Prepopik

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Prepopik™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Prepopik™ in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin
• Eltrombopag
• Elvitegravir
• Gefitinib
• Ketoconazole
• Ledipasvir
• Levomethadyl
• Licorice
• Mefenamic Acid
• Mycophenolate Mofetil
• Mycophenolic Acid
• Pazopanib
• Phenytoin
• Raltegravir
• Rilpivirine
• Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amprenavir
• Atevirdine
• Cefditoren Pivoxil
• Chloroquine
• Chlortetracycline
• Ciprofloxacin
• Dasatinib
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dicumarol
• Dolutegravir
• Doxycycline
• Enoxacin
• Felodipine
• Fexofenadine
• Gabapentin
• Gabapentin Enacarbil
• Gemifloxacin
• Grepafloxacin
• Isradipine
• Levofloxacin
• Levothyroxine
• Lomefloxacin
• Methacycline
• Minocycline
• Moxifloxacin
• Nicardipine
• Norfloxacin
• Oxytetracycline
• Pefloxacin
• Potassium Phosphate
• Potassium Phosphate, Dibasic
• Potassium Phosphate, Monobasic
• Quinidine
• Rolitetracycline
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Polystyrene Sulfonate
• Sparfloxacin
• Tacrolimus
• Tetracycline
• Ticlopidine
• Tipranavir
• Zalcitabine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain), unstable or
• Electrolyte imbalance (e.g., low calcium, magnesium, potassium, sodium in the blood) or
• Fluid imbalance or
• Heart attack, recent or
• Heart disease (e.g., cardiomyopathy) or
• Heart rhythm problems (e.g., prolonged QT, uncontrolled arrhythmia), history of or
• Withdrawal from alcohol or benzodiazepines (e.g., alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—May increase risk for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration or
• Inflammatory bowel disease or
• Kidney problems or
• Seizures, history of or
• Trouble swallowing or
• Ulcerative colitis, active and severe—Use with caution. May make these conditions worse.

• Gastric retention (problems with emptying of food or fluid from the stomach) or
• Intestinal problems (e.g., blockage, perforation) or
• Kidney disease, severe or
• Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide and patient instructions. You must read, understand, and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine in two dosing regimens: Split-Dose dosing regimen and Day-Before dosing regimen. Your doctor will tell you how to take this medicine depending on your colonoscopy schedule, distance traveled, and other personal circumstances.

To use this medicine:

• One dose of this medicine consists of two packets of powder, each packet is mixed with cold water and taken at separate dosing times. Drink the liquid right away after mixing. Do not prepare the solution in advance.
• Do not take the powder directly without mixing it with cold water. Doing so, may increase risk of side effects.
• Use the supplied medicine cup when preparing the solution.
• Drink the additional prescribed amount of clear fluids (e.g., water, apple juice, white cranberry juice, white grape juice, or ginger ale) after every dose of this medicine to prevent dehydration.
• Do not eat solid foods or drink milk while taking this medicine.
• Drink clear liquids until your colonoscopy.

Avoid taking other laxatives while you are taking this medicine.

Avoid taking any medicine by mouth within 1 hour before taking Prepopik™. Oral medicines may not be absorbed completely.

If you are taking chlorpromazine (Thorazine®), digoxin (Lanoxin®), penicillamine (Cuprimine®, Depen®), iron supplements, and certain antibiotics (such as ciprofloxacin, doxycycline, minocycline, tetracycline, Avelox®, Levaquin®, Vigamox®), take these medicines at least 2 hours before starting Prepopik™ and 6 hours after taking Prepopik™.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder for solution):
  • For cleansing of the colon:
    • Adults—Your doctor will prescribe your dosing regimen to be taken the day or night before your colonoscopy.
      • Split-dose dosing regimen: Take your first packet the night before colonoscopy, and the second dose the next day, in the morning or at least 5 hours before your colonoscopy.
      • Day-Before dosing regimen: Take your first packet in the afternoon or early evening, and the second dose at least 6 hours after the first dose, the night before colonoscopy.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use Prepopik as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine as your doctor has told you. Follow all instructions you have been given closely. This includes when to take Prepopik, foods and drinks to avoid before the exam, and when to stop eating and drinking before the exam. Talk with your doctor if you have any questions.
• Do not take other drugs within 1 hour of starting this medicine. Talk with your doctor about how to take your other drugs with Prepopik.
• Mix with water as told before you take this medicine. Do not swallow the dry powder.
• Drink clear liquids before, during, and after taking Prepopik. Do not drink any liquids that are purple or red.
• If you have very bad belly pain, swelling, or bloating after the first dose, do not take the second dose until they go away. Talk with your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.
• Call your doctor if you are not able to finish this medicine before your exam.

Prepopik® (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Pregnancy

Pregnancy Category B

Reproduction studies with Prepopik® have been performed in pregnant rats at oral doses up to 2000 mg/kg/day (about 1.2 times the recommended human dose based on the body surface area), and did not reveal any evidence of impaired fertility or harm to the fetus due to Prepopik®. The reproduction study in rabbits was not adequate, as treatment-related mortalities were observed at all doses. A pre and postnatal development study in rats showed no evidence of any adverse effect on pre and postnatal development at oral doses up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on the body surface area). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Prepopik® should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prepopik® is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Prepopik® in pediatric patients has not been established.

Geriatric Use

In controlled clinical trials of Prepopik®, 215 of 1201 (18%) patients were 65 years of age or older. The overall incidence of treatment-emergent adverse events was similar among patients ≥65 years of age (73%) and patients <65 years of age (71%). Among all patients ≥65 years of age, the proportion of patients with successful colon cleansing was greater in the Prepopik® group (81.1%) than in the comparator group (70.9%).

Renal Insufficiency

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) may be at increased risk for further renal injury. Advise these patients of the importance of adequate hydration before, during and after the use of Prepopik®. Consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients. In patients with severely reduced renal function (creatinine clearance < 30 mL/min), accumulation of magnesium in plasma may occur. The signs and symptoms of hypermagnesemia may include, but are not limited to, diminished or absent deep tendon reflexes, somnolence, hypocalcemia, hypotension, bradycardia, muscle, respiratory paralysis, complete heart block, and cardiac arrest.

Prepopik® (sodium picosulfate, magnesium oxide and anhydrous citric acid) for oral solution is available in 2 flavors, orange and cranberry flavor, and is provided in two packets. The contents of each is to be dissolved in 5 ounces of cold water and consumed.

Each packet for both flavors contains 10 mg sodium picosulfate, 3.5 g magnesium oxide and 12 g anhydrous citric acid. The product also contains the following inactive ingredients: potassium hydrogen carbonate, saccharine sodium and orange or cranberry flavors. The orange flavor contains acacia gum, lactose, ascorbic acid and butylated hydroxyanisole, and the cranberry flavor contains maltodextrin, glyceryl triacetate (triacetin) and sodium octenyl succinated starch. The following is a description of the three active ingredients:

Sodium picosulfate is a stimulant laxative.

Sodium picosulfate

• Chemical name: 4,4´-(2-pyridylmethylene) diphenyl bis(hydrogen sulfate) disodium salt, monohydrate
• Chemical formula: C18H13NNa2O8S2.H2O
• Molecular weight: 499.4
• Structural formula:

.H2O

• Sodium picosulfate

Magnesium citrate, which is formed in solution by the combination of magnesium oxide and anhydrous citric acid, is an osmotic laxative.

Magnesium oxide

• Chemical name: Magnesium oxide
• Chemical formula: Mg O
• Molecular weight: 40.3
• Structural formula: Mg O

Anhydrous citric acid

• Chemical name: 2-hydroxypropane-1,2,3-tricarboxylic acid
• Chemical formula: C6H8O7
• Molecular weight: 192.1
• Structural formula:

Anhydrous citric acid

Rx only
NDC 55566-9300-2

Orange
Flavor

Prepopik®
(sodium picosulfate, magnesium oxide, and
anhydrous citric acid) for oral solution
10 mg/3.5 g/12 g per packet

ATTENTION PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Contains 2 packets

Store at 25°C (77°F)
Excursions permitted at 15-30°C (59-86°F)
[See USP controlled room temperature]

FERRING
PHARMACEUTICALS

Do not take Prepopik if your healthcare provider has told you that you 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. See the end of this leaflet for a complete list of ingredients.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes the most important information about Prepopik. If you would like more information, talk with your healthcare provider. You can also ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, go to www.ferring.com or call 1-888-337-7464.