PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride

Dosage Overview

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution may be used with or without one of the supplied flavor packs.

Administration Instructions Prior to Dosage

On the day prior to the colonoscopy, instruct patients to:

1. Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.
2. If adding a PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution flavor packs are for use only in combination with the contents of the accompanying 4 liter container.
3. Early in the evening prior to colonoscopy, fill the supplied container containing the PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters.
4. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.

Dosage

The following is the recommended dose of reconstituted PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

• Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).
• Pediatric Patients > 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour.

The first bowel movements should occur approximately one hour after the start of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution administration. Continue drinking until the watery stool is clear and free of solid matter.

The following adverse reactions have been identified during post-approval use of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG.

Mechanism of Action

The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

Pharmacodynamics

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

Pharmacokinetics

The pharmacokinetics of PEG3350 following administration of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

See FDA-Approved Patient Labeling (Medication Guide). Instruct patients:

• To let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
• Not to take other laxatives while they are taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution.
• To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
• That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
• That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and con-tact their health care provider. Medication should be discontinued until they speak to their physician.
• To contact their healthcare provider if they develop signs and symptoms of dehydration. [see Warnings and Precautions (5.1)].
• That oral medication administered within one hour of the start of administration of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution may be flushed from the GI tract and the medication may not be absorbed completely.

Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185

Medication Guide

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution (PEG-3350, so-DEE-um klor-IDE, so-DEE-um bi-CAR-bon-ate and po-TASS-ee-um klor-IDE for oral solution)

Read this Medication Guide before you start taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution and other osmotic 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 body salts with PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride 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 PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution:

• vomiting that prevents you from keeping down the solution
• dizziness
• urinating less often than normal
• headache

See Section “What are the possible side effects of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution” for more information about side effects.

What is PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution is a prescription medicine used by adults to clean the colon before a colonoscopy. PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride 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. PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution is safe and effective for use in pediatric patients aged 6 months and older.

Who should not take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

Do not take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution if your heathcare provider has told you that you have:

• a blockage in your bowel (obstruction)
• an opening in the wall of your stomach or intestine (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (bowel)
• an allergy to any of the ingredients in PEG-3350, sodium chloride, sodium bicar-bonate and potassium chloride for oral solution. See the end of this leaflet for a complete list of ingredients in PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution.

What should I tell my healthcare provider before taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

Before you take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution, tell your healthcare provider if you:

• have heart problems
• have stomach or bowel problems
• have ulcerative colitis
• have problems with swallowing or gastric reflux
• have a history of seizures
• are withdrawing from drinking alcohol
• have a low blood salt (sodium) level
• have kidney problems
• any other medical conditions
• are pregnant. It is not known if PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution passes into your breast milk. You and your healthcare provider should decide if you will take PEG3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution while breastfeeding.

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

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride 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)
• non-steroidal anti-inflammatory medicines (NSAID) pain medicines
• laxatives

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of 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 PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

You must read, understand, and follow these instructions to take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution the right way.

• Take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution exactly as your healthcare provider tells you to take it.
• Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.
• The first bowel movement should occur approximately one hour after you start drinking the solution.
• You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until the discomfort goes away.
• Continue drinking until the watery stool is clear and free of solid matter. This usually requires 3 liters and it is best to drink all of the solution.
• Do not take undissolved PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Each jug of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution must be reconstituted with water (diluted) to 4 liters total volume before drinking.
• Do not take other laxatives while taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution.
• Do not eat solid foods on the day before your colonoscopy and until after your colonoscopy. Drink only clear liquids:
  • the day before your colonoscopy
  • while taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution
  • after taking PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution until 2 hours before your colonoscopy

What are the possible side effects of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution can cause serious side effects, including:

• See Section “What is the most important information I should know about PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride 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 (abdominal) cramping
  • headache
  • urinate less than usual
  • trouble drinking clear liquid
• heart problems. PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution may cause irregular heartbeats.
• seizures
• 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 PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution include:

• nausea
• stomach (abdominal) fullness
• bloating
• stomach (abdominal) cramps
• vomiting
• anal irritation

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution. For more information, ask your healthcare provider or pharmacist.

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 PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

• Store PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution at room temperature, between 59°F to 86°F (15°C to 30°C).

  Keep PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution and all medicines out of the reach of children.

General information about the safe and effective use of PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution for a condition for which it was not prescribed. Do not give PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution to other people, even if they are going to have the same procedure you are. It may harm them.

This Medication Guide summarizes important information about PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.

For more information, go to www.affordablepharm.com or call 1-800-514-5617.

What are the ingredients in PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for oral solution?

Active ingredients: polyethylene glycol 3350, sodium bicarbonate, sodium chloride, and potassium chloride.

Inactive ingredients: cherry flavoring, lemon-lime flavoring, orange flavoring, pineapple flavoring (flavor only)

Affordable Pharmaceuticals, LLC Braintree, MA 02185, USA

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

Revised 9/2013

Principal Display Panel – Bottle Label

FILL TO THE TOP OF THE LINE ON BOTTLE

NDC 10572-400-01

TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing.

PEG-3350, Sodium Chloride,
Sodium Bicarbonate
and Potassium Chloride
for Oral Solution

With Flavor Packs

When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L

Each disposable jug contains, in powdered form: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g, flavor ingredients 2.0 g.

RX ONLY

Affordable
Pharmaceuticals LLC

Braintree, MA 02185 Rev 09/13