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Anwendungsgebiete

PEG-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. PEG-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 ( 1 )

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PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution ( 4 , 11 )

Warnhinweise und Vorsichtsmaßnahmen

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 )

5.1Serious Fluid and Serum Chemistry Abnormalities

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Serious Fluid and Serum Chemistry Abnormalities

Nebenwirkungen

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 PEG-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 PEG-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. 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 Affordable Pharmaceuticals, LLC at 1-800-514-5617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Warnhinweise und Vorsichtsmaßnahmen

5.1Serious Fluid and Serum Chemistry Abnormalities

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Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Serious Fluid and Serum Chemistry Abnormalities

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5.2Cardiac Arrhythmias

5.3Seizures

5.4Renal Impairment

5.5Colonic Mucosal Ulcerations and Ischemic Colitis Administration

5.6Use in Patients with Significant Gastrointestinal Disease

5.7Aspiration Use

5.8Not for Direct Ingestion

Wechselwirkungen

7.2Potential for Altered Drug Absorption

7.3Stimulant Laxatives

Schwangerschaft und Stillzeit

8.1Pregnancy

Nebenwirkungen

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