Overview
11 DESCRIPTION For oral solution: Each 4 liter (4L) GaviLyte-N jug contains a white powder for reconstitution. GaviLyte-N 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 420g, sodium bicarbonate 5.72 g, sodium chloride 11.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 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. 12.2 Pharmacodynamics GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours. 12.3 Pharmacokinetics The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.
Indications
- 1 INDICATIONS AND USAGE GaviLyte-N 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 ) GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
Common Doses
- 240 mL
- 25 mL
- 30 mL
Dosage
2 DOSAGE AND ADMINISTRATION GaviLyte-N, supplied as a powder, must be reconstituted with water before its use ( 2.1 , 5.8 ) On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids) ( 2.2 ). If adding a GaviLyte-N flavor pack, pour the contents of flavor powder (i.e., cherry, lemon or orange) into container prior to reconstitution ( 2.2 ). Early in the evening prior to colonoscopy, fill container containing GaviLyte-N powder with lukewarm water to 4 liter fill line ( 2.2 ).
Contraindications
- 4 CONTRAINDICATIONS 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 GaviLyte-N ( 4 , 11 ) GaviLyte-N 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 GaviLyte-N for oral solution [see How Supplied/Storage and Handling (16) ]
Side Effects
- 6 ADVERSE REACTIONS 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 Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 )] .
Interactions
- 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 GaviLyte-N 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.