Land: Südafrika
Sprache: Englisch
Quelle: South African Health Products Regulatory Authority (SAHPRA)
Janssen
PREPULSID® 5 mg tablets. PREPULSID® 10 mg tablets. PREPULSID® 20 mg tablets. SCHEDULING STATUS: Schedule 4. PROPRIETARY NAME (and dosage form): PREPULSID ® 5 mg tablets. PREPULSID ® 10 mg tablets. PREPULSID ® 20 mg tablets. COMPOSITION: Regular mononhydrate tablet: Each 5 mg tablet contains 5,2 mg cisapride monohydrate equivalent to 5 mg cisapride anhydrous. Each 10 mg tablet contains 10,4 mg cisapride monohydrate equivalent to 10 mg cisapride anhydrous. Each 20 mg tablet contains 20,8 mg cisapride monohydrate equivalent to 20 mg cisapride anhydrous. PHARMACOLOGICAL CLASSIFICATION: A.11 Medicines acting on the gastro-intestinal tract. PHARMACOLOGICAL ACTION: IN ANIMALS In isolated organs PREPULSID prevents gastric atony and enhances gastric peristaltic activity, antroduodenal co- ordination and small and large bowel motility. In dogs PREPULSID enhances digestive antroduodenal motility and co-ordination, accelerates gastric emptying, increases small bowel propulsive contractions and shortens intestinal transit time. Gastric secretion is not affected. The mechanism of action of PREPULSID is mainly due to an enhancement of the physiological release of acetylcholine at the myenteric plexus level. PREPULSID does not induce muscarinic or nicotinic receptor stimulation, nor does it inhibit acetylcholinesterase activity. In vitro studies have shown that cisapride has serotonin (5-HT 4 ) receptor agonist activity in the colon. IN MAN GASTROINTESTINAL MOTILITY: Oesophagus PREPULSID increases oesophageal peristaltic activity and lower oesophageal sphincter tone. PREPULSID decreases oesophageal reflux of gastric contents and improves oesophageal clearance. Stomach PREPULSID increases gastric and duodenal contractility and introduodenal co-ordination. PREPULSID decreases duodenagastric reflux. PREPULSID accelerat Lesen Sie das vollständige Dokument