Prucalopride Succinate

Prucalopride

Prucalopride, an FDA-approved medication containing Prucalopride Succinate, is used to treat chronic idiopathic constipation (CIC) in adults. Stimulating intestinal movement alleviates constipation symptoms like abdominal discomfort and bloating. Available in 1 mg and 2 mg tablet forms, the typical dose is 2 mg daily, preferably in the morning with or without food. Prucalopride is suitable for adults with CIC who haven’t responded to other treatments. Side effects may include headache, nausea, diarrhea, abdominal pain, and dizziness. Caution is advised in certain groups, such as pregnant or breastfeeding women and those with severe kidney or liver issues. If a dose is missed, take it when remembered unless it’s almost time for the next dose. Store Prucalopride tablets at room temperature and consult a healthcare provider about any concerns or interactions with other medications.

Product Overview

Prucalopride is a medication used to treat chronic idiopathic constipation (CIC) in adults. The FDA approved it, and it contains the active ingredient Prucalopride Succinate. It works by stimulating the intestines’ movement, which helps alleviate constipation by increasing bowel movements and reducing symptoms such as abdominal discomfort and bloating.

Prucalopride is available in tablet form and comes in strengths of 1 milligram (mg) and 2 mg. The recommended dose is 2 mg once daily, preferably in the morning with or without food. It’s important to follow your healthcare provider’s instructions regarding dosage and duration of treatment. It is generally suitable for adults with chronic constipation who have not adequately responded to other treatments.

Common side effects of Prucalopride may include headache, nausea, diarrhea, abdominal pain, and dizziness. It should be taken with caution in specific populations, such as pregnant or breastfeeding women, individuals with severe kidney or liver impairment, and those with a history of heart conditions. If a dose of Prucalopride is missed, it should be taken as soon as remembered unless it’s almost time for the next dose. Doubling up on doses should be avoided.

Prucalopride tablets should be stored at room temperature, away from moisture and heat. Patients should be aware of potential drug interactions and should inform their healthcare provider of all medications they are taking. Before starting Prucalopride, individuals should discuss their medical history and any concerns with their healthcare provider to ensure its safe and appropriate use.

Uses of Prucalopride

• It is used to treat chronic idiopathic constipation (CIC)

How to Use Prucalopride?

Dosage

Strengths and Forms

Form: Oral tablets

Strengths: 1mg, 2mg

Recommended Dosage for Different Patients

For Adults with Chronic Idiopathic Constipation:

• The typically recommended dose is 2 mg orally once a day.

For Patients with Renal Impairment:

• No adjustment is recommended if your renal function is mild to moderate (CrCl at least 30 mL/min).
• If you have severe renal failure (CrCl less than 30mL/min), take 1 mg orally once daily.
• If you need dialysis due to end-stage renal disease, you should not use this product.

[Note: These Prucalopride dosage recommendations may differ from individual to individual. Discuss it with your healthcare professional, and they’ll decide your dosage accordingly.]

How to Take It?

• Follow your healthcare provider’s instructions regarding dosage. The typical dose is 2 mg once daily.
• Preferably take Prucalopride tablets in the morning with or without food.
• Swallow the tablet whole with water. Do not crush, chew, or break it.
• Take Prucalopride consistently at the same time each day to maintain its effectiveness.
• Continue taking Prucalopride for the duration your healthcare provider prescribes, even if symptoms improve.

[Note: Your doctor will decide the right amount of Prucalopride for you based on your condition, following guidelines and studies on the drug. They’ll adjust your Pregnyl dosage as needed over time.]

How Does Prucalopride Work?

Prucalopride works by stimulating the intestines’ movement, specifically the digestive tract muscles. It belongs to a class of medications called selective serotonin-4 (5-HT4) receptor agonists. When ingested, Prucalopride binds to and activates the serotonin receptors in the gastrointestinal tract. This activation increases the release of neurotransmitters, which stimulates the intestinal wall muscles to contract more efficiently. These contractions help propel food and waste through the digestive system, increasing the frequency and ease of bowel movements. Enhancing intestinal motility helps alleviate constipation and associated symptoms such as abdominal discomfort, bloating, and straining during bowel movements.

Important Safety Information

Side Effects

Common side effects of Prucalopride may include:

• Headache
• Nausea
• Diarrhea
• Abdominal pain or discomfort
• Dizziness

Mild side effects of Prucalopride may include:

• Fatigue
• Flatulence (gas)
• Dry mouth
• Indigestion
• Muscle cramps

Adverse side effects of Prucalopride may include:

• Severe diarrhea or dehydration
• Fainting or syncope
• Allergic reactions such as rash, itching, or swelling
• Abnormal heart rhythms (arrhythmias)
• Changes in mood or behavior

[Note: This list may not cover all possible side effects of Prucalopride. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

Serotonin Syndrome Risk: Prucalopride may increase the risk of serotonin syndrome when used with other serotonergic medications or in patients with certain medical conditions. Symptoms of serotonin syndrome include agitation, hallucinations, confusion, rapid heart rate, high blood pressure, sweating, fever, nausea, vomiting, diarrhea, and muscle stiffness. Seek medical attention immediately if you experience any of these symptoms.

GI Perforation: Cases of gastrointestinal (GI) perforation have been reported in patients taking Prucalopride, particularly those with conditions that may increase the risk of GI perforation, such as severe constipation, inflammatory bowel disease, or tumors. Discontinue Prucalopride if signs or symptoms of GI perforation occur.

Potential Cardiac Effects: Prucalopride may prolong the QT interval, leading to abnormal heart rhythms (arrhythmias). Caution should be exercised when prescribing Prucalopride to patients with a history of QT prolongation, taking drugs known to prolong the QT interval, or having electrolyte abnormalities. Monitoring for signs of QT prolongation is recommended.

Suicidal Ideation and Behavior: There have been reports of suicidal ideation and behavior in patients treated with Prucalopride. Patients should be monitored for signs of depression or changes in mood or behavior. Discontinue Prucalopride if suicidal ideation or behavior is suspected.

Renal Impairment: Use Prucalopride with caution in patients with moderate to severe renal impairment. Due to altered drug metabolism and elimination, dosage adjustments may be necessary in these patients.

Hepatic Impairment: Prucalopride is contraindicated in patients with severe hepatic impairment. It should be used with caution in patients with moderate hepatic impairment, and dosage adjustments based on individual patient factors should be considered.

Potential Interaction with Cytochrome P450 3A4 Inhibitors: Prucalopride is primarily metabolized by the cytochrome P450 3A4 enzyme system. Concomitant use of strong CYP3A4 inhibitors may increase prucalopride concentrations, potentially leading to adverse effects. Use caution and consider dosage adjustments when Prucalopride is administered with potent CYP3A4 inhibitors.

Precautions

• Use caution when taking Prucalopride with other medications affecting serotonin levels.
• Watch for signs of gastrointestinal (GI) perforation, especially if you have conditions that may increase the risk.
• Be cautious if you have a history of heart rhythm abnormalities or are taking medications affecting heart rhythms.
• Monitor your mood and seek medical attention if you experience changes while taking Prucalopride.
• Consult your doctor if you have kidney or liver impairment, as dosage adjustments may be needed.
• Be aware of potential drug interactions and inform your doctor about all medications you are taking.
• Consult your doctor before using Prucalopride if you are pregnant, planning to become pregnant, or breastfeeding.
• Use caution in elderly patients, who may be more sensitive to Prucalopride’s effects.
• Attend regular follow-up appointments with your doctor to monitor your response to Prucalopride and discuss any concerns.

Prucalopride Contraindications

• If you have a known hypersensitivity to Prucalopride or any of its components.
• If you have a history of mechanical gastrointestinal obstruction, perforation, or severe inflammatory conditions of the digestive tract.
• In patients with intestinal perforation, obstruction, or conditions predisposing to obstruction, such as ileus or fecal impaction.
• In patients with severe hepatic impairment.
• In patients with hereditary galactose intolerance.
• In patients under 18 years of age.

Missed Dose

• Take it as soon as you remember, but skip the missed dose if it’s almost time for your next scheduled dose.
• Refrain from doubling up on doses to make up for a missed one.
• Resume your regular dosing schedule and continue taking Prucalopride as prescribed.

[Note: If you have missed a Prucalopride dose and are still determining when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

Symptoms of overdose may include severe diarrhea, dehydration, fainting, or other serious adverse effects. Do not attempt to treat the overdose on your own.

[Note: If you applied more than the recommended dose of Prucalopride, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Keep it in its original container with the lid tightly closed.
• Store at room temperature, away from moisture and heat.
• Avoid storing Prucalopride in the bathroom or near the kitchen sink, where it can be exposed to moisture.
• Keep Prucalopride out of reach of children and pets.
• Do not use Prucalopride beyond the expiration date printed on the label or packaging.

[Note: Discuss with your healthcare professional about the proper disposal of any unused Prucalopride tablet and any questions you may have regarding its storage.]

Prucalopride Interactions

• Acidophilus Probiotic Blend
• Alpha-Lipoic-Acid-300
• Aspirin Low Strength
• Bactrim
• Benadryl
• Cymbalta
• Eliquis
• Jardiance
• Lyrica
• Seroquel
• Singulair
• Tylenol
• Vitamin B Complex 100
• Vitamin B12
• Vitamin B6
• Vitamin C
• Vitamin D3
• Dexilant
• Flonase
• Linzess
• Metoprolol Succinate ER
• Metoprolol Tartrate
• MiraLAX
• Mucinex
• Paracetamol
• Quercetin

[Note: This is not a comprehensive list of drugs. There could be other drugs that interact with Prucalopride. Tell your doctor about prescription, over-the-counter medicines, and herbal products.]

Prucalopride Alternatives

• Trulance (plecanatide)
• Motegrity (prucalopride)
• Linzess (linaclotide)
• Zelnorm (tegaserod)
• Lactulose (generlac)
• Plecanatide (trulance)
• Tegaserod (zelnorm)

[Note: Your doctor will choose the best Prucalopride alternative for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

How long does a Prucalopride tablet take to work?

Prucalopride tablets typically take 2 to 4 hours for most people to see results. It works by increasing bowel movement, making stools easier to pass. The common side effects include headache, nausea, and diarrhea. Remember to take it as your doctor prescribes, usually one 2 mg tablet daily. While some improvement may be seen within the first week, full effects may take a few days. Always consult your healthcare provider for personalized advice.

Is it safe to take Prucalopride during pregnancy?

Prucalopride is not recommended for use during pregnancy. While animal studies have not shown evidence of increased fetal damage, there is no controlled data on human pregnancy. It’s essential to consult your healthcare provider for personalized advice. If you’re pregnant or planning to become pregnant, consider alternative options and discuss them with your doctor.

How does Prucalopride affect breastfeeding?

It can be used with caution while breastfeeding. It is excreted into breast milk in small amounts. Most laxatives are either not absorbed or minimally absorbed from the gastrointestinal tract, resulting in low or negligible breast milk levels. Lifestyle interventions such as increased dietary fiber and exercise should be tried first. If a laxative is needed, always use the lowest dose for the shortest time possible. Remember to consult your healthcare provider for personalized advice. 

When should I take a Prucalopride tablet?

No time of day is too early or too late to take a Prucalopride tablet. The medication is usually taken once a day, either with or without food. Your prescribing physician will determine the exact dosage of this medication. It is generally taken twice a day in the form of two milligrams.

Can Prucalopride treat gastroparesis? 

It has been proven that Prucalopride is beneficial in cases of gastroparesis and constipation. Gastroparesis occurs when the gut’s movement is reduced, resulting in constipation and delayed stomach emptying. This usually happens when a person has diabetes or has undergone surgery.

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