POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES 236 g/274.31g
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES · POWDER, FOR SOLUTION · Novel Laboratories, Inc.
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES is a powder, for solution containing polyethylene glycol-3350 and electrolytes at 236 g/274.31g, taken oral. Manufactured by Novel Laboratories, Inc..
Key Facts
- Brand Name
- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
- Generic Name
- POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES
- NDC Code (Product)
40032-090- Manufacturer
- Novel Laboratories, Inc.
- Strength
- 236 g/274.31g
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090231
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 06/01/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PEG-3350 and electrolytes for oral solution, USP 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 indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Preparation and Administration (2.1): Correct fluid and electrolyte abnormalities before treatment with PEG-3350 and electrolytes for oral solution. Reconstitute PEG-3350 and electrolytes for oral solution with water prior to ingestion. Do not take oral medications within 1 hour before the start or during administration of PEG-3350 and electrolytes for oral solution. (2.1) Do not take other laxatives while taking PEG-3350 and electrolytes for oral solution. Consume only clear liquids; avoid red and purple liquids. Consume water or other clear liquids up until 2 hours before the time of the colonoscopy. Do not consume solid food within 2 hours before starting PEG-3350 and electrolytes for oral solution. Adult Dosing Regimen (2.2): On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting PEG-3350 and electrolytes for oral solution. Begin the recommended dosage regimen for PEG-3350 and electrolytes for oral solution early in the evening on the day before colonoscopy Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear. For complete in…
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 , 5.8 ) 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 Ileus Hypersensitivity to components of PEG-3350 and electrolytes for oral solution ( 5.8 )
Drug Interactions
7 DRUG INTERACTIONS Some drugs increase risks due to fluid and electrolyte changes ( 7.1 ) 7.1 Drugs that May Increase Risks Due to Fluid and Electrolyte Abnormalities Use caution when prescribing PEG-3350 and electrolytes for oral solution for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 )]. Consider additional patient evaluations as appropriate. 7.2 Potential for Reduced Drug Absorption PEG-3350 and electrolytes for oral solution can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of PEG-3350 and electrolytes for oral solution [see Dosage and Administration ( 2.1 )] . 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and PEG-3350 and electrolytes for oral solution may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking PEG-3350 and e…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating abdominal cramps, vomiting and anal irritation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novel Laboratories, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 )…
Frequently Asked Questions
What is POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES used for?
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES contains POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES a controlled substance?
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES is not classified as a controlled substance by the DEA.
What is the generic name for POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES?
The generic name for POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES is POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES. There are 2 other brand versions of POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES.
What is the NDC code for POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES 236 g/274.31g?
The NDC (National Drug Code) for POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES 236 g/274.31g is 40032-090, listed by Novel Laboratories, Inc..