Pronunciation:

SIT-rik AS-id, mag-NEE-zee-um OX-ide, SOE-dee-um pye-koe-sul-fate

Brand Names:

• Clenpiq
• Prepopik

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Laxative, Stimulant Combination

Uses of This Medicine:

Citric acid, magnesium oxide, and sodium picosulfate combination is used to cleanse the colon (bowel) in preparation for a procedure called colonoscopy. This medicine is a laxative. It works by causing you to have diarrhea to clean your colon. Cleaning your colon will help your doctor see inside of it more clearly during colonoscopy.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Clenpiq® and Prepopik® in children younger than 9 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of citric acid, magnesium oxide, and sodium picosulfate combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, and unwanted effects (eg, fluid or electrolyte imbalance), which may require caution in patients receiving this medicine.

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.

Other 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aclidinium
• Amantadine
• Amiloride
• Amitriptyline
• Amoxapine
• Anisotropine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Bornaprine
• Brompheniramine
• Butylscopolamine
• Canrenoate
• Canrenone
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Cimetropium
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Doxepin
• Emepronium
• Eplerenone
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glycopyrrolate
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Ipratropium
• Isopropamide
• Loxapine
• Mebeverine
• Meclizine
• Mepenzolate
• Methantheline
• Methixene
• Methscopolamine
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Paroxetine
• Perphenazine
• Pimozide
• Pinaverium
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Solifenacin
• Spironolactone
• Stramonium
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Triamterene
• Trifluoperazine
• Trihexyphenidyl
• Trimethobenzamide
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium
• Valethamate

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.

• Acalabrutinib
• Aceclofenac
• Acemetacin
• Aliskiren
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Azilsartan
• Azilsartan Medoxomil
• Baloxavir Marboxil
• Benazepril
• Bictegravir
• Bromfenac
• Bufexamac
• Cabotegravir
• Candesartan
• Captopril
• Cefuroxime Axetil
• Celecoxib
• Choline Salicylate
• Cilazapril
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Digoxin
• Dipyrone
• Dolutegravir
• Droxicam
• Eltrombopag
• Elvitegravir
• Enalapril
• Enalaprilat
• Eprosartan
• Erdafitinib
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosinopril
• Gefitinib
• Ibuprofen
• Indomethacin
• Infigratinib
• Irbesartan
• Ketoconazole
• Ketoprofen
• Ketorolac
• Ledipasvir
• Levomethadyl
• Licorice
• Lisinopril
• Lornoxicam
• Losartan
• Loxoprofen
• Lumiracoxib
• Magnesium Sulfate
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Moexipril
• Morniflumate
• Mycophenolic Acid
• Nabumetone
• Naproxen
• Nepafenac
• Neratinib
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Octreotide
• Olmesartan
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazopanib
• Perindopril
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piroxicam
• Polyethylene Glycol 3350
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinapril
• Raltegravir
• Ramipril
• Rilpivirine
• Rofecoxib
• Rosuvastatin
• Salicylic Acid
• Salsalate
• Selpercatinib
• Sodium Polystyrene Sulfonate
• Sodium Salicylate
• Sotorasib
• Spirapril
• Sulindac
• Telmisartan
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Trandolapril
• Valdecoxib
• Valsartan
• Vismodegib
• Zofenopril

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
• Delafloxacin
• Delavirdine
• Demeclocycline
• Dicumarol
• Doxycycline
• Enoxacin
• Felodipine
• Fexofenadine
• Gabapentin
• Gabapentin Enacarbil
• Gemifloxacin
• Grepafloxacin
• Isradipine
• Levofloxacin
• Levothyroxine
• Lomefloxacin
• Lymecycline
• Methacycline
• Minocycline
• Moxifloxacin
• Nicardipine
• Norfloxacin
• Omadacycline
• Oxytetracycline
• Pefloxacin
• Potassium Phosphate
• Potassium Phosphate, Dibasic
• Potassium Phosphate, Monobasic
• Quinidine
• Rolitetracycline
• Sarecycline
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sotalol
• Sparfloxacin
• Tacrolimus
• Tetracycline
• Ticlopidine
• Tipranavir
• Zalcitabine

Other interactions—

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
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, prolonged QT, uncontrolled arrhythmia), history of or
• Hypocalcemia (low calcium in the blood) or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hyponatremia (low sodium level in the blood) or
• Withdrawal from alcohol or benzodiazepines—May increase risk for seizures, arrhythmia, or kidney problems.

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

• Fluid and electrolyte imbalance—Use with caution. These conditions may increase risk for more side effects and must be corrected first before using this medicine.

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

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

Proper Use of This Medicine:

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.

You may drink clear liquid (eg, black coffee or tea without milk, cream, soy, or nondairy creamer, clear broth or bouillon, clear juices without pulp, frozen juice bars, ginger ale, other sodas, plain gelatin, plain or flavored water, sports drinks) up until 2 hours before your colonoscopy. Do not drink red or purple liquids.

Do not eat solid foods or drink alcohol, dairy, drinks, juices with pulp, soy milk, or any drinks, gelatin, or other liquids that are red or purple a day before your colonoscopy.

To use Clenpiq®:

• This medicine is available in a ready-to-drink bottle and is equal to one dose. You will need two doses of this medicine. Drink all of this medicine straight from the bottle.
• Drink five or more 8 ounce cups of clear liquids after the first dose of this medicine and drink four or more 8 ounce cups after the second dose.
• You may have bloating or an upset stomach before the loose stools start.

To use Prepopik®:

• One dose of this medicine consists of 2 packets of powder. Each packet is mixed with cold water (5 ounces) for 2 to 3 minutes 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 at least five 8 ounce cups of clear liquids over the next 5 hours after the first dose and drink at least three 8 ounce cups of clear liquids 2 hours before your colonoscopy after the second dose.
• You may have bloating or an upset stomach before the loose stools start.

Avoid taking other laxatives while you are taking this medicine.

Do not take any medicine by mouth within 1 hour before using citric acid, magnesium oxide, and sodium picosulfate combination. Oral medicines may not be absorbed completely.

Take chlorpromazine, digoxin, iron supplement, penicillamine, or antibiotics (eg, fluoroquinolone, tetracycline) at least 2 hours before or not less than 6 hours after taking this medicine.

Do not drink anything at least 2 hours before the colonoscopy.

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 cleansing of the colon:
  • For oral dosage form (powder for solution):
    • Adults and children 9 years of age and older—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 younger than 9 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • Adults and children 9 years of age and older—Your doctor will prescribe your dosing regimen to be taken the day or night before your colonoscopy.
      • Split-dose dosing regimen: Take your first bottle 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 bottle in the afternoon or early evening, and the second dose at least 6 hours after the first dose, the night before colonoscopy.
    • Children younger than 9 years of age—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—

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.

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

Do not refrigerate or freeze Clenpiq® or the mixed Prepopik®.

Precautions While Using This Medicine:

It is important that your doctor check your or your child's progress closely for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Contact your doctor right away if you or your child have decreased urination, dizziness, headache, or vomiting. These could be symptoms of a loss of too much body fluid (dehydration).

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

This medicine may increase your risk for seizures. This is more likely to occur if you take medicine for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have low sodium level in the blood (hyponatremia). Talk to your doctor if you have any concerns.

If you or your child have severe bloating, distension, or abdominal or stomach pain after taking the first dose, stop taking this medicine or delay taking the second dose until your symptoms improve.

This medicine may cause serious stomach or bowel problems (eg, colon ulcers, ischemic colitis). Check with your doctor right away if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

Fainting may occur during treatment with this medicine, which may increase risk of falls, head injuries, and fractures. Your doctor may ask you to drink more clear liquids.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Bleeding of the rectum

bloody stools

chest tightness

confusion

cough

decreased urine output

diarrhea

dizziness or fainting

dry mouth

fast, slow, or irregular heartbeat

fever

headache

hives, itching, skin rash

increased thirst

jerking or shaking of the muscles

joint pain, stiffness, or swelling

loss of bowel control

loss of consciousness

muscle pain or cramps

nausea

numbness or tingling in the hands, feet, or lips

pinpoint red or purple spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

stomach pain and tenderness

swelling of the eyelids, face, lips, ankles, hands, or feet

trouble breathing or swallowing

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Pain in the rectum

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.