Data from FDA - Curated by EPG Health - Last updated 05 December 2017

Indication(s)

1 INDICATIONS AND USAGE GaviLyte-N for oral solution 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.

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Advisory information

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) ]
Adverse reactions
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 adverse reactions have been identified during post-approval use of GaviLyte-N. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nausea, abdominal fullness and bloating are the most common adverse reactions (occurred in up to 50% of patients) to administration of GaviLyte-N. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually 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-electrolyte solution 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.

Usage information

Dosing and administration
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). After capping container, shake vigorously several times (2.2). Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy (2.3). Adults: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour (2.3) Pediatric patients (aged 6 months or greater ): Drink 25 mL/kg/hour orally or administer by NGT. Continue drinking until watery stool is clear and free of solid matter (2.3). 2.1 Dosage Overview GaviLyte-N, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see Dosage and Administration (2.2), Warnings and Precautions (5.8)]. The 4 liter reconstituted GaviLyte-N solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. GaviLyte-N may be used with or without one of the supplied flavor packs. 2.2 Administration Instructions Prior to Dosage On the day prior to the colonoscopy, instruct patients to: Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast. If adding a GaviLyte-N flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon, or orange) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The GaviLyte-N flavor packs are for use only in combination with the contents of the accompanying 4 liter container. Early in the evening prior to colonoscopy, fill the supplied container containing the GaviLyte-N powder (and if applicable, a flavor powder) with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters. After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours. 2.3 Dosage The following is the recommended dose of reconstituted GaviLyte- solution for adults and pediatric patients ≥ 6 months. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration. Adults: Instruct patients to drink a total of up to 4 liters 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. For NGT, rate is 20 -30 mL per minute (1.2 – 1.8 liters per hour). Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted GaviLyte-N, the solution may be given by nasogastric (NGT). NGT administration is at the rate of 25 mL/kg/hour. The first bowel movements should occur approximately one hour after the start of GaviLyte-N administration. Continue drinking until the watery stool is clear and free of solid matter.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with GaviLyte-N. It is also not known whether GaviLyte-N can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-N should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GaviLyte-N is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of GaviLyte-N in pediatric patients aged 6 months and older is supported by evidence from adequate and well-controlled clinical trials of GaviLyte-N in adults with additional safety and efficacy data from published studies of similar formulations. Use of GaviLyte-N 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 one child and hypokalemia has been reported in 3 children. 8.5 Geriatric Use Clinical studies of GaviLyte-N did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GaviLyte-N is administered to a nursing woman.

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. Consider additional patient evaluations as appropriate [see Warnings and Precautions (5.1, 5.2, 5.3, and 5.4)] in patients taking these concomitant medications. 7.2 Potential for Altered Drug Absorption Oral medication administered within one hour of the start of administration of GaviLyte-N may be flushed from the gastrointestinal tract and the medication may not be absorbed properly. 7.3 Stimulant Laxatives Concurrent use of stimulant laxatives and GaviLyte-N may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GaviLyte-N.

More information

Category Value
Authorisation number ANDA090019
Agency product number 8MDF5V39QO
Orphan designation No
Product NDC 43386-050
Date Last Revised 01-11-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 979099
Marketing authorisation holder Lupin Pharmaceuticals,Inc.