Trilyte

Name: Trilyte

Indications

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is indicated for bowel cleansing prior to colonoscopy.

Clinical pharmacology

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) induces a diarrhea which rapidly cleanses the bowel, usually within four hours. The osmotic activity of polyethylene glycol 3350 and the electrolyte concentration result in virtually no net absorption or excretion of ions or water. Accordingly, large volumes may be administered without significant changes in fluid or electrolyte balance.

Patient information

Instructions for Patient:

  1. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) 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 SHAKE WELL until the powder has completely dissolved. No additional ingredients should be added to the solution.
  6. 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 TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .
  7. Adults: Drink one 8 ounce (240 mL) cup of the solution rapidly every 10 minutes. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Pediatric Patients (aged 6 months or greater): Drink at a rate of 25 mL/kg/hour. A loose watery bowel movement should result in approximately one hour. Continue drinking until the watery stool is clear and free of solid matter.

NOTE: The solution is more palatable if chilled in the refrigerator before drinking. However, chilled solution is not recommended for infants. Keep reconstituted solution refrigerated. Use within 48 hours. Discard unused portion.

Patient Product Information

What is TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs?

TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is a solution (PEG lavage) that cleanses the bowel in preparation for a colonoscopy.

What flavors are available with TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs?

TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs features five flavors-Lemon Lime, Orange, Pineapple, Cherry and Citrus Berry.

How should I take TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs?

TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs should be taken in an eight-ounce glass every 10 minutes and drunk rapidly (not in small sips) according to your physician's instructions.

How long does it take to work?

TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs begins to work in about an hour. The whole process takes approximately four to six hours.

Can children take TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs?

Yes, children six months and older can take the solution according to the physician's instructions.

What are the side effects of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs?

Nausea, abdominal fullness, and bloating occur in up to 50% of patients. Abdominal cramps, vomiting and anal irritation occur less frequently. Side effects are temporary and subside quickly.

As with all polyethylene glycol (PEG) lavages, nausea, abdominal fullness, and bloating are the most common adverse reactions, occurring in up to 50% of patients. Oral medication administered within 1 hour of the start of administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs may be flushed from the gastrointestinal tract and not absorbed.

Ask your healthcare professional whether TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is right for you. For complete prescribing information for TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs, visit www.yourcolonhealth.com or www.trilyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .com.

How do I prepare the solution?

The solution can be used with or without flavor packs. The flavor packs are designed to make the solution taste better. Prepare the solution as follows:

  1. To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE adding water. Discard unused flavor packs.
  2. SHAKE WELL to incorporate flavoring into the powder.
  3. Add LUKEWARM tap water to the top of the FILL line marked 4 liters.
  4. Replace cap tightly and SHAKE WELL until all ingredients have dissolved.
  5. No additional ingredients, for example, flavorings, should be added to the solution.

IMPORTANT NOTES:

If you are NOT using a flavor pack, omit steps 1 and 2 above.

Lukewarm tap water should be used to prepare the solution. After the solution is mixed, it can be chilled in the refrig- erator to make it more pleasant to drink. It is NOT recommended that a chilled solution be given to infants. The solu- tion should be used within 48 hours of mixing. Discard any unused portions.

If you have any questions, talk to your healthcare professional. He or she is always the best source of information and advice.

As with all polyethylene glycol (PEG) lavages, nausea, abdominal fullness, and bloating are the most common adverse reactions, occurring in up to 50% of patients. Oral medication administered within 1 hour of the start of administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs may be flushed from the gastrointestinal tract and not absorbed.

Ask your healthcare professional whether TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs is right for you.

For complete prescribing information for TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) with flavor packs, visit www.yourcolonhealth.com or www.trilyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .com.

What happens if i miss a dose?

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.

What should i avoid while taking polyethylene glycol electrolyte solution?

Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.

Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

Side effects

Nausea, abdominal fullness and bloating are the most common adverse reactions (occurring in up to 50% of patients) to administration of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs. Abdominal cramps, vomiting and anal irritation occur less frequently. These adverse reactions are transient and subside rapidly. Isolated cases of urticaria, rhinorrhea, dermatitis, and (rarely) anaphylactic reaction have been reported which may represent allergic reactions.

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.

Read the entire FDA prescribing information for TriLyte (PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride)

Read More »

How is this medicine (TriLyte) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take TriLyte as your doctor has told you. Follow all instructions you have been given closely. This includes when to take this medicine, foods and drinks to avoid before the exam, and when to stop eating and drinking before the exam. Talk with your doctor if you have any questions.
  • Do not take other drugs within 1 hour of starting TriLyte. Talk with your doctor about how to take your other drugs with this medicine.
  • Mix with water as told before you take TriLyte (polyethylene glycol-electrolyte solution). Do not swallow the dry powder.
  • Some products come with flavors that can be added to the solution. Only add flavors that come with the kit.
  • Chill the solution to make it taste better. However, do not give chilled solution to an infant. Talk with your doctor.
  • Shake well before use.
  • Drink clear liquids before, during, and after taking this medicine. Do not drink any liquids that are purple or red.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Call your doctor if you are not able to finish TriLyte before your exam.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Belly pain.
  • Swelling of belly.
  • Very upset stomach or throwing up.
  • Very bad headache.
  • Throwing up blood or throw up that looks like coffee grounds.
  • Black, tarry, or bloody stools.
  • Bleeding from rectum or rectal pain.
  • This medicine may cause you to be dehydrated or have electrolyte problems. Rarely, this may be very bad or deadly. Tell your doctor right away if you get very dizzy, pass out, feel very tired or weak, or have a fast heartbeat, a heartbeat that does not feel normal, or seizures. Tell your doctor right away if you have headache, mood changes, confusion, muscle pain or weakness, more thirst, not hungry, dry mouth, dry eyes, very bad upset stomach or throwing up, if you are unable to pass urine, or if you have a change in the amount of urine produced.

What are some other side effects of TriLyte?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Anal irritation.
  • Bloating.
  • Feeling full.
  • Upset stomach or throwing up.
  • Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL - lemon lime flavor pack label

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

lemon lime
flavor pack

FOR USE ONLY IN COMBINATION WITH
THE ACCOMPANYING
CONTAINER.

 

net wt. 3.22 g

TriLyte  WITH FLAVOR PACKS
polyethylene glyocol 3350, sodium chloride, sodium bicarbonate and potassium chloride powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51525-6831
Route of Administration ORAL, NASOGASTRIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 420 g  in 4 L
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 11.2 g  in 4 L
SODIUM BICARBONATE (SODIUM CATION) SODIUM BICARBONATE 5.72 g  in 4 L
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 1.48 g  in 4 L
Product Characteristics
Color WHITE Score     
Shape Size
Flavor LEMON, LIME (lemon-lime) , CHERRY, CITRUS (citrus-berry) , ORANGE, PINEAPPLE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:51525-6831-4 4 L in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076491 09/23/2013
Labeler - Wallace Pharmaceuticals Inc. (962531955)
Revised: 08/2013   Wallace Pharmaceuticals Inc.
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