Prucalopride

What is Prucalopride?

• Prucalopride (Motegrity) is a serotonin-4 (5-HT4) receptor agonist used to treat chronic idiopathic constipation.

Prucalopride

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What are the uses of this medicine?

• Prucalopride (Motegrity) is a prescription medicine used in adults to treat a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown.

How does this medicine work?

• Prucalopride (proo kal' oh pride) is a highly selective serotonin type 4 (5-HT4) receptor agonist that increases the release of serotonin by the specialized enterochromaffin cells in the mucosa of the gut and stimulates intestinal peristalsis and tone.
• Serotonin (5-HT) is released in response to chemical and mechanical stimulation and acts through the type 4 receptors that are common in the intestinal mucosa to increase peristalsis and intestinal tone.
• 5-HT4 receptors are also found in the central nervous system, urinary bladder and atria of the heart, which may explain some of the adverse effects of 5-HT4 receptor agonists.
• Prucalopride was found to improve symptoms of bloating and gastric distension in patients with gastroparesis and to decrease symptoms of reflux in patients with GERD.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to Prucalopride.
• have a tear in your stomach or intestinal wall (bowel perforation), a bowel blockage (intestinal obstruction) or serious conditions of the intestinal wall such as Crohn's disease or ulcerative colitis.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Prucalopride was approved in the United States in 2018 for treatment of idiopathic chronic constipation.
• Prucalopride is available in tablets of 1 and 2 mg under the brand name Motegrity.

How should this medicine be used?

Recommended dosage: In Adults:

• 2 mg once daily.

In Patients with severe renal impairment (creatinine clearance (CrCL) less than 30 mL/min:

• 1 mg once daily.

Administration:

• Prucalopride comes as a tablet to take by mouth.
• Take 1 Motegrity tablet each day or as directed by your healthcare provider.
• Take Motegrity exactly as your healthcare provider tells you to take it.
• Take Motegrity with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 1 mg, 2 mg of prucalopride

This medicine is available in fallowing brand namesː

• Motegrity

What side effects can this medication cause?

The most common side effects of this medicine may include:

• headache
• stomach area (abdominal) pain or bloating
• nausea
• diarrhea
• dizziness
• vomiting
• gas
• fatigue

Motegrity may cause serious side effects, including:

• Uncommon but potentially severe adverse events include depression, suicidal ideation and behavior and hypersensitivity reactions.

• Two 5-HT4 receptor agonists were approved for treatment of chronic constipation in the past (cisapride in 1993, tegaserod in 2002), both of which were subsequently withdrawn from general use because of serious adverse events including cardiac arrhythmias and prolongation of the QTc interval.
• Prucalopride is a more highly selective 5HT4 receptor agonist and has not been linked to an increased rate of these cardiac adverse events.

What special precautions should I follow?

• Inform patients, their caregivers, and family members that suicidal ideation and behavior, self-injurious ideation as well as new onset or worsening depression have been reported in patients treated with Motegrity. Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior. Instruct patients, caregivers, and family members to discontinue Motegrity immediately and contact their healthcare provider if any of these symptoms occur.
• Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to Motegrity during pregnancy.
• Prucalopride can pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Motegrity.
• Prucalopride has been associated with a minimal rate of transient serum enzyme elevations during therapy and has not been implicated in cases of clinically apparent liver injury with jaundice.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache, nausea, and diarrhea.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treat symptomatically and institute supportive measures, as required.
• Extensive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.

Can this medicine be used in pregnancy?

• Available data from case reports with prucalopride use in pregnant women are insufficient to identify any drug-associated risks of miscarriage, major birth defects, or adverse maternal or fetal outcomes.
• It is not known if Motegrity will harm your unborn baby.
• There is a pregnancy registry for women who become pregnant during treatment with Motegrity. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Can this medicine be used in children?

• The safety and effectiveness of Motegrity have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: prucalopride
• Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The coating contains hypromellose, lactose monohydrate, polyethylene glycol 3000, titanium dioxide and triacetin. The 2 mg tablet also contains red iron oxide, yellow iron oxide and FD&C Blue #2.

Who manufactures and distributes this medicine?

Distributed by:

• Takeda Pharmaceuticals America, Inc. Lexington, MA
• Motegrity and the Motegrity Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.

What should I know about storage and disposal of this medication?

• Store Motegrity at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Motegrity in the original container to protect from moisture.

• Dailymed label info on Prucalopride
• FDA Prucalopride

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