PRUCALOPRIDE

5-HT4 Agonist

Brand names: Prucalopride, Motegrity

Oral

Mechanism of Action

12.1 Mechanism of Action Prucalopride, a selective serotonin type 4 (5-HT 4 ) receptor agonist, is a gastrointestinal (GI) prokinetic agent that stimulates colonic peristalsis (high-amplitude propagating contractions [HAPCs]), which increases bowel motility. Prucalopride was devoid of effects mediated via 5-HT 2A , 5-HT 2B , 5-HT 3 , motilin or CCK-A receptors in vitro at concentrations exceeding 5-HT 4 receptor affinity by 150-fold or greater. In isolated GI tissues from various animal species, prucalopride facilitated acetylcholine release to enhance the amplitude of contractions and stimulate peristalsis. In rats and dogs, prucalopride stimulated gastrointestinal motility with contractions starting from the proximal colon to the anal sphincter.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Prucalopride tablets are contraindicated in patients with: A history of hypersensitivity to prucalopride tablets. Reactions including dyspnea
• rash
• pruritus
• urticaria
• and facial edema have been observed [see Adverse Reactions ( 6.2 )]. Intestinal perforation or obstruction due to structural or functional disorder of the gut wall

FDA Warnings

5 WARNINGS AND PRECAUTIONS Suicidal Ideation and Behavior: Monitor patients for suicidal ideation and behavior as well as self-injurious ideation and new-onset or worsening of depression
A causal association between treatment with prucalopride tablets and an increased risk of suicidal ideation and behavior has not been established

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Headache

>10%

Nausea

1-10%

Diarrhea

1-10%

Fatigue

1-10%

Constipation

1-10%

Dizziness

1-10%

Abdominal Pain

0.1-1%

Vomiting

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral