Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Rx Only
DESCRIPTION
DESCRIPTION SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride and one 2 g flavor pack (optional). When dissolved in water to a volume of 4 liters, PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is administered orally or via nasogastric tube as a gastrointestinal lavage. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack is available in lemon flavor. This preparation can be used without the addition of a PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients known to be hypersensitive to any of the components. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.
WARNINGS
WARNINGS SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE Flavor Pack is for use only in combination with the contents of the accompanying 4 liter container. No additional ingredients, e.g. flavorings, should be added to the solution. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE should be used with caution in patients with severe ulcerative colitis. Use of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, and SODIUM BICARBONATE 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 1 child and hypokalemia has been reported in 3 children.
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and 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 reaction following the administration of PEG-ELS 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” infiltrate on chest X-ray after vomiting and aspirating PEG.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE administration, but in no case should solid food be given for at least two hours before the solution is given. Oral administration Adults: At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric tube administration: Adults: At a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour). Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear. The first bowel movement should occur approximately one hour after the start of PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE administration. Ingestion of 4 liters of PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients. Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE on the evening before the examination. Preparation of the solution : PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE solution is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to insure that the ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.
HOW SUPPLIED
HOW SUPPLIED SECTION
PEG 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE with Flavor Pack is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has an attached lemon flavor pack, in powdered form, for the addition of the flavor pack by the pharmacist prior to dispensing. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND SODIUM BICARBONATE FOR ORAL SOLUTION with Flavor Pack : PEG 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and lemon flavor pack 2 g (optional). 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 in sealed container at 25°C. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion. NDC 40032-050-19 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
