GoLYTELY

Do not use this medication if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. Polyethylene glycol electrolyte solution can cause dangerous or life-threatening side effects in people with these conditions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02.

Date modified: September 05, 2017
Last reviewed: February 12, 2014

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of PEG-electrolyte solution in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of PEG-electrolyte solution in the elderly. However, elderly patients are more likely to have serious side effects (eg, upper GI bleeding, trouble breathing), which may require caution in patients using this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amantadine
• Atropine
• Belladonna
• Belladonna Alkaloids
• Benztropine
• Biperiden
• Clidinium
• Darifenacin
• Dicyclomine
• Eplerenone
• Fesoterodine
• Glycopyrrolate
• Hyoscyamine
• Methscopolamine
• Oxybutynin
• Procyclidine
• Scopolamine
• Solifenacin
• Tolterodine
• Trihexyphenidyl
• Trospium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril
• Amiloride
• Amphetamine
• Benazepril
• Benzphetamine
• Canrenoate
• Captopril
• Cilazapril
• Delapril
• Dextroamphetamine
• Digoxin
• Elvitegravir
• Enalaprilat
• Enalapril Maleate
• Fosinopril
• Gefitinib
• Imidapril
• Indomethacin
• Ketoconazole
• Ledipasvir
• Licorice
• Lisdexamfetamine
• Lisinopril
• Mefenamic Acid
• Memantine
• Methamphetamine
• Moexipril
• Pazopanib
• Pentopril
• Perindopril
• Quinapril
• Ramipril
• Spirapril
• Spironolactone
• Temocapril
• Trandolapril
• Triamterene
• Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dasatinib
• Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (chest pain), unstable or
• Electrolyte imbalance (eg, low calcium, magnesium, potassium, sodium in the blood) or
• Fluid imbalance or
• Heart attack, recent or
• Heart disease (eg, cardiomyopathy) or
• Withdrawal from alcohol or benzodiazepines (eg, alprazolam, clonazepam, diazepam, lorazepam, Xanax®)—May increase risk for seizures, arrhythmia, or kidney problems.

• Congestive heart failure or
• Dehydration or
• Heart rhythm problems (eg, prolonged QT interval, uncontrolled arrhythmia), history of or
• Inflammatory bowel disease or
• Kidney problems or
• Seizures, history of or
• Trouble swallowing or
• Ulcerative colitis, active and severe—Use with caution. May make these conditions worse.

• Gastric retention (problems with emptying of food or fluid from the stomach) or
• Intestinal problems (eg, blockage, ileus, perforation) or
• Toxic megacolon (a very dilated intestine)—Should not be used in patients with these conditions.

This section provides information on the proper use of a number of products that contain polyethylene glycol 3350 and electrolytes. It may not be specific to Golytely. Please read with care.

Your doctor may have special instructions for you, depending on the type of test you are going to have. If you have not received such instructions, or if you do not understand them, check with your doctor in advance.

Take this medicine exactly as directed. Otherwise, the test you are going to have may not work and may have to be done again.

This medicine comes with a Medication Guide. You must read, understand, and follow these instructions carefully. Ask your doctor if you have any questions.

It is best if you do not eat any solid food for 3 to 4 hours before you start using this medicine. You must not eat anything for 2 hours before starting to use this medicine. Once you drink your first dose of medicine, do not eat anything until after you are finished with your test.

You may drink clear liquids (eg, water, ginger ale, decaffeinated cola, decaffeinated tea, broth, gelatin) up until 2 hours before the time of the test. However, check first with your doctor. Do not drink red and purple liquids.

To use the medicine:

• The powder must be mixed with water before it is used. Do not swallow the powder directly. Add lukewarm water to the fill mark on the bottle. If you are using flavoring powder that came with the medicine, add it before you add the water. Do not add any extra flavorings to the medicine.
• Shake well until all the ingredients are dissolved.
• After you mix the solution, you must use it within 48 hours.
• You will need to drink 240 milliliters (mL) of the mixed medicine about every 10 minutes. It is best to drink it fast instead of sipping it.
• About 1 hour after you drink the first glass of liquid, you should have your first loose stool or mild diarrhea. This is how the medicine cleans out your bowels. You may have bloating or an upset stomach before the loose stools start.
• Keep drinking 240 mL of the mixed medicine about every 10 minutes until your stools are clear. Most people need to drink all of the liquid (4 liters) to get completely clear stools.
• If you cannot swallow the liquid, it can be given through a tube inserted into your nose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cleansing of the colon:
  • For oral dosage form (powder for oral solution):
    • Adults—240 milliliters (mL) every 10 minutes.
    • Children—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach fullness
• bloating
• nausea

• Abdominal or stomach cramps
• irritation of the anus
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to clean out the GI (gastrointestinal) tract.

For oral solution: Each 4 liter (4L) GOLYTELY jug contains a white powder for reconstitution. GOLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution.

Each 4 liter jug contains: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g. The solution is clear and colorless when reconstituted to a final volume of 4 liters with water.

Polyethylene Glycol 3350, NF

Sodium Sulfate, USP

The chemical name is Na2SO4. The average Molecular Weight is 142.04. The structural formula is:

Sodium Bicarbonate, USP

The chemical name is NaHCO3. 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

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 GOLYTELY.
• 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 GOLYTELY solution may be flushed from the GI tract and the medication may not be absorbed completely

Distributed by Braintree Laboratories, Inc. Braintree, MA 02185

Medication Guide

GOLYTELY® (Go-lite-ly)

(PEG-3350 and Electrolytes for Oral Solution)

Read this Medication Guide before you start taking GOLYTELY. 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 GOLYTELY?

GOLYTELY 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 GOLYTELY 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 GOLYTELY:

• 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 GOLYTELY” for more information about side effects.

What is GOLYTELY?

GOLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GOLYTELY 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 GOLYTELY is safe and effective in children.

Who should not take GOLYTELY?

Do not take GOLYTELY 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 (bowel perforation)
• problems with food and fluid emptying from your stomach (gastric retention)
• a very dilated intestine (toxic megacolon)
• an allergy to any of the ingredients in GOLYTELY. See the end of this leaflet for a complete list of ingredients in GOLYTELY.

What should I tell my healthcare provider before taking GOLYTELY?

Before you take GOLYTELY, 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 GOLYTELY 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 GOLYTELY passes into your breast milk. You and your healthcare provider should decide if you will take GOLYTELY while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. GOLYTELY may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of GOLYTELY.

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

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 GOLYTELY?

You must read, understand, and follow these instructions to take GOLYTELY the right way.

• Take GOLYTELY 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 than 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 GOLYTELY powder that has not been mixed with water (diluted), it may increase your risk of nausea, vomiting and fluid loss (dehydration).
• Each jug of GOLYTELY must be reconstituted with water (diluted) to 4 liters total volume before drinking.
• Do not take other laxatives while taking GOLYTELY.
• 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 GOLYTELY
  • after taking GOLYTELY until 2 hours before your colonoscopy

  Do not eat or drink anything 2 hours before your colonoscopy.

• Drink clear liquids before, during, and after you take GOLYTELY to avoid fluid loss (dehydrated). Examples of clear liquids are:
  • water
  • clear fruit juices without pulp including apple, white grape, or white cranberry
  • strained limeade or lemonade
  • coffee or tea (Do not use any dairy or non-dairy creamer)
  • clear broth
  • clear soda
  • gelatin (without added fruit or topping)
  • popsicles without pieces of fruit or fruit pulp

  Do not eat or drink anything colored red or purple.

What are the possible side effects of GOLYTELY?

GOLYTELY can cause serious side effects, including:

• See Section “What is the most important information I should know about GOLYTELY?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take GOLYTELY 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. GOLYTELY may cause irregular heartbeats.
• seizures
• 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 GOLYTELY include:

• nausea
• stomach (abdominal) fullness
• bloating
• stomach (abdominal) cramps
• vomiting
• 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 GOLYTELY. 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 GOLYTELY?

• Store GOLYTELY at room temperature, between 59°F to 86°F (15°C to 30°C).

  Keep GOLYTELY and all medicines out of the reach of children.

General information about the safe and effective use of GOLYTELY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GOLYTELY for a condition for which it was not prescribed. Do not give GOLYTELY 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 GOLYTELY. 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 1-800-874-6756.

What are the ingredients in GOLYTELY?

Active ingredients: polyethylene glycol 3350, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride.

Inactive ingredients: Pineapple Flavored GOLYTELY only (natural and artificial pineapple flavor powder, maltodextrin, gum arabic, sodium saccharin, silicon dioxide)

Braintree Laboratories, Inc.

Braintree, MA 02185, USA

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised 9/2013

Principal Display Panel

FILL TO THE TOP OF THE LINE ON BOTTLE

NDC 52268-100-01

TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing.

Dispense the enclosed Medication Guide to each patient.

GOLYTELY®

PEG-3350 and Electrolytes for Oral Solution

When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium , 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride and 17.6 mmol/L polyethylene glycol 3350.

Each disposable jug contains, in powdered form: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g.

RX only M 9/13

Braintree

Laboratories, Inc

Braintree, MA 02185

FILL TO THE TOP OF THE LINE ON BOTTLE

NDC 52268-101-01

TO PHARMACIST AND PATIENT:
Mixing information is on base
label. Package insert may be
removed before dispensing. Dispense the enclosed Medication Guide to each patient.

Pineapple Flavor

GOLYTELY®

PEG-3350 and Electrolytes for Oral Solution

When reconstituted with water to a volume of 4 liters, this solution contains 125 mmol/L sodium , 10 mmol/L potassium, 40 mmol/L sulfate, 20 mmol/L bicarbonate, 35 mmol/L chloride and 17.6 mmol/L polyethylene glycol 3350.

Each disposable jug contains, in powdered form: polyethylene glycol 3350 236 g, sodium sulfate (anhydrous) 22.74 g, sodium bicarbonate 6.74 g, sodium chloride 5.86 g, potassium chloride 2.97 g, flavor ingredients 3.0 g.

RX only M 9/13

Braintree

Laboratories, Inc

Braintree, MA 02185

NDC 52268-700-01
Rx only

GOLYTELY®
PEG-3350 AND ELECTROLYTES
FOR ORAL SOLUTION
1 Gallon (3.785 Liters)

Instructions

A GOLYTELY® solution is made up by dissolving the contents of this packet in one gallon of tap
water according to the following procedure:

1. Obtain a food-grade clear container with a volume of at least one gallon.
2. After cutting open the packet, pour the entire contents into the container.
3. Add lukewarm drinking water to bring the volume of the solution to one gallon.
4. Do not add any other ingredients, flavors, etc.
5. Shake and/or mix thoroughly to ensure that the ingredients are dissolved.
6. The solution is more palatable if chilled in the refrigerator before drinking. Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portion.
7. For best results, no solid food should be consumed for the 3 to 4 hour period before drinking the solution; but in no case should solid food be eaten within two hours of taking GOLYTELY.
8. Drink one 8 oz. glassful of the solution rapidly every 10 minutes. A loose watery bowel movement should result in approximately one hour. Continue drinking until the rectal effluent is clear or the entire contents (1 gallon) have been consumed or as directed by your physician.

Usual dosage: 1 gallon (3.785 liters).
This package contains:
Polyethylene glycol 3350…..227.1 grams
Sodium sulfate, anhydrous….21.5 grams
Sodium bicarbonate………….6.36 grams
Sodium chloride………………5.53 grams
Potassium chloride…………..2.82 grams

APPROXIMATE NET WEIGHT: 263 grams
Distributed by Braintree Laboratories, Inc., Braintree, MA 02185