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These highlights do not include all the information needed to use PEG-3350 and Electrolytes for Oral Solution safely and effectively. See full prescribing information for PEG-3350 and Electrolytes for Oral Solution. Polyethylene glycol 3350 and electrolyt | PEG-3350 and Electrolytes [Affordable Pharmaceuticals, LLC] | BioPortfolio

13:00 EST 27th January 2019 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

PEG-3350 and Electrolytes 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 and Electrolytes for Oral Solution solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. PEG-3350 and Electrolytes for Oral Solution is also available with pineapple flavor.

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

The following is the recommended dose of reconstituted PEG-3350 and Electrolytes for Oral Solution solution for adults. 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.

The first bowel movements should occur approximately one hour after the start of PEG-3350 and Electrolytes for Oral Solution administration. Continue drinking until the watery stool is clear and free of solid matter.

For oral solution: One 4 liter jug with powder for reconstitution with water.

Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

PEG-3350 and Electrolytes for Oral Solution is contraindicated in the following conditions:

Advise patients to hydrate adequately before, during, and after the use of PEG-3350 and Electrolytes for Oral Solution. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PEG-3350 and Electrolytes for Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with PEG-3350 and Electrolytes for Oral Solution. Advise patients to hydrate adequately before, during, and after the use of PEG-3350 and Electrolytes for Oral Solution. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PEG-3350 and Electrolytes for Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with PEG-3350 and Electrolytes for Oral Solution.

In addition, use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [ ] In addition, use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients who have conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment [ see Drug Interactions ( 7.1) ]

There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias. There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.

There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities. There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.

Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia. Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.

Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal antiinflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients. Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal antiinflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.

Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes for Oral Solution may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes for Oral Solution may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PEG-3350 and Electrolytes for Oral Solution. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of PEG-3350 and Electrolytes for Oral Solution. If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PEG-3350 and Electrolytes for Oral Solution. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of PEG-3350 and Electrolytes for Oral Solution.

Use with caution in patients with severe active ulcerative colitis. Use with caution in patients with severe active ulcerative colitis.

Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Such patients should be observed during administration of PEG-3350 and Electrolytes for Oral Solution, especially if it is administered via nasogastric tube. Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Such patients should be observed during administration of PEG-3350 and Electrolytes for Oral Solution, especially if it is administered via nasogastric tube.

The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances. The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

The following adverse reactions have been identified during post-approval use of PEG-3350 and Electrolytes 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 and Electrolytes 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.

Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [ see Warnings and Precautions ( 5.1, 5.2, 5.3, and 5.4) ] in patients taking these concomitant medications.

Oral medication administered within one hour of the start of administration of PEG-3350 and Electrolytes for Oral Solution may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Concurrent use of stimulant laxatives and PEG-3350 and Electrolytes for Oral Solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PEG-3350 and Electrolytes for Oral Solution.

Pregnancy Category C. Animal reproduction studies have not been conducted with PEG-3350 and Electrolytes for Oral Solution. It is also not known whether PEG-3350 and Electrolytes for Oral Solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG 3350 and Electrolytes for Oral Solution should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PEG-3350 and Electrolytes for Oral Solution is administered to a nursing woman.

Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established.

Clinical studies of PEG-3350 and Electrolytes for Oral Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

For oral solution: Each 4 liter (4L) PEG-3350 and Electrolytes for Oral Solution jug contains a white powder for reconstitution. PEG-3350 and Electrolytes for Oral Solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.

Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na SO . The average Molecular Weight is 142.04. The structural formula is:

Sodium Bicarbonate, USP

The chemical name is NaHCO . The average Molecular Weight is 84.01. The structural formula is:

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na Cl

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

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.

PEG-3350 and Electrolytes for Oral Solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

The pharmacokinetics of PEG3350 following administration of PEG-3350 and Electrolytes for Oral Solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

Long term studies in animals have not been performed to evaluate carcinogenic potential of PEG-3350 and Electrolytes for Oral Solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of PEG-3350 and Electrolytes for Oral Solution have not been performed.

In powdered form, for oral administration as a solution following reconstitution.

PEG-3350 and Electrolytes for Oral Solution is available in a disposable jug and a packet in powdered form containing:

Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. When made up to 4 liters volume with water, the solution contains PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavoring ingredients 3 g. When made up to 4 liters volume with water, the solution contains PEG 3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L.

Storage:

Store in sealed container at 59° to 86°F (15°C to 30°C). When reconstituted, keep solution refrigerated. Use within 48 hours, Discard unused portion.

Keep out of reach of children.

PEG-3350 and Electrolytes for Oral Solution                                NDC 10572-100-01

Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution       NDC 10572-101-01

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

Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185

Medication Guide

PEG-3350 and Electrolytes for Oral Solution

(PEG-3350 and i-lek-truh-lahyts for oral solution)

Read this Medication Guide before you start taking PEG-3350 and Electrolytes 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 and Electrolytes for Oral Solution?

PEG-3350 and Electrolytes 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:

Your chance of having fluid loss and changes in body salts with PEG-3350 and Electrolytes for Oral Solution is higher if you:

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 and Electrolytes for Oral Solution:

See Section “ What are the possible side effects of PEG-3350 and Electrolytes for Oral Solution” for more information about side effects.

What is PEG-3350 and Electrolytes for Oral Solution?

PEG-3350 and Electrolytes for Oral Solution is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. PEG-3350 and Electrolytes 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 PEG-3350 and Electrolytes for Oral Solution is safe and effective in children.

Who should not take PEG-3350 and Electrolytes for Oral Solution?

Do not take PEG-3350 and Electrolytes for Oral Solution if your heathcare provider has told you that you have:

What should I tell my healthcare provider before taking PEG-3350 and Electrolytes for Oral Solution?

Before you take PEG-3350 and Electrolytes for Oral Solution, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. PEG-3350 and Electrolytes 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 and Electrolytes for Oral Solution.

Especially tell your healthcare provider if you take:

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 and Electrolytes for Oral Solution?

You must read, understand, and follow these instructions to take PEG-3350 and Electrolytes for Oral Solution the right way.

What are the possible side effects of PEG-3350 and Electrolytes for Oral Solution?

PEG-3350 and Electrolytes for Oral Solution can cause serious side effects, including:

The most common side effects of PEG-3350 and Electrolytes for Oral Solution include:

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 and Electrolytes 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 and Electrolytes for Oral Solution?

Keep PEG-3350 and Electrolytes for Oral Solution and all medicines out of the reach of children.

General information about the safe and effective use of PEG-3350 and Electrolytes for Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PEG-3350 and Electrolytes for Oral Solution for a condition for which it was not prescribed. Do not give PEG-3350 and Electrolytes 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 and Electrolytes 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 and Electrolytes for Oral Solution?

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

Inactive ingredients: Pineapple Flavored PEG-3350 and Electrolytes for Oral Solution only (natural and artificial pineapple flavor powder, maltodextrin, gum arabic, sodium saccharin, silicon dioxide)

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

NDC 10572-100-01

PEG-3350 and Electrolytes for Oral Solution

Rx only

Principal Display Panel - Bottle Label

NDC 10572-101-01

PINEAPPLE FLAVOR

PEG-3350 and Electrolytes for Oral Solution

Rx only

Manufacturer

Affordable Pharmaceuticals, LLC

Active Ingredients

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