PEG-3350 and Electrolytes
Generic: POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE
Basic Information
Manufacturer
A-S Medication Solutions
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
7a2d8dab-750f-43c1-933c-4169a840c60c
Indications & Usage
1 INDICATIONS AND USAGE PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 )
PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Renal impairment [see Warnings and Precautions ( 5.4 )] Colonic mucosal ulcerations and ischemic 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 )] The following adverse reactions associated with the use of PEG-3350 and Electrolytes for Oral Solution were identified in clinical trials or postmarketing reports.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.
Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )] .
Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).
Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].
Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation.
To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.
Cardiovascular: arrhythmia, atrial fibrillation, peripheral edema, asystole, and acute pulmonary edema after aspiration [see Warnings and Precautions ( 5.2 )] .
Nervous system: tremor, seizure [see Warnings and Precautions ( 5.3 )] Hypersensitivity: Urticaria/rash, pruritus, dermatitis, rhinorrhea, dyspnea, chest and throat tightness, fever, angioedema, anaphylaxis and anaphylactic shock [see Contraindications ( 4 ), Warnings and Precautions ( 5.8 )] Gastrointestinal: Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients).
Other less common adverse reactions include: abdominal cramps, vomiting, “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG, anal irritation, and upper GI bleeding from Mallory-Weiss Tear, esophageal perforation [usually with gastroesophageal reflux disease (GERD)].
Most common adverse reactions are: nausea, abdominal fullness, bloating abdominal cramps, vomiting and anal irritation.
To report SUSPECTED ADVERSE REACTIONS, contact Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.