Prucalopride 2mg Tablets

Prucalopride is a selective, high-affinity serotonin-4 (5-HT4) receptor agonist. By activating 5-HT4 receptors, particularly in the gastrointestinal tract, it stimulates colonic motility, increases bowel movement frequency, and improves stool consistency. It enhances propulsive colonic motility, which is often impaired in chronic constipation.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. Seek immediate medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:

Rash
Hives
Itching
Red, swollen, blistered, or peeling skin with or without fever
Wheezing
Tightness in the chest or throat
Trouble breathing, swallowing, or talking
Unusual hoarseness
Swelling of the mouth, face, lips, tongue, or throat

Additionally, inform your doctor right away if you experience new or worsening behavioral or mood changes, such as:

Depression
Thoughts of suicide

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Headache
Upset stomach or vomiting
Stomach pain or diarrhea
Bloating
Gas
* Feeling dizzy, tired, or weak

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel problems, such as bowel blockage, Crohn's disease, a hole in the gastrointestinal (GI) tract, or ulcerative colitis.
+ Kidney disease.
+ Difficulty digesting specific sugars, including lactose, glucose, or galactose, as indicated by previous medical evaluations.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.

• Drugs that prolong QT interval (e.g., Class IA and Class III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolones): Theoretical risk of additive QT prolongation, though prucalopride itself has not shown significant QT prolongation at therapeutic doses.
• P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine, quinidine, verapamil): May increase prucalopride exposure, but generally not considered clinically significant due to prucalopride's wide therapeutic index and primary renal excretion.

• Resolution of constipation symptoms (e.g., increased bowel movement frequency, softer stools, reduced straining)
• Abdominal pain or discomfort
• Nausea
• Headache
• Diarrhea
• Dizziness
• Fatigue
• Changes in mood or behavior (e.g., depression, anxiety, suicidal thoughts)

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data are limited.

Prucalopride is excreted into human milk. The amount of prucalopride in breast milk is low, but potential for adverse effects on the breastfed infant (e.g., diarrhea) exists. Weigh the developmental and health benefits of breastfeeding against the mother’s clinical need for prucalopride and any potential adverse effects on the breastfed infant.

Safety and efficacy have not been established in pediatric patients (<18 years of age) for chronic idiopathic constipation. Not recommended for use in this population.

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which may necessitate a dose adjustment (1 mg daily) if CrCl is <30 mL/min. Monitor for adverse effects.

• Prucalopride is a selective 5-HT4 agonist, distinct from other laxatives, and is indicated for chronic idiopathic constipation (CIC) in adults when other treatments have failed.
• It is generally well-tolerated, with the most common side effects being headache, nausea, and abdominal pain, which often diminish with continued use.
• Dose adjustment is crucial for patients with severe renal impairment (CrCl <30 mL/min) to 1 mg once daily.
• Patients should be advised to continue lifestyle modifications (hydration, fiber, exercise) alongside prucalopride therapy.
• Although rare, monitor for new or worsening psychiatric symptoms, including depression and suicidal ideation, especially in patients with a history of such conditions.

• Linaclotide (Linzess)
• Plecanatide (Trulance)
• Lubiprostone (Amitiza)
• Lactulose
• Polyethylene glycol (PEG)
• Bisacodyl
• Senna
• Fiber supplements (e.g., psyllium, methylcellulose)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.