Prucalopride


Concise Prescribing Info
Indications/Uses
Chronic idiopathic constipation.
Dosage/Direction for Use
Adult : PO 2 mg once daily.
Dosage Details
Oral
Chronic idiopathic constipation
Adult: 2 mg once daily.
Elderly: Initially, 1 mg once daily, may increase to 2 mg once daily if necessary.
Renal Impairment
Severe (GFR <30 mL/min/1.73 m2): 1 mg once daily. Patient on dialysis: Contraindicated.
Hepatic Impairment
Severe (Child-Pugh Class C): Initially, 1 mg once daily, may increase to 2 mg once daily if necessary.
Administration
May be taken with or without food.
Contraindications
Intestinal obstruction or perforation, obstructive ileus, active severe inflammatory bowel conditions (e.g. Crohn’s disease, toxic megacolon/megarectum, and ulcerative colitis). Renal impairment requiring dialysis. Pregnancy and lactation.
Special Precautions
Patient w/ history of arrhythmias or ischaemic CV disease, severe and unstable concomitant disease (e.g. cancer, AIDS, neurological or psychiatric, pulmonary, IDDM or other endocrine disroders). Severe hepatic (Child-Pugh Class C) and renal (GFR <30 mL/min/1.73 m2) impairment. Elderly.
Adverse Reactions
Nervous: Headache, dizziness, fatigue, malaise, tremors.
CV: Palpitations.
GI: Nausea, abdominal pain and distention, diarrhoea, vomiting, flatulence, dyspepsia, anorexia, rectal bleeding, gastroenteritis.
Genitourinary: Polyuria, pollakiuria.
Musculoskeletal: Muscle spasm.
Others: Fever.
Patient Counseling Information
This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor bowel movement frequency.
Drug Interactions
May decrease serum concentration of contraceptives (i.e. oestrogens, progestins). May enhance adverse effect of levosulpiride. Increased serum concentration w/ P-glycoprotein/ABCB1 inhibitors. Reduced effect w/ atropine-like substance.
Action
Description: Prucalopride is a selective 5-HT4 receptor agonist w/ prokinetic effect. It stimulates peristaltic reflex, intestinal secretions, and GI motility.
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Absolute bioavailability: >90%. Time to peak plasma concentration: 2-3 hr.
Distribution: Extensively distributed; enters breast milk. Volume of distribution: 567 L. Plasma protein binding: Approx 30%.
Metabolism: Metabolised slowly in the liver.
Excretion: Via urine (approx 60-65% as unchanged drug); faeces (approx 5% as unchanged drug). Terminal elimination half-life: Approx 24 hr.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store between 15-30°C.
ATC Classification
A06AX05 - prucalopride ; Belongs to the class of other laxatives.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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