PEG-3350, Electrolytes, and Ascorbate

polyethylene glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid · Kit

Prescription (Rx)

Uses

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. ( 1 )

Dosage and administration

Preparation and Administration:
• Two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution are required for a complete preparation for colonoscopy, using a “Two-Day” preferred method or “One-Day” alternative method dosing regimen. ( 2.1 )
• Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution must be reconstituted in water prior to ingestion. ( 2.1 )
• Additional clear liquids must be consumed after each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in both dosing regimens. ( 2.1 , 5.1 )
• Do not take other laxatives while taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. ( 2.1 , 5.5 )
• Do not take oral medications within 1 hour of starting each dose. ( 2.1 ) Dosing Regimen:
• Two-Day (Split-Dose) (Preferred Method): Dose 1 the evening before the colonoscopy, and Dose 2 the morning of the colonoscopy (approximately 12 hours after the start of Dose 1, and at least 3 ½ hours prior to the colonoscopy). ( 2.2 )
• One-Day (Evening Only) (Alternative Method) : Dose 1 at least 3 ½ hours prior to bedtime the evening before the colonoscopy and Dose 2 approximately 1 ½ hours after starting Dose 1 the evening before the colonoscopy. ( 2.3 )
• For complete information on dosing, preparation and administration see full prescribing information ( 2.1 , 2.2 , 2.3 ) 2.1 Important Preparation and Administration Instructions
• Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.1 )].
• Two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution are required for a complete preparation for colonoscopy. The time interval between the two doses depends on the regimen prescribed and the planned timing of the colonoscopy procedure. [see Dosage and Administration ( 2.2 , 2.3 ) ] .
• The “Split-Dose” is the preferred method and consists of two separate doses: the first dose is taken the evening before the colonoscopy, and the second dose is taken the next day, the morning of the day of the colonoscopy [see Dosage and Administration ( 2.2 )].
• The “Evening Only” is the alternative method and consists of two separate doses: both doses are taken in the evening before the day of the colonoscopy, with a minimum of 1.5 hours between the start of the first dose and the start of the second dose [see Dosage and Administration ( 2.3 )].
• Both Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution dosing regimens require administration of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution using the mixing container provided to reconstitute the contents of Pouch A and B with water to the Fill Line. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )].
• Additional clear liquids (including water) must be consumed in both dosing regimens [see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions ( 5.1 )] .
• Consume only clear liquids (no solid food) from the start of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution treatment until after the colonoscopy.
• Do not eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• Do not take other laxatives while taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Drug Interactions ( 7.3 )] .
• Do not take oral medications within 1 hour before or after starting each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Drug Interactions ( 7.2 )].
• Ensure completion of Dose 2, including all additional liquids, at least 2 hours before the colonoscopy.
• Storage : After reconstitution, store Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in an upright position and keep refrigerated. Use within 24 hours after it is mixed in water. 2.2 Two-Day Split-Dosing Regimen (Preferred Method) The Two-Day Split-Dosing regimen is the preferred dosing method. Instruct adult patients that on the day before the clinical procedure, they can consume breakfast, followed by a light lunch (no solid foods), and clear soup and/or plain yogurt for dinner, which must be completed at least 1 hour prior to the start of the first Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution dose. Instruct adult patients to take two separate doses in conjunction with fluids as follows: Dose 1 – In the evening before the colonoscopy, approximately 10 to 12 hours before Dose 2: 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3. Thoroughly mix with a spoon or shake with lid on securely until the contents of Pouch A and B are completely dissolved. 4. Drink 8 ounces of the solution every 15 minutes. This should take about 1 hour. Be sure to drink all the solution. 5. Refill the mixing container halfway to the Fill Line (at least 16 ounces) with a clear liquid and drink all this liquid before going to bed. Dose 2 – Take next morning, on the day of the colonoscopy, approximately 12 hours after the start of Dose 1 and at least 3 ½ hours prior to colonoscopy: 1. Empty the contents of 1 Pouch A and 1 Pouch B into the mixing container that comes with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 2. Add lukewarm water to the Fill Line on the mixing container (32 fluid ounces). Do not add other ingredients to the Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. 3.

Dosage forms and strengths

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is supplied as a white to yellow powder for reconstitution and is available in a carton that contains 2 pouches labeled Pouch A and 2 pouches labeled Pouch B.
• Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride. Pouch A contains lemon flavoring [see Description ( 11 )] .
• Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. For Oral Solution: 2 pouches labeled Pouch A and 2 pouches labeled Pouch B. ( 3 )
• Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride. Pouch A contains lemon flavoring. ( 3 )
• Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. ( 3 )

Contraindications

Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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 )]
• Gastric retention
• Ileus
• Toxic colitis or toxic megacolon
• Hypersensitivity to any ingredient in Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.10 ) and Description ( 11 )]
• Gastrointestinal (GI) obstruction ( 4 , 5.6 )
• Bowel perforation ( 4 , 5.6 )
• Gastric retention ( 4 )
• Ileus ( 4 )
• Toxic colitis or toxic megacolon ( 4 )
• Hypersensitivity to any ingredient in Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution ( 4 , 5.10 )

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 , 7.1 )
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 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 laboratory testing. ( 5.4 , 7.1 , 8.6 )
• Colonic mucosal ulcerations : Consider potential for ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. ( 5.5 )
• Suspected GI obstruction or perforation : Rule out the diagnosis before administration. ( 5.6 )
• Patients at risk for aspiration: Observe during administration. ( 5.7 )
• Glucose-6-phosphate dehydrogenase deficiency (G-6-PD) : Use with caution. ( 5.8 )
• Risks in patients with phenylketonuria : Contains phenylalanine ( 5.9 )
• Hypersensitivity reactions, including anaphylaxis : Inform patients to seek immediate medical care if symptoms occur. ( 5.10 ) 5.1 Serious Fluid and Electrolyte Abnormalities Advise patients to hydrate adequately before, during, and after the use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. If a patient develops significant vomiting or signs of dehydration after taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Bowel preparations can cause fluid and electrolyte disturbances, which can lead to serious adverse reactions including cardiac arrhythmias, seizures, and renal impairment [see Adverse Reactions ( 6.2 )] . Correct fluid and electrolyte abnormalities before treatment with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities [such as diuretics, angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs)] or in patients with known or suspected hyponatremia. Consider performing pre-dose and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients [see Drug Interactions ( 7.1 )]. 5.2 Cardiac Arrhythmias There have been rare reports of serious arrhythmias (including atrial fibrillation) associated with the use of ionic osmotic laxative products for bowel preparation. These occur predominantly in patients with underlying cardiac risk factors and electrolyte disturbances. Use caution when prescribing Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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, cardiomyopathy, or electrolyte imbalance). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. 5.3 Seizures There have been rare 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, Electrolytes, and Ascorbate 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 Use in Patients with Renal Impairment Use Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution with caution in patients with renal impairment or patients taking concomitant medications that affect renal function (such as diuretics, ACE inhibitors, angiotensin receptor blockers, or nonsteroidal anti-inflammatory drugs) [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, Electrolytes, and Ascorbate for Oral Solution, and consider performing pre-dose and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use in Specific Populations ( 8.6 )]. 5.5 Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative Colitis Osmotic laxatives 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, Electrolytes, and Ascorbate for Oral Solution may increase the risk of mucosal ulceration or ischemic colitis and is not recommended. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. 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, Electrolytes, and Ascorbate for Oral Solution [see Contraindications ( 4 )] . Use with caution in patients with severe ulcerative colitis.

Side effects

The following serious or otherwise important adverse reactions for bowel preparations are described elsewhere in the labeling:
• Serious Fluid and Electrolyte Abnormalities [see Warnings and Precautions (5.1) ]
• Cardiac Arrhythmias [see Warnings and Precautions (5.2) ]
• Seizures [see Warnings and Precautions (5.3)]
• Patients with Renal Impairment [see Warnings and Precautions (5.4)]
• Colonic Mucosal Ulceration, Ischemic Colitis and Ulcerative 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)]
• Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency [see Warnings and Precautions (5.8)]
• Risks in Patients with Phenylketonuria [see Warnings and Precautions (5.9)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥ 5%) are:
• Two-Day (Split-Dose): malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. ( 6.1 )
• One-Day (Evening-Only): abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies (14) ] . The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively. Since diarrhea was considered as a part of the efficacy assessment, it was not defined as an adverse reaction in these trials. Table 1: Common Adverse Reactions Reported in at least 2% of patients in either treatment group in Patients Undergoing Colonoscopy in Study 1 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution Two-Day Split Dosing Regimen (N=180) 4 Liter PEG + Electrolytes Solution (N=179) Malaise 19% 18% Nausea 14% 20% Abdominal pain 13% 15% Vomiting 8% 13% Upper abdominal pain 6% 6% Dyspepsia 3% 1% Table 2: Common Adverse Reactions Reported in at least 5% of patients in either treatment group Patients were specifically asked about the occurrence of the following symptoms: shivering, anal irritations, abdominal bloating or fullness, sleep loss, nausea, vomiting, weakness, hunger sensation, abdominal cramps or pain, thirst sensation, and dizziness. in Patients Undergoing Colonoscopy in Study 2 Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution One-Day Evening Only Dosing Regimen (N=169) 90 mL Oral Sodium Phosphate Solution (N=171) Abdominal distension 60% 41% Anal discomfort 51% 52% Thirst 47% 65% Nausea 47% 47% Abdominal pain 39% 32% Sleep disorder 35% 29% Rigors 34% 30% Hunger 30% 71% Malaise 27% 53% Vomiting 7% 8% Dizziness 7% 18% Headache 2% 5% Hypokalemia 0% 6% Hyperphosphatemia 0% 6% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution or other PEG-based products. 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. Cardiovascular: tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema, asystole, acute pulmonary edema and syncope, and dehydration. Gastrointestinal: upper gastrointestinal bleeding from a Mallory-Weiss tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)]. Hypersensitivity reactions: anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness, rhinorrhea, dermatitis, fever, and chills [see Warnings and Precautions ( 5.10 )]. Nervous system: tremor, seizure. Renal: renal impairment and/or failure. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution as a Two-Day Split-Dosing and One-Day Evening Only Dosing Regimen was evaluated in two randomized, active-controlled, multicenter, investigator-blinded clinical trials in adult patients scheduled to have an elective colonoscopy [see Clinical Studies (14) ] . The safety analysis for Study 1 included 359 adult patients ranging in age from 18 to 88 years (mean age 59), with 52% female and 48% male patients. The safety analysis for Study 2 included 340 adult patients ranging in age from 21 to 76 years (mean age 53), with 53% male and 47% female patients. Tables 1 and 2 display adverse reactions reported in at least 2% and 5% of patients in either treatment group in Study 1 and Study 2, respectively.

Drug interactions

Drugs that increase risk for fluid and electrolyte imbalance. ( 7.1 ) 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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, seizures, arrhythmias, or QT prolongation 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, Electrolytes, and Ascorbate for Oral Solution can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Dosage and Administration ( 2.1 )] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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, Electrolytes, and Ascorbate for Oral Solution [see Warnings and Precautions ( 5.5 , 5.6 )]. 7.1 Drugs That May Increase Risks due to Fluid and Electrolyte Abnormalities Use caution when prescribing Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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, seizures, arrhythmias, or QT prolongation 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, Electrolytes, and Ascorbate for Oral Solution can reduce the absorption of other co-administered drugs. Administer oral medications at least 1 hour before the start of administration of each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution [see Dosage and Administration ( 2.1 )] .

Use in specific populations

8.1 Pregnancy Risk Summary There are no available data on Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There are no data available on the presence of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution and any potential adverse effects on the breastfed child from Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in pediatric patients have not been established. 8.5 Geriatric Use Of the 413 patients in clinical trials receiving Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1) ] . 8.6 Renal Impairment Use Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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 the use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate 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)].

Pregnancy

Pediatric use

8.4 Pediatric Use The safety and effectiveness of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution in pediatric patients have not been established.

Geriatric use

8.5 Geriatric Use Of the 413 patients in clinical trials receiving Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, 91 (22%) patients were aged 65 or older, while 25 (6%) patients were over 75 years of age. No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients. However, elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities [see Warnings and Precautions (5.1) ] .

Overdosage

Overdosage of more than the recommended dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution may lead to severe electrolyte disturbances, including hyponatremia and/or hypokalemia, as well as dehydration and hypovolemia, with signs and symptoms of these disturbances. Certain severe electrolyte disturbances may lead to cardiac arrhythmias, seizures, and renal failure [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )] . Monitor for fluid and electrolyte disturbances and treat symptomatically.

Description

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an osmotic laxative consisting of 4 pouches (2 of Pouch A and 2 of Pouch B) containing white to yellow powder for reconstitution. Each Pouch A contains 100 grams of polyethylene glycol (PEG) 3350, 7.5 grams of sodium sulfate, 2.691 grams of sodium chloride, and 1.015 grams of potassium chloride, plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring containing citral, lime oil, maltodextrin, acacia gum, vitamin E, and other natural flavoring agents. Pouch A contains 111.9 g of powder for oral solution. Each Pouch B contains 4.7 grams of ascorbic acid and 5.9 grams of sodium ascorbate. Pouch B contains 10.6 g of powder for oral solution. When 1 Pouch A and 1 Pouch B are dissolved together in water to a volume of 1 liter, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution is an oral solution having a lemon taste. The entire, reconstituted, 2-liter Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution colon preparation contains 200 grams of polyethylene glycol-3350, 15 grams of sodium sulfate, 5.38 grams of sodium chloride, 2.03 grams of potassium chloride, 9.4 grams of ascorbic acid, and 11.8 grams of sodium ascorbate plus the following excipients: aspartame (sweetener), acesulfame potassium (sweetener), and lemon flavoring. A mixing container for reconstitution is enclosed. Phenylketonurics: Contains Phenylalanine 131 mg per treatment.

Mechanism of action

12.1 Mechanism of Action The primary mode of action is osmotic action of polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid, which induce a laxative effect. The physiological consequence is increased water retention in the lumen of the colon, resulting in loose stools.

How supplied

Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution (polyethylene glycol 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, and ascorbic acid for oral solution) is supplied as a white to yellow powder for reconstitution and is lemon flavored. NDC 68682-201-75, Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, single-use outer carton:
• Each outer carton contains a disposable mixing container with lid for reconstitution of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution, prescribing information and patient information, and one inner carton.
• Each inner carton contains 2 pouches labeled Pouch A and 2 pouches labeled Pouch B. Storage Store carton/container at room temperature, between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). When reconstituted, store upright and keep solution refrigerated. Use within 24 hours [see Dosage and Administration (2.1) ] .

Patient information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients:
• That two doses of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution are required for a complete preparation for colonoscopy either as a Split-Dose (2-Day), or Evening Only (1-Day) dosing regimen [see Instructions for Use] .
• Not to take other laxatives while they are taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution.
• That Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution contains 131 mg of phenylalanine per treatment [see Warnings and Precautions (5.9) ] .
• That each pouch needs to be reconstituted in water before ingestion and that they should drink additional clear liquids. Examples of clear liquids can be found in the Instructions for Use .
• Not to take oral medications within one hour of starting each dose of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution.
• To follow the directions in the Instructions for Use , for either the Two-Day Split-Dosing or the One-Day Evening Only Dosing regimen, as prescribed.
• To consume additional clear liquids before, during, and after the use of Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution to prevent dehydration [see Warnings and Precautions (5.1) ] .
• To contact their healthcare provider if they develop significant vomiting or signs of dehydration after taking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution or if they experience altered consciousness or seizures [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )]
• Not to eat or drink alcohol, milk, anything colored red or purple or any other foods containing pulp material.
• To stop drinking Polyethylene Glycol-3350, Electrolytes, and Ascorbate for Oral Solution temporarily or drink each portion at longer intervals if they develop severe abdominal discomfort or distention until these symptoms diminish. If severe symptoms persist, tell patients to contact their healthcare provider. Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA © 2025 Bausch Health Companies Inc. or its affiliates 9676405 70015788-02

Label text from the FDA structured product label by Oceanside Pharmaceuticals (revised Oct 1, 2025). Long sections are shortened; the complete label is on DailyMed.

PEG-3350, Electrolytes, and Ascorbate NDC products (1)

NDC	Strength & form	Labeler	Type
68682-201	Kit	Oceanside Pharmaceuticals	NDA

Frequently asked questions

What is PEG-3350, Electrolytes, and Ascorbate used for?

What are the side effects of PEG-3350, Electrolytes, and Ascorbate?

Who makes PEG-3350, Electrolytes, and Ascorbate?

PEG-3350, Electrolytes, and Ascorbate is listed by 1 labeler in the FDA NDC directory, including Oceanside Pharmaceuticals.