PEG-3350 and Electrolytes
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 electrolytes for oral solution Initial U.S. Approval: 1984
448db7a5-1fea-4bf3-b1f5-e9d027a36603
HUMAN PRESCRIPTION DRUG LABEL
Sep 28, 2022
Affordable Pharmaceuticals, LLC
DUNS: 182815311
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Bottle Label
NDC 10572-101-01
PINEAPPLE FLAVOR
PEG-3350 and Electrolytes
for Oral Solution
Rx only
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
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 is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1)
CONTRAINDICATIONS SECTION
4 CONTRAINDICATIONS
PEG-3350 and Electrolytes for Oral Solution is contraindicated in the following conditions:
- Gastrointestinal (GI) obstruction [see Warnings and Precautions ( 5.6)]
- Bowel perforation [see Warnings and Precautions ( 5.6)]
- Toxic colitis or toxic megacolon
- Gastric retention
- Ileus
- Hypersensitivity to any component of PEG-3350 and Electrolytes for Oral Solution [see Warnings and Precautions ( 5.8)]
- Gastrointestinal (GI) obstruction ( 4, 5.6)
- Bowel perforation ( 4, 5.6)
- Toxic colitis or toxic megacolon ( 4)
- Gastric retention ( 4)
- Ileus ( 4)
- Hypersensitivity to components of PEG-3350 and Electrolytes for Oral Solution ( 4, 5.8)
ADVERSE REACTIONS SECTION
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Renal impairment [see Warnings and Precautions ( 5.4)]
- Colonic mucosal ulcerations and ischemic colitis [see Warnings and Precautions ( 5.5)]
- Patients with significant gastrointestinal disease [see Warnings and Precautions ( 5.6)]
- Aspiration [see Warnings and Precautions ( 5.7)]
The following adverse reactions associated with the use of PEG-3350 and Electrolytes for Oral Solution were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.
- Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2)] .
- Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3)]
- Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4), Warnings and Precautions ( 5.8)]
- Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients). Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].
Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or****www.fda.gov/medwatch. (6)
DRUG INTERACTIONS SECTION
7 DRUG INTERACTIONS
7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte
Abnormalities
Use caution when prescribing PEG-3350 and Electrolytes for Oral Solution for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4)] . Consider additional patient evaluations as appropriate.
7.2 Potential for Reduced Drug Absorption
PEG-3350 and Electrolytes for Oral Solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of PEG-3350 and Electrolytes for Oral Solution [see Dosage and Administration ( 2.1)] .
7.3 Stimulant Laxatives
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 [see Warnings and Precautions ( 5.5)] .
Some drugs increase risks due to fluid and electrolyte changes ( 7.1)
RECENT MAJOR CHANGES SECTION
RECENT MAJOR CHANGES
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Warnings and Precautions, Aspiration: ( 5.7) |
05/2021 |
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride and 3 g flavoring ingredients per 4 liters. (3)
USE IN SPECIFIC POPULATIONS SECTION
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
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.
8.3 Nursing Mothers
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.
8.4 Pediatric Use
Safety and effectiveness of PEG-3350 and Electrolytes for Oral Solution in pediatric patients have not been established.
8.5 Geriatric Use
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.
8.6 Renal Impairment
Use PEG-3350 and Electrolytes for Oral Solution with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions ( 7.1)] . These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of PEG-3350 and Electrolytes for Oral Solution and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions ( 5.4)] .
DESCRIPTION SECTION
11 DESCRIPTION
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 supplied in a 4 liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder.
Polyethylene Glycol 3350, USP
Sodium Sulfate, USP
The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:
Sodium Bicarbonate, USP
The chemical name is NaHCO 3. 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
CLINICAL PHARMACOLOGY SECTION
12 CLINICAL PHARMACOLOGY
12.1 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.
12.2 Pharmacodynamics
PEG-3350 and Electrolytes for Oral Solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3 Pharmacokinetics
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.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
PEG-3350 and Electrolytes for Oral Solution is supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white powder.
- When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
PEG-3350 and Electrolytes for Oral Solution 4 Liter Disposable Jug NDC
10572-100-01
Pineapple Flavor PEG-3350 and Electrolytes for Oral Solution 4 Liter
Disposable Jug NDC 10572-101-01
Storage
Store in sealed container at 15° to 30°C (59° to 86°F).
Store reconstituted solution of PEG-3350 and Electrolytes for Oral Solution at
2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct patients:
- To reconstitute PEG-3350 and Electrolytes for Oral Solution with water prior to ingestion.
- Not to take other laxatives while they are taking PEG-3350 and Electrolytes for Oral Solution.
- Not to take oral medications within 1 hour before the start or during the administration of PEG-3350 and Electrolytes for Oral Solution.
- To take only clear liquids but avoid red and purple liquids.
- To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
- To follow the directions in the Instructions for Use on how to prepare and administer the product.
- If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
- To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures [see Warnings and Precautions ( 5.1, 5.2, 5.3, 5.4)] .
- To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions ( 5.8)] .
Distributed by Affordable Pharmaceuticals, LLC, Braintree, MA 02185
SPL MEDGUIDE SECTION
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**Medication Guide** PEG-3350 and Electrolytes for Oral Solution (PEG-3350 and i-lek-truh-lahyts for oral solution) |
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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. |
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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: *abnormal heartbeats (arrhythmias) 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 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. |
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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 (loose stools). 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. |
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**Who should not take PEG-3350 and Electrolytes for Oral Solution?** Do not takePEG-3350 and Electrolytes for Oral Solution if your healthcare provider has told you that you have:
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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:
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Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PEG-3350 and Electrolytes for Oral Solution may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting PEG-3350 and Electrolytes for Oral Solution or after you start taking 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. |
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**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.
○ the day before your colonoscopy ○ while taking PEG-3350 and Electrolytes for Oral Solution ○ after taking PEG-3350 and Electrolytes for Oral Solution until 2 hours before your colonoscopy. ○ water ○ clear broth ○ clear fruit juices without pulp including ○ clear soda apple, white grape, or white cranberry ○ gelatin (without added fruit or ○ strained limeade or lemonade topping) ○ coffee or tea (Do not use any dairy ○ popsicles without pieces of or non-dairy creamer) fruit or fruit pulp
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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: *See Section “What is the most important information I should know about PEG-3350 and Electrolytes for Oral Solution?” *changes in certain blood tests. Your healthcare provider may do blood tests before and after you take PEG-3350 and Electrolytes 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 • stomach (abdominal) cramping • nausea • headache • bloating • urinate less than usual • dizziness • trouble drinking clear liquid *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 and Electrolytes for Oral Solution include: • nausea • chest x-ray that shows water in the • stomach (abdominal) fullness lungs (infiltrate) after vomiting or • bloating inhaling food or liquid (aspirate). • stomach (abdominal) cramps • anal irritation • vomiting • esophageal bleeding 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. |
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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. |
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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. |
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What are the ingredients in PEG-3350 and Electrolytes for Oral Solution? PEG-3350 and Electrolytes for Oral Solution comes in a 4-liter jug with PEG-3350 and Electrolytes for Oral Solution powder. Active ingredients: Powder for solution: polyethylene glycol 3350, sodium sulfate (anhydrous), sodium bicarbonate, sodium chloride, and potassium chloride. Inactive Ingredients: Pineapple Flavored PEG-3350 and Electrolytes for Oral Solutiononly (natural and artificial pineapple flavor powder, maltodextrin, gum arabic, sodium saccharin, silicon dioxide) Affordable Pharmaceuticals, LLC Braintree, MA 02185, USA For more information go to www.affordablepharma.com or call 1-800-514-5617. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 05/2021