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  药店国别: 英国药房
产地国家: 德国
所属类别: 作用于消化系统药物->胃溃疡
处方药:处方药
包装规格: 200微克/ 1毫升/支, 10支/批
计价单位:
  点击放大  
生产厂家英文名:
Amdipharm Mercury (AMCo) Group
该药品相关信息网址1:
https://pubchem.ncbi.nlm.nih.gov/compound/glycopyrrolate
该药品相关信息网址2:
https://en.wikipedia.org/wiki/Glycopyrronium_bromide
原产地英文商品名:
Glycopyrronium Bromide 200 micrograms/ml Solution for Injection (Minimum order: 20)
原产地英文药品名:
glycopyrronium bromide
中文参考商品译名:
Glycopyrronium Bromide 200微克/ 毫升注射用溶液 (最低订购量:20)
中文参考药品译名:
甘罗溴铵
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
For gastrointestinal fistula, gastric ulcer and duodenal ulcer, chronic gastritis, excessive secretion of gastric juice.
英文适应病症2:
Intravenous or intramuscular injection can be used for pre-anesthetic administration to inhibit glandular secretion
英文适应病症3:
Used to reduce adverse reactions caused by anti-neuromuscular blockers
英文适应病症4:
Treatment of hyperhidrosis and bronchospasm
临床试验期:
完成
中文适应病症参考翻译1:
用于胃肠痉挛,胃溃疡及十二指肠溃疡、慢性胃炎、胃液分泌过多等
中文适应病症参考翻译2:
静注或肌注可用于麻醉前给药以抑制腺体分泌
中文适应病症参考翻译3:
用于减少抗神经肌肉阻滞剂引起的不良反应
中文适应病症参考翻译4:
治疗多汗症和支气管痉挛
药品信息:


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 详细处方信息以本药内容附件PDF文件(2018112623321717.pdf)的“原文Priscribing Information”为准
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部分Konakion MM处方资料(仅供参考

药品英文名:

Glycopyrronium Bromide

药品别名

甘罗溴铵、甘罗溴胺、格隆溴胺、胃长宁、溴环扁吡酯、甲比戊痉平、Glycopyrrolate Bromide、Robinul

药物剂型

1.片剂:0.25mg,0.5mg,1mg,2mg;

2.胶囊:0.5mg;

3.注射剂:0.2mg(1ml)。

药理作用

本药是一种类似阿托品的季铵类抗胆碱能药物,具有较强的抑制胃液分泌作用及轻微的胃肠道解痉作用。本药可以调节胃肠蠕动,降低胃液分泌量和游离酸浓度以及抑制气管和支气管的过度分泌。另外,本药还具有比阿托品更强的抗唾液分泌作用,且作用维持时间更长。此外,由于本药的季铵基团限制了它通过诸如血-脑脊液屏障这样的脂细胞膜,所以与中枢神经系统相关的不良反应发生极少。本药比等量的阿托品效力强5~6倍;其抗流涎作用较阿托品为佳,镇静作用较东莨菪碱轻;其加速心率、视力模糊,发热等不良反应较阿托品轻;延迟性瞳孔散大在阿托品全身用药时较为显著,但本药仅会引起很小的变化;本药与新斯的明合用纠正竞争性肌肉松弛药过量,与阿托品合用新斯的明相比,心动过速出现较少,止涎作用较佳。

药动学

本药口服给药生物利用度低,仅10%~25%吸收。肌注后10min达最大血药浓度,迷走阻滞作用持续2~3h,抑制腺体分泌作用可持续约7h;儿童口服后90min达最大血药浓度。本药不易透过血-脑脊液屏障,在脑脊液和胎盘中浓度低。本药48.5%经肾排泄,少量以原形经胆汁排泄,是否排泄入乳汁尚不清楚。静脉注射后1min内即可起效。

适应证

1.用于胃肠痉挛,胃溃疡及十二指肠溃疡、慢性胃炎、胃液分泌过多等。

2.静注或肌注可用于麻醉前给药以抑制腺体分泌。

3.用于减少抗神经肌肉阻滞剂引起的不良反应。

4.治疗多汗症和支气管痉挛。

禁忌证

1.幽门梗阻。

2.青光眼。

3.前列腺肥大。

4.对本药及其他抗胆碱能药物过敏者。

5.重症肌无力。

6.麻痹性肠梗阻或肠弛缓。

7.反流性食管炎。

8.溃疡性结肠炎或中毒性巨结肠症。

9.急性出血导致的心血管状态不稳定。

10.梗阻性尿路病变。

注意事项

1.慎用:

(1)自主神经功能障碍;

(2)充血性心力衰竭;

(3)冠心病;

(4)高血压;

(5)甲状腺功能亢进;

(6)回肠造口术或结肠造瘘术;

(7)心动过速;

(8)轻度肝、肾疾病;

(9)儿童和老年患者。

2.药物对妊娠的影响:

(1)本药0.004mg/kg的剂量可加快孕妇的心率,但对胎儿的心率无影响。且孕妇的血压和子宫收缩无明显改变。分娩时需用抗胆碱药治疗时,适用本药;

(2)已有研究表明,与未孕妇女相比,本药对孕妇(妊娠头三个月)的胃排空影响更大。

3.药物对哺乳的影响:本药可能引起泌乳的减少。

4.用药前后及用药时应当检查或监测:

(1)注意监测胃内容物量和pH值;

(2)用药过程中应监测心电图以预防心律失常的发生;

(3)观察胃肠疼痛或其他消化性溃疡症状的缓解;

(4)观察唾液、气管、支气管及咽部的分泌减少的情况;

(5)观察本药不良反应出现的情况。

(6)警惕过敏反应的出现。

5.用药期间应避免驾驶或从事具有潜在危险的工作。

6.本药不能与碱性药物混合。

不良反应

1.心血管系统:可引起心律失常。

2.中枢神经系统:可引起头痛、头晕、嗜睡、失眠、精神错乱。由于本药不能通过血-脑脊液屏障,故由其引起的中枢神经系统不良反应比其他抗胆碱能药少。

3.内分泌/代谢系统:本药可能引起泌乳的减少。

4.消化系统:

(1)本药的抗胆碱能特性可使食管下段括约肌松弛,降低食管下端压力,增加胃食管反流的可能性。其作用持续时间比阿托品长,且抗唾液分泌作用比阿托品更强,因此本药引起反流的可能性就更高;

(2)服药初期可出现口干(口苦)现象,在一到两周内可减轻或消失;

(3)本药还可能引起味觉丧失。

5.泌尿生殖系统:本药可能引起勃起功能障碍。

6.眼:国外有资料报道,本药大剂量会引起瞳孔放大,但还未发现本药常用剂量肌内注射或静脉注射会引起散瞳。此外,本药还可能引起睫状肌麻痹。

7.皮肤:本药可引起出汗减少,在环境温度高时可能导致发热和热衰竭。此外本药还可引起荨麻疹。

8.骨骼/肌肉:本药可引起神经肌肉阻滞并导致肌无力或瘫痪。

9.致畸性/对妊娠的影响:美国食品和药品管理局的妊娠危险性分类为B级。

10.其他:本药可引起过敏反应。

药物相应作用

1.本药与普鲁卡因胺合用时,可对房室结传导产生相加的抗迷走神经效应,其机制可能为两者药理作用的相互叠加。

2.本药与西沙必利合用时,可减弱西沙必利的促胃肠动力作用。

3.本药与利托君合用时,可导致室上性心动过速。

4.本药与环丙烷同时应用于麻醉治疗时可引起室性心律失常。

5.用药期间饮酒可使患者注意力下降。 专家点评 本品为抗胆碱药。临床很少用药。能选择性作用胃肠道,有较强抑制胃液分泌作用。用于溃疡病、胃炎、胃酸过多症等。本品为季铵抗毒蕈碱药。

其周围作用类似阿托品。

但本品抑制腺体分泌作用较强,临床多用于麻醉前给药,亦可作为消化性溃疡和缓解内脏痉挛的辅助药。

English name of the drug:

Glycopyrronium Bromide

Drug alias

Glyrobromide, glycopyrrolate, glycopyrrolate, stomach Changning, glycopyrrolate, indomethacin, Glycopyrrolate Bromide, Robinul

Pharmaceutical dosage form

1. Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg;

2. Capsule: 0.5mg;

3. Injection: 0.2 mg (1 ml).

Pharmacological action

This drug is a quaternary ammonium anticholinergic drug similar to atropine. It has a strong inhibitory effect on gastric secretion and a slight gastrointestinal dispelling effect. The drug can regulate gastrointestinal motility, reduce gastric secretion and free acid concentration, and inhibit excessive secretion of trachea and bronchus. In addition, the drug also has a stronger anti-saliva secretion than atropine, and the effect lasts longer. In addition, since the quaternary ammonium group of the drug limits its passage through a lipid cell membrane such as the blood-cerebrospinal fluid barrier, adverse reactions associated with the central nervous system occur very little. The drug is 5-6 times stronger than the equivalent atropine; its anti-drogue effect is better than atropine, and the sedative effect is lighter than that of scopolamine; its accelerated heart rate, blurred vision, fever and other adverse reactions are lighter than atropine; delayed pupil dilation Atropine is more effective when used systemically, but this drug only causes small changes; this drug is combined with neostigmine to correct competitive muscle relaxant overdose, and tachycardia is less than atropine combined with neostigmine. The anti-snoring effect is better.

Pharmacokinetics

The oral administration of the drug has low bioavailability and is only absorbed by 10% to 25%. The maximum blood concentration was reached 10 minutes after intramuscular injection, and the vagal block effect lasted for 2 to 3 hours. The inhibition of gland secretion lasted for about 7 hours; the maximum blood concentration was reached after 90 minutes of oral administration. The drug does not easily penetrate the blood-cerebrospinal fluid barrier and has a low concentration in the cerebrospinal fluid and placenta. 48.5% of the drug is excreted by the kidney, and a small amount is excreted in the original shape through the bile. It is not clear whether it is excreted into the milk. It can take effect within 1 minute after intravenous injection.

Indications

1. For gastrointestinal fistula, gastric ulcer and duodenal ulcer, chronic gastritis, excessive secretion of gastric juice.

2. Intravenous or intramuscular injection can be used for pre-anesthetic administration to inhibit glandular secretion.

3. Used to reduce adverse reactions caused by anti-neuromuscular blockers.

4. Treatment of hyperhidrosis and bronchospasm.

Contraindications

1. Pyloric obstruction.

2. Glaucoma.

3. Prostatic hypertrophy.

4. Those who are allergic to this medicine and other anticholinergic drugs.

5. Myasthenia gravis.

6. Paralytic ileus or intestinal flaccidity.

7. Reflux esophagitis.

8. Ulcerative colitis or toxic megacolon.

9. Cardiovascular instability caused by acute bleeding.

10. Obstructive urinary tract disease.

Notes

1. Use with caution:

(1) autonomic dysfunction;

(2) Congestive heart failure;

(3) coronary heart disease;

(4) High blood pressure;

(5) Hyperthyroidism;

(6) ileostomy or colostomy;

(7) tachycardia;

(8) mild liver and kidney disease;

(9) Children and elderly patients.

2. Effect of drugs on pregnancy:

(1) The dose of 0.004mg/kg of this drug can accelerate the heart rate of pregnant women, but has no effect on the fetal heart rate. There was no significant change in blood pressure and uterine contractions in pregnant women. This medicine is applicable when it is necessary to treat with anticholinergic drugs during childbirth;

(2) Studies have shown that this drug has a greater effect on gastric emptying in pregnant women (first trimester of pregnancy) than in pregnant women.

3. Effects of drugs on breastfeeding: This drug may cause a decrease in lactation.

4. Check or monitor before and after medication and medication:

(1) Pay attention to monitoring the amount of stomach contents and pH value;

(2) ECG should be monitored during medication to prevent arrhythmia;

(3) Observe the relief of gastrointestinal pain or other peptic ulcer symptoms;

(4) Observing the decrease in secretion of saliva, trachea, bronchi, and pharynx;

(5) Observe the occurrence of adverse reactions of this drug.

(6) Be alert to the emergence of allergic reactions.

5. Avoid driving or engaging in potentially hazardous work during medication.

6. This medicine cannot be mixed with alkaline drugs.

Adverse reactions

1. Cardiovascular system: can cause arrhythmia.

2. Central nervous system: can cause headache, dizziness, lethargy, insomnia, mental confusion. Because the drug can not pass the blood-cerebrospinal fluid barrier, the central nervous system adverse reactions caused by it are less than other anticholinergic drugs.

3. Endocrine/metabolic system: This medicine may cause a decrease in lactation.

4. Digestive system:

(1) The anticholinergic properties of this drug can relax the lower esophageal sphincter, reduce the pressure on the lower end of the esophagus, and increase the possibility of gastroesophageal reflux. Its duration of action is longer than that of atropine, and its anti-saliva secretion is stronger than atropine, so the possibility of reflux is higher in this drug;

(2) Dry mouth (mouth bitterness) may occur in the initial stage of administration, and may be alleviated or disappeared within one to two weeks;

(3) This medicine may also cause loss of taste.

5. Urogenital system: This medicine may cause erectile dysfunction.

6. Eyes: There are reports in foreign countries that a large dose of this drug will cause pupil dilation, but it has not been found that the usual dose of this drug, intramuscular or intravenous injection, can cause dilated sputum. In addition, the drug may also cause ciliary muscle paralysis.

7. Skin: This medicine can cause a decrease in sweating and may cause fever and heat exhaustion when the ambient temperature is high. In addition, the drug can also cause urticaria.

8. Bone/Muscle: This medicine can cause neuromuscular blockage and cause muscle weakness or paralysis.

9. Teratogenicity/Effects on Pregnancy: The US Food and Drug Administration's pregnancy risk is classified as Class B.

10. Other: This medicine can cause allergic reactions.

Usage and Usage

1. Oral administration: 1 to 2 mg each time, 3 to 4 times a day, after meals and before going to bed. The maintenance amount is 1 mg each time, twice a day. A single dose of 4mg, a daily maximum of 12mg.

2. Intramuscular injection: for pre-anesthesia administration, intramuscular injection 0.2 ~ 0.4mg. 3. Intravenous injection: for pre-anesthesia administration, intravenous injection 0.2 ~ 0.4mg. 4. Preoperative medication: To counteract the arrhythmia (such as bradycardia) associated with drug-induced or vagal traction during surgery, 0.1 mg can be administered intravenously. 5. For peptic ulcer: can be taken orally 1 ~ 2mg, 2 to 3 times a day.

The corresponding effect of drugs

1. When used in combination with procainamide, this drug may have an additive anti-vagal effect on the atrioventricular node conduction, and the mechanism may be a superposition of the pharmacological effects of the two.

2. When combined with cisapride, this drug can attenuate the gastrointestinal motility of cisapride.

3. When this medicine is combined with Litojun, it can cause supraventricular tachycardia.

4. This drug can cause ventricular arrhythmia when applied to anesthesia at the same time as cyclopropane.

5. Drinking alcohol during medication can reduce the patient's attention. Expert Reviews This product is an anticholinergic drug. It is rarely used clinically. It can selectively act on the gastrointestinal tract and has a strong inhibitory effect on gastric secretion. For ulcer disease, gastritis, hyperacidity and so on. This product is a quaternary ammonium antimuscarinic drug.

The effect around it is similar to atropine.

But this product inhibits glandular secretion, and is used clinically for pre-anesthesia administration. It can also be used as an auxiliary medicine for peptic ulcer and relief of visceral fistula.


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 详细处方信息以本药内容附件PDF文件(2018112623321717.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-11-26
附件:
2018112623321717.pdf    

 
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