POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES

Other

Brand names: POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES

Oral

Mechanism of Action

12.1 Mechanism of Action The primary mode of action is thought to be through the osmotic effect of polyethylene glycol 3350 which causes water to be retained in the colon and produces a watery stool.

Indications

1 INDICATIONS AND USAGE PEG-3350 and electrolytes for oral solution

USP is a combination of PEG 3350

an osmotic laxative

Contraindications

• 4 CONTRAINDICATIONS Gastrointestinal (GI) obstruction ( 4
• 5.6 ) Bowel perforation ( 4
• 5.6 ) Toxic colitis or toxic megacolon ( 4 ) Gastric retention ( 4 ) Ileus ( 4 ) Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after use
1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias
2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold
3 ) Patients at risk for aspiration: Observe during administration

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

1-10%

Nausea

1-10%

Constipation

1-10%

Fatigue

1-10%

Vomiting

1-10%

Shortness of Breath

1-10%

Headache

0.1-1%

Weakness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral