TRILYTE 420 g/4L
polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride · POWDER, FOR SOLUTION · Aurobindo Pharma Limited
TRILYTE is a powder, for solution containing polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride at 420 g/4L, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- TRILYTE
- Generic Name
- polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride
- NDC Code (Product)
84386-013- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 420 g/4L
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076491
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 04/14/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & 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 liqui…
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 )
Drug Interactions
7 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.
Adverse Reactions
6 ADVERSE REACTIONS 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 rea…
Frequently Asked Questions
What is TRILYTE used for?
TRILYTE contains polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is TRILYTE a controlled substance?
TRILYTE is not classified as a controlled substance by the DEA.
What is the generic name for TRILYTE?
The generic name for TRILYTE is polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride. There are no other listed brand versions of polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride.
What is the NDC code for TRILYTE 420 g/4L?
The NDC (National Drug Code) for TRILYTE 420 g/4L is 84386-013, listed by Aurobindo Pharma Limited.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)