  【Drug Name】 Common name: 西沙必利片
English name: Cisapride Tablet
Chinese Pinyin: xishabili pian
Major ingredient of the product is Cisapride, whose chemical name is (±)-cis-4-amino-5-Cl-N-[1-[3-(p-fluoro phenoxy) propyl]-3-methoxy-4-peperidyl]-2-methoxy benzamide-hydrate.
【Indications】
1. As the product is capable of increasing gastrointestinal motility, it is applicable for gastroparesis syndrome or upper gastrointestinal discomfort which is negative in X-ray and endoscopic examination, with the indications of early satiety, fullness after meals, reduced food intake, gastrectasia, excessive belching, anorexia, emesis or chief complaint similar to ulcer (upper abdominal burning).
2. Stomach-esophageal reflux, including treatment and maintenance treatment of esophagitis.
3. Lack of power propulsion and gastrointestinal content retention caused by intestinal pseudo-obstruction associated with movement dysfunction.
4. As the product is capable of restoring forward movement of colon, it may be used for long term treatment of chronic constipation patients.
【Usage and Dosage】
Oral ingestion: the product should be taken in 15min prior to each meal or at bedtime (in case of a fourth ingestion).
Dosage: total 15-30mg (i.e. 3-6 tablets) a day according to disease conditions should be taken in twice or three times, 5mg (i.e. 1 tablet) at a time. Such a dosage may be doubled. The maximum dosage of each day is 30mg, i.e. 6 tablets.
【Property】
The product is white tablet
【Pharmacological Effect】
1. Animals:
- The product is capable of preventing stomach relaxation, accelerating peristole, and coordinating movement of sinuses ventriculi-duodenum, small intestine and large intestine;
- The product is capable of strengthening digestive activity of sinuses ventriculi-duodenum, coordinating and strengthening gastric emptying, increasing peristalsis of small intestine and large intestine, and shortening time of bowel movement, without any impact on gastric secretion;
- Action mechanism of the product is mainly to promote physiological release of acetylcholine in myenteric plexus;
- The product does not stimulate muscarinie and nicotine receptors, nor inhibit activity of acetylcholine esterase;
- The product is free from dopamine receptor blockage with the treatment dosage;
- The product is mainly distributed in stomach and intestinal tissues.
2. Human:
Gastrointestinal mobility effect;
- Esophagus: - the product is capable of strengthening esophageal peristalsis and lower esophageal sphincter tension;
- The product is capable of preventing stomach contents flowing back to esophagus and improving clearance rate of esophageal;
- Stomach: - the product is capable of strengthening contraction of stomach and duodenum and coordination of sinuses ventriculi-duodenum;
- The product is capable of reducing duodenum-stomach reflux;
- The product is capable of improving emptying of stomach and duodenum;
- Intestine: - The product is capable of strengthening bowel movements and prompting transportation of small intestine and large intestine.
3. Other effects:
- As the product is lack of cholinergic effect, it will not increase basic gastric acid secretion, as well as gastric acid secretion caused by pentagastrin;
- As the product is relatively lack of dopamine antagonist nature, it does not affect content of plasma prolactin almost;
- The product does not affect psychomotor function, blood pressure, respiratory rate, body temperature, body weight and anti-coagulation function;
- The pharmacological effect of the product starts from 30-60min after oral ingestion.
- Electrophysiological study data shows that, under certain conditions, the product is capable of postponing re-polarization of heart, thus prolonging QT intervals.
【Adverse Effect】
Due to pharmacological activity of the product, it may cause transient abdominal cramp, borborygmus and diarrhea. Dosage may be halved in case of abdominal cramp.
【Specification】 5mg
【Storage】Seal stored in a dry place
【Package】 Aluminum-plastic blister packaging, 12 tablets x 1 piece/box, 12 tablets x 2 pieces/box
【Effective Date】 two years
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