Crohn's disease
英文适应病症3:
Ulcerative proctitis
临床试验期:
完成
中文适应病症参考翻译1:
溃疡性结肠炎
中文适应病症参考翻译2:
克罗恩病
中文适应病症参考翻译3:
溃疡性直肠炎
药品信息:

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 详细处方信息以本药内容附件PDF文件(202122119321319.pdf)的“原文Priscribing Information”为准
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 部分中文美沙拉嗪处方资料(仅供参考)

英文药名: Canasa (Mesalamine Suppositories)

中文药名: 美沙拉嗪, 5-氨基水杨酸栓剂

药品说明
英文名: Mesalazine
别名: 5-氨基水杨酸 5-Amino Salicylic Acid
性状: 本品为淡褐色至粉红色针状结晶,无臭或有轻微的臭味。在空气中颜色变深。在水中微溶,在乙醇、丙酮及甲醇中极微溶,在氯仿,乙醚,丁醇及丙醇中不溶。在稀盐酸和稀氢氧化碱的溶解。

适应症: 用于治疗溃疡性结肠炎、Crohn病;栓剂用于治疗溃疡性直肠炎,可同时协用美沙拉嗪片剂。

药理作用: 美沙拉嗪作用于肠道炎症粘膜,抑制引起炎症的前列腺素的合成和炎性介质白三烯的形成,从而对肠道壁炎症起显著的消炎作用,对发火的肠壁结缔组织效用尤佳,从而对溃疡性结肠炎、克隆病(Crohn's Disease)起治疗作用。美沙拉嗪缓释片由乙基纤维素包衣的美少拉嗪向颗粒(直径0.7-1mm)组成,在胃中开始崩解,微颗粒通过幽门进入小肠,不需胃排空,无药物大量倾释现象,无血药峰浓度,在胃中残留时间短,服药后20分钟内血中即可测出美沙拉嗪,在整个pH宽的肠道内以常速持续均匀释放,在肠道传递时间的降低对美沙拉嗪的释放影响极小,且吸收相对没有改变,它不受肠内菌丛的影响。自十二指肠至结肠均匀缓慢持续释放美沙拉嗪。口服美沙拉嗪约50%在小肠内释放,50%在大肠内释放。缓释片还可防止美沙拉嗪在近端小肠被过早吸收,从而保证它在远端小肠具有较高的生物利用度。因美沙拉嗪在整个肠道的均匀释放,它可安全、有效地治疗慢性肠道炎症性疾病。美沙拉嗪栓剂由缓释微囊组成,可直接到达作用部位,缓慢释放,局部浓度高,栓剂形状与生理结构吻合,可有效地治疗溃疡性结肠炎。 体内过程 美沙拉嗪的常规制剂口服后广泛被上消化道吸收,很少达到结肠,t1/2约1小时,蛋白结合率为40%-50%。因此,多制成缓释剂型,以使其在结肠中发挥局部作用。美沙拉嗪在结肠释放后转化为乙酰氨基水杨酸,乙酰氨基水杨酸一部分被肠道内细菌分解,从粪便中排出,另一部分由肠粘膜吸收,约40%与血浆蛋白结合,在体内代谢生成乙酰化物,约80%与血浆蛋白结合,从尿中排出,t1/2为5-10小时,很少透过胎盘和进入乳汁。

规格: 栓剂:0.5g, 1g。

用法用量: 用量
口服:成人,溃疡性结肠炎(急性发作):每天4次,每次1g;维持治疗,每天3次,每次0.5g。
Crohn病:每天4次,每次1g。2岁以上儿童,每公斤体重每日服20-30mg,分次给药。
栓剂:成人,每日1-2次,每次1栓剂。两岁以上儿童,遵医嘱。

不良反应:
1.可能引起轻微胃肠不适、恶心、口干、便秘或腹泻。
2.个别人有头晕、头痛、定向障碍;关节痛、痉挛性肌痛及氨基转移酶和BUN升高。

注意事项
1.对水杨酸类药物及本品的赋形剂过敏者忌用。
2.肝、肾功能不全者慎用。怀孕及哺乳的病人慎用。2岁以下儿童不宜用。
3.本品与氰钴胺片剂(维生素B12片)同时服用时,将影响氰钴胺片的吸收。
4.用法注意:片剂:最好整粒吞服,也可掰开或用水冲服;但绝不可嚼碎或压碎。若因故漏服一剂量时,应尽快补服或与下次剂量同时补服。若有多次剂量漏服,仍按处方继续服用及尽快与医师联系。栓剂:使用前应先排便,用乳胶指套将栓剂从肛门塞入,若栓剂在10分钟内流泻时,需重新塞入另一栓剂,为方便塞入,可用水、凡士林及其他润滑物润湿。若因故漏用一剂量时,应按处方继续使用,若多次剂量漏用,仍按处方继续使用。

贮藏: 片剂置室温(15-25℃)贮存,不可在失效期后服用;栓剂,应以原包装置室温中(15-25℃)贮存,不可在失效期后使用。

2004年11月9日,Axcan PH公司宣布,美国FDA已经批准每日使用1次的1g美沙拉嗪栓(mesalamine suppository)用于治疗直肠溃疡。
仅在美国市场,直肠栓剂的年市场价值就近8000万美元。据IMS公司2004年8月公布的数据显示,Axcan 公司CANASA 500mg的处方量占美国市场美沙拉嗪直肠栓剂处方量的55%,已经成为美国市场上处方量最大的美沙拉嗪直肠栓剂商标名药。
Axcan公司已经在加拿大以SALOFALK为商标名销售1g直肠栓,该新产品在美国以CANASA为商品名上市。
直肠溃疡是溃疡性结肠炎的一种,是最常见的炎症性肠疾病。近30%的溃疡性结肠炎患者起病于直肠溃疡。据估计,目前在美国有100万炎症性肠疾病患者,每年的新增病例近40万。

Canasa Suppositories
Pronunciation: me-SAL-a-meen
Generic Name: Mesalamine
Brand Name: Canasa

Canasa Suppositories are used for:
Treating various forms of mild to moderate inflammation of the colon.

Canasa Suppositories are a 5-aminosalicylic acid (5-ASA). It works by preventing the production of substances that cause the inflammation of the colon.

Do NOT use Canasa Suppositories if:
you are allergic to any ingredient in Canasa Suppositories, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen), or salicylates (eg, aspirin)
you are younger than 18 years old and you have the flu or chickenpox or have received a live vaccine (eg, varicella, influenza) within the past 6 weeks
you are taking probenecid or sulfinpyrazone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Canasa Suppositories:
Some medical conditions may interact with Canasa Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines (including sulfasalazine), foods, or other substances
if you have had a stroke, bleeding in the brain, or an aneurysm
if you have a history of liver or kidney problems, pancreas problems (eg, pancreatitis), Kawasaki syndrome, or a rheumatic (inflammatory) disease (eg, rheumatoid arthritis)
if you have a history of heart problems (eg, inflammation of the sac around your heart)
if you have the flu or chickenpox, or if you have recently received a live vaccine (eg, varicella, influenza)

Some MEDICINES MAY INTERACT with Canasa Suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:
Ginkgo biloba extract because side effects, such as increased bleeding, may occur
Corticosteroids (eg, prednisone) because they may decrease Canasa Suppositories's effectiveness
Carbonic anhydrase inhibitors (eg, acetazolamide), insulin, meglitinide antidiabetics (eg, repaglinide), sulfonylureas (eg, glipizide), or valproic acid because the risk of their side effects may be increased by Canasa Suppositories
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), probenecid, spironolactone, or sulfinpyrazone because their effectiveness may be decreased by Canasa Suppositories

This may not be a complete list of all interactions that may occur. Ask your health care provider if Canasa Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Canasa Suppositories:
Use Canasa Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Wash your hands before and after using Canasa Suppositories. If the suppository is too soft to use, put it in the refrigerator for about 15 minutes. You may also run cold water over it. Remove the wrapper. Moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum. Use your finger to push it in completely.
Do not handle the suppository too much. This will cause the suppository to melt before it can be inserted.
For best results, keep the suppository inserted for at least 1 to 3 hours.
Use Canasa Suppositories for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Canasa Suppositories, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Canasa Suppositories.

Important safety information:
Canasa Suppositories may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Canasa Suppositories with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Canasa Suppositories may stain clothing, other fabrics, or surfaces. Avoid contact of Canasa Suppositories with your clothes, other fabrics, or surfaces.
Canasa Suppositories may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Canasa Suppositories. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Some patients may experience an intolerance reaction to Canasa Suppositories. Signs of intolerance are very similar to symptoms of inflammatory bowel disease. They may include severe or persistent stomach pain or cramping, blood diarrhea, fever, headache, or rash. If you experience any of these symptoms, contact your doctor right away.
Salicylates have been linked to a serious illness called Reye syndrome. Do not give Canasa Suppositories to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
Lab tests, including kidney function, liver function, or complete blood cell counts, may be performed while you use Canasa Suppositories. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Canasa Suppositories with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
Canasa Suppositories should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Canasa Suppositories while you are pregnant. It is not known if Canasa Suppositories are found in breast milk. If you are or will be breast-feeding while you use Canasa Suppositories, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Canasa Suppositories:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; gas; hair loss; headache; mild stomach discomfort or pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or coffee ground-like vomit; bloody stools; chest pain; dark urine; fever, chills, or sore throat; severe headache; shortness of breath; sudden or severe stomach pain or cramping; unusual bruising or bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; diarrhea; dizziness; drowsiness; fast or difficult breathing; fever; headache; hearing loss; ringing in the ears; seizures; sweating; vomiting of blood; weakness.

Proper storage of Canasa Suppositories:
Store Canasa Suppositories below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Canasa Suppositories out of the reach of children and away from pets.

General information:
If you have any questions about Canasa Suppositories, please talk with your doctor, pharmacist, or other health care provider.
Canasa Suppositories are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Canasa Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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 详细处方信息以本药内容附件PDF文件(202122119321319.pdf)的“原文Priscribing Information”为准
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更新日期: 2021-2-22
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