Prucalopride: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Monitoring Parameters

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:
Mechanism of Action: 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

Storage

Store between 15-30°C.

MIMS Class

GIT Regulators, Antiflatulents & Anti-Inflammatories

ATC Classification

A06AX05 - prucalopride ; Belongs to the class of other laxatives.

References

Anon. Prucalopride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/04/2017.

Buckingham R (ed). Prucalopride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2017.

Joint Formulary Committee. Prucalopride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/04/2017.

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