Label: POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED powder, for solution
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR powder, for solution
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESWITH ORANGE FLAVOR- polyethylene glycol 3350 and electrolytes with orange flavor powder, for solution
- NDC Code(s): 64380-765-21, 64380-766-21, 64380-767-21
- Packager: Strides Pharma Science Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 9, 2022
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION safely and effectively. See full prescribing information for POLYETHYLENE GLYCOL 3350 and ELECTROLYTES FOR ORAL SOLUTION.
POLYETHYLENE GLYCOL 3350 and ELECTROLYTES for oral solution. Initial U.S. Approval: 1984INDICATIONS AND USAGE
Polyethylene Glycol 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) (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration (2.1): (2)
- Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol 3350 and electrolytes for oral solution.
- Reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion.
- Do not take oral medications within 1 hour before the start or during administration of Polyethylene Glycol 3350 and electrolytes for oral solution. (2.1)
- Do not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution.
- Consume only clear liquids; avoid red and purple liquids.
- Consume water or other clear liquids up until 2 hours before the time of the colonoscopy.
- Do not consume solid food within 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution.
Adult Dosing Regimen (2.2): (2)
- On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution.
- Begin the recommended dosage regimen for Polyethylene Glycol 3350 and electrolytes for oral solution early in the evening on the day before colonoscopy
- Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
- For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2)
DOSAGE FORMS AND STRENGTHS
For Oral Solution: polyethylene glycol 3350 236 grams, sodium sulfate (anhydrous) 22.74 grams, sodium bicarbonate 6.74 grams, sodium chloride 5.86 grams, potassium chloride 2.97 grams, and flavoring ingredients acesulfame potassium 0.2 grams and flavor lemon 0.1 gram for lemon flavor, acesulfame potassium 0.2 grams and flavor orange 0.4 grams for orange flavor respectively; supplied in one 5 liter disposable jug (3)
CONTRAINDICATIONS
- 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 Polyethylene Glycol 3350 and electrolytes for oral solution (4, 5.8)
WARNINGS AND PRECAUTIONS
- Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1)
- Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. (5.2)
- Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. (5.3, 7.1)
- Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. (5.4, 7.1, 8.6)
- Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5, 7.3)
- Patients at risk for aspiration: Observe during administration. (5.7)
- Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8)
ADVERSE REACTIONS
DRUG INTERACTIONS
Some drugs increase risks due to fluid and electrolyte changes (7.1) (7)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2022
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Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Instructions
2.2 Dosage Regimen
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Fluid and Serum Chemistry Abnormalities
5.2 Cardiac Arrhythmias
5.3 Seizures
5.4 Renal Impairment
5.5 Colonic Mucosal Ulcerations and Ischemic Colitis
5.6 Use in Patients with Significant Gastrointestinal Disease
5.7 Aspiration
5.8 Hypersensitivity Reactions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities
7.2 Potential for Reduced Drug Absorption
7.3 Stimulant Laxatives
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
- *
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
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2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Instructions
- Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.1)].
- Reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion, do not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution [see Dosage and Administration (2.2)]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
- Do not take oral medications within 1 hour before the start of or during administration of Polyethylene Glycol 3350 and electrolytes for oral solution [see Drug Interactions (7.2)].
- Do not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution [see Drug Interactions (7.3)].
- Consume only clear liquids, avoid red and purple liquids.
- Patients may 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.
- The solution is more palatable if chilled prior to administration.
- Do not consume solid food within 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution.
- If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue Polyethylene Glycol 3350 and electrolytes for oral solution until the symptoms abate.
2.2 Dosage Regimen
Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting Polyethylene Glycol 3350 and electrolytes for oral solution. Begin the recommended dosage regiment for Polyethylene Glycol 3350 and electrolytes for oral solution early in the evening on the day before colonoscopy.
Instruct patients to take Polyethylene Glycol 3350 and electrolytes for oral solution in conjunction with clear liquids as follows:
4 Liter Jug
- Fill the supplied container containing the Polyethylene Glycol 3350 and electrolytes for oral solution powder with lukewarm drinking water to the 4-liter fill line
- Do not add any other ingredients, flavors, etc.
- After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
- Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.
- After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.
Administration via a Nasogastric Tube
For patients with a nasogastric tube, administer the reconstituted Polyethylene Glycol 3350 and electrolytes for oral solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).
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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 (acesulfame potassium 0.2 g and flavor lemon 0.1 g for lemon flavor , acesulfame potassium 0.2 g and flavor orange 0.4 g for orange flavor).
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4 CONTRAINDICATIONS
Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.8)]
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5 WARNINGS AND PRECAUTIONS
5.1 Serious Fluid and Serum Chemistry Abnormalities
Advise patients to hydrate adequately before, during, and after the use of Polyethylene Glycol 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 Polyethylene Glycol 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. Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol 3350 and electrolytes for oral solution, .
In addition, use caution when prescribing Polyethylene Glycol 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)].
5.2 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 Polyethylene Glycol 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). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
5.3 Seizures
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 Polyethylene Glycol 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 [see Drug Interactions (7.1)].
5.4 Renal Impairment
Use caution when prescribing Polyethylene Glycol 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 anti-inflammatory drugs) [see Drug Interactions (7.1)]. 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 [see Use is Specific Populations (8.6)].
5.5 Colonic Mucosal Ulcerations and Ischemic Colitis
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 Polyethylene Glycol 3350 and electrolytes for oral solution, may increase this risk [see Drug Interactions (7.3)]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
5.6 Use in Patients with Significant Gastrointestinal Disease
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering Polyethylene Glycol 3350 and electrolytes for oral solution [see Contraindications (4)]. Use with caution in patients with severe active ulcerative colitis.
5.7 Aspiration
Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Observe these patients during administration of Polyethylene Glycol 3350 and electrolytes for oral solution, especially if it is administered via nasogastric tube.
Do not combine Polyethylene Glycol 3350 and electrolytes for oral solutions with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of Polyethylene Glycol 3350 and electrolytes for oral solutions, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of chocking and potential aspiration were reported.
5.8 Hypersensitivity Reactions
Polyethylene Glycol 3350 and electrolytes for oral solution contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions (6)]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.
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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 Polyethylene Glycol 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).
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7 DRUG INTERACTIONS
7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities
Use caution when prescribing Polyethylene Glycol 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
Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution [see Dosage and Administration (2.1)].
7.3 Stimulant Laxatives
Concurrent use of stimulant laxatives and Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution [see Warnings and Precautions (5.5)].
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8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Animal reproduction studies have not been conducted with Polyethylene Glycol 3350 and electrolytes for oral solution. It is also not known whether Polyethylene Glycol 3350 and electrolytes for oral solution, can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution, is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness of Polyethylene Glycol 3350 and electrolytes for oral solution, in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of Polyethylene Glycol 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 Polyethylene Glycol 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 Polyethylene Glycol 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)].
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11 DESCRIPTION
Polyethylene Glycol 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 5 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 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 5 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, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and lemon flavor 0.1 gram as a white powder.
Polyethylene Glycol 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 5 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, 2.97 g potassium chloride, acesulfame potassium 0.2 grams and orange flavor 0.4 grams as a white powder.
Polyethylene Glycol 3350, NF
The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:
The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:
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
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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
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16 HOW SUPPLIED/STORAGE AND HANDLING
Polyethylene Glycol 3350 and electrolytes for oral solution, USP is supplied in a 5-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 and electrolytes for oral solution, USP with Lemon Flavor is supplied in a 5-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, 2.97 g potassium chloride, acesulfame potassium 0.2 g and lemon flavor 0.1 g as a white powder.
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor is supplied in a 5-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, 2.97 g potassium chloride, acesulfame potassium 0.2 g and orange flavor 0.4 g as a white powder.
• When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 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.
Polyethylene Glycol 3350 and electrolytes for oral solution, USP is available in following flavors:
Drug product
NDC
Package
Polyethylene Glycol 3350 and electrolytes for oral solution, USP
64380-765-21
5 L disposable jug with a 4 L fill line
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Lemon Flavor
64380-766-21
Polyethylene Glycol 3350 and electrolytes for oral solution, USP with Orange Flavor
64380-767-21
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see Controlled Room Temperature].
Store reconstituted solution of Polyethylene Glycol 3350 and electrolytes for oral solution at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].
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17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct patients:
- To reconstitute Polyethylene Glycol 3350 and electrolytes for oral solution with water prior to ingestion.
- Not to take other laxatives while they are taking Polyethylene Glycol 3350 and electrolytes for oral solution.
- Not to take oral medications within 1 hour before the start or during the administration of Polyethylene Glycol 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)].
Strides Pharma Science Ltd.
Bengaluru-562106, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 10/2022
Medication Guide available at:
www.strides.com/medication-guides
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MEDICATION GUIDE
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES FOR ORAL SOLUTION, USP
(pol″ ee eth′ i leen glye′ kol 3350)
Read this Medication Guide before you start taking Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution?
Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes 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 Polyethylene Glycol 3350 and electrolytes for oral solutions:
- 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 Polyethylene Glycol 3350 and electrolytes for oral solution" for more information about side effects.
What is Polyethylene Glycol 3350 and electrolytes for oral solution?
Polyethylene Glycol 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. Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution is safe and effective in children.
Who should not take Polyethylene Glycol 3350 and electrolytes for oral solution?
Do not take Polyethylene Glycol 3350 and electrolytes for oral solution if your healthcare 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).
- a very dilated intestine (toxic megacolon).
- problems with food and fluid emptying from your stomach (gastric retention).
- a problem with food moving too slowly through your intestines (ileus).
- an allergy to any of the ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution. See the end of this Medication Guide for a complete list of ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution.
What should I tell my healthcare provider before taking Polyethylene Glycol 3350 and electrolytes for oral solution?
Before you take Polyethylene Glycol 3350 and electrolytes 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.
- have any other medical conditions.
- are pregnant. It is not known if Polyethylene Glycol 3350 and electrolytes 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 Polyethylene Glycol 3350 and electrolytes for oral solution passes into your breast milk. You and your healthcare provider should decide if you will take Polyethylene Glycol 3350 and electrolytes 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.
Polyethylene Glycol 3350 and electrolytes for oral solution may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting Polyethylene Glycol 3350 and electrolytes for oral solution or after you start taking Polyethylene Glycol 3350 and electrolytes 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.
- starch-based thickeners. For patients who have trouble swallowing, do not mix Polyethylene Glycol 3350 and electrolytes for oral solution with starch-based thickeners.
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 Polyethylene Glycol 3350 and electrolytes for oral solution?
You must read, understand, and follow these instructions to take Polyethylene Glycol 3350 and electrolytes for oral solution the right way.
- Take Polyethylene Glycol 3350 and electrolytes for oral solution exactly as your healthcare provider tells you to take it
- See the "Instructions for Use" on the bottle label for instructions on how to mix, take or give Polyethylene Glycol 3350 and electrolytes for oral solution.
- Do not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution powder that has not been mixed with water (diluted). It may increase your risk of nausea, vomiting and fluid loss (dehydration).
- Do not take other laxatives while taking Polyethylene Glycol 3350 and electrolytes for oral solution.
- Drink reconstituted solution at a rate of 8 ounces (240 ml) every 10 minutes. Rapid drinking of each portion is better than drinking small amounts.
- Do not eat or drink anything colored red or purple.
- Do not eat solid foods at least 2 hours before taking Polyethylene Glycol 3350 and electrolytes for oral solution. You may eat a light breakfast 2 hours before taking Polyethylene Glycol 3350 and electrolytes for oral solution. For best results, do not consume solid food for 3 to 4 hours before drinking Polyethylene Glycol 3350 and electrolytes for oral solution.
- Drink only water and clear liquids:
- the day before your colonoscopy
- while taking Polyethylene Glycol 3350 and electrolytes for oral solution
- after taking Polyethylene Glycol 3350 and electrolytes for oral solution until 2 hours before your colonoscopy.
- Drink clear liquids before, during, and after you take Polyethylene Glycol 3350 and electrolytes for oral solution to avoid fluid loss (dehydrated). Examples of clear liquids are:
- water
- clear broth
- clear fruit juices without pulp including apple, white grape, or white cranberry
- clear soda
- strained limeade or lemonade
- gelatin (without added fruit or topping)
- coffee or tea (Do not use any dairy or non-dairy creamer)
- popsicles without pieces of fruit or fruit pulp
- You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, slow or temporarily stop (discontinue) drinking the solution and contact your healthcare provider.
- The first bowel movement should occur approximately one hour after you start drinking the solution.
- Continue drinking until the watery stool is clear and free of solid matter.
What are the possible side effects of Polyethylene Glycol 3350 and electrolytes for oral solution?
Polyethylene Glycol 3350 and electrolytes for oral solution can cause serious side effects, including:
- See Section "What is the most important information I should know about Polyethylene Glycol 3350 and electrolytes for oral solution?"
-
changes in certain blood tests. Your healthcare provider may do blood tests before and after you take Polyethylene Glycol 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
- nausea
- bloating
- dizziness
- stomach (abdominal) cramping
- headache
- urinate less than usual
- 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP include:
- nausea
- stomach (abdominal) fullness
- bloating
- stomach (abdominal) cramps
- vomiting
- chest x-ray that shows water in the lungs (infiltrate) after vomiting or inhaling food or liquid (aspirate).
- anal irritation
- 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 Polyethylene Glycol 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 Polyethylene Glycol 3350 and electrolytes for oral solution, USP?
- Store Polyethylene Glycol 3350 and electrolytes for oral solution, USP at room temperature, between 59°F to 86°F (15°C to 30°C).
- Store mixed (reconstituted) solution of Polyethylene Glycol 3350 and electrolytes for oral solution at 36° to 46°F (2°C to 8°C). Do not freeze.
- Use mixed (reconstituted) solution of Polyethylene Glycol 3350 and electrolytes for oral solution within 48 hours.
- After 48 hours, throw away (discard) any mixed (reconstituted) solution of Polyethylene Glycol 3350 and electrolytes for oral solution that is not used.
Keep Polyethylene Glycol 3350 and electrolytes for oral solution, USP and all medicines out of the reach of children.
General information about the safe and effective use of Polyethylene Glycol 3350 and electrolytes for oral solution.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Polyethylene Glycol 3350 and electrolytes for oral solution, USP for a condition for which it was not prescribed. Do not give Polyethylene Glycol 3350 and electrolytes for oral solution, USP 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 Polyethylene Glycol 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.strides.com or call toll free number 1-877-244-9825.
What are the ingredients in Polyethylene Glycol 3350 and electrolytes for oral solution, USP?
Polyethylene Glycol 3350 and electrolytes for oral solution, USP comes in a 5-liter jug with polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride powder.
Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.
Inactive ingredients: Lemon and Orange Flavored Polyethylene Glycol 3350 and electrolytes for oral solution, USP only (acesulfame potassium, natural orange flavor powder, natural flavor lemon powder)
Manufactured by:
Strides Pharma Science Ltd.
Bengaluru-562106, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
Revised: 10/2022
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guide available at:
www.strides.com/medication-guides
FILL TO THE TOP OF THE LINE ON BOTTLE
Rx Only
Dispense the enclosed Medication Guide to each patient.
Polyethylene Glycol 3350 and Electrolytes
for Oral Solution, USP
Read this Instructions for Use and the Medication Guide before you start taking Polyethylene Glycol 3350 and electrolytes for oral solution.
Important information
• Do not take undissolved Polyethylene Glycol 3350 and electrolytes for oral solution powder that has not been mixed with water (diluted). It may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Do not eat solid foods at least 2 hours before taking Polyethylene Glycol 3350 and electrolytes for oral solution. For best results, do not consume solid food for 3 to 4 hours before drinking Polyethylene Glycol 3350 and electrolytes for oral solution.
Prepare and take Polyethylene Glycol 3350 and electrolytes for oral solution
1 Add lukewarm drinking water to the fill mark (4 liters) on the jug. Do not add any other ingredients or flavors.
2 Place the cap securely on the jug. Shake the jug very well (vigorously) several times to make sure that the ingredients are mixed well (dissolved).
3 Drink one 8-ounce (240 mL) cup of the mixed solution rapidly every 10 minutes. A loose watery bowel (stool) movement should result in approximately 1 hour. Continue drinking until you finish the entire contents (4-liters), your stools are clear, or as directed by your healthcare provider. If giving Polyethylene Glycol 3350 and electrolytes for oral solution through the nasogastric (NG) tube, place Polyethylene Glycol 3350 and electrolytes for oral solution into the NG tube at a rate of 20 to 30 ml per minute (1.2 or 1.8 liters per hour).
4 Throw away (discard) unused Polyethylene Glycol 3350 and electrolytes for oral solution within 48 hours (2 days).
Keep Polyethylene Glycol 3350 and electrolytes for oral solution and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration
Manufactured by:
Strides Pharma Science Ltd.
Bengaluru-562106, India
Distributed by:
Strides Pharma Inc.
East Brunswick, NJ 08816
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FILL TO THE TOP OF THE LINE ON BOTTLE
NDC 64380-765-21
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing
Dispense the enclosed Medication Guide to each patient
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP
When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium, 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride and 17.6 mmol/L polyethylene glycol 3350
Each disposable jug contains, in powdered form: 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
RX
only
Manufactured by Strides Pharma Science Ltd., Bengaluru-562106, India
Distributed by Strides Pharma Inc. East Brunswick
image
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient
Lemon Flavor
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP with Lemon Flavor
When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium , 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride and 17.6 mmol/L polyethylene glycol 3350
Each disposable jug contains, in powdered form: 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, flavorlemon 0.1 g
RX
only
Manufactured by Strides Pharma Science Ltd., Bengaluru-562106, India
Distributed by Strides Pharma Inc. East Brunswick
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient
Orange Flavor
Polyethylene Glycol 3350 and Electrolytes for Oral Solution, USP with Orange Flavor
When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium , 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride and 17.6 mmol/L polyethylene glycol 3350
Each disposable jug contains, in powdered form: 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, flavor orange 0.4 g
RX
only
Manufactured by Strides Pharma Science Ltd, Bengaluru-562106, India
Distributed by Strides Pharma Inc. East Brunswick
image
-
INGREDIENTS AND APPEARANCE
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVORED
polyethylene glycol 3350 and electrolytes - unflavored powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-765 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 236 g in 4 L SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM CATION 22.74 g in 4 L SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 6.74 g in 4 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 5.86 g in 4 L POTASSIUM CHLORATE (UNII: H35KS68EE7) (POTASSIUM CATION - UNII:295O53K152, CHLORATE ION - UNII:08Z8093742) POTASSIUM CHLORATE 2.97 g in 4 L Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64380-765-21 4 L in 1 JUG; Type 0: Not a Combination Product 01/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204558 01/10/2019 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES WITH LEMON FLAVOR
polyethylene glycol 3350 and electrolytes with lemon flavor powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-766 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 236 g in 4 L SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM CATION 22.74 g in 4 L SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 6.74 g in 4 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 5.86 g in 4 L POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 2.97 g in 4 L Product Characteristics Color WHITE Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64380-766-21 4 L in 1 JUG; Type 0: Not a Combination Product 01/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204558 01/10/2019 POLYETHYLENE GLYCOL 3350 AND ELECTROLYTESWITH ORANGE FLAVOR
polyethylene glycol 3350 and electrolytes with orange flavor powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-767 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 236 g in 4 L SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM CATION 22.74 g in 4 L SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 6.74 g in 4 L SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 5.86 g in 4 L POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698) POTASSIUM CHLORIDE 2.97 g in 4 L Product Characteristics Color WHITE Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64380-767-21 4 L in 1 JUG; Type 0: Not a Combination Product 01/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204558 01/10/2019 Labeler - Strides Pharma Science Limited (650738743) Registrant - Strides Pharma Global Pte. Ltd. (659220961) Establishment Name Address ID/FEI Business Operations Strides Pharma Science Limited 918513263 ANALYSIS(64380-765, 64380-766, 64380-767) , MANUFACTURE(64380-765, 64380-766, 64380-767) , PACK(64380-765, 64380-766, 64380-767)