GaviLyte -H , generic of HalfLytely®*
TM
(PEG-3350, sodium chloride, sodium bicarbonate
and potassium chloride for oral solution and
bisacodyl delayed-release tablet)
Your doctor has prescribed GaviLyte-H for pre-colonoscopy bowel prep. GaviLyte-H is a
value-branded generic 2-liter volume, offering an alternative bowel prep process that is effective
and offers you a choice. This handy guide offers step-by-step instructions and tips to help ensure
that you properly prep your bowels the right way, the first time. While this information acts as a
good reference, please refer to the Full Prescribing Information for complete details.
Package contents:
• 2-liter container
• Flavor packs
• GaviLyte-H powder
• 1 Bisacodyl delayed-release tablet
STEP 1
Take one 5 mg bisacodyl
delayed-release tablet with
water. Do NOT chew or
crush the tablet.
STEP 2
Tear open one Flavor Pack of
choice and pour into GaviLyte-H
bottle. Discard unused packs.
Prepare the solution by filling
the container to the 2L mark
with lukewarm drinking water.
Make sure to fill all the way to
the FILL LINE.
HELPFUL HINTS
Be Prepared
It’s best to be ready before you
begin drinking the solution. Since
you’ll be spending most of the time in the
bathroom, it’s important to remain comfortable.
• Keep a book, magazine, tablet, laptop or
other electronic device nearby. This will help
keep you preoccupied both in and out of
the bathroom.
• Wear clothing that is comfortable and easy to
take off and put back on.
• Moistened wipes will help you avoid the
irritation that comes from using toilet paper
repeatedly. Keep them in your bathroom.
• If abdominal distention or discomfort
occurs, stop drinking the solution
temporarily or drink each portion at
longer intervals until symptoms improve.
DO NOT Eat or Drink
• Anything colored red or purple
• Any solid foods 3 to 4 hours before
drinking the solution
• Any solid foods for 2 hours after taking
the solution
• Any opaque liquids or alcoholic beverages
• No antacids should be taken within one hour
of taking the bisacodyl DR tablet.
Stick it Out
If you don't drink the
entirety of the solution,
there's a chance your colon won't be
properly cleansed.
• As a result, the colonoscopy may take
longer, and there's a chance your
doctor may ask you to go through the
bowel prep process all over again.
• Now, we know this isn't the most
pleasant process, but it's definitely
better than having to do it twice.
Finishing the entire solution is the most
important part to successful bowel
preparation.
DO Eat and Drink
Consume only clear liquids
after taking the solution until
the colonoscopy is completed.
• Water
• Clear broth or bouillon
• Fruit juices without pulp including orange,
apple, white grape or white cranberry
• Plain gelatin dessert that is not red or purple
• Coffee and tea
• Lemonade or limeade
• Ginger ale
STEP 3
Cap the container. Shake
vigorously to dissolve the
powder. If desired, refrigerate
the solution before drinking.
(Refrigerated bowel prep is not
recommended for children.)
SAFETY
INFORMATION
Should not be used in
patients with:
gastrointestinal obstruction, bowel
perforation, toxic colitis or toxic
megacolon, gastric retention, ileus,
or in patients with a known
sensitivity to any ingredients.
Use with caution in patients with: risk
of fluid and electrolyte abnormalities,
arrhythmias, seizures and renal
impairment or suspected GI
obstruction/perforation. Observe
patients at risk for aspiration.
Ischemic colitis has been reported.
Adverse Reaction rates observed in
clinical studies cannot be directly
compared to rates in other studies or
reflect rates observed in practice.
Most common adverse reactions
(>3%) are overall discomfort,
abdominal fullness, abdominal
cramping, nausea, and vomiting.
Post approval of the following
adverse reactions have been
identified:
Allergic Reactions: Cases of
urticaria, rhinorrhea, dermatitis and
anaphylactic reactions were reported.
Please see the Medication Guide
located on the back of this sheet.
Visit gavilyte.com for more information.
Full Prescribing Information is available at gavilyte.com
*HalfLytely® is a registered trademark of Braintree Laboratories, Inc.
STEP 4
Wait for a bowel movement (or
maximum of 6 hours) then
drink the 2L solution at a rate
of 8 ounces every 10 minutes.
Drink all the solution.
Gastrointestinal: There are isolated
reports of serious events following
the administration of PEG-based
products in patients over 60 years
old including upper GI bleeding from
a Mallory-Weiss tear, esophageal
perforation, asystole, and acute
pulmonary edema after vomiting and
aspirating the PEG-based solution.
During administration of 4 liters of
PEG-3350 colon cleanse the
following serious adverse reactions
were seen: two deaths in end-stage
renal failure patients who developed
diarrhea, vomiting and dysnatremia.
Ischemic colitis has been reported,
however, a causal relationship
between these ischemic colitis cases
and the use of GaviLyte-H and
bisacodyl delayed-release tablet,
USP has not been established.
Neurologic: There have been
reports of generalized tonic-colonic
seizures associated with use of large
volume (4 liter) PEG-based colon
preparation products in patients with
no prior history of seizures. Cases of
dizziness and syncope have been
reported. Some drugs increase risks
due to fluid and electrolyte changes,
e.g. diuretics, ACE inhibitors,
angiotensin receptor blockers, or
NSAIDs. Oral medication taken
within 1 hour of dosing might not be
properly absorbed. Do not take the
bisacodyl tablet within 1 hour of
taking antacid.
PED-07-v05b
Medication Guide
GaviLyte -H (GAV-ee-LITE-H) and Bisacodyl (BIS-a-CO-dil)
Delayed-Release Tablet, USP
(PEG-3350, sodium chloride, sodium bicarbonate and potassium
chloride for oral solution and bisacodyl delayed-release tablet,
USP)
Read this Medication Guide before you start taking GaviLyte-H
and bisacodyl delayed-release tablet, USP. 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-H and bisacodyl delayed-release tablet,
USP?
GaviLyte-H and bisacodyl delayed-release tablet, USP 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:
• seizures. This can happen even if you have never had
a seizure.
• kidney problems
• abnormal heartbeats that can cause death
Your chance of having fluid loss and changes in body salts
with GaviLyte-H and bisacodyl delayed-release tablet, USP
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-H and bisacodyl
delayed-release tablet, USP:
• dizziness
• urinating less often than normal
• headache
See “What are the possible side effects of GaviLyte-H and
bisacodyl delayed-release tablet, USP?” for more
information about side effects.
What is GaviLyte-H and bisacodyl delayed-release tablet,
USP?
GaviLyte-H and bisacodyl delayed-release tablet, USP is a
prescription medicine used by adults to clean the colon before a
colonoscopy. GaviLyte-H and bisacodyl delayed-release tablet,
USP 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. It is
not known if GaviLyte-H and bisacodyl delayed-release tablet,
USP is safe and effective in children.
Who should not take GaviLyte-H and bisacodyl
delayed-release tablet, USP?
Do not take GaviLyte-H and bisacodyl delayed-release tablet,
USP 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-H and
bisacodyl delayed-release tablet, USP. See the end of this
leaflet for a complete list of ingredients in GaviLyte-H and
bisacodyl delayed-release tablet, USP.
What should I tell my healthcare provider before taking
GaviLyte-H and bisacodyl delayed-release tablet, USP?
Before you take GaviLyte-H and bisacodyl delayed-release
tablet, USP, 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
• have any other medical conditions
™
• are pregnant. It is not known if GaviLyte-H and bisacodyl
delayed-release tablet, USP 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-H and bisacodyl delayed-release tablet, USP passes
into your breast milk. You and your healthcare provider should
decide if you will take GaviLyte-H and bisacodyl
delayed-release tablet, USP while breastfeeding.
Tell your healthcare provider about all the medicines you
take, including prescription and non-prescription medicines,
vitamins, and herbal supplements.
GaviLyte-H and bisacodyl delayed-release tablet, USP 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-H and bisacodyl delayed-release tablet,
USP.
Especially tell your healthcare provider if you take:
• medicines for blood pressure or heart problems
• medicines for kidney problems
• medicines for depression
• water pills (diuretics)
• non-steroidal anti-inflammatory medicines (NSAID)
pain medicines
• laxatives
• antacids
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-H and bisacodyl
delayed-release tablet, USP?
See the Patient Directions on the outer product carton for
dosing instructions. You must read, understand, and follow
these instructions to take GaviLyte-H and bisacodyl
delayed-release tablet, USP the right way.
• Take GaviLyte-H and bisacodyl delayed-release tablet, USP
exactly as your healthcare provider tells you to take it.
• Do not take other laxatives while taking GaviLyte-H and
bisacodyl delayed-release tablet, USP.
• Do not take antacids within 1 hour of taking the
bisacodyl tablet.
• Do not chew or crush the bisacodyl tablet. Take the tablet
with water.
• Do not eat solid foods while taking GaviLyte-H and bisacodyl
delayed-release tablet, USP. Only clear liquids are allowed
while taking and after taking GaviLyte-H and bisacodyl
delayed-release tablet, USP until your colonoscopy.
• Stop drinking GaviLyte-H solution temporarily or allow for
longer time between each dose if you have stomach
discomfort, pain or bloating until your symptoms improve.
• Stop taking GaviLyte-H and bisacodyl delayed-release tablet,
USP and call your healthcare provider right away if you
develop hives or a rash. These may be signs of an
allergic reaction.
What are the possible side effects of GaviLyte-H and
bisacodyl delayed-release tablet, USP?
GaviLyte-H and bisacodyl delayed-release tablet, USP can cause
serious side effects, including:
• See “What is the most important information I should
know about GaviLyte-H and bisacodyl delayed-release
tablet, USP?”
• changes in certain blood tests. Your healthcare provider
may do blood tests after you take GaviLyte-H and bisacodyl
delayed-release tablet, USP to check your blood for changes.
Tell your healthcare provider if you have any symptoms of too
much fluid loss, including:
• vomiting
• nausea
• bloating
• dizziness
• stomach (abdominal) cramping
• headache
• urinate less than usual
• trouble drinking clear liquid
• heart problems. GaviLyte-H and bisacodyl delayedrelease tablet, USP may cause irregular heartbeats.
• seizures
• decreased blood flow to the intestine (ischemic colitis).
There have been reports of ischemic colitis in people who
have taken GaviLyte-H and bisacodyl delayed-release tablet,
USP at higher doses. Tell your healthcare provider right away if
you have severe stomach (abdominal) pain or rectal bleeding.
These may be symptoms of ischemic colitis.
The most common side effects of GaviLyte-H and bisacodyl
delayed-release tablet, USP include:
• discomfort
• bloating
• stomach (abdominal) cramping
• nausea
• vomiting
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-H and bisacodyl
delayed-release tablet, USP. 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-H and bisacodyl
delayed-release tablet, USP?
• Store GaviLyte-H and bisacodyl delayed-release tablet, USP at
20-25°C (68-77°F); Excursions permitted between 15-30°C
(59-86°F).
• GaviLyte-H solution that has been mixed with water may be
refrigerated. Mixed solution should be taken within 48 hours.
Keep GaviLyte-H and bisacodyl delayed-release tablet, USP
and all medicines out of the reach of children.
General information about the safe and effective use of
GaviLyte-H and bisacodyl delayed-release tablet, USP.
Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use GaviLyte-H and
bisacodyl delayed-release tablet, USP for a condition for which it
was not prescribed. Do not give GaviLyte-H and bisacodyl
delayed-release tablet, USP to other people, even if they are
going to have the same procedure you are. It may harm them.
This Medication Guide summarizes the most important
information about GaviLyte-H and bisacodyl delayed-release
tablet, USP. 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-H and bisacodyl
delayed-release tablet, USP?
Active ingredients bisacodyl tablet: bisacodyl.
Inactive ingredients bisacodyl tablet: lactose (anhydrous) NF,
microcrystalline cellulose NF, croscarmellose sodium NF,
magnesium stearate NF, methacrylic acid copolymer, talc,
titanium dioxide, triethyl citrate, D&C red # 27/phloxine
aluminum lake, colloidal anhydrous silica, sodium bicarbonate,
sodium lauryl sulfate, FD&C blue # 2/indigo carmine aluminum
lake and FD&C yellow # 6/sunset yellow FCF aluminum lake.
Active ingredients GaviLyte-H solution: polyethylene glycol
3350, sodium chloride, sodium bicarbonate, potassium chloride.
Inactive ingredients GaviLyte-H solution: cherry, lemon and
orange flavor packs.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Manufactured for:
GAVIS Pharmaceuticals LLC
Somerset, NJ 08873
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Iss. 12/2014
PI0701700201