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TriLyte

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TriLyte

Indications
Dosage
How Supplied

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

Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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