PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 420 g/4L
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride · POWDER, FOR SOLUTION · Affordable Pharmaceuticals, LLC
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride is a powder, for solution containing polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride at 420 g/4L, taken oral. Manufactured by Affordable Pharmaceuticals, LLC.
Key Facts
- Brand Name
- PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
- Generic Name
- polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
- NDC Code (Product)
10572-302- Manufacturer
- Affordable Pharmaceuticals, LLC
- Strength
- 420 g/4L
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA019797
- Drug Class
- Osmotic Laxative [EPC]
- Marketing Start
- 02/08/2013
Recall History
LUPIN SOMERSET
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Side 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, 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION PEG-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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution 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 ). Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3 ) Pediatric patients (aged 6 months or greater): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter ( 2.3 ). 2.1 Dosage Overview PEG-3350, sodium chloride, sodium bicarbonate and potassium chl…
Contraindications
4 CONTRAINDICATIONS 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 )
Drug 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 PEG-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. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may be flushed from the gastrointestinal tract and the medication may not be absorbed properly. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and PEG-3350, sodium chloride, sodium bicarbonate and potass…
Adverse Reactions
6 ADVERSE REACTIONS 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…
Frequently Asked Questions
What is PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride used for?
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride contains polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride a controlled substance?
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride is not classified as a controlled substance by the DEA.
What is the generic name for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride?
The generic name for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride is polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride. There are 2 other brand versions of polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride.
What is the NDC code for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 420 g/4L?
The NDC (National Drug Code) for PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 420 g/4L is 10572-302, listed by Affordable Pharmaceuticals, LLC.