Label: POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE - polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride powder, for solution

  • NDC Code(s): 40032-050-19
  • Packager: Novel Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 05/09

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • DESCRIPTION

    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.

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  • CLINICAL PHARMACOLOGY

    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.

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  • INDICATIONS AND USAGE

    PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE for Oral Solution is indicated for bowel cleansing prior to colonoscopy.

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  • CONTRAINDICATIONS

    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.

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  • WARNINGS

    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.

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  • PRECAUTIONS

    General

    Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, especially if it is administered via nasogastric tube. 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, POTASSIUM CHLORIDE, SODIUM BICARBONATE.

    Information for Patients

    PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE produces a watery stool which cleanses the bowel before examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE.

    Adults drink 240 mL (8 oz.) every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Continue drinking until the watery stool is clear and free of solid matter. Any unused portion should be discarded. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occur, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear.

    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.

    Drug Interactions

    Oral medication administered within one hour of the start of administration of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE may be flushed from the gastrointestinal tract and not absorbed.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenic and reproductive studies with animals have not been performed.

    Pregnancy

    Category C. Animal reproduction studies have not been conducted with PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE. It is also not known whether PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE should be given to a pregnant woman only if clearly needed.

    Pediatric Use

    Safety and effectiveness of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of PEG-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE in adults with additional safety and efficacy data from published studies of similar formulations.

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  • ADVERSE REACTIONS

    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.

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  • DOSAGE AND ADMINISTRATION

    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.

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  • HOW SUPPLIED

    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

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE 
    polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate powder, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:40032-050
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 420 g  in 438.4 g
    SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 11.2 g  in 438.4 g
    SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 5.72 g  in 438.4 g
    POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 1.48 g  in 438.4 g
    Inactive Ingredients
    Ingredient Name Strength
    ALPHA-TOCOPHEROL, DL-  
    SACCHARIN SODIUM  
    MALTODEXTRIN  
    ACACIA  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:40032-050-19 438.4 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090019 05/28/2009
    Labeler - Novel Laboratories, Inc. (793518643)
    Registrant - Novel Laboratories, Inc. (793518643)
    Establishment
    Name Address ID/FEI Business Operations
    Novel Laboratories, Inc. 793518643 MANUFACTURE, REPACK
    Establishment
    Name Address ID/FEI Business Operations
    Dow Chemical Company 801038019 API MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Mallinckrodt Baker Inc. 001213481 API MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Church and Dwight Co, Inc. 001211952 API MANUFACTURE
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