Prepopik

What is Prepopik?

• Prepopik is a combination of sodium picosulfate, a stimulant laxative, and magnesium oxide and anhydrous citric acid which form magnesium citrate, an osmotic laxative.

Sodium picosulfate

What are the uses of this medicine?

• Prepopik is a prescription medicine used by adults and children 9 years of age and older, to clean the colon before a colonoscopy.
• Prepopik cleans your colon by causing you to have diarrhea.
• Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.

How does this medicine work?

• Sodium picosulfate is hydrolyzed by colonic bacteria to form an active metabolite: bis-(p-hydroxy-phenyl)-pyridyl-2-methane, BHPM, which acts directly on the colonic mucosa to stimulate colonic peristalsis.
• Magnesium oxide and citric acid react to create magnesium citrate in solution, which is an osmotic agent that causes water to be retained within the gastrointestinal tract.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have: serious kidney problems.

• a blockage in your intestine (bowel obstruction).
• an opening in the wall of your stomach or intestines (bowel perforation).
• a very dilated intestine (toxic megacolon).
• problems with the emptying of food and fluid from your stomach (gastric retention).
• an allergy to any of the ingredients in Prepopik.

What drug interactions can this medicine cause?

• Prior or concomitant use of antibiotics may reduce efficacy of PREPOPIK.
• Oral medication administered within one hour of the start of administration of PREPOPIK solution may be flushed from the GI tract and the medication may not be absorbed.
• Use caution when prescribing PREPOPIK for patients with conditions or who are using medications that increase the risk for fluid and electrolyte disturbances. This includes patients receiving drugs which may be associated with hypokalemia (such as diuretics or corticosteroids,
• or drugs where hypokalemia is a particular risk, such as cardiac glycosides) or hyponatremia. Use caution when PREPOPIK is used in patients on nonsteroidal anti-inflammatory drugs (NSAIDS) or drugs known to induce Antidiuretic Hormone Secretion (SIADH), such as tricyclic antidepressants, selective serotonin re-uptake inhibitors, antipsychotic drugs and carbamazepine, as these drugs may increase the risk of water retention and/or electrolyte imbalance.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

Recommended dosage:

• PREPOPIK, supplied as a powder, must be reconstituted with cold water right before its use.

There are two dosing regimens, each requires two separate dosing times:

• The preferred method is the “Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.

The alternative method is the “Day Before” method and consists of two separate doses:

• the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy).

• Additional fluids must be consumed after every dose in both dosing regimens.
• Instruct patients to consume only clear liquids (no solid food or milk) on the day before the colonoscopy up until 2 hours before the time of the colonoscopy.
• Instruct patients that if they experience severe bloating, distention, or abdominal pain following the first dose, delay the second dose until their symptoms resolve.

Administration:

• Take Prepopik exactly as your healthcare provider tells you to take it.
• Do not take Prepopik powder that has not been mixed with water. It may increase your risk of nausea, vomiting, and fluid loss (dehydration).
• Each packet of Prepopik powder must be mixed with 5 ounces of cold water before drinking.
• It is important for you to drink the additional prescribed amount of clear liquids listed in the Instructions for Use to prevent fluid loss (dehydration).
• Two doses of Prepopik are required for a complete colonoscopy preparation. 1 packet of Prepopik for oral solution equals 1 dose.
• There are 2 different methods for taking Prepopik. It is better (preferred) to use the Split-Dose method. If you cannot do the Split-Dose method, you can take Prepopik using the Day-Before method. See the Instructions for Use for more information.
• All people taking Prepopik should follow these general instructions starting 1 day before your colonoscopy:
• only drink clear liquids all day and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before the colonoscopy.
• after taking Prepopik if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.
• While taking Prepopik, do not:
• take any other laxatives.
• take any medicines by mouth (oral) within 1 hour of starting Prepopik.
• eat solid foods, dairy such as milk, or alcohol while taking Prepopik and until after your colonoscopy.
• eat or drink anything colored red or purple.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As oral solution: each of 2 packets contains 16.1 g of powder: 10 mg sodium picosulfate, 3.5 g magnesium oxide, and 12 g anhydrous citric acid

This medicine is available in fallowing brand namesː

• Prepopik

What side effects can this medication cause?

The most common side effects of Prepopik in adults include:

• nausea
• headache
• vomiting

The most common side effects of Prepopik in children 9 to 16 years of age include:

• nausea
• vomiting
• stomach area (abdominal) pain

Prepopik can cause serious side effects, including:

• Changes in certain blood tests
• Ulcers of the bowel or bowel problems (ischemic colitis)

What special precautions should I follow?

• Risk of fluid and electrolyte abnormalities, arrhythmia, seizures, and renal impairment may increase with Prepopik. Encourage adequate hydration, assess concurrent
• medications, and consider laboratory assessments prior to and after use.
• As in other magnesium containing bowel preparations, use caution when prescribing PREPOPIK for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Use caution, ensure adequate
• hydration and consider testing.
• Osmotic laxatives may produce colonic mucosal aphthous ulcerations and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of additional stimulant laxatives with PREPOPIK may increase this risk.
• If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PREPOPIK. Use with caution in patients with severe active ulcerative colitis.
• Each packet must be dissolved in 5 ounces of cold water and administered at separate times according to the dosing regimen. Ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

What to do in case of emergency/overdose?

Management of overdosage:

• The patient who has taken an overdose should be monitored carefully, and treated symptomatically for complications.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women. PREPOPIK should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of PREPOPIK in pediatric patients has not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid
• Inactive ingredients: potassium hydrogen carbonate, saccharin sodium, orange flavor which contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole or the cranberry flavor which contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch.

Who manufactures and distributes this medicine?

• Manufactured for: Ferring Pharmaceuticals Inc.

Parsippany, NJ USA

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

• Store Prepopik at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Prepopik
• FDA Prepopik

Prepopik Resources
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