Trilyte

polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride · Powder, For Solution · Oral

Prescription (Rx) Osmotic Laxative Potassium Salt

Uses

1 INDICATIONS AND USAGE TRILYTE is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. TRILYTE is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1 )

Dosage and administration

2 DOSAGE AND ADMINISTRATION TRILYTE, supplied as a powder, must be reconstituted with water before its use ( 2.1 , 5.8 ) On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids) ( 2.2 ). Early in the evening prior to colonoscopy, fill container containing TRILYTE powder with lukewarm water to 4 liter fill line ( 2.2 ). After capping container, shake vigorously several times ( 2.2 ). Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy ( 2.3 ). Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3 ) Pediatric patients (aged 6 months or greater ): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter ( 2.3 ). 2.1 Dosage Overview TRILYTE, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2) , Warnings and Precautions (5.8) ]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7) ] . The 4-liter reconstituted TRILYTE solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, 1.48 grams of potassium chloride, lemon flavor (contains dl-alpha-tocopherol and maltodextrin) 1.597 g and saccharin sodium 0.199 g. 2.2 Administration Instructions Prior to Dosage On the day prior to the colonoscopy, instruct patients to: a) Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. b) Early in the evening prior to colonoscopy , fill the supplied container containing the TRILYTE powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. c) After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours. 2.3 Dosage The following is the recommended dose of reconstituted TRILYTE solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20 to 30 mL per minute (1.2 to 1.8 liters per hour). Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted TRILYTE solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour. The first bowel movements should occur approximately one hour after the start of TRILYTE administration. Continue drinking until the watery stool is clear and free of solid matter.

Dosage forms and strengths

For oral solution: One 4 liter jug with powder for reconstitution with water. Each 4 liter jug contains: polyethylene glycol 3350 USP 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g, lemon flavor (contains dl-alpha-tocopherol and maltodextrin) 1.597 g and saccharin sodium 0.199 g. When made up to 4 liters volume with water, the solution contains PEG 3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. For oral solution: polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams, lemon flavor (contains dl-alpha-tocopherol and maltodextrin) 1.597 g and saccharin sodium 0.199 g; supplied in one 4 liter disposable jug ( 3 )

Contraindications

4 CONTRAINDICATIONS TRILYTE is contraindicated in the following conditions: Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to any component of TRILYTE [see How Supplied/Storage and Handling (16) ] Gastrointestinal (GI) obstruction, ileus, or gastric retention ( 4 , 5.6 ) Bowel perforation ( 4 , 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Known allergy or hypersensitivity to components of TRILYTE ( 4 , 11 )

Warnings and precautions

Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment-assess concurrent medications and consider testing in some patients ( 5.1 , 5.2 , 5.3 , 5.4 ) Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing ( 5.4 ) Suspected GI obstruction or perforation – rule out the diagnosis before administration ( 4 , 5.6 ) Patients at risk for aspiration – observe during administration ( 5.7 ) Not for direct ingestion – dilute and take with additional water ( 5.8 ) 5.1 Serious Fluid and Serum Chemistry Abnormalities Advise patients to hydrate adequately before, during, and after the use of TRILYTE. 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 TRILYTE, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with TRILYTE. In addition, use caution when prescribing TRILYTE 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 TRILYTE for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias. 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 TRILYTE 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. 5.4 Renal Impairment Use caution when prescribing TRILYTE 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). 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. 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 TRILYTE may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). 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 TRILYTE. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of TRILYTE. 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. Such patients should be observed during administration of TRILYTE, especially if it is administered via nasogastric tube. Do not combine TRILYTE with starch-based thickeners [see Dosage and Administration (2.1) ] . Polyethylene glycol (PEG), a component of TRILYTE, 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 choking and potential aspiration were reported. 5.8 Not for Direct Ingestion The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

Side effects

The following serious or otherwise important adverse reactions are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions (5.1) ] . Cardiac Arrhythmias [see Warnings and Precautions (5.2) ]. Seizures [see Warnings and Precautions (5.3) ] . Renal Impairment [see Warnings and Precautions (5.4) ] Colonic Mucosal Ulcerations, 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) ] Direct Ingestion [see Warnings and Precautions (5.8) ] . The following adverse reactions have been identified during post-approval use of TRILYTE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of TRILYTE. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG. Most common adverse reactions (≥ 3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Drug interactions

Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) Oral medication taken within 1 hour of start of each dose may not be absorbed properly ( 7.2 ) 7.1 Drugs that May Lead to Fluid and Electrolyte Abnormalities Use caution when prescribing TRILYTE for patients who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5.1 , 5.2 , 5.3 , and 5.4) ] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of TRILYTE may be flushed from the gastrointestinal tract and the medication may not be absorbed properly. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and TRILYTE may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking TRILYTE.

Use in specific populations

8.1 Pregnancy Animal reproduction studies have not been conducted with TRILYTE. It is also not known whether TRILYTE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TRILYTE 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 TRILYTE is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of TRILYTE in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of TRILYTE in adults with additional safety and efficacy data from published studies of similar formulations. Use of TRILYTE in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in one child and hypokalemia has been reported in 3 children. 8.5 Geriatric Use Clinical studies of TRILYTE 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.

Pregnancy

Pediatric use

8.4 Pediatric Use Safety and effectiveness of TRILYTE in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of TRILYTE in adults with additional safety and efficacy data from published studies of similar formulations. Use of TRILYTE in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in one child and hypokalemia has been reported in 3 children.

Geriatric use

8.5 Geriatric Use Clinical studies of TRILYTE 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.

Description

For oral solution: Each 4 liter (4 L) TRILYTE jug contains a white to off white powder for reconstitution. TRILYTE is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 USP 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g, lemon flavor (contains dl-alpha-tocopherol and maltodextrin) 1.597 g and saccharin sodium 0.199 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, USP 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 Chemical Structure 1 Chemical Structure 2

Mechanism of action

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.

How supplied

In powdered form, for oral administration as a solution following reconstitution. TRILYTE is available in a disposable jug in powdered form containing: TRILYTE: polyethylene glycol 3350 USP 420 g, sodium bicarbonate USP 5.72 g, sodium chloride USP 11.2 g, potassium chloride USP 1.48 g, lemon flavor (contains dl-alpha-tocopherol and maltodextrin) 1.597 g and saccharin sodium 0.199 g. When made up to 4 liters volume with water, the solution contains PEG 3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. 5 Liter disposable jug with a 4 Liter fill line NDC 84386-013-04 Storage: Store in sealed container at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children.

Patient information

See FDA-Approved Patient Labeling ( Medication Guide ). Instruct patients: To let you know if they have trouble swallowing or are prone to regurgitation or aspiration. Not to take other laxatives while they are taking TRILYTE. To consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider. That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician. To contact their healthcare provider if they develop signs and symptoms of dehydration [see Warnings and Precautions (5.1) ] . That oral medication administered within one hour of the start of administration of TRILYTE solution may be flushed from the GI tract and the medication may not be absorbed completely. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 12/2025

Label text from the FDA structured product label by Aurobindo Pharma Limited (revised Apr 15, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Polyethylene Glycol 3350 in 1 product
Sodium Bicarbonate in 1 product
Sodium Chloride in 1 product
Potassium Chloride in 1 product

Trilyte NDC products (1)

NDC	Strength & form	Labeler	Type
84386-013	Polyethylene Glycol 3350 420 g/4L; Sodium Bicarbonate 5.72 g/4L; Sodium Chloride 11.2 g/4L; Potassium Chloride 1.48 g/4L Powder, For Solution	Aurobindo Pharma Limited	ANDA

Frequently asked questions

What is Trilyte used for?

What are the side effects of Trilyte?

Who makes Trilyte?

Trilyte is listed by 1 labeler in the FDA NDC directory, including Aurobindo Pharma Limited.