药品名称
通用名称：美沙拉嗪，5-氨基水杨酸
英文名：Mesalazine，5-Amino Salicylic Acid, Asacolitin, Claversal, Enterasin, Etiasa, Fisalamine, FIV-ASA, Pentasa-R, Zinc 5-aminosalicylate, Mesalazinum, Mesasal, Rowasa, Salofalk, Saloflk, 5-Aminosalicylic Acid, 5-ASA
规格
灌肠: 2gm/60ml，4gm/60ml; 肠溶片剂: 0.5g; 栓剂: 0.5g, 1.0g/支。
药理作用
对肠壁的炎症有显著的抑制作用；美沙拉嗪可以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，从而对肠粘膜的炎症起显著抑制作用。对有炎症的肠壁的结缔组织效果更佳。
适应症
用于溃疡性结肠炎、溃疡性直肠炎和克隆氏病(Crohn's Disease)。
用法用量
片剂:
成人
①溃疡性结肠炎:1.0/次；4次/日，维持治疗剂量为0.5/次；3次/日。
②克隆氏病:1.0/次；3～4次/日。
儿童:每日20～30mg/kg。
栓剂:成人:1个/次；1～2个/日。儿童:两岁可以考虑使用，具体剂量遵医嘱。
不良反应
可能出现轻度的胃部不适。
注意事项
①对水杨酸类药物以及本品的赋形剂过敏者忌用。
②肝肾功能不全者慎用；妊娠及哺乳期妇女慎用；两岁以下儿童不宜用。
③与氰钴胺片(VitB12片)同有，将影响氰钴胺片的吸收。
④服药时要整粒囫囵吞服，绝不可嚼碎或压碎。
Salofalk (mesalazine)
Main use：Ulcerative colitis
Active ingredient：Mesalazine
Manufacturer：Dr Falk
How does it work?
Salofalk tablets, granules, suppositories, enema and rectal foam all contain the active ingredient mesalazine, which is a type of medicine called an aminosalicylate. It is used to reduce inflammation in the intestines in a condition called ulcerative colitis.
Ulcerative colitis is a condition in which there is inflammation of the large intestine. This results in ulceration and bleeding in the intestine and causes symptoms that include abdominal pain and diarrhoea that is mixed with blood, pus and mucus.
Mesalazine works by reducing the inflammation in the intestine, which in turn reduces the symptoms of the disease. The way in which mesalazine does this is not fully understood.
Salofalk suppositories, enema and rectal foam are administered into the back passage (rectum) to deliver the mesalazine directly to the site of inflammation in the lower end of the large intestine and rectum. They are used for the short-term treatment of attacks of ulcerative colitis, particularly when the inflammation is largely in this area of the bowel.
Salofalk tablets and granules are taken by mouth. Both these dose forms have a special coating that allows the medicine to pass through the stomach and be released in the intestine. They are used for the short-term treatment of symptoms and can also be taken on a continuous basis to control the inflammation in the intestine and help prevent attacks.
What is it used for?
Ulcerative colitis.
All forms of Salofalk can be used to treat mild to moderate symptoms of ulcerative colitis. Salofalk tablets, granules and enema can also be used continuously to help prevent attacks.
Warning!
Salofalk tablets must be swallowed whole, not chewed.
Salofalk granules should be taken on the tongue and swallowed, without chewing, with plenty of liquid.
Salofalk suppositories, enema and rectal foam are for administration into the back passage and must not be taken by mouth.
This medicine may rarely cause a decrease in the normal amounts of blood cells in the blood. For this reason you should consult your doctor immediately if you experience any of the following symptoms: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want to take a blood test to check your blood cells.
If you are taking mesalazine by mouth, your kidney function should be checked before you start treatment. Your kidney function should then be monitored every three months for the first year of treatment, every six months for the next four years and once a year thereafter.
Use with caution in
Decreased kidney function.
Decreased liver function.
Asthma.
Salofalk granules should be used with caution in people with an inherited disorder of protein metabolism called phenylketonuria. The granules contain aspartame, which is a source of phenylalanine.
Not to be used in
Allergy to salicylates (eg aspirin).
Active peptic ulcer.
Blood clotting abnormalities.
Severely decreased kidney function.
Severely decreased liver function.
Salofalk tablets, suppositories, enema and rectal foam are not recommended for children under 12 years of age. Salofalk granules should not be used in children under 6 years of age.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
This medicine should be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the foetus. Seek medical advice from your doctor.
This medicine passes into breast milk in small amounts. The effect of this on the breastfed baby is unknown, therefore this medicine should be used with caution in breastfeeding mothers. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Abdominal pain.
Diarrhoea and vomiting.
Nausea.
Excess gas in the stomach and intestines (flatulence).
Headache.
Dizziness.
Allergic skin rashes.
Worsening of colitis symptoms.
Pain in the muscles or joints.
Inflammation of the pancreas (pancreatitis).
Inflammation of the liver (hepatitis).
Kidney problems.
Decreases in the normal numbers of blood cells in the blood.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.
You should not take indigestion remedies (antacids) at the same time of day as Salofalk tablets. This is because Salofalk tablets have a special enteric coating that lets them pass through the stomach and into the intestine, where the medicine is needed. Indigestion remedies reduce the acidity in the stomach, allowing the tablets to dissolve there rather than letting them reach the intestine.
If lactulose or other medicines that change the acidity of stools are taken with Salofalk tablets or granules, they may prevent the mesalazine being released from these dose forms in the large intestine, and so could make the Salofalk less effective.
There may be an increased risk of side effects on the blood cells if mesalazine is used in combination with azathioprine or mercaptopurine.
Other medicines containing the same active ingredient
Asacol
Ipocol
Mesren MR
Mezavant XL
Pentasa
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原产地英文商品名:
SALOFALK AEROSOL 1g/aplicacion 14aplicaciones/box
原产地英文药品名:
MESALAZINE
中文参考商品译名:
莎尔福气雾剂 1克/剂 14剂/盒
中文参考药品译名:
美沙拉嗪
生产厂家中文参考译名:
福柯博士医药
生产厂家英文名:
DR Falk Pharma Espana 