colyte® with flavor packs is a colon lavage preparation provided as watersoluble components for solution.  In solution this preparation with one flavor pack added delivers the following, in grams per liter.

Polyethylene glycol 3350	60
Sodium chloride	1.46
Potassium chloride	0.745
Sodium bicarbonate	1.68
Sodium sulfate	5.68
Flavor ingredients	0.805

When dissolved in sufficient water to make 4 liters, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350.  The reconstituted solution is isosmotic and has a mildly salty taste.  This preparation can be used without the flavor packs and is administered orally or via nasogastric tube.

Each orange flavor pack (3.22 g) contains hypromellose, natural and artificial orange powder, saccharin sodium, colloidal silicon dioxide.  Each citrus berry flavor pack (3.22 g) contains hypromellose, artificial citrus berry powder, saccharin sodium, colloidal silicon dioxide.  Each lemon lime flavor pack (3.22 g) contains, hypromellose, natural and artificial lemon lime powder, Prosweet® Powder Natural, saccharin sodium, colloidal silicon dioxide.  Each cherry flavor pack (3.22 g) contains hypromellose, artificial cherry powder, saccharin sodium, colloidal silicon dioxide.  Each pineapple flavor pack (3.22 g) contains hypromellose, artificial pineapple flavor powder, Magna Sweet™, saccharin sodium, colloidal silicon dioxide.

Last updated on RxList: 5/4/2009

colyte® with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.

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 PATIENT INFORMATION).  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.

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.

colyte® with flavor packs  4 liter  NDC 0091-7036-23

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.

Also available as:

colyte® 4 liter  NDC 0091-4401-23

Instructions for Pharmacist:

Dispense bottle and all attached flavor packs to the patient.

Schwarz Pharma, Inc., Milwaukee, WI 53201, USA.

Last updated on RxList: 5/4/2009

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

Oral medication administered within one hour of the start of administration of colyte® with flavor packs may be flushed from the gastrointestinal tract and not absorbed.

Last updated on RxList: 5/4/2009

Flavor packs are for use only in combination with the contents of the accompanying 4 liter container.  No other additional ingredients (e.g., flavorings) should be added to the solution.  colyte® with flavor packs should be used with caution in patients with severe ulcerative colitis.

General

Patients with impaired gag reflex, unconscious or semiconscious patients and patients prone to regurgitation or aspiration should be observed during the administration of colyte® with flavor packs, especially if it is administered via nasogastric tube.

If gastrointestinal obstruction or perforation is suspected appropriate studies should be performed to rule out these conditions before administration of colyte® with flavor packs.

Patient Information

colyte® with flavor packs produces a watery stool which cleanses the bowel prior to examination.

For best results, no solid food should be ingested during the 3 – 4 hour period prior to the initiation of colyte® with flavor packs administration.  In no case should solid foods be eaten within 2 hours of drinking colyte® with flavor packs.

The rate of administration is 240 mL (8 fl. oz.) every 10 minutes.  Rapid drinking of each portion is preferred rather than drinking small amounts continuously.

The first bowel movement should occur approximately one hour after the start of colyte® with flavor packs administration.

Administration of colyte® with flavor packs should be continued until the watery stool is clear and free of solid matter.  This normally requires the consumption of approximately 3 – 4 liters (3 – 4 quarts), although more or less may be required in some patients.  The unused portion should be discarded.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Studies to evaluate carcinogenic 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® with flavor packs, and it is not known whether colyte® with flavor packs can affect reproductive capacity or harm the fetus when administered to a pregnant patient.  colyte® with flavor packs should be given to a pregnant patient only if clearly needed.

Pediatric Use

Safety and effectiveness 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.

Last updated on RxList: 5/4/2009

No information provided.

colyte® with flavor packs is contraindicated in patients known to be hypersensitive to any of the components.  Colyte® with flavor packs is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Last updated on RxList: 5/4/2009

colyte® with flavor packs cleanses the bowel by induction of diarrhea.  The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water.  Accordingly, large volumes may be administered without significant changes in fluid and electrolyte balance.

Last updated on RxList: 5/4/2009

Instructions for Patient:

1. colyte® with flavor packs can be used with or without the addition of one flavor pack.
   1. If you prefer an unflavored solution, discard the flavor packs and proceed to step 5.
   2. If you prefer a flavored solution, proceed to step 2.
2. Choose one of the flavor packs.
3. Tear open the selected flavor pack at the indicated marking and pour the contents into the bottle BEFORE adding any water.  Discard the unused flavor packs.
4. SHAKE WELL to incorporate flavoring into the powder.
5. Add tap water to the top of the FILL line marked 4 liters.  Recap tightly and mix or shake well until the powder has completely dissolved. No additional ingredients should be added to the solution.
6. Refrigerate the solution until ready to drink.  Chilling improves the taste.  Store no longer than 48 hours.
7. For best results, solid food should not be eaten during the 3 to 4 hour period before you start drinking the solution.  Never eat solid food within 2 hours of drinking the solution.
8. Drink a glassful (8 oz.) of the solution every 10 minutes.  It is best to drink the solution rapidly, rather than sipping slowly.  Continue drinking a glassful every 10 minutes until your watery stool is clear and free of solid matter.  This normally requires drinking 3 to 4 liters (3 to 4 quarts).  The bottle should be empty (4 liters consumed) or the remaining solution should be at or below the 1 liter mark (at least 3 liters consumed).

KEEP RECONSTITUTED SOLUTION REFRIGERATED.

USE WITHIN 48 HOURS.  DISCARD UNUSED PORTION.

Last updated on RxList: 5/4/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PEG/ELECTROLYTE - ORAL

(PEG/ih-LECK-troh-lite)

COMMON BRAND NAME(S): Colyte, Golytely, Nulytely

USES: PEG (polyethylene glycol) with electrolyte is used to clean out the intestines before certain bowel exam procedures such as colonoscopy or barium enema X-rays. It is a laxative that works by drawing large amounts of water into the colon. This effect results in watery bowel movements. Clearing stool from the intestines helps your doctor to better examine the intestines during your procedure.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for constipation that does not respond to other medications.

HOW TO USE: Follow any special diet instructions provided by your doctor. For best results, do not eat solid food for 3 or more hours before starting to take this product. Never eat solid food within 2 hours of drinking the mixed liquid. Usually, you may eat solid food after the procedure.

Before using this product, mix it as directed. Read and follow all directions provided by the manufacturer to mix this product. After mixing, place the container in the refrigerator until ready to drink. Chilling the mixed liquid will improve its taste.

This product is taken by mouth without food or as directed by your doctor. It may also be given through a nose-to-stomach (nasogastric) tube. Dosage is based on your age.

Quickly drink one 8-ounce glass (240 milliliters) of the mixture every 10 minutes until you finish the entire container (4 liters), or take as directed by your doctor. It is best to drink the mixed liquid quickly instead of sipping slowly. Ask your doctor or pharmacist if you have any questions about how to mix or take this product or what to expect after taking this product.

Watery bowel movements usually begin about 1 hour after you start to drink the mixed liquid. Since the bowel movements can be very large and watery, you may drink more clear liquids so that you do not lose too much body water (become dehydrated).

Do not take any other medications by mouth within 1 hour of starting to drink the mixed liquid because your body may not absorb the other medications. Ask your doctor or pharmacist if you are not sure when to take your other medications.

SIDE EFFECTS: Very watery bowel movements are expected with this medication. Nausea, bloating, or feelings of fullness in the stomach/abdomen are very common. Stomach/abdominal cramps, vomiting, and anal irritation occur less often. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If severe bloating or abdominal pain occurs, wait longer (15-30 minutes) between each glass of the mixture, or temporarily stop drinking the mixture until the symptoms improve.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: vomit that is bloody or looks like coffee grounds, chest pain, fainting, sudden shortness of breath.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking electrolyte with PEG, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blocked intestines (gastrointestinal obstruction), intestines that are not moving (ileus), hole in the intestines, severe infection in the intestines (e.g., toxic colitis, toxic megacolon).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe ulcers/swelling of the colon (ulcerative colitis), problems with the normal urge to close the throat when the back of the mouth/throat is touched (poor gag reflex), history of vomiting easily/often, history of breathing food/other substances into the lungs.

Special caution should be taken if this medication is given to an unconscious or partly conscious person.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dehydration and loss of salts in the blood (e.g., potassium, sodium).

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially dehydration and loss of salts in the blood (e.g., potassium, sodium). Children younger than 2 years may be more likely to develop low blood sugar from not eating. Seek immediate medical attention if you notice symptoms of low blood sugar in your child, such as shakiness, unusual sleepiness, abnormal/prolonged crying.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: Not applicable.

STORAGE: Store the unmixed powder at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. After mixing the solution, store it in the refrigerator and use within 48 hours. Discard any unused mixture. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.