POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES — polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride and potassium chloride powder, for solution
Novel Laboratories, Inc.
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.
2 DOSAGE AND ADMINISTRATION
2.1 Important Preparation and Administration Instructions
- Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution [see Warnings and Precautions (5.1)].
- Reconstitute PEG-3350 and electrolytes for oral solutionwith water prior to ingestion, do not take undissolved PEG-3350 and electrolytes for oral solution [see Dosage and Administration (2.2)].
- Do not take oral medications within 1 hour before the start of or during administration of PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.2)].
- Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution [see Drug Interactions (7.3)].
- Consume only clear liquids, avoid red and purple liquids.
- Patients may consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
- The solution is more palatable if chilled prior to administration.
- Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution.
- If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue PEG-3350 and electrolytes for oral solution until the symptoms abate.
2.2 Dosage Regimen
Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regiment for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy.
Instruct patients to take PEG-3350 and electrolytes for oral solution in conjunction with clear liquids as follows:
This preparation can be used with or without the lemon flavor pack. The pharmacist will add the lemon flavor pack prior to dispensing (see packet instructions)
4 Liter Jug
- Fill the supplied container containing the PEG-3350 and electrolytes for oral solution powder with lukewarm drinking water to the 4-liter fill line
- Do not add any other ingredients, flavors, etc
- After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
- Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.
- After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.
Administration via a Nasogastric Tube
For patients with a nasogastric tube, administer the reconstituted PEG-3350 and electrolytes for oral solution solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).
3 DOSAGE FORMS AND STRENGTHS
For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride as a white to off-white powder. When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG-3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.
PEG-3350 and electrolytes for oral solution is contraindicated in the following conditions:
- Gastrointestinal (GI) obstruction (5.6)
- Bowel perforation (5.6)
- Toxic colitis or toxic megacolon
- Gastric retention
- Hypersensitivity to components of PEG-3350 and electrolytes for oral solution (5.8)
5 WARNINGS AND PRECAUTIONS
5.1 Serious Fluid and Serum Chemistry Abnormalities
Advise patients to hydrate adequately before, during, and after the use of PEG-3350 and electrolytes for oral solution. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking PEG-3350 and electrolytes for oral solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Fluid and electrolyte abnormalities should be corrected before treatment with PEG-3350 and electrolytes for oral solution.
In addition, use caution when prescribing PEG-3350 and electrolytes for oral solution for patients who have conditions, or 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 renal impairment [see Drug Interactions (7.1) ]
5.2 Cardiac Arrhythmias
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing PEG-3350 and electrolytes for oral solution for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.
There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing PEG-3350 and electrolytes for oral solution for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia [see Drug Interactions (7.1)].
5.4 Renal Impairment
Use caution when prescribing PEG-3350 and electrolytes for oral solution for patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs) [see Drug Interactions (7.1)]. Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Use is Specific Populations (8.6)]
5.5 Colonic Mucosal Ulcerations and Ischemic Colitis
Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and PEG-3350 and electrolytes for oral solution may increase this risk. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
5.6 Use in Patients with Significant Gastrointestinal Disease
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PEG-3350 and electrolytes for oral solution. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of PEG-3350 and electrolytes for oral solution.
Use with caution in patients with severe active ulcerative colitis.
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