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

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

GaviLyte-G is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

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-G 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. [see Drug Interactions (7.1)]

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.

Gavilyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug 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 as a white to off-white powder.

Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na₂SO₄. The average Molecular Weight is 142.04. The structural formula is:

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. Observe these patients during administration of  GaviLyte-G,  especially if it is administered via nasogastric tube.

Do not combine GaviLyte-G with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of GaviLyte-G, 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 chocking and potential aspiration were reported.

Safety and effectiveness of GaviLyte-G in pediatric patients have not been established.

Clinical studies of GaviLyte-G 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.

Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting Gavilyte-G. Begin the recommended dosage regiment for Gavilyte-G early in the evening on the day before colonoscopy.

Instruct patients to take Gavilyte-G in conjunction with clear liquids as follows:

This preparation can be used with or without the lemon flavor pack.

The pharmacist will add the lemon flavor pack prior to dispensing

(see packet instructions)

4 Liter Jug

• Fill the supplied container containing the Gavilyte-G powder with lukewarm drinking water to the 4-liter fill line
• Do not add any other ingredients, flavors, etc.
• After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
• Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.
• After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.

Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted Gavilyte-G solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

• Gastrointestinal (GI) obstruction  (4, 5.6)
• Bowel perforation (4, 5.6)
• Toxic colitis or toxic megacolon (4)
• Gastric retention (4)
• Ileus (4)
• Hypersensitivity to components of Gavilyte-G  (4, 5.8)

Most common adverse reactions are: nausea, abdominal fullness and bloating, abdominal cramps, vomiting and anal irritation (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)

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-G is administered to a nursing woman.

Use caution when prescribing GaviLyte-G 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) [see Drug Intersections (7.1)]. 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. [see Use is Specific Populations (8.6)].

Use Gavilyte-G with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions (7.1)]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of Gavilyte-G and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)].

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

The pharmacokinetics of PEG 3350 following administration of GaviLyte-G were not assessed. Available pharmacokinetic information for oral PEG 3350 suggests that it is poorly absorbed.

GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (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-G 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). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

Concurrent use of stimulant laxatives and GaviLyte-G may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Gavilyte-G [see Warnings and Precautions (5.5)].

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: Encourage adequate hydration, assess    concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1)
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. (5.2)
• Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. (5.3, 7.1)
• Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. (5.4, 7.1, 8.6)
• Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5, 7.3)
• Patients at risk for aspiration: Observe during administration. (5.7)
• Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8)

Preparation and Administration (2.1):

• Correct fluid and electrolyte abnormalities before treatment with Gavilyte-G.
• Reconstitute Gavilyte-G with water prior to ingestion.
• Do not take oral medications within 1 hour before the start or during administration of Gavilyte-G. (2.1)
• Do not take other laxatives while taking Gavilyte-G.
• Consume only clear liquids; avoid red and purple liquids.
• Consume water or other clear liquids up until 2 hours before the time of the colonoscopy.
• Do not consume solid food within 2 hours before starting Gavilyte-G.

Adult Dosing Regimen (2.2):

• On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting Gavilyte-G.
• Begin the recommended dosage regimen for  Gavilyte-G early in the evening on the day before colonoscopy
• Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
• For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2)

For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride and 2 g favoring agent supplied in one 4 liter disposable jug. (3)

Gavilyte-G contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions (6 )]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).

Instruct patients:

• To reconstitute Gavilyte-G with water prior to ingestion.
• Not to take other laxatives while they are taking Gavilyte-G.
• Not to take oral medications within 1 hour before the start or during the administration of Gavilyte-G.
• To take only clear liquids but avoid red and purple liquids.
• To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
• To follow the directions in the Instructions for Use on how to prepare and administer the product.
• If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
• To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)].
• To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.8)].

LUPIN and the

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples FL, 34108

SAP code: 278923

Rev: 11/2024

Gavilyte-G (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-liter disposable jug 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 as a white to off white powder.

•   When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.

Gavilyte-G 4 Liter Disposable Jug                                                                                 NDC 43386-090-19

Storage

Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of Gavilyte-G at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

GaviLyte-G

Container Label

Lemon Flavor Pack

Gavilyte-G can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of Gavilyte-G [see Dosage and Administration (2.1)].

Advise patients to hydrate adequately before, during, and after the use of GaviLyte-G. 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-G, 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.Correct Fluid and electrolyte abnormalities before treatment with GaviLyte-G.

In addition, use caution when prescribing GaviLyte-G 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-G may increase this risk[see Drug Interactions (7.3)]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

• Correct fluid and electrolyte abnormalities before treatment with Gavilyte-G [see Warnings and Precautions (5.1)].
• Reconstitute Gavilyte-G with water prior to ingestion, do not take undissolved Gavilyte-G [see Dosage and Administration (2.2)]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
• Do not take oral medications within 1 hour before the start of or during administration of Gavilyte-G [see Drug Interactions (7.2)].
• Do not take other laxatives while taking Gavilyte-G [see Drug Interactions (7.3)]. Consume only clear liquids, avoid red and purple liquids.
• Patients may consume water or other 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.
• Do not consume solid food within 2 hours before starting Gavilyte-G. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution.
• If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue Gavilyte-G until the symptoms abate.

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GaviLyte-G. [see Contraindications (4)].

Use with caution in patients with severe active ulcerative colitis.

Use caution when prescribing GaviLyte-G for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. Consider additional patient evaluations as appropriate.

GaviLyte-G is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.

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-G 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. [see Drug Interactions (7.1)]

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.

Gavilyte-G is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4 liter disposable jug 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 as a white to off-white powder.

Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na₂SO₄. The average Molecular Weight is 142.04. The structural formula is:

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. Observe these patients during administration of  GaviLyte-G,  especially if it is administered via nasogastric tube.

Do not combine GaviLyte-G with starch-based thickeners [see Dosage and Administration (2.1)]. Polyethylene glycol (PEG), a component of GaviLyte-G, 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 chocking and potential aspiration were reported.

Safety and effectiveness of GaviLyte-G in pediatric patients have not been established.

Clinical studies of GaviLyte-G 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.

Instruct adult patients that on the day before the colonoscopy procedure, they may consume a light breakfast at least 2 hours before starting Gavilyte-G. Begin the recommended dosage regiment for Gavilyte-G early in the evening on the day before colonoscopy.

Instruct patients to take Gavilyte-G in conjunction with clear liquids as follows:

This preparation can be used with or without the lemon flavor pack.

The pharmacist will add the lemon flavor pack prior to dispensing

(see packet instructions)

4 Liter Jug

• Fill the supplied container containing the Gavilyte-G powder with lukewarm drinking water to the 4-liter fill line
• Do not add any other ingredients, flavors, etc.
• After capping the container, shake vigorously several times to ensure that the ingredients are dissolved.
• Drink at a rate of 8 ounces every 10 minutes until the entire contents are consumed or the rectal effluent is clear. A loose watery bowel movement should result in approximately one hour.
• After reconstitution, keep solution refrigerated 2° to 8°C (36° to 46°F). Do not freeze. Use within 48 hours, discard unused portion.

Administration via a Nasogastric Tube For patients with a nasogastric tube, administer the reconstituted Gavilyte-G solution at a rate of 20 to 30 mL per minute (1.2 to 1.8 liters per hour).

• Gastrointestinal (GI) obstruction  (4, 5.6)
• Bowel perforation (4, 5.6)
• Toxic colitis or toxic megacolon (4)
• Gastric retention (4)
• Ileus (4)
• Hypersensitivity to components of Gavilyte-G  (4, 5.8)

Most common adverse reactions are: nausea, abdominal fullness and bloating, abdominal cramps, vomiting and anal irritation (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)

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-G is administered to a nursing woman.

Use caution when prescribing GaviLyte-G 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) [see Drug Intersections (7.1)]. 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. [see Use is Specific Populations (8.6)].

Use Gavilyte-G with caution in patients with renal impairment or patients taking concomitant medications that may affect renal function [see Drug Interactions (7.1)]. These patients may be at risk for renal injury. Advise these patients of the importance of adequate hydration before, during and after use of Gavilyte-G and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients [see Warnings and Precautions (5.4)].

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

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

The pharmacokinetics of PEG 3350 following administration of GaviLyte-G were not assessed. Available pharmacokinetic information for oral PEG 3350 suggests that it is poorly absorbed.

GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults. (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-G 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). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

Concurrent use of stimulant laxatives and GaviLyte-G may increase the risk of mucosal ulceration or ischemic colitis. Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking Gavilyte-G [see Warnings and Precautions (5.5)].

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: Encourage adequate hydration, assess    concurrent medications, and consider laboratory assessments prior to and after use. (5.1, 5.2, 7.1)
• Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. (5.2)
• Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizure, including medications that lower the seizure threshold. (5.3, 7.1)
• Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider testing. (5.4, 7.1, 8.6)
• Mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. (5.5, 7.3)
• Patients at risk for aspiration: Observe during administration. (5.7)
• Hypersensitivity reactions including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. (5.8)

Preparation and Administration (2.1):

• Correct fluid and electrolyte abnormalities before treatment with Gavilyte-G.
• Reconstitute Gavilyte-G with water prior to ingestion.
• Do not take oral medications within 1 hour before the start or during administration of Gavilyte-G. (2.1)
• Do not take other laxatives while taking Gavilyte-G.
• Consume only clear liquids; avoid red and purple liquids.
• Consume water or other clear liquids up until 2 hours before the time of the colonoscopy.
• Do not consume solid food within 2 hours before starting Gavilyte-G.

Adult Dosing Regimen (2.2):

• On day prior to colonoscopy, instruct patients to consume a light breakfast at least 2 hours before starting Gavilyte-G.
• Begin the recommended dosage regimen for  Gavilyte-G early in the evening on the day before colonoscopy
• Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.
• For complete information on dosing, preparation and administration, see the full prescribing information. (2.1, 2.2)

For Oral Solution: 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, 2.97 g potassium chloride and 2 g favoring agent supplied in one 4 liter disposable jug. (3)

Gavilyte-G contains PEG and may cause serious hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and pruritus [see Adverse Reactions (6 )]. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should signs and symptoms occur.

Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).

Instruct patients:

• To reconstitute Gavilyte-G with water prior to ingestion.
• Not to take other laxatives while they are taking Gavilyte-G.
• Not to take oral medications within 1 hour before the start or during the administration of Gavilyte-G.
• To take only clear liquids but avoid red and purple liquids.
• To consume water or other clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy.
• To follow the directions in the Instructions for Use on how to prepare and administer the product.
• If they experience severe bloating, distention or abdominal pain, to slow or temporarily discontinue drinking the solution and to contact their healthcare provider.
• To contact their healthcare provider if they develop signs and symptoms of dehydration or if they experience altered consciousness or seizures. [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)].
• To discontinue administration of the solution and contact their healthcare provider if they develop symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.8)].

LUPIN and the

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Manufactured for:

Lupin Pharmaceuticals, Inc.

Naples FL, 34108

SAP code: 278923

Rev: 11/2024

Gavilyte-G (polyethylene glycol 3350 and electrolytes for oral solution) is supplied in a 4-liter disposable jug 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 as a white to off white powder.

•   When reconstituted with water to a volume of 4 liters, the solution contains 59 g/L PEG3350, 5.69 g/L sodium sulfate, 1.69 g/L sodium bicarbonate, 1.47 g/L sodium chloride and 0.743 g/L potassium chloride.

Gavilyte-G 4 Liter Disposable Jug                                                                                 NDC 43386-090-19

Storage

Store in sealed container at 15° to 30°C (59° to 86°F). Store reconstituted solution of Gavilyte-G at 2° to 8°C (36° to 46°F). Do not freeze [see Dosage and Administration (2.1)].

GaviLyte-G

Container Label

Lemon Flavor Pack

Gavilyte-G can reduce the absorption of other administered drugs. Administer oral medications within one hour before the start of administration of Gavilyte-G [see Dosage and Administration (2.1)].

Advise patients to hydrate adequately before, during, and after the use of GaviLyte-G. 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-G, 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.Correct Fluid and electrolyte abnormalities before treatment with GaviLyte-G.

In addition, use caution when prescribing GaviLyte-G 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-G may increase this risk[see Drug Interactions (7.3)]. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD).

• Correct fluid and electrolyte abnormalities before treatment with Gavilyte-G [see Warnings and Precautions (5.1)].
• Reconstitute Gavilyte-G with water prior to ingestion, do not take undissolved Gavilyte-G [see Dosage and Administration (2.2)]. Do not reconstitute with other liquids and/or add starch-based thickeners to the mixing container [see Warnings and Precautions (5.7)].
• Do not take oral medications within 1 hour before the start of or during administration of Gavilyte-G [see Drug Interactions (7.2)].
• Do not take other laxatives while taking Gavilyte-G [see Drug Interactions (7.3)]. Consume only clear liquids, avoid red and purple liquids.
• Patients may consume water or other 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.
• Do not consume solid food within 2 hours before starting Gavilyte-G. For the best results, do not consume solid food for 3 to 4 hours before drinking the solution.
• If severe bloating, distention or abdominal pain occurs, slow or temporarily discontinue Gavilyte-G until the symptoms abate.

If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering GaviLyte-G. [see Contraindications (4)].

Use with caution in patients with severe active ulcerative colitis.

Use caution when prescribing GaviLyte-G for patients with conditions and/or who are using medications that increase the risk for fluid and electrolyte disturbances or may increase the risk of renal impairment, seizure, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)]. Consider additional patient evaluations as appropriate.