TRILYTE
Generic: POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE
Basic Information
Manufacturer
Aurobindo Pharma Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
79f5e596-8d51-4227-afcc-f5e341150957
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 )
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 )
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 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 .
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 .