Generic Name

Prucalopride

Precaution

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. This drug may cause dizziness and fatigue, if affected, do not drive or operate machinery. Monitoring Parameters: Monitor bowel movement frequency.

Indication

Chronic idiopathic constipation

Contra Indication

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.

Dose

N/A

Side Effect

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.

Pregnancy Category

Mode of Action

Prucalopride is a selective 5-HT4 receptor agonist w/ prokinetic effect. It stimulates peristaltic reflex, intestinal secretions, and GI motility.

Interaction

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.

Pregnancy Category Note

Pregnancy Available data from case reports with use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes Animal data In animal reproduction studies, no adverse developmental effects were observed with prucalopride during organogenesis in pregnant rats and rabbits at doses up to ~390x and 780x, respectively, the recommended human dose of 2 mg/day Lactation Prucalopride is present in breast milk No data are available of effects on breastfed children or milk production Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child from prucalopride or from the underlying maternal condition

Adult Dose

Oral Chronic idiopathic constipation Adult: 2 mg once daily. Elderly: Initially, 1 mg once daily, may increase to 2 mg once daily if necessary. Hepatic Impairment Severe (Child-Pugh Class C): Initially, 1 mg once daily, may increase to 2 mg once daily if necessary.

Child Dose

N/A

Renal Dose

Severe (GFR <30 mL/min/1.73 m2): 1 mg once daily. Patient on dialysis: Contraindicated.

Administration

May be taken with or without food.