Gavilyte-N polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate 3350 420 g/438.4g; 11.2 g/438.4g; 5.72 g/438.4g; 1.48 g/438.4g Powder, For Solution, 438.4 g — NDC 43386-050-19 (Billing 43386-0050-19)
This is a package of 438.4 g of Gavilyte-N polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate 3350 420 g/438.4g; 11.2 g/438.4g; 5.72 g/438.4g; 1.48 g/438.4g Powder, For Solution from Lupin Pharmaceuticals,Inc., marketed since May 2009 and currently FDA-listed; retail pharmacies pay about $0.0046 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 059931
- GCN: 25865
- GPI-14 (Medi-Span): 46992004302120
- HICL (First Databank): 033276
- AHFS class code: 56:12.00.00
- RxCUI (RxNorm): 801054
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Osmotic Laxative class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Polyethylene glycol-electrolyte solution (PEG-ES) is used to empty the colon (large intestine, bowel) before a colonoscopy (examination of the inside of the colon to check for colon cancer and other abnormalities) or barium enema (a test in which the colon is filled with a fluid and then x-rays are taken) so that the doctor will have a clear view of the walls of the colon. PEG-ES is in a class of medications called osmotic laxatives. It works by causing watery diarrhea so that the stool can be emptied from the colon. The medication also contains electrolytes to prevent dehydration and other se...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.005 | — |
| Medicaid paysCMS SDUD · 12 mo | $0.0068 | — |
| Medicare drug plans payPart D · Q2 2026 | $0.0100 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 43386-0050-19 You're viewing this Main listing | 438.4 g in 1 BOTTLE Sample | 2009-05-28 | — | Active |
Therapeutic equivalents
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
2 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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.
⏱️ Dosage 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 ).
2.1Dosage 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) ]. 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.
2.2Administration 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.
2.3Dosage 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.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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 ) For oral solution: One 4 liter jug with powder for reconstitution with water. Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2 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.
⛔ 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) ]
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS 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 )
5.1Serious 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 [see Drug Interactions (7.1) ]
5.2Cardiac 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.
5.3Seizures 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.
5.4Renal 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.
5.5Colonic 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).
5.6Use in Patients with Significant Gastrointestinal Disease If gastrointestinal obstruction or perforation is suspected,… [Excerpted — this section continues on DailyMed.]
🤒 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 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 )] . Seizures [see Warnings and Precautions ( 5.3 )] . Renal Impairment [see Warnings and Precautions ( 5.4 )] .
Colonic Mucosal Ulcerations, Ischemic Colitis and Ulcerative Colitis [see Warnings and Precautions ( 5.5 )] . Patients with Significant Gastrointestinal Disease [see Warnings and Precautions ( 5.6 )] . Aspiration [see Warnings and Precautions ( 5.7 )] .
Direct Ingestion [see Warnings and Precautions ( 5.8 )] . 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.
🔄 Drug 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 )
7.1Drugs 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.
7.2Potential 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.
7.3Stimulant 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.3Nursing 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.
8.4Pediatric 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.
8.5Geriatric 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 ▾
8.1Pregnancy 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 ▾
8.4Pediatric 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.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
12.3Pharmacokinetics The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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
📋 Description ▾
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 11.2 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 NaHCO 3 . 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 PEG structure Sod-Bicarbonate
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 are registered trademarks of Lupin Pharmaceuticals, Inc. Manufactured by: Novel Laboratories, Inc.
Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Naples FL, 34108 SAP Code: 276329 Rev. 11/2024 Image
💬 Medication Guide ▾
MEDICATION GUIDE GaviLyte™- N (GAV-ee-LITE-N) (polyethylene glycol 3350 (420 g), sodium chloride, sodium bicarbonate and potassium chloride oral solution) Read this Medication Guide before you start taking GaviLyte-N. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about GaviLyte-N?
GaviLyte-N and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: abnormal heartbeats that can cause death seizures . This can happen even if you have never had a seizure. kidney problems Your chance of having fluid loss and changes in body salts with GaviLyte-N is higher if you: have heart problems have kidney problems take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking GaviLyte-N: vomiting that prevents you from keeping down the solution dizziness urinating less often than normal headache See Section "What are the possible side effects of GaviLyte-N" for more information about side effects.
What is GaviLyte-N? GaviLyte-N is a prescription medicine used by adults to clean the colon before a colonoscopy. GaviLyte-N cleans your colon by causing you to have diarrhea.
Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. GaviLyte-N is safe and effective for use in pediatric patients aged 6 months and older. Who should not take GaviLyte-N?
Do not take GaviLyte-N if your healthcare provider has told you that you have: a blockage in your bowel (obstruction) an opening in the wall of your stomach or intestine (bowel perforation) problems with food and fluid emptying from your stomach (gastric retention) a very dilated intestine (bowel) an allergy to any of the ingredients in GaviLyte-N. See the end of this leaflet for a complete list of ingredients in GaviLyte-N. What should I tell my healthcare provider before taking GaviLyte-N?
Before you take GaviLyte-N, tell your healthcare provider if you: have heart problems have stomach or bowel problems have ulcerative colitis have problems with swallowing or gastric reflux have a history of seizures are withdrawing from drinking alcohol have a low blood salt (sodium) level have kidney problems any other medical conditions are pregnant. It is not known if GaviLyte-N will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.
It is not known if GaviLyte-N passes into your breast milk. You and your healthcare provider should decide if you will take GaviLyte-N while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
GaviLyte-N may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of GaviLyte-N. Especially tell your healthcare provider if you take: medicines for blood pressure or heart problems medicines for kidney problems medicines for seizures water pills (diuretics) non-steroidal anti-inflammatory medicines (NSAID) pain medicines laxatives starch-based thickeners.
For patients who have trouble swallowing, do not mix GaviLyte-N with starch-based thickeners. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure if you are taking any of the medicines listed above. Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take GaviLyte-N? You must read, understand, and follow these instructions to take GaviLyte-N the right way.
Take GaviLyte-N e… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.3Nursing 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.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics The pharmacokinetics of PEG3350 following administration of GaviLyte-N were not assessed. Available pharmacokinetic information for oral PEG3350 suggests that it is poorly absorbed.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics GaviLyte-N induces as diarrhea which rapidly cleanses the bowel, usually within four hours.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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.
📄 Recent Major Changes ▾
RECENT MAJOR CHANGES Warnings and Precautions, Aspiration: ( 5.7 ) 05/2021
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL GaviLyte-N Container Label Flavor Packs (Cherry Flavor, Lemon Flavor and Orange Flavor) label Flavor Packs