Prucalopride 1mg Tablets

Prucalopride is a selective, high-affinity serotonin-4 (5-HT4) receptor agonist. By activating 5-HT4 receptors in the gastrointestinal tract, it stimulates colonic motility, leading to increased bowel movements and improved stool consistency. It promotes propulsive contractions, which are essential for the passage of stool.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
New or worsening behavioral or mood changes, including:
+ Depression
+ Thoughts of suicide

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor for guidance:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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. Your doctor can provide medical advice on managing side effects.

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 allergic reaction you experienced, including any symptoms that occurred.
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 certain sugars, including lactose, glucose, or galactose, as indicated by your doctor.

This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. This includes:

All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
* All your health problems, including those not listed here.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.

It is essential to inform all 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 breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.

• Drugs that prolong QT interval (theoretical risk, monitor ECG if co-administered)
• Other prokinetic agents (e.g., metoclopramide, domperidone) - potential for additive effects

• Frequency of bowel movements
• Stool consistency (Bristol Stool Scale)
• Straining during defecation
• Feeling of incomplete evacuation
• Abdominal pain
• Abdominal bloating
• Nausea
• Headache
• Dizziness
• Mood changes (e.g., depression, anxiety, suicidal thoughts)

Prucalopride may cause fetal harm based on animal studies. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.

It is unknown if prucalopride is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for prucalopride and any potential adverse effects on the breastfed infant from prucalopride or from the underlying maternal condition. Based on its pharmacokinetic properties (low protein binding, high bioavailability, renal excretion), transfer into milk is possible but likely low. Monitor breastfed infants for diarrhea.

Safety and effectiveness have not been established in pediatric patients less than 18 years of age. Not recommended for this population.

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which necessitates dose adjustment for severe renal impairment. Monitor for adverse effects as elderly patients may be more sensitive.

• Prucalopride is a good option for chronic idiopathic constipation (CIC) when osmotic laxatives or fiber supplements have been insufficient.
• It is a highly selective 5-HT4 agonist, which contributes to its efficacy and potentially lower side effect profile compared to less selective agents.
• Patients should be advised that while some may experience a bowel movement within 24 hours, the full therapeutic benefit for CIC may take several days or weeks.
• Emphasize the importance of adequate fluid intake and dietary fiber alongside medication for optimal results.
• Counsel patients on potential side effects like headache, nausea, and abdominal pain, which are often transient and resolve with continued use.
• Monitor for new or worsening psychiatric symptoms, including depression and suicidal ideation, as these have been reported in clinical trials.

• Polyethylene glycol (PEG)
• Lactulose
• Lubiprostone (Amitiza)
• Linaclotide (Linzess)
• Plecanatide (Trulance)
• Tegaserod (Zelnorm - for IBS-C in women <65 with no cardiovascular disease)
• Fiber supplements (e.g., psyllium, methylcellulose)
• Stool softeners (e.g., docusate)
• Stimulant laxatives (e.g., bisacodyl, senna - for short-term use)

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 reach out to 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 help healthcare professionals provide the best possible care.