Motegrity 2mg Tablets

Prucalopride is a selective, high-affinity serotonin-4 (5-HT4) receptor agonist. By activating 5-HT4 receptors, it stimulates colonic motility, leading to increased bowel movements and improved stool consistency. It enhances propulsive colonic motility, which is often impaired in chronic constipation.

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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, or swelling of the mouth, face, lips, tongue, or throat.
- New or worsening behavioral or mood changes, including depression or 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 or gas
- Feeling dizzy, tired, or weak

Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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. Describe the allergic reaction you experienced, including the 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 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, you must discuss this with your doctor. This conversation will help you understand the potential benefits and risks of taking this medication to both you and your baby, allowing you to make an informed decision.

• Drugs that prolong QT interval (theoretical risk, though prucalopride itself has minimal QT effect at therapeutic doses)
• P-glycoprotein inhibitors (e.g., cyclosporine, quinidine, verapamil, amiodarone, ritonavir, clarithromycin) - potential for increased prucalopride exposure, but not considered clinically significant based on studies.

• Abdominal pain
• Nausea
• Diarrhea
• Headache
• Dizziness
• Fatigue
• Depression or suicidal thoughts (rare, but reported in clinical trials)

Limited human data on prucalopride use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies have shown adverse developmental outcomes. Use only if the potential benefit justifies the potential risk to the fetus.

Limited human data suggest that prucalopride is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Motegrity and any potential adverse effects on the breastfed infant from Motegrity or from the underlying maternal condition.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for chronic idiopathic constipation.

No dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, so dose adjustment should be based on creatinine clearance (CrCl) if impaired.

• Motegrity is intended for chronic use and is not for acute constipation relief.
• Patients should be advised that it may take several days to achieve a full therapeutic effect.
• Common side effects such as headache, nausea, abdominal pain, and diarrhea are usually transient and tend to decrease with continued use.
• Ensure patients maintain adequate hydration while on therapy.
• Assess renal function prior to initiating therapy and adjust dose accordingly for severe renal impairment.

• Linaclotide (Linzess)
• Lubiprostone (Amitiza)
• Plecanatide (Trulance)
• Polyethylene Glycol (PEG) 3350 (e.g., MiraLAX)
• Fiber supplements (e.g., psyllium, methylcellulose)
• Osmotic laxatives (e.g., magnesium hydroxide, lactulose)
• Stimulant laxatives (e.g., bisacodyl, senna - for short-term use)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 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.