Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor
Generic Name: polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride with lemon flavor
Brand Names:
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 Bicarbonate And Potassium Chloride With Orange Flavor
11 DESCRIPTION For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.
Overview
11 DESCRIPTION For oral solution: Each 5 liter (5L) polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution's 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 ).
Side Effects
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)].
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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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.
Warnings
5 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. 4 CONTRAINDICATIONS 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution ( 4, 11 ) Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassi...
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING In powdered form, for oral administration as a solution following reconstitution. Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with Flavor P...
Frequently Asked Questions
What is Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor used for?▼
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.
What are the side effects of Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor?▼
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)].
What are the important warnings for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium Chloride With Lemon Flavor?▼
5 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. 4 CONTRAINDICATIONS 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 polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution ( 4, 11 ) Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassi...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.