Gavilyte N Drug Information
Generic name: POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE
Osmotic Laxative [EPC]
Uses of Gavilyte N
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 GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
Dosage & Administration of Gavilyte N
Dosage Overview GaviLyte-N, supplied as a powder, must be reconstituted with water
before its use; it is not for direct ingestion. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container. 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.
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.
Dosage
The following is the recommended dose of reconstituted GaviLyte-N 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 solution, 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.
Side Effects of Gavilyte N
Most common adverse reactions (≥3%) are: nausea, abdominal fullness and bloating. Abdominal cramps, vomiting and anal irritation occur less frequently 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 . Cardiac Arrhythmias . Seizures . Renal Impairment . Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative Colitis . Patients with Significant Gastrointestinal Disease . Aspiration . Direct Ingestion . 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.
Warnings & Cautions for Gavilyte N
Serious Fluid and Serum Chemistry Abnormalities Advise patients to hydrate adequately before
during, and after the use of GaviLyte-N. Use caution in patients with congestive heart failure when replacing fluids. If a patient develops significant vomiting or signs of dehydration including signs of orthostatic hypotension after taking GaviLyte-N, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN) and treat accordingly. Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment.
Fluid and electrolyte abnormalities should be corrected before treatment with GaviLyte-N. In addition, use caution when prescribing GaviLyte-N for patients who have conditions, or 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 renal impairment
Cardiac Arrhythmias
There have been rare reports of serious arrhythmias associated with the use of ionic osmotic laxative products for bowel preparation. Use caution when prescribing GaviLyte-N for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias.
Seizures
There have been reports of generalized tonic-clonic seizures and/or loss of consciousness associated with use of bowel preparation products in patients with no prior history of seizures. The seizure cases were associated with electrolyte abnormalities (e.g., hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia) and low serum osmolality. The neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.
Use caution when prescribing GaviLyte-N for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia.
Renal Impairment Use caution when prescribing GaviLyte-N for patients with impaired renal
function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). Advise these patients of the importance of adequate hydration, and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients.
Colonic Mucosal Ulcerations and Ischemic Colitis
Administration of osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and GaviLyte-N may increase this risk. The potential for mucosal ulcerations resulting from the bowel preparation should be considered when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).
Use in Patients with Significant Gastrointestinal Disease
If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GaviLyte-N. 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-N. Use with caution in patients with severe active ulcerative colitis.
Aspiration Use with caution in patients with impaired gag reflex, unconscious, or
semiconscious patients, and patients prone to regurgitation or aspiration. Such patients should be observed during administration of GaviLyte-N, especially if it is administered via nasogastric tube. Do not combine GaviLyte- N with starch-based thickeners.
Polyethylene glycol (PEG), a component of GaviLyte - N, when mixed with starch-thickened liquids reduces the viscosity of the starch-thickened liquid. When a PEG-based product used for another indication was mixed in starch-based pre-thickened liquids used in patients with dysphagia, thinning of the liquid occurred and cases of choking and potential aspiration were reported.
Not for Direct Ingestion
The contents of each jug must be diluted with water to a final volume of 4 liters (4 L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.
Drug Interactions with Gavilyte N
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 in patients taking these concomitant medications.
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.
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.
Pregnancy Safety for Gavilyte N
Pregnancy 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.
Pediatric Use of Gavilyte N
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.
Contraindications for Gavilyte N
Gastrointestinal (GI) obstruction, ileus, or gastric retention Bowel perforation Toxic colitis or toxic megacolon Known allergy or hypersensitivity to components of GaviLyte-N 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
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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