Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - Unflavored, Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride with Lemon Flavor, Polyethylene Glycol 3350, Sodium Chloride, Sodium Bi
Generic: POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVORED, POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE WITH LEMON FLAVOR, POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BI
Basic Information
Manufacturer
Strides Pharma Science Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
37c111ec-5b62-42b9-bbb2-3b0c530e34c9
Indications & Usage
1 INDICATIONS AND USAGE Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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 Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
Adverse Reactions
6 ADVERSE REACTIONS 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 Strides Pharma Inc.
at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
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.
Abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc.
at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.
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.