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

Name: PEG-3350, sodium sulfate, sodium bicarbonate, sodium chloride and potassium chloride

Side effects

Nausea, abdominal fullness and bloating are the most common adverse reactions, occurring in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient. Isolated cases of urticaria, rhinorrhea, dermatitis and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported, which may represent allergic reactions.

Patient information

GaviLyte-C with flavor pack produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be ingested during the 3 to 4 hour period prior to the initiation of GaviLyte-C with flavor pack administration. In no case should solid foods be eaten within 2 hours of drinking GaviLyte-C with flavor pack. The rate of administration is 240 mL (8 fl. oz.) every 10 minutes. Rapid drinking of each portion is preferred rather than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of GaviLyte-C with flavor pack administration.

Administration of GaviLyte-C with flavor pack should be continued until the watery stool is clear and free of solid matter. This normally requires the consumption of approximately 3 to 4 liters (3 to 4 quarts), although more or less may be required in some patients. The unused portion should be discarded.

Indications

GaviLyte-G is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination.

How supplied

GaviLyte-G is supplied in a disposable jug, in powdered form, for oral administration as a solution following reconstitution. Each jug has the attached lemon flavor pack, in powdered form, for the addition of the flavor packet by the pharmacist priorto dispensing.

Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g and lemon flavor pack 2 g (optional). When made up to 4 liters volume with water, the solution contains PEG-335017.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L

Storage

Store in sealed container at 59°-86°F. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused potion,

NDC 43386-090-19

Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: GAVIS Pharmaceuticals, LLC., Somerset, NJ 08873. Revised: 2012

Overdose

No information provided.

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© GaviLyte-G Patient Information is supplied by Cerner Multum, Inc. and GaviLyte-G Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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