英文药名: Nalcrom(cromoglycate sodium capsules)

中文药名: 色甘酸钠胶囊

生产厂家: Sanofi Aventis
药品名称
中文通用名称: 色甘酸钠
英文通用名称: Sodium Cromoglicate
其 它 名 称: 咽泰, 咳乐钠, 色甘酸二钠, Inostral, Intal, Cromoglycate Sodium,Cromolyn, Cromolyn Sodium, 色甘酸钠滴眼液, 色甘酸钠气雾剂, 色甘酸钠滴鼻液, Cromolyn Sodium Inhalation Aerosol Soln, Cromoglycate Disodium, Nalcrom, 宁敏, 衍行, Sodium Cromoglicate Aerosol, Sodium Cromoglicate Eye Drops, Sodium Cromoglicate for Inhalation, 吸入用色甘酸钠, 吸入用色甘酸钠胶囊, Sodium Cromoglicate Nasal Drops
产 品 分 类: 西药\呼吸系统用药\平喘药\过敏介质阻释药
适应症
1.可用于预防各型哮喘发作。
2.可用于过敏性鼻炎、季节性花粉症、春季角膜炎、结膜炎、过敏性湿疹及某些皮肤瘙痒症。
3.可用于溃疡性结肠炎和直肠炎。
用法用量
成人
•常规剂量
•吸入给药
1.支气管哮喘：
(1)干粉吸入：一次20mg，一日4次；症状减轻后，一日40-60mg；维持量，一日20mg。
(2)气雾吸入：一次3.5-7mg，一日3-4次，一日最大剂量32mg。
2.过敏性鼻炎：每侧一次10mg，一日4-6次。
•经眼给药季节性花粉症和春季过敏性角膜结膜炎：2%滴眼液，每侧一次2滴，一日4次，重症可适当增加到一日6次。在好发季节提前2-3周使用。
•外用过敏性湿疹及皮肤瘙痒症：5%-10%软膏涂患处。
•直肠给药溃疡性结肠炎、直肠炎：灌肠，一次200mg。
•肾功能不全时剂量
酌情减量。
•肝功能不全时剂量
酌情减量。
儿童
•常规剂量
•吸入给药
1.支气管哮喘：
(1)干粉吸入：5岁以上儿童用成人量，不能吸粉剂的幼儿避免使用。
(2)气雾吸入：
①6岁以上儿童：一日吸2次，剂量同成人。
②6岁以下儿童：很难做到使患儿协调吸药，故较少选用本药。
2.过敏性鼻炎：干粉吸入：6岁以上儿童，每侧一次10mg，一日2-3次。
•经眼给药结膜炎：4岁及4岁以上儿童，4%溶液，一次1-2滴，一日4-6次。
任何疑问，请遵医嘱！
给药说明
1.由于本药系预防性地阻断肥大细胞脱颗粒，而非直接舒张支气管，因此对于季节性外源性过敏原引起的支气管哮喘病例应在支气管哮喘好发时期前2-3周使用本药。运动性哮喘可在运动前15分钟给药。
2.极少数人在开始用药时出现哮喘加重，此时可先吸入少许扩张支气管的气雾剂，如异丙肾上腺素、沙丁胺醇。
3.原来用肾上腺皮质激素或其它平喘药治疗者，用本药后应继续用原药至少1周或至症状改善后，才能逐渐减量或停用原用药物。
4.获明显疗效后，可减少给药次数。如需停药，亦应逐步减量后再停，不能突然停药，以防哮喘复发。
5.本药对伴有肺气肿或慢性支气管炎的病人，疗效有限。对急性哮喘和哮喘持续状态无效。故如遇急性发作，应立即以常规方法治疗，并停用本药。
6.哮喘持续发作及严重呼吸困难者，色甘酸钠吸入不属首选治疗，应先用解痉药物或皮质激素以控制症状。
不良反应
1.偶见排尿困难、尿急、尿痛、头晕、严重或持续性头痛、喘鸣加重、关节痛或肿胀、肌痛或肌无力、恶心或呕吐、皮疹或皮肤瘙痒、口唇与眼睑肿胀、胸部紧束感、呼吸或吞咽困难等。
2.少数患者喷雾吸入干粉可出现鹗、咽喉干痒、呛咳、胸部紧迫感、鼻腔充血、支气管痉挛，甚至诱发哮喘。
3.对少数用滴鼻液、滴眼液的病人，初用时有局部刺激感。
[国外不良反应参考]
1.吸入可能导致短暂的支气管痉挛、喘鸣、咳嗽、鼻充血以及喉刺激症状。恶心、头痛、眩晕、味苦、关节疼痛和肿胀也有报道。在治疗几周或几个月后有时会出现其它一些反应，如哮喘加重、荨麻疹、肺嗜酸粒细胞浸润症、排尿困难以及尿频等。严重的反应[如显著的支气管痉挛、血管神经性水肿(如喉头水肿)以及其它过敏反应等]罕有报道，这些反应有时被称作假过敏。
2.鼻腔内使用可能导致短暂的鼻粘膜刺激症、喷嚏，偶尔出现鼻出血。
3.口服可引起恶心、皮疹和关节痛。
4.本药滴眼引起的短暂的烧灼和螫刺感也偶有报道。
注意事项
1.禁忌症对本药过敏者。
2.慎用肝、肾功能不全者。
3.药物对妊娠的影响孕妇慎用。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为B级。
4.药物对哺乳的影响哺乳期妇女慎用。
规格
色甘酸钠胶囊100mg。 
Nalcrom 100mg(Sodium Cromoglycate)
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Product Name
Nalcrom 100mg (Sodium Cromoglycate) 100 Capsules/Pack
Also known as Gastrocrom
Active Ingredient
Sodium Cromoglycate
Manufacturer
Douglas Pharmaceuticals

Nalcrom general information
What is Nalcrom used for?
Nalcrom capsules 100mg are used to treat chronic inflammatory conditions of the bowel (large intestine), such as proctitis (inflammation of the lining of the rectum) and proctocolitis (inflammation of the rectum and colon).  Proctitis and proctocolitis is commonly associated with inflammatory bowel diseases (IBD) and can also be caused by infection, both sexually transmitted and food borne infections, radiation therapy for cancer, antibiotics, and allergy to milk proteins in infants.  Symptoms include watery stools often containing mucus, bleeding from the rectum, diarrhoea and lower abdominal pain.  Nalcrom capsules 100mg are also used to treat ulcerative colitis, a chronic IBD that is thought to be an autoimmune condition, where cells of immune system that are found in the large intestine attacks normal healthy cells. 
This causes swelling, ulceration and loss of function of the colon and rectum, with symptoms including diarrhoea containing blood, lower abdominal pain, fatigue, weight loss, loss of appetite and bloating.  Nalcrom capsules 100mg are also used to treat food allergy disease, which is an allergic reaction to certain types of food, and should only be used following investigation of the diet into what food is causing the allergy. 
The most common foods that cause allergy are cow’s milk, egg, peanut, tree nuts, soy, wheat, shell fish and fish proteins.  Gastrointestinal symptoms of food allergy include include abdominal cramps, nausea, vomiting, and diarrhoea. 
When using Nalcrom capsules 100mg for treatment of food allergy, it is important to avoid eating foods that may cause an allergic reaction.  Nalcrom capsules 100mg help dampen down the allergic reaction that is a common factor in each of these conditions, to relieve symptoms.
How does Nalcrom work?
Nalcrom capsules 100mg contain sodium cromoglicate, an antiallergenic agent that works as a mast cell stabilizer and is used to treat conditions caused by allergic reactions in the bowel.  Mast cells are white blood cell that are part of the immune system and form the first line of defence against the environment, being found in tissues exposed to the environment like the intestines and lungs.  When mast cells are triggered by a pathogen or allergen, they produce chemicals including histamine and cytokines that are mediators in the allergic response and inflammatory response. 
Mast cells also play an important role in normal function of the intestine, including secretion of fluid by the intestinal mucosal lining, permeability of the intestinal mucosa, gastrointestinal motility, (peristalsis - which is muscular contraction that helps move food through the intestine) and visceral sensation by stimulation nerve cells in the intestinal wall. 
Under certain conditions, the numbers of mast cells can increase above normal levels resulting in production of these mediators in higher than normal levels.  Increased numbers of mast cells is thought to be involved in the pathogenesis of chronic inflammatory disorders of the bowel including IBD and is the result of a local inflammatory response.  A food allergy can be described as an exaggerated by the immune system response to a harmless protein (the allergen). 
If permeability of the intestine is altered by the release of mast cell mediators, this may also allow the food allergen to become absorbed and cause systemic allergic reactions.  Infection or allergy in the intestine can result in abnormal immune and allergic reactions resulting in the symptoms due to chronic inflammatory bowel disorders and food allergy.  Sodium cromoglicate in Nalcrom capsules 100mg inhibits the release of mast cell mediators, which stabilises the mast cells, preventing the local inflammatory reaction in the gastrointestinal tract, as well as the possibility of a secondary systemic reaction in other organs caused by leakage of antigenic materials into the general circulation.  This action of Sodium cromoglicate in Nalcrom capsules 100mg reduces symptoms induced by these mediators in chronic inflammatory conditions of the bowel and food allergy. 
What does Nalcrom contain?
Nalcrom capsules contain the active ingredient sodium cromoglicate 100mg, used to treat chronic inflammatory conditions of the bowel.  They also contain purified water, No 2 hard gelatin capsules, Black ink containing water, ethyl alcohol, Iso-propyl alcohol, propylene alcohol, N-butyl alcohol, Shellac, potassium hydroxide, Iron oxide black (E172)
Treating inflammatory bowel conditions with Nalcrom
Nalcrom capsules 100mg contain sodium cromoglicate, an antiallergenic agent that is used to treat chronic inflammatory conditions of the bowel (large intestine), such as proctitis (inflammation of the lining of the rectum) and proctocolitis (inflammation of the rectum and colon).  Proctitis and proctocolitis are commonly associated with inflammatory bowel diseases (IBD) and can also be caused by infection, both sexually transmitted and food borne infections, radiation therapy for cancer, antibiotics, and allergy to milk proteins in infants.  Symptoms include watery stools often containing mucus, bleeding from the rectum, diarrhoea and lower abdominal pain. 
Nalcrom capsules 100mg are used to treat ulcerative colitis, a chronic IBD that is thought to be an autoimmune condition, where cells of immune system that are found in the large intestine attack normal healthy cells. 
This causes swelling, ulceration and loss of function of the colon and rectum, with symptoms including diarrhoea containing blood, lower abdominal pain, fatigue, weight loss, loss of appetite and bloating.  Mast cells are white blood cell that are part of the immune system and form the first line of defence against the environment, being found in tissues exposed to the environment like the intestines. 
When mast cells are triggered by a pathogen or allergen, they produce chemicals including histamine and cytokines that are mediators in the allergic and inflammatory responses. 
Mast cells also play an important role in normal function of the intestine, including secretion of fluid by the intestinal mucosal lining, permeability of the intestinal mucosa, gastrointestinal motility, (peristalsis - which is muscular contraction that helps move food through the intestine) and visceral sensation by stimulation nerve cells in the intestinal wall. 
Under certain conditions, the numbers of mast cells can increase above normal levels resulting in production of these mediators in higher than normal levels.  Increased numbers of mast cells is thought to be involved in the pathogenesis of chronic inflammatory disorders of the bowel including IBD causing a local inflammatory reaction in the intestine. 
Sodium cromoglicate in Nalcrom capsules 100mg inhibits the release of mast cell mediators, which stabilises the mast cells, preventing the local inflammatory reaction in the gastro-intestinal tract, as well as the possibility of a secondary systemic reaction in other organs caused by leakage of antigenic materials into the general circulation, this reduces symptoms induced by these mediators in chronic inflammatory conditions of the bowel. 
Nalcrom for food allergy
Nalcrom capsules 100mg contain sodium cromoglicate, an antiallergenic agent that is used to treat food allergy disease, which is an allergic reaction to certain types of food, and should only be used following investigation of the diet into what food is causing the allergy.  The most common foods that cause allergy are cow’s milk, egg, peanut, tree nuts, soy, wheat, shell fish and fish proteins. 
Gastrointestinal Symptoms of food allergy include symptoms include abdominal cramps, nausea, vomiting, and diarrhoea. 
When using Nalcrom capsules 100mg for treatment it is important to avoid eating foods that may cause an allergic reaction.  Mast cells are white blood cell that are part of the immune system and form the first line of defence against the environment, being found in tissues exposed to the environment like the intestines.  When mast cells are triggered by an allergen, they produce chemicals including histamine and cytokines that are mediators in the allergic and inflammatory responses. 
Mast cells also play an important role in normal function of the intestine, including secretion of fluid by the intestinal mucosal lining, permeability of the intestinal mucosa, gastrointestinal motility, (peristalsis - which is muscular contraction that helps move food through the intestine) and visceral sensation by stimulation nerve cells in the intestinal wall.  Under certain conditions, the numbers of mast cells can increase above normal levels resulting in production of these mediators in higher than normal levels.  Increased numbers of mast cells is thought to be involved in the pathogenesis of an allergic reaction to some foods. 
A food allergy can be described as an exaggerated response by the immune system to a harmless protein (the allergen). If permeability is altered by the release of mast cell mediators, this may allow the food allergen to become absorbed and cause systemic allergic reactions. 
Sodium cromoglicate in Nalcrom capsules 100mg inhibits the release of mast cell mediators, which stabilises the mast cells, preventing local allergic reaction in the gastro-intestinal tract, as well as the possibility of a secondary systemic reaction in other organs caused by leakage of antigenic materials into the general circulation.  This action of Sodium cromoglicate in Nalcrom capsules 100mg reduces symptoms induced by these mediators in food allergy. 
What are the side effects of Nalcrom?
Side effects are not common when using Nalcrom capsules 100mg and those reported include nausea, skin rashes and joint pains.
When should Nalcrom not be used?
You should not use Nalcrom capsules 100mg if you:
•are allergic to sodium cromoglicate or any ingredients in Nalcrom
•are pregnant or are breastfeeding, without discussion with your doctor
How should Nalcrom be taken?
You should take your Nalcrom capsules 100mg four times daily and before a meal.  The dose you take and for how long depends on your doctors recommendation, age (different dose for adults and children) and what you are being treated for. You should continue you take your Nalcrom capsules 100mg until your symptoms have been controlled, which may take several weeks followed by maintenance as directed by your doctor.
How long should you take Nalcrom?
You should continue you take your Nalcrom capsules 100mg until your symptoms have been controlled, which may take several weeks followed by maintenance as directed by your doctor.
Missed dose of Nalcrom
If you miss a dose of Nalcrom capsules 100mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.
How should Nalcrom be stored?
You should store your Nalcrom capsules 100mg below 25°C in a cool dry place