Clenpiq is an oral solution prescribed for colon cleansing before colonoscopy in adults and pediatric patients aged 9 and older. It is FDA-approved and ready to drink.
1.1 What is Clenpiq?
Clenpiq is an oral solution containing sodium picosulfate, magnesium oxide, and anhydrous citric acid. It is a prescription bowel prep medication used to cleanse the colon before colonoscopy. Clenpiq works by stimulating bowel movements and softening stool. It is approved for use in adults and pediatric patients aged 9 years and older. The solution is ready to drink and does not require mixing with other liquids. It is designed to be taken in two doses, one in the evening and one in the morning, to ensure thorough cleansing.
1.2 Purpose of Clenpiq in Colonoscopy Preparation
The primary purpose of Clenpiq is to cleanse the colon thoroughly, allowing for clear visualization during a colonoscopy. It works by stimulating bowel movements and softening stool, ensuring a clean colon. This preparation is crucial for accurate detection of abnormalities, such as polyps or lesions. Clenpiq’s effectiveness ensures that the procedure is conducted efficiently, reducing the need for repeat examinations. Proper use of Clenpiq as directed by healthcare providers is essential for achieving optimal results.
Important Safety Information
Clenpiq is contraindicated in severe renal impairment, GI obstruction, or ileus. Correct fluid/electrolyte abnormalities before use. Ensure proper hydration to minimize risks.
2.1 Contraindications for Clenpiq Use
Clenpiq is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/minute), gastrointestinal obstruction, or ileus. It should not be used in individuals with known hypersensitivity to its components; Additionally, Clenpiq is not recommended for patients with severe electrolyte imbalances or those requiring dialysis. Healthcare providers should be informed of any pre-existing medical conditions before prescribing Clenpiq to ensure safe and appropriate use. Always follow FDA guidelines and consult a healthcare professional for personalized advice.
2.2 Warnings and Precautions
Clenpiq should be used with caution in patients with electrolyte imbalances or renal impairment. Correct fluid and electrolyte abnormalities before administration. Monitor for signs of dehydration or electrolyte shifts, especially in vulnerable populations. Clenpiq may increase the risk of colon perforation in patients with certain gastrointestinal conditions. Patients should avoid consuming solid foods, dairy, or colored liquids during preparation. Adhere to clear liquid diets and hydration guidelines to minimize risks. Not recommended for use with other laxatives or oral medications within one hour of intake. Ensure proper storage and handling to maintain efficacy.
Dosage and Administration
Clenpiq is taken in two doses: one the evening before colonoscopy and the second 5 hours before the procedure. Refrigerate the bottles the day before use. Always drink the solution directly and follow with clear liquids as instructed. Do not mix with other liquids or take within one hour of oral medications. Ensure proper hydration throughout the preparation process.
3.1 Timing of Clenpiq Intake
The first dose of Clenpiq should be taken the evening before the colonoscopy, typically between 5:00 PM and 9:00 PM. The second dose is taken the morning of the procedure, approximately 5 hours before the scheduled time. Patients must complete the entire preparation as instructed, with clear liquids consumed after each dose; Refrigerate the bottles the afternoon before use to ensure the solution is ready to drink when needed. Proper timing is crucial for effective colon cleansing;
3.2 Split-Dose Dosage Regimen
Clenpiq is administered in two split doses for optimal colon cleansing. The first dose is taken the evening before colonoscopy, and the second dose is taken 5 hours before the procedure. Each dose is consumed directly from the bottle without mixing. Following each dose, patients must drink clear liquids as instructed. The split-dose regimen helps ensure thorough bowel preparation while minimizing disruption to the patient’s schedule. Adherence to the timing is essential for effective cleansing.
3.3 Instructions for Consuming Clear Liquids
After taking Clenpiq, patients must drink clear liquids to stay hydrated and ensure effective cleansing. Acceptable clear liquids include water, clear broths, and certain juices without pulp. Avoid solid foods, dairy, and colored beverages like red or purple drinks. Clear liquids should be consumed until 2 hours before the colonoscopy. Proper hydration is critical for the procedure’s success and to minimize potential side effects. Patients should follow their healthcare provider’s specific instructions regarding fluid intake.
Indications and Usage
Clenpiq is indicated for colon cleansing in adults and pediatric patients aged 9 and older. It is FDA-approved and ready to drink, ensuring effective colonoscopy preparation.
4.1 Approved Use in Adults and Pediatric Patients
Clenpiq is FDA-approved for colon cleansing in adults and pediatric patients aged 9 and older. It is taken in two doses: one the evening before colonoscopy and another 5 hours before the procedure. The solution is ready to drink without dilution. Patients must consume clear liquids only, starting the day before, to ensure proper hydration and effectiveness.
4.2 Specific Patient Populations
Clenpiq is contraindicated in severe renal impairment (creatinine clearance <30 mL/minute) and GI obstruction. Diabetic patients must monitor blood sugar closely, as Clenpiq may affect glucose levels. Pediatric patients aged 9-16 should follow adult dosing under medical supervision. The split-dose regimen is safe for most patients but may require adjustment based on individual health conditions. Always consult a healthcare provider for personalized guidance.
Side Effects and Adverse Reactions
Common side effects include nausea, abdominal pain, and diarrhea. In pediatric patients, vomiting is also frequent. Report adverse reactions to the FDA at 1-800-FDA-1088.
5.1 Common Side Effects in Adults and Children
Common side effects of Clenpiq in adults include nausea, diarrhea, and abdominal pain. In pediatric patients aged 9 to 16, nausea, vomiting, and stomach discomfort are frequently reported. These reactions are typically mild to moderate. Patients should discuss any unusual or severe symptoms with their healthcare provider. For more information, consult the FDA-approved Medication Guide or report adverse effects to the FDA at 1-800-FDA-1088.
5.2 Reporting Adverse Effects to the FDA
Patient experiencing adverse effects from Clenpiq should report them to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. This process helps monitor drug safety and improve patient care. Patients are encouraged to discuss any concerns with their healthcare provider and report negative side effects promptly to ensure accurate safety monitoring and updates to prescribing information.
Storage and Handling
Store Clenpiq at room temperature (68°F to 77°F or 20°C to 25°C). Keep it out of reach of children and avoid refrigeration or freezing.
6.1 Proper Storage Conditions
Clenpiq should be stored at room temperature between 68°F and 77°F (20°C to 25°C). It must be kept in the original bottle, tightly closed, and protected from light. Do not refrigerate or freeze the solution, as this may affect its effectiveness. Ensure the product is out of reach of children and pets to avoid accidental ingestion. Proper storage ensures the quality and safety of the medication until use.
6.2 Keeping Clenpiq Out of Reach of Children
Clenpiq must be stored securely out of the reach of children to prevent accidental ingestion. This is crucial due to the potential risks of electrolyte imbalances or gastrointestinal distress in minors. Always keep the medication in a high, inaccessible location, such as a locked cabinet. Never leave Clenpiq unattended or in areas where children may easily find it. Proper storage helps ensure safety and prevents unintended exposure. The FDA emphasizes the importance of safeguarding medications.
FDA-Approved Patient Labeling
The FDA-approved patient labeling includes a Medication Guide and detailed Instructions for Use. Patients are advised to read these materials carefully before starting Clenpiq treatment.
7.1 Medication Guide and Instructions for Use
The Medication Guide provides essential information about Clenpiq, including its proper use, potential side effects, and safety precautions. Patients should read it carefully before starting treatment. The Instructions for Use outline step-by-step guidance on how to take Clenpiq, such as the split-dose regimen and hydration requirements. These materials are designed to help patients understand their treatment and ensure safe and effective use of the medication. Always follow the FDA-approved labeling for Clenpiq.
7.2 Role of the FDA in Monitoring Safety
The FDA plays a crucial role in monitoring the safety of Clenpiq by reviewing adverse event reports and ensuring compliance with safety standards. Patients are encouraged to report any negative side effects to the FDA through MedWatch at www.fda;gov/medwatch or by calling 1-800-FDA-1088. This helps the FDA assess the medication’s safety profile and update prescribing information as needed. The FDA’s oversight ensures that Clenpiq remains safe and effective for its intended use.
Preparation Instructions
Clenpiq preparation involves drinking the first dose the evening before colonoscopy and the second dose the morning of the procedure, with clear liquids in between.
8.1 Evening Before Colonoscopy
On the evening before your colonoscopy, take the first dose of Clenpiq between 5:00 PM and 9:00 PM. Drink the entire contents of one bottle directly, without mixing. After consuming Clenpiq, drink at least five 8-ounce glasses of clear liquids over the next five hours. Stay near a restroom as the effects will begin soon. Avoid eating solid foods or dairy and refrain from drinking red or purple liquids. Follow your healthcare provider’s instructions carefully to ensure proper preparation.
8.2 Morning of Colonoscopy
On the morning of your colonoscopy, take the second dose of Clenpiq 5 hours before your scheduled procedure. Drink the entire contents of the second bottle directly. After consuming Clenpiq, drink at least four 8-ounce glasses of clear liquids. Stop drinking all fluids at least 2 hours before your procedure. Ensure you complete the entire preparation as instructed to avoid rescheduling. Follow your healthcare provider’s guidelines for timing and hydration to achieve optimal results.
8.3 General Hydration Guidelines
Proper hydration is essential when using Clenpiq. Begin hydrating the day before your colonoscopy by drinking only clear liquids. Continue this until 2 hours before the procedure. After each Clenpiq dose, drink the recommended amount of clear fluids (e.g., water, clear broth, or ginger ale). Avoid colored drinks, alcohol, and dairy. Complete all fluids at least 2 hours before your colonoscopy. Following these guidelines ensures adequate preparation and helps prevent complications. Proper hydration supports the effectiveness of Clenpiq.
Adhering to Clenpiq instructions ensures effective colon cleansing for a successful colonoscopy. Proper hydration and following guidelines are crucial for optimal preparation and safety.
9.1 Importance of Following Clenpiq Instructions
Following Clenpiq instructions is crucial for effective colon cleansing and a successful colonoscopy. Proper timing, hydration, and clear liquid intake ensure the procedure is not rescheduled. Deviating from guidelines can lead to incomplete preparation, potentially requiring repeat procedures. Adhering to the prescribed regimen minimizes side effects and ensures safety. Patients must avoid solid foods, dairy, and colored drinks to achieve optimal results. Compliance with instructions is key to a safe and effective colonoscopy experience.
9.2 Final Tips for Successful Colonoscopy Prep
To ensure a successful colonoscopy, stay hydrated by drinking clear liquids as instructed. Avoid solid foods, dairy, and colored drinks to prevent interference. Complete the entire Clenpiq regimen, even if bowel movements appear clear. Finish all prep at least four hours before the procedure. Be near a restroom after starting Clenpiq, as effects begin quickly. Follow your healthcare provider’s advice and review the FDA-approved guide for any additional tips. Proper preparation enhances the accuracy of the colonoscopy results.