GAVILYTE G TM- polyethylene glycol-3350 and electrolytes powder, for solution
Lupin Pharmaceuticals,Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use GaviLyte™- G safely and effectively. See full prescribing information for GaviLyte™- G.
GaviLyte™- G (PEG-3350 (236 g) and Electrolytes for Oral Solution, USP) Initial U.S. Approval:1984 RECENT MAJOR CHANGESWarnings and Precautions, Aspiration: (5.7) 05/2021 INDICATIONS AND USAGEGaviLyte-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) DOSAGE AND ADMINISTRATIONPreparation and Administration (2.1):
Adult Dosing Regimen (2.2):
DOSAGE FORMS AND STRENGTHSFor 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) CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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. DRUG INTERACTIONSSome drugs increase risks due to fluid and electrolyte changes (7.1) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2022 |
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
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).
For Oral Solution: 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 PEG-3350, 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.
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)]
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.
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)]
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)].
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).
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 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.
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.
The following clinically significant adverse reactions are described elsewhere in the labeling:
The following adverse reactions associated with the use of Gavilyte-G were identified in clinical trials or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or establish a causal relationship to drug exposure.
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 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)].
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)].
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.
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.
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.
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 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
The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:
The chemical name is NaHCO3. The average Molecular Weight is 84.01. The structural formula is:
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
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.
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.
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)].
Advise the patient to read the FDA-Approved Patient Labeling (Medication Guide and Instructions for Use).
Instruct patients:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
Lupin Pharmaceuticals, Inc.
Somerset, NJ 08873
SAP code: 266100
Rev: 03/2022
(PEG-3350 (236 g) and Electrolytes for Oral Solution, USP)
Read this Medication Guide before you start taking GaviLyte-G. 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-G?
GaviLyte-G 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:
Your chance of having fluid loss and changes in body salts with GaviLyte-G is higher if you:
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-G:
See Section "what are the possible side effects of GaviLyte-G?" for more information about side effects.
GaviLyte-G is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GaviLyte-G cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy.
It is not known if GaviLyte-G is safe and effective in children.
Who should not take GaviLyte-G?
Do not take GaviLyte-G if your heathcare provider has told you that you have:
What should I tell my healthcare provider before taking GaviLyte-G?
Before you take GaviLyte-G, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
GaviLyte-G may affect how other medicines work. Do not take medicines by mouth within 1 hour of starting Gavilyte-G or after you start taking
Gavilyte-G.
Especially tell your healthcare provider if you take:
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.
You must read, understand, and follow these instructions to take GaviLyte-G the right way.
What are the possible side effects of GaviLyte-G?
GaviLyte-G can cause serious side effects, including:
The most common side effects of GaviLyte-G include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of GaviLyte-G. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store GaviLyte-G?
Keep GaviLyte-G and all medicines out of the reach of children.
General information about the safe and effective use of GaviLyte-G.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GaviLyte-G for a condition for which it was not prescribed. Do not give GaviLyte-G to other people, even if they are going to have the same procedure you are. It may harm them.
This Medication Guide summarizes important information about GaviLyte-G. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals.
What are the ingredients in GaviLyte-G?
Gavilyte-G comes in a 4-liter jug with Gavilyte-G powder.
Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.
Inactive ingredients: Lemon Flavored GaviLyte-G only (natural lemon flavor, maltodextrin, sodium saccharin)
This Medication Guide has been approved by the U.S. Food and Drug Administration.
For more information call 1-866-403-7592.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
Lupin Pharmaceuticals, Inc.
Somerset, NJ 08873
SAP code: 266100
Rev: 03/2022
GAVILYTE G
TM
polyethylene glycol-3350 and electrolytes powder, for solution |
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Labeler - Lupin Pharmaceuticals,Inc. (089153071) |
Registrant - Novel Laboratories, Inc. (793518643) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Novel Laboratories, Inc. | 793518643 | MANUFACTURE(43386-090) , ANALYSIS(43386-090) , PACK(43386-090) |