Prucalopride


Generic Medicine Info
Indications and Dosage
Oral
Chronic constipation
Adult: In cases where other laxatives fail to provide adequate relief: 2 mg once daily. Review treatment if there is no response after 4 weeks. Treatment recommendations may vary among individual products and between countries (refer to specific product or local guidelines).
Elderly: Initially, 1 mg once daily, may be increased to 2 mg once daily if necessary. Review treatment if there is no response after 4 weeks.
What are the brands available for Prucalopride in Hong Kong?
Renal Impairment
ESRD requiring dialysis: Contraindicated. Severe (GFR <30 ml/min/1.73 m2): 1 mg once daily.
Hepatic Impairment
Severe (Child-Pugh class C): Initially, 1 mg once daily, may be increased to 2 mg if necessary. Dosage recommendations may vary among individual products and between countries (refer to specific product or local guidelines).
Administration
Prucalopride May be taken with or without food.
Contraindications
Intestinal perforation or obstruction due to structural or functional disorder of the gut wall; obstructive ileus; severe inflammatory conditions of the gastrointestinal tract (e.g. Crohn's disease, ulcerative colitis and toxic megacolon or megarectum). ESRD requiring dialysis.
Special Precautions
Patient with history of arrhythmia, ischaemic heart disease; severe and clinically unstable concomitant disease (e.g. cancer, AIDS, lung or other CV disease; neurological, psychiatric, and other endocrine disorders). Renal and severe hepatic impairment (Child-Pugh class C) impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Severe diarrhoea; suicide, suicide attempts, and suicide ideation (including cases of self-injurious ideation and new or worsening depression).
Cardiac disorders: Palpitations.
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, flatulence, dyspepsia, abnormal bowel sounds, abdominal distension, rectal haemorrhage.
General disorders and administration site conditions: Fatigue, fever, malaise.
Metabolism and nutrition disorders: Decreased appetite.
Nervous system disorders: Dizziness, headache, tremors, migraine.
Renal and urinary disorders: Pollakiuria.
Patient Counseling Information
This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery. Women of childbearing potential must use effective contraception during treatment.
Monitoring Parameters
Monitor for improvement and frequency of bowel movements. Closely monitor for new onset or persistent worsening of depression or the emergence of suicidal thoughts and behaviours.
Overdosage
Symptoms: Nausea, headache, diarrhoea. Management: Symptomatic and supportive treatment. In cases of excessive fluid loss, correcting electrolyte disturbances may be necessary.
Action
Description:
Mechanism of Action: Prucalopride, a dihydrobenzofurancarboxamide, is a selective, high-affinity type 4 serotonin (5-HT4) receptor agonist with prokinetic properties. It enhances bowel motility by binding with high affinity to 5-HT4 receptors, thereby promoting the release of acetylcholine to increase the amplitude of contractions and stimulate colonic peristalsis.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Bioavailability: >90%. Time to peak plasma concentration: 2-3 hours.
Distribution: Extensively distributed. Enters breast milk. Plasma protein binding: Approx 30%.
Metabolism: Metabolised very slowly in the liver.
Excretion: Mainly via urine (84.2%; 60-65% as unchanged drug); faeces (13.3%; 5% as unchanged drug). Elimination half-life: Approx 24 hours.
Chemical Structure

Chemical Structure Image
Prucalopride

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3052762, Prucalopride. https://pubchem.ncbi.nlm.nih.gov/compound/Prucalopride. Accessed Jan. 27, 2025.

Storage
Store between 15-30°C. Protect from moisture.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories / Laxatives, Purgatives
ATC Classification
A06AX05 - prucalopride ; Belongs to the class of other laxatives.
References
Anon. Prucalopride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 22/11/2024.

Brayfield A, Cadart C (eds). Prucalopride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 26/12/2024.

Joint Formulary Committee. Prucalopride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/11/2024.

Mercury Pharma (NZ). Resotrans 1 mg and 2 mg Film Coated Tablet data sheet 23 January 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 22/11/2024.

Motegrity Tablet, Film Coated (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/11/2024.

Prucalopride 1 mg Film-coated Tablets (DHP Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 22/11/2024.

Prucalopride. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 22/11/2024.

Resolor (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/11/2024.

Disclaimer: This information is independently developed by MIMS based on Prucalopride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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