These Highlights Do Not Include All The Information Needed To Use Gavilyte – N Safely And Effectively. See Full Prescribing Information For Gavilyte – N

Warnings and Precautions, Aspiration: (5.7)                    05/2021

GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

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.

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.

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.

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 11.2 g, potassium chloride 1.4 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.

Polyethylene Glycol 3350, NF

Sodium Bicarbonate, USP

The chemical name is NaHCO₃. The average Molecular Weight is 84.01. The structural formula is:

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na+ Cl-

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

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 [see Dosage and Administration (2.1)]. 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.

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.

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.

•   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)].
•   Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
•   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.

• 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)

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.

• 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)

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.

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.

GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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)

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.

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.

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.

• Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients (5.1, 5.2,5.3, 5.4)
• Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing (5.4)
• Suspected GI obstruction or perforation – rule out the diagnosis before administration (4, 5.6)
• Patients at risk for aspiration – observe during administration (5.7)
• Not for direct ingestion – dilute and take with additional water (5.8)

• 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).

For oral solution:  polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams, and flavoring ingredients 2 grams; supplied in one 4 liter disposable jug(3)

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.

See FDA-Approved Patient Labeling (Medication Guide).  Instruct patients:

• To let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
• Not to take other laxatives while they are taking GaviLyte-N.
• To 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.
• That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
• That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician.
• To contact their healthcare provider if they develop signs and symptoms of dehydration [see Warnings and Precautions (5.1)].
• That oral medication administered within one hour of the start of administration of GaviLyte-N solution may be flushed from the GI tract and the medication may not be absorbed completely.

LUPIN and the

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples FL, 34108

SAP Code: 276329

Rev. 11/2024

In powdered form, for oral administration as a solution following reconstitution. GaviLyte-N is available in a disposable jug in powdered form containing:

GaviLyte-N with Flavor Packs : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Each jug has an attached package containing 3 flavor packs (optional); one each 2.0 g: Cherry, Lemon, and Orange flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing.

Lemon Flavor GaviLyte-N :  polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Storage:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].  When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

Keep out of reach of children.

GaviLyte-N with Flavor Packs NDC 43386-050-19

GaviLyte-N

Container Label

Flavor Packs (Cherry Flavor, Lemon Flavor and Orange Flavor)

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.

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.

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 [see Drug Interactions (7.1)]

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).

Long term studies in animals have not been performed to evaluate carcinogenic potential of GaviLyte-N. Studies to evaluate the possible impairment of fertility or mutagenic potential of GaviLyte-N have not been performed.

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.

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.

GaviLyte-N is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.

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.

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.

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.

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 11.2 g, potassium chloride 1.4 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.

Polyethylene Glycol 3350, NF

Sodium Bicarbonate, USP

The chemical name is NaHCO₃. The average Molecular Weight is 84.01. The structural formula is:

Sodium Chloride, USP

The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is:

Na+ Cl-

Potassium Chloride, USP

The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is:

K-Cl

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 [see Dosage and Administration (2.1)]. 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.

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.

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.

•   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)].
•   Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
•   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.

• 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)

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.

• 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)

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.

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.

Warnings and Precautions, Aspiration: (5.7)                    05/2021

GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours.

The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.

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)

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.

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.

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.

• Risk of fluid and electrolyte abnormalities, arrhythmias, seizures and renal impairment– assess concurrent medications and consider testing in some patients (5.1, 5.2,5.3, 5.4)
• Patients with renal insufficiency– use caution, ensure adequate hydration and consider testing (5.4)
• Suspected GI obstruction or perforation – rule out the diagnosis before administration (4, 5.6)
• Patients at risk for aspiration – observe during administration (5.7)
• Not for direct ingestion – dilute and take with additional water (5.8)

• 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).

For oral solution:  polyethylene glycol 3350 420 grams, sodium bicarbonate 5.72 grams, sodium chloride 11.2 grams, potassium chloride 1.48 grams, and flavoring ingredients 2 grams; supplied in one 4 liter disposable jug(3)

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.

See FDA-Approved Patient Labeling (Medication Guide).  Instruct patients:

• To let you know if they have trouble swallowing or are prone to regurgitation or aspiration.
• Not to take other laxatives while they are taking GaviLyte-N.
• To 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.
• That if they experience severe bloating, distention or abdominal pain, the administration of the solution should be slowed or temporarily discontinued until the symptoms abate. Advise patients to report these events to their health care provider.
• That if they have hives, rashes, or any allergic reaction, they should discontinue the medication and contact their health care provider. Medication should be discontinued until they speak to their physician.
• To contact their healthcare provider if they develop signs and symptoms of dehydration [see Warnings and Precautions (5.1)].
• That oral medication administered within one hour of the start of administration of GaviLyte-N solution may be flushed from the GI tract and the medication may not be absorbed completely.

LUPIN and the

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples FL, 34108

SAP Code: 276329

Rev. 11/2024

In powdered form, for oral administration as a solution following reconstitution. GaviLyte-N is available in a disposable jug in powdered form containing:

GaviLyte-N with Flavor Packs : polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L. Each jug has an attached package containing 3 flavor packs (optional); one each 2.0 g: Cherry, Lemon, and Orange flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing.

Lemon Flavor GaviLyte-N :  polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

Storage:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].  When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.

Keep out of reach of children.

GaviLyte-N with Flavor Packs NDC 43386-050-19

GaviLyte-N

Container Label

Flavor Packs (Cherry Flavor, Lemon Flavor and Orange Flavor)

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.

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.

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 [see Drug Interactions (7.1)]

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).

Long term studies in animals have not been performed to evaluate carcinogenic potential of GaviLyte-N. Studies to evaluate the possible impairment of fertility or mutagenic potential of GaviLyte-N have not been performed.

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.

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.