Label: GAVILYTE G TM- polyethylene glycol-3350 and electrolytes powder, for solution
- NDC Code(s): 43386-090-19
- Packager: GAVIS Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated June 1, 2009
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- SPL UNCLASSIFIED SECTION
GaviLyte – G is a white powder in a 4 liter jug for reconstitution, containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride and 2.97 g potassium chloride. When dissolved in water to a volume of 4 liters, GaviLyte – G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) is an isosmotic solution, for oral administration, having a mildly salty taste. GaviLyte – G is administered orally or via nasogastric tube as a gastrointestinal lavage.Close
- CLINICAL PHARMACOLOGY
GaviLyte – G 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.Close
- INDICATIONS AND USAGE
GaviLyte – G is indicated for bowel cleansing prior colonoscopy and barium enema X-ray examination.Close
GaviLyte – G is contraindicated in patients known to hypersensitive to any of the components. GaviLyte – G is contraindicated in patients with gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon or ileus.Close
The lemon 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. GaviLyte – G should be used with caution in patients with severe ulcerative colitis.Close
Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of GaviLyte – G, 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 GaviLyte – G.
Information for Patients
GaviLyte – G 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 could 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 GaviLyte – G.
Drink 240 mL (8 oz.) every 10 minutes. 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 GaviLyte – G 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. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters and it is best to drink all of the solution. Any unused solution should be discarded.
Oral medication administered within one hour of the start of administration of GaviLyte – G 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.
Category C. Animal reproduction studies have not been conducted with GaviLyte – G. It is also not known whether GaviLyte – G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte – G should be given to a pregnant woman only if clearly needed.
- ADVERSE REACTIONS
Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of GaviLyte – G. 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 reactions 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" infiltrates on chest X-ray after vomiting and aspirating PEG.Close
- DOSAGE AND ADMINISTRATION
The recommended dose for adults is 4 liters of GaviLyte – G solution prior to gastrointestinal examination, as ingestion of this dose produces a satisfactory preparation in over 95% of patients. Ideally, the patients should fast for approximately three or four hours prior to GaviLyte – G administration, but in no case should solid food be given for at least two hours before the solution is given.
GaviLyte – G is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Oral administration is 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.
Nasogastric tube administration is the rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour). The first bowel movement should occur approximately one hour after the start of GaviLyte – G administration.
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 GaviLyte – G on the evening before the examination, particularly if the patient is to have a barium enema.
Preparation of the solution: GaviLyte – G is prepared by filling the container to the 4 liter mark with water and shaking vigorously several times to ensure that the Ingredients are dissolved. Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.Close
- 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 prior to dispensing.
Disposable Jug: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, 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-3350 17.6 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 portion.
Novel Laboratories, Inc.
Somerset NJ 08873
GAVIS Pharmaceuticals, LLC
Somerset NJ 08873
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
GAVILYTE G TM
polyethylene glycol-3350 and electrolytes powder, for solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43386-090 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P) POLYETHYLENE GLYCOL 3350 236 g in 274.31 g SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 5.86 g in 274.31 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 6.74 g in 274.31 g POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 2.97 g in 274.31 g SODIUM SULFATE ANHYDROUS (UNII: 36KCS0R750) (SULFATE ION - UNII:7IS9N8KPMG) SODIUM SULFATE ANHYDROUS 22.74 g in 274.31 g Inactive Ingredients Ingredient Name Strength ACACIA (UNII: 5C5403N26O) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MALTODEXTRIN (UNII: 7CVR7L4A2D) ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) Product Characteristics Color Score Shape Size Flavor LEMON Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43386-090-19 274.31 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090231 06/01/2009 Labeler - GAVIS Pharmaceuticals, LLC (829838551) 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