DailyMed Label: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

DailyMed Label: PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

2021

DailyMed Prescription

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride

Affordable Pharmaceuticals, LLC

NDC: 10572-302

NDC: 10572-302

NDC: 10572-302

NDC: 10572-302

NDC: 10572-302

For oral solution: Each 4 liter (4L) PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution jug contains a white powder for reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium chloride, sodium bicarbonate and potassium chloride) for oral solution. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.4 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water. Polyethylene Glycol 3350, USP Sodium Bicarbonate, USP The chemical name is NaHCO 3 . The average Molecular Weight is 84.01. The structural formula is: Sodium Chloride, USP The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is: Na + Cl - Potassium Chloride, USP The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is: K-Cl PEG-3350 Structural Formula Sodium Bicarb Structural Formula

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 )

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 ). PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.8) ] . Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )] . The 4-liter reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, 1.4 grams of potassium chloride and 2 grams of flavor ingredients. On the day prior to the colonoscopy, instruct patients to: Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. Early in the evening prior to colonoscopy , fill the supplied container containing the PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours. The following is the recommended dose of reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or 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.    • Adults: Instruct patients to drink a total of up to 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).    • Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour. The first bowel movements should occur approximately one hour after the start of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution administration. Continue drinking until the watery stool is clear and free of solid matter.

For oral solution: One 4 liter jug with powder for reconstitution with water. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. For oral solution: polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams, and flavoring ingredients 2 grams; supplied in one 4 liter disposable jug ( 3 )

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 )

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 ) Advise patients to hydrate adequately before, during, and after the use of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. In addition, use caution when prescribing PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 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 )] . 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, sodium chloride, sodium bicarbonate and potassium chloride 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). Pre-dose and post-colonoscopy ECGs should be considered 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, sodium chloride, sodium bicarbonate and potassium chloride 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. Use caution when prescribing PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 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). 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. 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD). If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Use with caution in patients with severe active ulcerative colitis. Use with caution in patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration. Such patients should be observed during administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, especially if it is administered via nasogastric tube. Do not combine PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution with starch-based thickeners [see Dosage and Administration ( 2.1 )] . Polyethylene glycol (PEG), a component of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported. The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.

The following serious or otherwise important adverse reactions are described elsewhere in the labeling:

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 ) 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. 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. Concurrent use of stimulant laxatives and PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution.

Animal reproduction studies have not been conducted with PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. It is also not known whether PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is administered to a nursing woman. Safety and effectiveness of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in adults with additional safety and efficacy data from published studies of similar formulations. Use of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in one child and hypokalemia has been reported in 3 children. Clinical studies of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In powdered form, for oral administration as a solution following reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. Keep out of reach of children. Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution          NDC 10572-302-01

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. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution induces as diarrhea which rapidly cleanses the bowel, usually within four hours. The pharmacokinetics of PEG3350 following administration of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

Long term studies in animals have not been performed to evaluate carcinogenic potential of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Studies to evaluate the possible impairment of fertility or mutagenic potential of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution have not been performed.

Principal Display Panel – Bottle Label FILL TO THE TOP OF THE LINE ON BOTTLE NDC 10572-302-01 TO PHARMACIST AND PATIENT: Mixing information is on base label. Package insert may be removed before dispensing. Lemon-Lime Flavor PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L Each disposable jug contains, in powdered form: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g, flavor ingredients 2.0 g. RX ONLY Affordable Pharmaceuticals LLC Braintree, MA 02185 Rev 09/13 PDP - Bottle Label