Clenpiq

Generic name: citric acid, magnesium oxide, and sodium picosulfate
Brand names: Clenpiq, Prepopik
Drug class: Laxatives

Medically reviewed by  A Ras MD.

What is Clenpiq?

Clenpiq is a prescription medicine used by adults and children 9 years of age and older, to clean the colon before a colonoscopy. Clenpiq 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.

It is not known if Clenpiq is safe and effective in children under 9 years of age.

Description

CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear solution with possible presence of visible particles. CLENPIQ is supplied as two bottles in each carton.

Each bottle of CLENPIQ contains 10 mg sodium picosulfate, USP; 3.5 g magnesium oxide, USP; and 12 g anhydrous citric acid, USP. The product also contains the following inactive ingredients:

acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch.

The following is a description of the three active ingredients contained in CLENPIQ:

Sodium picosulfate is a stimulant laxative.

 Mechanism of Action

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.

What is the most important information I should know about Clenpiq?

Clenpiq and other bowel preparations can cause serious side effects, including:

• Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause:
  • abnormal heartbeats that can cause death.
  • seizures. This can happen even if you have never had a seizure.
  • kidney problems.

Your chance of having fluid loss and changes in blood salts with Clenpiq is higher if you:

• have heart problems
• have kidney problems
• take water pills or non-steroidal anti-inflammatory drugs (NSAIDS)

Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking Clenpiq:

• vomiting
• urinating less often than normal
• dizziness
• headache

See “What are the possible side effects of Clenpiq?” for more information about side effects.

Who should not take Clenpiq?

Do not take Clenpiq 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 Clenpiq. See the end of this leaflet for a complete list of ingredients in Clenpiq.

What should I tell my healthcare provider before taking Clenpiq?

Before taking Clenpiq, tell your healthcare provider about all of your medical conditions, including if you:

• have problems with serious loss of body fluid (dehydration) and changes in blood salts (electrolytes).
• have a history of seizures or take medicines for seizures.
• are withdrawing from drinking alcohol or from taking benzodiazepines.
• have low blood salt (sodium) level.
• have kidney problems or take medicines for kidney problems.
• have heart problems.
• have stomach or bowel problems including ulcerative colitis.
• have problems with swallowing or gastric reflux.
• are pregnant. It is not known if Clenpiq will harm your unborn baby. Talk to your provider if you are pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Clenpiq passes into your breast milk. You and your healthcare provider should decide if you will take Clenpiq while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Clenpiq may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Clenpiq.

Especially tell your healthcare provider if you take:

• medicines for blood pressure or heart problems.
• medicines for kidney problems.
• medicines for seizures.
• water pills (diuretics).
• nonsteroidal anti-inflammatory medicines (pain medicines).
• medicines for depression or mental health problems.
• laxatives. Do not take other laxatives while taking Clenpiq.

The following medicines should be taken at least 2 hours before starting Clenpiq and not less than 6 hours after taking Clenpiq:

• tetracycline
• fluoroquinolone antibiotics
• iron
• digoxin (Lanoxin)
• chlorpromazine
• penicillamine (Cuprimine, Depen)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking the medicines listed above.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Clenpiq?

See the Instructions for Use that come with Clenpiq for dosing instructions. You must read, understand, and follow these instructions to take Clenpiq the right way.

• Take Clenpiq exactly as your healthcare provider tells you to take it.
• Clenpiq comes ready to drink and does not need to be mixed with anything else before you take your dose of medicine.
• Clenpiq is a clear liquid that may have particles.
• 1 bottle of Clenpiq equals 1 dose. Two separate doses of Clenpiq are required for complete colonoscopy preparation.
• Clenpiq is taken using the Split-Dose method. See the instructions for use for more information.
• All people taking Clenpiq 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 Clenpiq 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 Clenpiq, do not:
  • take any other laxatives.
  • take any medicines by mouth (oral) within 1 hour of starting Clenpiq.
  • eat solid foods, dairy such as milk, or alcohol while taking Clenpiq and until after your colonoscopy.
  • eat or drink anything colored red or purple.

Contact your healthcare provider right away if after taking Clenpiq you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking Clenpiq.

What are the possible side effects of Clenpiq?

Clenpiq can cause serious side effects, including:

• See “What is the most important information I should know about Clenpiq?”
• Changes in certain blood tests. Your healthcare provider may do blood tests after you take Clenpiq to check your blood for changes.
• Tell your healthcare provider if you have any symptoms of too much fluid loss, including:
  • vomiting
  • stomach area (abdomen) cramping
  • seizures
  • nausea
  • urinate less than usual
  • heart problems
  • bloating
  • trouble drinking clear liquids
  • dizziness
  • troubles swallowing
• Ulcers of the bowel or bowel problems (ischemic colitis). Tell your healthcare provider right away if you have severe stomach-area (abdominal) pain or rectal bleeding.

The most common side effects of Clenpiq in adults include:

• nausea
• headache
• high magnesium levels in your blood
• stomach area (abdominal) pain
• dehydration or dizziness

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

• nausea
• vomiting
• stomach area (abdominal) pain

These are not all the possible side effects of Clenpiq.

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

General information about the safe and effective use of Clenpiq

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Clenpiq for a condition for which it was not prescribed. Do not give Clenpiq to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Clenpiq that is written for health professionals.

How should I store Clenpiq?

• Store Clenpiq at room temperature, between 68 to 77°F (20° to 25°C).
• Do not put Clenpiq in the refrigerator or freezer.

Keep Clenpiq and all medicines out of the reach of children.

What are the ingredients in Clenpiq?

Active ingredients: sodium picosulfate, magnesium oxide, and anhydrous citric acid

Inactive ingredients: acesulfame potassium, cranberry flavor, disodium edetate, malic acid, sodium benzoate, sodium hydroxide,, sodium metabisulfite, sucralose, and water. The cranberry flavor contains glyceryl triacetate (triacetin), maltodextrin, and sodium octenyl succinated starch.

Label

PRINCIPAL DISPLAY PANEL – 10 MG/3.5 G/12 G BOTTLE CARTON

• Cranberry
  Flavor
  NDC 55566-6700-1
• CLENPIQ™
• (sodium picosulfate, magnesium oxide,
  and anhydrous citric acid) Oral Solution
• 10 mg/3.5 g/12 g per 160 mL bottle
• CLENPIQ™ is a ready-to-drink
  oral solution that doesn’t need to be diluted.
• Read the enclosed Instructions for Use and Medication Guide
  AT LEAST 2 DAYS BEFORE your colonoscopy
  and again right before taking CLENPIQ™.
• Contains two (2) 160 mL bottles
• Rx only
• FERRING
  PHARMACEUTICALS

SRC: NLM .