Clinical Monograph: GUTRAP SR™ (Acotiamide Hydrochloride Hydrate 300mg)
​GUTRAP SR™ is a specialized prokinetic agent indicated for the symptomatic treatment of functional dyspepsia (FD). Formulated as a Sustained Release (SR) tablet, it ensures a controlled delivery of Acotiamide Hydrochloride Hydrate to maintain therapeutic plasma concentrations and optimize patient compliance. ​Pharmacodynamics & Mechanism of Action ​Acotiamide is a first-in-class muscarinic receptor antagonist that operates through a targeted dual mechanism:
​Acetylcholinesterase Inhibition: It selectively inhibits acetylcholinesterase (AChE) in the gastrointestinal tract, preventing the breakdown of acetylcholine. This leads to enhanced cholinergic neurotransmission, which stimulates antral and duodenal motility, effectively accelerating gastric emptying.
​M1/M2 Receptor Antagonism: By acting on muscarinic receptors, it improves gastric accommodation—the ability of the proximal stomach to relax and expand during food intake—thereby addressing the primary physiological cause of early satiety.
​Sustained Release Kinetic: The SR matrix provides a prolonged release profile of the 300mg dose, ensuring continuous symptomatic relief throughout the postprandial period.
​Therapeutic Indications ​GUTRAP SR™ is clinically indicated for the management of the following symptom clusters associated with Functional Dyspepsia (postprandial distress syndrome):
​Postprandial Fullness: Reduction of prolonged gastric retention and the sensation of epigastric heaviness.
​Upper Abdominal Bloating: Mitigation of post-meal distention and pressure.
​Early Satiety: Restoration of normal gastric capacity and the ability to complete standard meal portions.
​Pharmaceutical Characteristics
​Active Ingredient: Acotiamide Hydrochloride Hydrate 300mg.
​Dosage Form: Sustained Release Tablet.
​Pharmacological Class: Gastroprokinetic / AChE Inhibitor.
​Packaging: 1 x 10 Tablets per blister.
​Clinical Considerations ​Administration: Typically administered before meals. The sustained-release nature allows for a refined dosing schedule compared to immediate-release formulations.
​Regulatory Classification: Schedule H Prescription Drug.
​Safety Profile: Generally well-tolerated with a low incidence of systemic side effects due to its localized gastrointestinal activity.
​Storage: Store in a controlled environment, protected from excessive moisture and thermal exposure.