Colyte with Flavor Packs

Name: Colyte with Flavor Packs

How should I take Colyte with Flavor Packs (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a powder medicine that must be mixed with water before using it. Follow all directions on your medicine label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.

Do not take polyethylene glycol electrolyte solution if it has been less than 1 hour since you last ate solid food. For best results, take the medicine 2 to 4 hours after you last ate.

Store unmixed medicine at room temperature away from moisture and heat.

Store the mixed medicine in a refrigerator in an upright position.

Drink plenty of clear liquids (such as water, broth, black coffee, tea, clear soda) before, during, and after your treatment. Avoid foods and beverages that contain pulp or are red or purple in color. You may also eat popsicles (not fruit bars or fudge bars) or gelatin without fruit pieces or toppings.

This medicine comes with instructions about when and what to eat or drink on your first day of treatment. Each brand may have different instructions.

Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

The usual dose of the medication is 8 ounces every 10 to 15 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.

Throw away any polyethylene glycol electrolyte solution you have not used within 24 to 48 hours after it was mixed (follow directions for your specific brand of this medicine).

Do not eat or drink anything within 2 hours before your medical test.

Colyte with Flavor Packs (polyethylene glycol electrolyte solution) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time. Call your doctor for instructions if you have:

  • gagging, choking, severe stomach pain or bloating;

  • no bowel movement within 2 hours after use;

  • nausea, vomiting, trouble drinking liquids, headache, little or no urinating; or

  • fever, sudden or severe stomach pain, severe diarrhea, rectal bleeding or bright red bowel movements.

Common side effects may include:

  • mild stomach cramps, gas, or bloating;

  • rectal pain or irritation;

  • hunger, thirst, mild nausea;

  • passing gas; or

  • dizziness, chills.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses For Colyte with Flavor Packs

The polyethylene glycol (PEG) and electrolytes solution is used to cleanse the colon (bowel) before certain medical tests (eg, colonoscopy, barium enema X-ray exam) or colon surgery.

The PEG-electrolyte solution is a laxative. It works by causing you to have diarrhea to clean your colon. Cleaning your colon will help your doctor see the inside of your colon more clearly during colonoscopy or other procedures.

This medicine is available only with your doctor's prescription.

Precautions While Using Colyte with Flavor Packs

It is important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Contact your doctor right away if you have decreased urination, dizziness, headache, or vomiting. These could be symptoms of a loss of too much body fluid (dehydration).

Do not take any medicine by mouth within 1 hour before taking PEG and electrolytes solution. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Colyte with Flavor Packs Side Effects

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:

Rare
  • 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:

More common
  • Abdominal or stomach fullness
  • bloating
  • nausea
Less common
  • 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.

Instructions for Use

Colyte®(co-light) with Flavor Packs
(peg-3350 & electrolytes for oral solution)

Read this Instructions for Use before you start taking Colyte. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

How should I take Colyte?

Colyte can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8.

Step 1: Remove the cap from the Colyte bottle.
Step 2: Tear open 1 flavor pack of your choice and pour contents into the Colyte bottle. Throw away the unused flavor pack.
Step 3: Replace the cap on the Colyte bottle. Shake the Colyte bottle well to mix the contents of the flavor pack into the powder.
Step 4: Remove the cap from the Colyte bottle. Add water to the top of the line on the Colyte bottle marked “FILL TO TOP OF LINE 4 LITERS”.
Step 5: Replace the cap on the Colyte bottle tightly and shake the Colyte bottle well to dissolve the powder. No other ingredients should be added to the Colyte bottle.
Step 6: Refrigerate the Colyte solution until you are ready to drink it. The Colyte solution should be used within 48 hours after mixing.
Step 7: Drink one 8 ounce glass of Colyte solution every 10 minutes. It is best to drink each glass of Colyte solution quickly, instead of sipping it slowly. Continue drinking one 8 ounce glass of Colyte solution every 10 minutes until your stool is clear, watery, and has no solid material in it. This normally requires drinking 3 to 4 liters of Colyte solution to clean your colon. The Colyte bottle should be empty or have less than 1 liter of Colyte solution remaining when your colon cleaning is completed.
Step 8: Safely throw away any Colyte solution that you do not use.

This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.


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

MEDA PHARMACEUTICALS and the MEDA PHARMACEUTICALS logo are trademarks and COLYTE is a registered trademark of Meda AB or a related entity.

CIA79029A    CL-682004-01      Rev. 2/2014


PRINCIPAL DISPLAY PANEL - 4 Liter Bottle Label

NDC 0037-6820-04

Note to Pharmacist:
DISPENSE ENCLOSED MEDICATION GUIDE.
Dispense bottle and all attached flavor packs to patient.

colyte® with flavor packs

(peg-3350 & electrolytes for oral solution)

Rx Only     CIA71674B     CL-682004-01     Rev. 2/2014

 

4 Liters

 

This bottle contains the following ingredients:

Polyethylene glycol 3350 240.00 grams
Sodium chloride 5.84 grams
Potassium chloride 2.98 grams
Sodium bicarbonate 6.72 grams
Sodium sulfate (anhydrous) 22.72 grams

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.


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.


APPROXIMATE NET WEIGHT: 278 GRAMS


MEDA
PHARMACEUTICALS™


4 Liters

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