PEG

Warnings and Precautions, Aspiration: ( 5.7 ) 05/2021

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 )

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 information on dosing, preparation and administration, see the full prescribing information. ( 2.1 , 2.2 ) 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 Solution with water prior to ingestion, do not take undissolved PEG-3350 and Electrolytes for Oral Solution [see Dosage and Administration ( 2.2 )] . Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions ( 5.7 )] . 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: 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 recons …

3 DOSAGE FORMS AND STRENGTHS 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 )

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 )

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, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis and (rarely) anaphylactic reaction have been reported which may represent allergic reactions. Published literature contains isolated reports of serious adverse reactions following the administration of PEG-electrolyte solution products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrates on chest X-ray after vomiting and aspirating PEG. Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 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.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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. 8.3 Nursing Mothers 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. 8.4 Pediatric Use 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. 8.5 Geriatric Use 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.

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.

11 DESCRIPTION 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, flavoring ingredients 2 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 polyethylene-glycol-str sod-bi-carbonate-str

16 HOW SUPPLIED/STORAGE AND HANDLING 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 52536-302-01