prucalopride

General

Pronunciation:
proo-kal-oh-pride


Trade Name(s)

  • Motegrity
  • Resotran Canadian Trade name

Ther. Class.

prokinetic agents

Pharm. Class.

five ht4 agonists

Indications

Treatment of chronic idiopathic constipation.

Action

Acts as a selective serotonin type 4 (5-HT4 ) receptor agonist, which stimulates colonic peristalsis and leads to increased bowel motility.

Therapeutic Effect(s):

Increased frequency of complete spontaneous bowel movements.

Pharmacokinetics

Absorption: >90% absorbed following oral administration.

Distribution: Extensively distributed to tissues.

Metabolism and Excretion: Primarily excreted by the kidneys, with 60–65% being excreted unchanged in the urine, and 5% in feces.

Half-life: 24 hr.

TIME/ACTION PROFILE (plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown2–3 hr24 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • Intestinal perforation or obstruction, obstructive ileus, Crohn's disease, ulcerative colitis, or toxic megacolon/megarectum;
  • End-stage renal disease requiring dialysis.

Use Cautiously in:

  • Depression;
  • Severe renal impairment (CCr <30 mL/min) (↓ dose);
  • OB:   Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
  • Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
  • Pedi:   Safety and effectiveness not established in children;
  • Geri:  May need to ↓ dose in older adults due to age-related ↓ in renal function.

Adverse Reactions/Side Effects

GI: abdominal pain, diarrhea, nausea, abdominal distension, flatulence, vomiting

Neuro: headache, depression, dizziness, fatigue, SUICIDAL THOUGHTS/BEHAVIOR

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

PO (Adults): 2 mg once daily.

Renal Impairment 
PO (Adults): CCr <30 mL/min:  1 mg once daily.

Availability

Tablets: 1 mg, 2 mg

Assessment

  • Assess bowel sounds and frequency, quantity, and consistency of stools periodically during therapy.
  • Monitor for signs and symptoms of persistent worsening of depression or the emergence of suicidal thoughts and behaviors.

Implementation

  • PO Administer once daily without regard to food.

Patient/Family Teaching

  • Instruct patient to take prucalopride as directed. Advise patient to read  Patient Information  before starting therapy and with each Rx refill in case of changes.
  • Advise patient and family members to discontinue prucalopride and notify health care professional immediately if suicidal ideation and behavior (unusual changes in mood or behavior, persistent worsening of depression, feeling sad or hopeless, thoughts or attempts at self harm, emergence of suicidal thoughts or behavior) occur.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Rep:  Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to prucalopride during pregnancy. Register patients by contacting MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visiting https://mothertobaby.org/pregnancy-studies/.

Evaluation/Desired Outcomes

Increased frequency of complete spontaneous bowel movements.