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TriLyte® with flavor packs
(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride) for Oral Solution

When reconstituted with water to a volume of 4 liters, this solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

This package contains the following ingredients:

Polyethylene Glycol 3350                            420 g
Sodium Bicarbonate                                   5.72 g
Sodium Chloride                                         11.2 g
Potassium Chloride                                   1.48 g

Store in sealed container at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

DESCRIPTION

TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® is a white powder for reconstitution containing 420 g polyethylene glycol 3350, 5.72 g sodium bicarbonate, 11.2 g sodium chloride, 1.48 g potassium chloride. Flavor packs, each containing 3.22 g of flavoring ingredients, are attached to the 4 liter bottle. See individual flavor packs for complete listing of ingredients. When dissolved in water to a volume of 4 liters, TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is an isosmotic solution, for oral administration, having a pleasant mineral water taste. One flavor pack can be added before reconstitution to flavor the solution. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is administered orally or via nasogastric tube as a gastrointestinal lavage.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is usually administered orally, but may be given via nasogastric tube to patients who are unwilling or unable to drink the solution. Ideally, the patient should fast for approximately three or four hours prior to TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration, but in no case should solid food be given for at least two hours before the solution is given.

Oral Administration: Adults: At a rate of 240 mL (8 oz.) every 10 minutes, until the rectal effluent is clear or 4 liters are consumed. Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear or 4 liters are consumed. Rapid drinking of each portion is preferred to drinking small amounts continuously. Nasogastric Tube Administration: Adults: At a rate of 20-30 mL per minute (1.2-1.8 liters per hour). Pediatric Patients (aged 6 months or greater): At a rate of 25 mL/kg/hour, until the rectal effluent is clear or 4 liters are consumed.

The first bowel movement should occur approximately one hour after the start of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration. Ingestion of 4 liters of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) solution prior to gastrointestinal examination produces satisfactory preparation in over 95% of patients.

Various regimens have been used. One method is to schedule patients for examination in midmorning or later, allowing the patients three hours for drinking and an additional one hour period for complete bowel evacuation. Another method is to administer TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) on the evening before the examination.

Preparation of the Solution: This preparation can be used with or without the flavor packs. The pharmacist should dispense the bottle and the attached flavor packs to the patient.

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 marked 4 liters. Replace cap tightly and SHAKE WELL until all ingredients have dissolved. No additional ingredients, e.g., flavorings, should be added to the solution.

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

Dissolution is facilitated by using lukewarm water. The solution is more palatable if chilled before administration. However, chilled solution is not recommended for infants. The reconstituted solution should be refrigerated and used within 48 hours. Discard any unused portion.

HOW SUPPLIED

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) is supplied in a 4 liter bottle with an attached package containing flavor packs.This preparation is supplied in powdered form (white to off-white powder) for oral administration as a solution following reconstitution. Each 4 liter bottle contains polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g. Each flavor pack contains 3.22 g flavoring ingredients. When made up to 4 liters volume with water, the solution contains PEG-3350 31.3 mmol/L, sodium 65 mmol/L, chloride 53 mmol/L, bicarbonate 17 mmol/L and potassium 5 mmol/L.

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride)                4 liter NDC 0091-0447-23

STORAGE: Store in sealed container at 25°C (77°F); excursions permitted between

15° - 30° C (59° - 86°F). When reconstituted, keep solution refrigerated. Use within 48 hours.

Discard unused portion.

SCHWARZ PHARMA, LLC Milwaukee, WI 53201, USA. TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® is a registered trademark of SRZ Properties, Inc. FDA rev date: 2/5/2004

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.

DRUG INTERACTIONS

Oral medication administered within one hour of the start of administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) may be flushed from the gastrointestinal tract and not absorbed.

WARNINGS

The flavor packs are for use with the accompanying 4 liter bottle. No additional ingredients, e.g., flavorings, should be added to the solution. TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs should be used with caution in patients with severe ulcerative colitis. Use of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

PRECAUTIONS

General: Patients with impaired gag reflex, unconscious, or semiconscious patients, and patients prone to regurgitation or aspiration should be observed during the administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) , especially if it is administered via nasogastric tube. If a patient experiences severe bloating, distention or abdominal pain, administration should be slowed or temporarily discontinued until the symptoms abate. If gastrointestinal obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .

Information for Patients: TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) produces a watery stool which cleanses the bowel prior to examination. Prepare the solution according to the instructions on the bottle. It is more palatable if chilled. For best results, no solid food should be consumed during the 3 to 4 hour period before drinking the solution, but in no case should solid foods be eaten within 2 hours of taking TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) .

Adults drink 240 mL (8 oz.) every 10 minutes. Pediatric patients (aged 6 months or greater) drink 25 mL/kg/hour. Rapid drinking of each portion is better than drinking small amounts continuously. The first bowel movement should occur approximately one hour after the start of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) administration. You may experience some abdominal bloating and distention before the bowels start to move. If severe discomfort or distention occurs, stop drinking temporarily or drink each portion at longer intervals until these symptoms disappear. Continue drinking until the watery stool is clear and free of solid matter. This usually requires at least 3 liters. Any unused portion should be discarded.

Use of TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) in children younger than 2 years of age should be carefully monitored for occurrence of possible hypoglycemia, as this solution has no caloric substrate. Dehydration has been reported in 1 child and hypokalemia has been reported in 3 children.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenic and reproductive studies with animals have not been performed.

Pregnancy: Category C. Animal reproduction studies have not been conducted with TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) . It is also not known whether TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) should be given to a pregnant woman only if clearly needed.

Pediatric Use: Safety and effectiveness of TriLyte (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) ® with flavor packs in pediatric patients aged 6 months and older are supported by evidence from adequate and well-controlled clinical trials of a similar product in adults with additional safety and efficacy data from published studies of similar formulations.

OVERDOSE

No information provided.

CONTRAINDICATIONS

TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is contraindicated in patients known to be hypersensitive to any of the components. TriLyte® with flavor packs (peg-3350, sodium chloride, sodium bicarbonate and potassium chloride) is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

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.