Picosulfate Sodium, Magnesium Oxide, and Citric Acid: Uses, Side Effects and Dosage

What is the most important information I should know about sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution:

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

See “What are the possible side effects of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?” for more information about side effects.

What is sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is a prescription medicine used by adults and children 9 years of age and older, to clean the colon before a colonoscopy. Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is safe and effective in children under 9 years of age.

Do not take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. See the end of this Medication Guide for a complete list of ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

Before taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution, 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution will harm your unborn baby. Talk to your healthcare provider if you are pregnant.

• are breastfeeding or plan to breastfeed. It is not known if sodium picosulfate, magnesium oxide and anhydrous citric acid passes into your breast milk. You and your healthcare provider should decide if you will take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution while breastfeeding.

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

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution may affect how other medicines work, and other medicines may affect how sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution works. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

The following medicines should be taken at least 2 hours before starting sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution and not less than 6 hours after taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution:

• tetracycline • digoxin (Lanoxin)
• fluoroquinolone antibiotics • chlorpromazine
• iron • 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

See the Instructions for Use for dosing instructions. You must read, understand, and follow these instructions to take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution the right way .

• Take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution exactly as your healthcare provider tells you to take it.
• Do not take sodium picosulfate, magnesium oxide and anhydrous citric acid powder that has not been mixed with water. It may increase your risk of nausea, vomiting, and fluid loss (dehydration).
• Each packet of sodium picosulfate, magnesium oxide and anhydrous citric acid 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution are required for a complete colonoscopy preparation. 1 packet of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution equals 1 dose.
• There are 2 different methods for taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. It is better (preferred) to use the Split-Dose method. If you cannot do the Split-Dose method, you can take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution using the Day-Before method. See the Instructions for Use for more information.
• All people taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution 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 sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution, do not:
• take any other laxatives.
• take any medicines by mouth (oral) within 1 hour of starting sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.
• eat solid foods, dairy such as milk, or alcohol while taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution and until after your colonoscopy.
• eat or drink anything colored red or purple.

Contact your healthcare provider right away if after taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution you have severe vomiting, signs of dehydration, changes in consciousness such as feeling confused, delirious or fainting (loss of consciousness) or seizures after taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

What are the possible side effects of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution can cause serious side effects, including:

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

The most common side effects of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in adults include:

• nausea • headache • vomiting

The most common side effects of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution in children 9 to 16 years of age include:

• nausea • vomiting • stomach area (abdominal) pain

These are not all the possible side effects of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

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

How should I store sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

• Store sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Keep sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution and all medicines out of the reach of children.

General information about the safe and effective use of sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution for a condition for which it was not prescribed. Do not give sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution to other people, even if they are going to have the same procedure you are. It may harm them. You can ask your pharmacist or healthcare provider for information about sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution that is written for health professionals.

What are the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution?

Sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution comes in a carton containing 2 packets, each containing 16.1 grams of powder in orange flavor, along with a pre-marked dosing cup.

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

Inactive ingredients: glyceryl behenate, orange flavor (contains dl-alpha-Tocopherol and Maize maltodextrin), potassium bicarbonate and saccharin sodium.

For more information, call Annora Pharma Private Limited at 1-866-495-1995.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Medication guide available at http://camberpharma.com/medication-guides

Manufactured for:

Camber Pharmaceuticals, Inc.,

Piscataway, NJ 08854

By: Annora Pharma Pvt. Ltd.

Sangareddy - 502313, Telangana, India.

Revised: 08/2022

INSTRUCTIONS FOR USE

Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid for Oral Solution

(SOW dee um pye ko SUL fate, mag NEE zhum OKS ide & SI trik AS id)

Before Taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution

There are 2 different methods for taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution. It is better (preferred) to use the Split-Dose method. If you cannot use the Split-Dose method, you can take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution using the Day-Before method. Talk with your healthcare provider before you start if you have any questions.

• Start a clear-liquid diet the day before your colonoscopy. Only drink clear liquids all day the day before your colonoscopy, and the next day until 2 hours before your colonoscopy. Stop drinking all fluids at least 2 hours before the colonoscopy.
• You must drink enough clear liquids to keep your body hydrated for the entire day before your colonoscopy.

Important:

See Table 1 for a list of liquids you can drink for your clear liquid diet.

Important:

See Table 2 for the items you cannot eat or drink before your colonoscopy.

Important:

• Sodium picosulfate, magnesium oxide and anhydrous citric acid is a powder that must be added to cold water right before use.
• Do not prepare the solution ahead of time. Take sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution right after it is prepared.
• Do not swallow the powder without adding it to cold water first.

Split-Dose Instructions

Dose 1 – In the evening the day before your colonoscopy (sometime between 5:00 PM to 9:00 PM)

• Fill the dosing cup with cold water up to the lower line (5 ounces).

Note: Do not use any other clear liquid to mix sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

• Open 1 packet of sodium picosulfate, magnesium oxide and anhydrous citric acid and add all of the powder to the cold water in the dosing cup. To open the sodium picosulfate, magnesium oxide and anhydrous citric acid packet cut along the dotted line at the top of the packet using scissors.
• Stir for 2 to 3 minutes to dissolve the powder. Use a clock or timer The dosing cup may feel slightly warm as the powder dissolves. This is normal.
• Drink all the solution right away.

Note: Sodium picosulfate, magnesium oxide and anhydrous citric acid powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.

• Follow this sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose by drinking at least five 8 ounce cups of clear liquid (using the upper line on the dosing cup provided- see figure below) over the next 5 hours.

• After taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.

Important: See Table 1 for a list of acceptable clear liquids.

Dose 2 - In the morning of colonoscopy (approximately 5 hours prior to colonoscopy)

Note: Do not eat solid food. Drink only clear liquids.

• Fill the dosing cup with cold water up to the lower line (5 ounces).

Note: Do not use any other clear liquid to mix sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

• Open the second packet of sodium picosulfate, magnesium oxide and anhydrous citric acid and add all the powder to the cold water in the dosing cup.
• Stir for 2 to 3 minutes to dissolve the powder. Use a clock or timer.
• Drink all the solution right away.

Note: Sodium picosulfate, magnesium oxide and anhydrous citric acid powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.

• Follow this sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose by drinking at least three 8 ounce cups of clear liquids (using the upper line on the dosing cup -see figure below). You can continue to drink clear liquids up to 2 hours before the colonoscopy.

Important: See Table 1 for a list of acceptable clear liquids.

Stop drinking clear liquids 2 hours before your colonoscopy, or as advised by your healthcare provider.

Day-Before Instructions

Dose 1 – In the afternoon or early evening the day before your colonoscopy (sometime between 4:00 PM to 6:00 PM)

• Fill the dosing cup with cold water up to the lower line (5 ounces).

Note: Do not use any other clear liquid to mix sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

• Open 1 packet of sodium picosulfate, magnesium oxide and anhydrous citric acid and add all the powder to the cold water in the dosing cup. To open the sodium picosulfate, magnesium oxide and anhydrous citric acid packet cut along the dotted line at the top of the packet using scissors.
• Stir for 2 to 3 minutes to dissolve the powder. Use a clock or timer. The dosing cup may feel slightly warm as the powder dissolves. This is normal.
• Drink all the solution right away.

Note: Sodium picosulfate, magnesium oxide and anhydrous citric acid powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.

• Follow this sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose by drinking at least five 8 ounce cups of clear liquids (using the upper line on the dosing cup -see figure below) over the next 5 hours.

After taking sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution if you have any bloating or feeling like your stomach is upset, wait to take your second dose until your stomach feels better.

Important: See Table 1 for a list of acceptable clear liquids.

Dose 2 – In the evening before your colonoscopy (sometime between 10:00 PM to 12:00 AM):

Note: Do not eat solid food. Drink only clear liquids.

• Fill the dosing cup with cold water up to the lower line (5 ounces).

Note: Do not use any other clear liquid to mix sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution.

• Open the second packet of sodium picosulfate, magnesium oxide and anhydrous citric acid and add all of the powder to the cold water in the dosing cup. Stir for 2 to 3 minutes to dissolve the powder. Use a clock or timer.
• Drink all of this solution right away.

Note: Sodium picosulfate, magnesium oxide and anhydrous citric acid powder should be mixed in cold water immediately before use. Do not prepare the solution ahead of time or store the solution for later use. Do not refrigerate or add ice to the solution.

• Follow this sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution dose by drinking at least three 8 ounce cups of clear liquids (using the upper line on the dosing cup -see figure below) over the next 5 hours.

Important: See Table 1 for a list of acceptable clear liquids.

Stop drinking clear liquids 2 hours before your colonoscopy, or as advised by your healthcare provider.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 08/2022