Sodium picosulfate, magnesium, and citric acid (Oral)

Citric acid, magnesium oxide, and sodium picosulfate combination is used to clean the colon (bowel) before a procedure called colonoscopy. This medicine is a laxative. It causes diarrhea to help clear your colon. A clean colon allows your doctor to see it more clearly during the colonoscopy.

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

It is important for your doctor to monitor you or your child closely for any problems or side effects that may be caused by this medicine. Blood and urine tests may be necessary to check for side effects.

Contact your doctor immediately if you or your child experience decreased urination, dizziness, headache, or vomiting. These may be signs of dehydration.

Contact your doctor right away if you notice any changes in your heart rhythm. You might feel dizzy or faint, or you could have a fast, pounding, or uneven heartbeat. Make sure your doctor is aware if you have had a heart rhythm issue, including QT prolongation.

This medicine may raise your risk for seizures. This is more likely to happen if you are taking medicine for depression, if you are withdrawing from alcohol or benzodiazepine use, or if you have low sodium levels in the blood (hyponatremia). Discuss any concerns with your doctor.

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

This medicine may lead to serious stomach or bowel issues (for example, colon ulcers, ischemic colitis). Contact your doctor immediately if you have stomach pain and tenderness, bloody stools, or rectal bleeding.

Fainting may happen during treatment with this medicine, which can increase the risk of falls, head injuries, and fractures. Your doctor may recommend that you drink more clear liquids.

Do not take any other medicines unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this drug or any other medicines. Additionally 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 Clenpiq® and Prepopik® in children younger than 9 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues 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 issues, 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 using this medicine while breastfeeding.

Interactions with Medications

Although certain drugs 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 using this medication, it is especially critical that your healthcare professional know if you are using any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medication with any of the following medications is not advised. Your doctor may decide not to treat you with this medication or change some of the other medications 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 medication with any of the following medications is usually not advised, but may be required in some cases. If both drugs are prescribed together, your clinician may change the dose or how frequently you use one or both of the drugs.

• 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 medication with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• 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

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 issues may affect the use of this drug. Make sure you tell your doctor if you have any other medical issues, 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 raise chance for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration or
• Fainting, history of or
• Inflammatory bowel disease or
• Kidney issues or
• Seizures, history of or
• Stomach or bowel blockage or perforation or
• Trouble swallowing or
• Ulcerative colitis, active and serious—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 prior to using this drug.

• 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.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Contact your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, 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, contact your healthcare professional.

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

In the U.S.

• Clenpiq
• Prepopik

Available Dosage Forms:

• Solution

Therapeutic Class: Laxative, Stimulant Combination

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®.