Colyte with Flavor Packs

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.

Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.

Polyethylene glycol electrolyte solution may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or 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.

People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

To make sure polyethylene glycol electrolyte solution is safe for you, tell your doctor if you have:

• heart disease;

• trouble swallowing;

• nausea or vomiting;

• a stomach disorder such as gastroesophageal reflux disease (GERD) or slow digestion;

• kidney disease;

• a history of seizures;

• low levels of sodium in your blood;

• a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease;

• if you take any medications; or

• if you have recently used alcohol.

FDA pregnancy category C. It is not known whether polyethylene glycol electrolyte solution will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether polyethylene glycol electrolyte solution passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Moviprep contains phenylalanine. Talk to your doctor before using if you have phenylketonuria (PKU).

Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.

• 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 the U.S.

• Colyte
• Colyte with Flavor Packs
• GaviLyte-C with Flavor Pack
• Golytely

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Laxative, Hyperosmotic

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.

Drugs That May Increase Risks Due to Fluid and Electrolyte Abnormalities

Use caution when prescribing Colyte for patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizures, arrhythmias, and prolonged QT in the setting of fluid and electrolyte abnormalities. Consider additional patient evaluations as appropriate (see Precautions) in patients taking these concomitant medications.

Potential for Altered Drug Absorption

Oral medication administered within one hour of the start of administration of Colyte may be flushed from the gastrointestinal tract and the medication may not be absorbed properly.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies to evaluate carcinogenesis or mutagenic potential or potential to adversely affect male or female fertility have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with Colyte to evaluate the carcinogenic potential. It is not known whether Colyte can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Colyte should be given to a pregnant woman only if clearly needed.

Nursing Mothers: 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 Colyte is administered to a nursing woman.

Pediatric Use: The safety and effectiveness of Colyte in pediatric patients have not been established.

Geriatric Use: Published literature contains isolated reports of serious adverse reactions following the administration of PEG-ELS products in patients over 60 years of age. These adverse events include upper GI bleeding from Mallory-Weiss Tear, esophageal perforation, asystole, sudden dyspnea with pulmonary edema, and “butterfly-like” infiltrate on chest x-ray after vomiting and aspirating PEG.

ADVERSE REACTIONS: Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of Colyte. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and usually subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and rarely anaphylaxis, angioedema, tongue edema, and face edema have been reported which may represent allergic reactions.

To report Suspected Adverse Reactions contact Meda Pharmaceuticals Inc. at toll free 1-866-210-5953 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION: Colyte® with flavor packs can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Colyte® with flavor packs administration.

Oral: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see PRECAUTIONS, Information for Patients). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 - 4 liters.

Nasogastric Tube: Colyte® with flavor packs is administered at a rate of 20 - 30 mL per minute (1.2 - 1.8 L/hour).

Preparation of Colyte® with flavor packs Solution:

This preparation can be used with or without the flavor packs.

1. To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs.
2. SHAKE WELL to incorporate flavoring into the powder.
3. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)

Note: If not using flavor packs, omit steps one and two, above.

HOW SUPPLIED: Colyte® with flavor packs is supplied in 4 liter bottles with an attached package containing flavor packs. Each 4 liter bottle contains polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS.
DISCARD UNUSED PORTION.

Rx Only

CL-682004-01      Rev. 2/2014

Manufactured for:
MEDA PHARMACEUTICALS™
Somerset, New Jersey 08873-4120
©2014 Meda Pharmaceuticals Inc.

Colyte® (co-light) with Flavor Packs

(peg-3350 & electrolytes for oral solution)

Read this Medication Guide before you start taking Colyte. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Colyte?

Colyte can cause serious side effect, 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 risk of having fluid loss and changes in body salts with Colyte is higher if you:
•have heart problems
•have kidney problems
•take water pills (diuretics) 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 Colyte:
•vomiting
•dizziness
•urinating less often than normal
•headache

See “What are the possible side effects of Colyte?” for more information about side effects.

What is Colyte?

Colyte is a prescription medicine used to clean the colon before a colonoscopy or barium enema X-ray examination. Colyte 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 or barium enema X-ray examination.
It is not known if Colyte is safe and effective in children.

Who should not take Colyte?

Do not take Colyte if your healthcare provider has told you that you have:
•a blockage in your intestine (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 Colyte. See the end of this leaflet for a complete list of ingredients in Colyte.

What should I tell my healthcare provider before taking Colyte?

Before you take Colyte, tell your healthcare provider if you:

•have heart problems
•have a history of seizures
•have kidney problems
•have ulcerative colitis
•have stomach or bowel problems
•have problems with swallowing or gastric reflux
•are withdrawing from drinking alcohol
•have a low blood salt (sodium) level
•have any other medical conditions
•are pregnant or plan to become pregnant. It is not known if Colyte will harm your unborn baby.
•are breastfeeding or plan to breastfeed. It is not known if Colyte passes into your breast milk. You and your healthcare provider should decide if you will take Colyte while breastfeeding.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Colyte may affect how other medicines work. Medicines taken by mouth may not be absorbed properly when taken within 1 hour before the start of Colyte.

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 Colyte?

See the Instructions for Use at the end of this Medication Guide for dosing instructions. You must read, understand, and follow these instructions to take Colyte the right way.
• Take Colyte exactly as your healthcare provider tells you to take it.
•The powder in the Colyte container must be mixed with water (diluted) before drinking. Do not take Colyte that has not been mixed with water, it may increase your risk of nausea, vomiting and fluid loss (dehydration).
•Do not eat any solid foods 3 hours before you start taking Colyte, while taking Colyte, and 2 hours after taking Colyte.
•Drink clear liquids before you start taking Colyte, while you take Colyte and after you finish taking Colyte to help prevent fluid loss (dehydration).
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.
Do not eat or drink anything 2 hours before your colonoscopy or barium enema X-ray examination.
•You should have your first bowel movement about 1 hour after you start taking Colyte. Continue to take Colyte according to the Instructions for Use until your stool is clear, watery, and has no solid material in it.
•Do not take other laxatives while taking Colyte.
•Stop drinking Colyte solution temporarily or allow for longer time between each dose if you have stomach discomfort, pain or bloating until your symptoms improve. If symptoms continue, tell your healthcare provider.

What are the possible side effects of Colyte?

Colyte can cause serious side effects, including:

•See “What is the most important information I should know about Colyte?”
• changes in certain blood tests. Your healthcare provider may do blood tests after you take Colyte 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-area (abdomen) cramping
• headache
• urinate less than usual
• trouble drinking clear liquid

• 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 Colyte include:
•nausea
•stomach-area (abdomen) fullness and bloating

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 Colyte. For more information, ask you 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 Colyte?

•Store Colyte at 68°F to 77°F (20°C to 25°C).
•Store Colyte that has been mixed with water in the refrigerator.
•Use Colyte within 48 hours after mixing with water. Safely throw away any Colyte that you do not use.

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

General information about the safe and effective use of Colyte.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Colyte for a condition for which it was not prescribed. Do not give Colyte 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 Colyte. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Colyte that is written for healthcare professionals.

For more information about Colyte, call 1-866-210-5953.

What are the ingredients in Colyte?

Active ingredients: polyethylene glycol (PEG) 3350, sodium chloride, potassium chloride, sodium bicarbonate, sodium sulfate

Inactive ingredients: Flavor pack ingredients:

Lemon lime flavor pack: hypromellose, natural and artificial lemon lime powder, Prosweet® Powder Natural, saccharin sodium, colloidal silicon dioxide.
Cherry flavor pack: hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide.

Attention Pharmacist: Dispense all
attached flavor packs to the patient.

Cherry
flavor pack

FOR USE ONLY IN COMBINATION
WITH THE ACCOMPANYING
CONTAINER.

net wt. 3.22 g