(PEG-3350, sodium chloride, sodium bicarbonate and potassium
chloride) Oral Solution
Read this Medication Guide before you start taking
NuLYTELY. 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
NuLYTELY 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 NuLYTELY is higher if you:
- have heart problems
- have kidney problems
- take water pills or non-steroidal anti-inflammatory drugs
Tell your healthcare provider right away if you have
any of these symptoms of a loss of too much body fluid (dehydration) while
- vomiting that prevents you from keeping down the solution
- urinating less often than normal
See Section “What are the possible side effects of
NuLYTELY” for more information about side effects.
What is NuLYTELY?
NuLYTELY is a prescription medicine used by adults to
clean the colon before a colonoscopy. NuLYTELY 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.
NuLYTELY is safe and effective for use in pediatric
patients aged 6 months and older.
Who should not take NuLYTELY?
Do not take NuLYTELY if your heathcare provider has told
you that you have:
- a blockage in your bowel (obstruction)
- an opening in the wall of your stomach or intestine
- problems with food and fluid emptying from your stomach
- a very dilated intestine (bowel)
- an allergy to any of the ingredients in NuLYTELY. See the
end of this leaflet for a complete list of ingredients in NuLYTELY.
What should I tell my healthcare provider before
Before you take NuLYTELY, 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 NuLYTELY will harm your
unborn baby. Talk to your doctor if you are pregnant or plan to become
- are breastfeeding or plan to breastfeed. It is not known
if NuLYTELY passes into your breast milk. You and your healthcare provider
should decide if you will take NuLYTELY while breastfeeding.
Tell your healthcare provider about all the medicines
you take, including prescription and non-prescription medicines, vitamins,
and herbal supplements.
NuLYTELY may affect how other medicines work. Medicines
taken by mouth may not be absorbed properly when taken within 1 hour before the
start of NuLYTELY.
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
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
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 NuLYTELY?
You must read, understand, and follow these instructions
to take NuLYTELY the right way.
- Take NuLYTELY exactly as your healthcare provider tells
you to take it.
- Drink 240 mL (8 oz.) every 10 minutes. Rapid drinking of
each portion is better that drinking small amounts.
- The first bowel movement should occur approximately one
hour after you start drinking the solution.
- You may experience some abdominal bloating and distention
before the bowels start to move. If severe discomfort or distention occur, stop
drinking temporarily or drink each portion at longer intervals until the
discomfort goes away.
- Continue drinking until the watery stool is clear and
free of solid matter. This usually requires 3 liters and it is best to drink
all of the solution.
- Do not take undissolved NuLYTELY powder that has not
been mixed with water (diluted), it may increase your risk of nausea, vomiting
and fluid loss (dehydration).
- Each jug of NuLYTELY must be reconstituted with water
(diluted) to 4 liters total volume before drinking.
- Do not take other laxatives while taking NuLYTELY.
- Do not eat solid foods on the day before your
colonoscopy and until after your colonoscopy. Drink only clear liquids:
- the day before your colonoscopy
- while taking NuLYTELY
- after taking NuLYTELY until 2 hours before your
What are the possible side effects of NuLYTELY?
NuLYTELY can cause serious side effects, including:
- See Section “What is the most important information I
should know about NuLYTELY?”
- changes in certain blood tests. Your
healthcare provider may do blood tests after you take NuLYTELY to check your
blood for changes. Tell your healthcare provider if you have any symptoms of
too much fluid loss, including:
- stomach (abdominal) cramping
- urinate less than usual
- trouble drinking clear liquid
- heart problems. NuLYTELY may cause irregular
- ulcers of the bowel or bowel problems (ischemic
colitis). Tell your healthcare provider right away if you have severe
stomach-area (abdomen) pain or rectal bleeding.
The most common side effects of NuLYTELY include:
- stomach (abdominal) fullness
- stomach (abdominal) cramps
- anal irritation
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 NuLYTELY.
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 NuLYTELY?
- Store NuLYTELY at room temperature, between 59°F to 86°F
(15°C to 30°C).
Keep NuLYTELY and all medicines out of the reach of
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. Do not use NuLYTELY for a condition
for which it was not prescribed. Do not give NuLYTELY 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 NuLYTELY. 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, go to www.braintreelabs.com or call
What are the ingredients in NuLYTELY?
Active ingredients: polyethylene glycol
3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium
Inactive ingredients: cherry flavoring,
lemon-lime flavoring, orange flavoring, pineapple flavoring (flavor packs only)