WARNING

Cisapride is a medication primarily used to treat gastroesophageal reflux disease (GERD) and certain stomach motility disorders. However, it has been associated with significant risks, leading to its withdrawal from many markets.

Here are the main risks associated with taking Cisapride:

• Cardiac Arrhythmias: Cisapride can prolong the QT interval in the heart’s electrical cycle, leading to a risk of serious cardiac arrhythmias (irregular heartbeats), including torsades de pointes, which can be life-threatening.
• Drug Interactions: Cisapride can interact with other medications that also prolong the QT interval, increasing the risk of arrhythmias when taken together. This includes many antibiotics, antifungals, and antidepressants.
• Contraindications: It is contraindicated in patients with known QT prolongation, electrolyte imbalances (such as low potassium or magnesium levels), and certain heart conditions.
• Adverse Effects: Common side effects include diarrhea, abdominal pain, and headache. Rarely, it can cause allergic reactions, liver problems, and neurological symptoms.
• Withdrawal: Due to these risks, Cisapride has been withdrawn from the market in several countries, and its use is heavily restricted in others. It is generally recommended only as a last resort when other treatments have failed, and under strict medical supervision.

Given these risks, it’s crucial for healthcare providers to carefully weigh the benefits against the potential dangers before prescribing Cisapride. It should only be used under close monitoring, especially in patients with underlying heart conditions or who are taking other medications that affect heart rhythm.

Why is this medication prescribed?

Cisapride was prescribed primarily for two main conditions:

• Gastroesophageal Reflux Disease (GERD): Cisapride was used to improve symptoms of GERD, such as heartburn and regurgitation, by enhancing gastrointestinal motility and promoting the movement of food through the digestive tract.
• Gastric Motility Disorders: It was also prescribed for certain stomach motility disorders, such as gastroparesis (delayed stomach emptying), where it helped in improving the movement of food through the stomach.

How should this medicine be used?

Cisapride was typically prescribed in the following manner:

• Dosage: The dosage of Cisapride varied depending on the condition being treated and the patient’s individual response. It was usually taken orally, in tablet or suspension form.
• Timing: It was commonly taken before meals and at bedtime to maximize its effects on gastrointestinal motility during the digestion process.
• Duration: Treatment duration was typically short-term and individualized based on the patient’s response and tolerability. Long-term use was avoided due to the risks associated with prolonged exposure to the medication.
• Monitoring: Patients using Cisapride were closely monitored for any signs of adverse effects, especially related to cardiac function, such as irregular heartbeats or symptoms suggestive of arrhythmias.
• Contraindications: Cisapride was contraindicated in patients with known QT prolongation, significant electrolyte imbalances (e.g., hypokalemia, hypomagnesemia), and certain cardiac conditions.
• Interactions: It interacted with many medications that also prolong the QT interval, such as antibiotics, antifungals, and antidepressants, necessitating careful consideration and monitoring when co-administered with other drugs.

Due to the significant risks associated with its use, Cisapride was often reserved for patients who did not respond to other treatments or where the benefits outweighed the potential risks. However, in many countries, it has been withdrawn from the market or is strictly regulated due to safety concerns.

Other uses for this medicine

However, there were some off-label or investigational uses of Cisapride that were explored, though not always recommended due to safety concerns:

• Functional Dyspepsia: Some studies investigated the use of Cisapride for functional dyspepsia (chronic or recurrent pain or discomfort centered in the upper abdomen without an identifiable cause). However, its use in this condition was not widely adopted due to safety issues.
• Constipation: Cisapride was occasionally considered for chronic constipation, particularly when related to impaired gastric motility. However, its use for this indication was limited due to concerns about its safety profile.

What special precautions should I follow?

When using Cisapride, it was essential to follow these special precautions:

• Cardiac Monitoring: Before starting Cisapride, it was important to assess cardiac health, including checking for baseline QT interval duration and ensuring electrolyte levels (especially potassium and magnesium) were within normal ranges. Regular monitoring of cardiac function during treatment was recommended to detect any signs of QT prolongation or arrhythmias.
• Avoiding Interactions: Cisapride had significant interactions with other medications that prolong the QT interval. Therefore, it was crucial to inform healthcare providers about all other medications, supplements, and herbal products being taken to avoid potentially dangerous interactions.
• Dosage and Administration: Cisapride should be taken exactly as prescribed, typically before meals and at bedtime. Dosage adjustments might be necessary based on individual response and tolerance, but exceeding recommended doses or altering the dosing schedule without medical advice was strongly discouraged.
• Monitoring for Side Effects: Patients and caregivers should be vigilant for any signs of adverse effects, such as irregular heartbeats, dizziness, fainting, or allergic reactions. Prompt medical attention should be sought if any concerning symptoms develop.
• Pregnancy and Lactation: The safety of Cisapride during pregnancy and breastfeeding was not well established. It was generally avoided during pregnancy unless clearly necessary and should not be used while breastfeeding due to potential risks to the infant.
• Special Populations: Caution was advised when prescribing Cisapride to elderly patients and those with pre-existing cardiac conditions, as they may be more susceptible to its cardiac effects.

Due to these precautions and the significant risks associated with Cisapride, including its potential to cause serious cardiac arrhythmias, its use was highly restricted or discontinued in many countries. Healthcare providers typically considered alternative treatments with safer profiles for similar conditions.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with chlorpromazine. However, maintaining a healthy diet and staying hydrated can support overall health and well-being, which is important when taking any medication.

What should I do if I forget a dose?

If you miss a dose of Cisapride, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.

What side effects can this medication cause?

Cisapride, while effective for certain gastrointestinal conditions, can also cause a range of side effects. These side effects vary in severity and occurrence. Common side effects include:

• Gastrointestinal Effects: Diarrhea, abdominal pain, nausea, and vomiting are relatively common side effects of Cisapride. These symptoms may occur as the medication affects gastrointestinal motility.
• Central Nervous System Effects: Headache and dizziness are reported in some patients using Cisapride.
• Cardiovascular Effects: Cisapride can prolong the QT interval in the heart’s electrical cycle, which can lead to serious cardiac arrhythmias like torsades de pointes. This is a potentially life-threatening side effect and a major reason why Cisapride is used with caution and under close medical supervision.
• Allergic Reactions: Although rare, allergic reactions to Cisapride can occur, presenting as rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
• Liver Effects: Hepatitis and other liver-related issues have been reported in some patients using Cisapride, although these are less common.
• Other: Less frequently, Cisapride may cause fatigue, muscle cramps, and changes in taste perception.

It’s important to note that the risk of serious side effects, particularly cardiac arrhythmias, is the primary reason for the withdrawal or severe restriction of Cisapride in many countries. Due to these risks, Cisapride is generally prescribed cautiously and typically reserved for patients who have not responded to other treatments or when the benefits outweigh the potential risks.

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

Storage and Disposal of Cisapride:

• Storage:
  • Store Cisapride at room temperature, away from moisture and heat.
  • Keep it in its original container, tightly closed, and out of reach of children and pets.
  • Do not store Cisapride in the bathroom or near the kitchen sink where it could be exposed to moisture.
• Disposal:
  • If your healthcare provider advises you to stop using Cisapride or if it has expired, dispose of it properly.
  • Follow any specific disposal instructions provided by your pharmacist or local waste disposal company.
  • Do not flush medications down the toilet unless instructed to do so.

In case of emergency/overdose

• Emergency: If you suspect an overdose or experience severe symptoms such as irregular heartbeats, fainting, or difficulty breathing, seek immediate medical attention. Call emergency services (911 in the US) or your local emergency number for assistance.
• Overdose: Symptoms of overdose may include severe dizziness, fainting, confusion, or seizures. It’s essential to avoid taking more than the prescribed dose of Cisapride to prevent serious health complications.

What other information should I know?

• Follow Prescribing Instructions: Take Cisapride exactly as prescribed by your healthcare provider. Do not adjust your dose or stop taking it without consulting them first.
• Regular Monitoring: Your doctor may periodically monitor your heart function and electrolyte levels during treatment with Cisapride to detect any potential complications early.
• Medical History: Inform your healthcare provider about your complete medical history, especially any history of heart problems, electrolyte imbalances, or liver disease.
• Drug Interactions: Cisapride can interact with several medications that affect heart rhythm (QT prolongation). Provide a list of all medications, supplements, and herbal products you are taking to avoid potential interactions.
• Pregnancy and Breastfeeding: Avoid using Cisapride during pregnancy and breastfeeding unless explicitly instructed by your healthcare provider due to potential risks to the fetus or infant.
• Adverse Effects: Be aware of potential side effects such as gastrointestinal discomfort, headache, or cardiac symptoms. Report any unusual symptoms promptly to your healthcare provider.

Following these guidelines and being informed about the proper storage, disposal, handling of emergencies/overdose, and other considerations will help ensure safe and effective use of Cisapride under medical supervision. Always consult your healthcare provider if you have any questions or concerns regarding your medication regimen.