GAVILYTE-N - polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate powder, for solution
Lupin Pharmaceuticals,Inc.
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(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:
Your chance of having fluid loss and changes in body salts with GaviLyte-N 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-N:
See Section "What are the possible side effects of GaviLyte-N" for more information about side effects.
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:
What should I tell my healthcare provider before taking GaviLyte-N?
Before you take GaviLyte-N, tell your healthcare provider if you:
Talk to your doctor if you are pregnant or plan to become pregnant.
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:
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-N the right way.
What are the possible side effects of GaviLyte-N?
GaviLyte-N can cause serious side effects, including:
The most common side effects of GaviLyte-N 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-N. 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-N?
Keep GaviLyte-N and all medicines out of the reach of children.
General information about the safe and effective use of GaviLyte-N.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GaviLyte-N for a condition for which it was not prescribed. Do not give GaviLyte-N 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-N. 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.
For more information, call 1-866-403-7592.
What are the ingredients in GaviLyte-N?
Active ingredients: polyethylene glycol 3350, sodium bicarbonate, sodium chloride, and potassium chloride.
Inactive ingredients: cherry flavoring, lemon flavoring, orange flavoring (flavor packs only)
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, MD 21202
This Medication Guide has been approved by the U.S. Food and Drug Administration.
SAP Code: 270544
Rev. 05/2022