Gavilyte G

Warnings and Precautions (

GaviLyte-G is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults (

• GaviLyte-G, supplied as a powder, must be reconstituted with water before its use (
  2.1 Dosage Overview

  GaviLyte-G, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion

  [see Dosage and Administration (2.2), Warnings and Precautions (5.8)].

  The 4 liter reconstituted GaviLyte-G solution contains: 236 grams of polyethylene glycol (PEG) 3350, 22.74 grams sodium sulfate (anhydrous), 6.74 grams of sodium bicarbonate, 5.86 grams of sodium chloride, and 2.97 grams of potassium chloride. GaviLyte-G is supplied with lemon flavor pack.
  ,
  5.8 Not for Direct Ingestion

  The contents of each jug must be diluted with water to a final volume of 4 liters (4L) and ingestion of additional water is important to patient tolerance. Direct ingestion of the undissolved powder may increase the risk of nausea, vomiting, dehydration, and electrolyte disturbances.
  )
• On day prior to colonoscopy, instruct patients to:
  • Eat a light breakfast or have clear liquids (avoid red and purple liquids) (
    2.2 Administration Instructions Prior to Dosage

    On the day prior to the colonoscopy, instruct patients to:

    • Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.
    • Early in the evening prior to colonoscopy
      , fill the supplied container containing the GaviLyte-G powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters.
    • After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.
    ).
  • Early in the evening prior to colonoscopy, fill container containing GaviLyte-G powder with lukewarm water to 4 liter fill line (
    2.2 Administration Instructions Prior to Dosage

    On the day prior to the colonoscopy, instruct patients to:

    • Take only clear liquids, but avoid red and purple liquids. Patients may consume a light breakfast.
    • Early in the evening prior to colonoscopy
      , fill the supplied container containing the GaviLyte-G powder with lukewarm water (to facilitate dissolution) to the 4 liter fill line. The solution is clear and colorless when reconstituted to a final volume of 4 liters.
    • After capping the container, shake vigorously several times to ensure that the ingredients are dissolved. When reconstituted use within 48 hours.
    )
  • After capping container, shake vigorously several times. Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy (
    2.3 Dosage

    The following is the recommended dose of reconstituted GaviLyte-G solution for adults. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

    • Adults:
      Instruct patients to drink a total of 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).

    The first bowel movements should occur approximately one hour after the start of GaviLyte-G administration.  Continue drinking until the watery stool is clear and free of solid matter.
    ).
• Adults:
  Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour (
  2.3 Dosage

  The following is the recommended dose of reconstituted GaviLyte-G solution for adults. Instruct patients they may consume water or clear liquids during the bowel preparation and after completion of the bowel preparation up until 2 hours before the time of the colonoscopy. The solution is more palatable if chilled prior to administration.

  • Adults:
    Instruct patients to drink a total of 4 liters at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or the rectal effluent is clear. Rapid drinking of each portion is preferred to drinking small amounts continuously. For NGT, rate is 20-30 mL per minute (1.2 – 1.8 liters per hour).

  The first bowel movements should occur approximately one hour after the start of GaviLyte-G administration.  Continue drinking until the watery stool is clear and free of solid matter.
  )

For oral solution: polyethylene glycol 3350 236 grams, sodium sulfate (anhydrous) 22.74 grams, sodium bicarbonate 6.74 grams, sodium chloride 5.86 grams, potassium chloride 2.97 grams and flavoring ingredients 2 gram; supplied in one 4 liter disposable jug.  (

Pregnancy Category C.

Animal reproduction studies have not been conducted with GaviLyte-G. It is also not known whether GaviLyte-G can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. GaviLyte-G should be given to a pregnant woman only if clearly needed.