"The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Current tests used to diagnose gastroparesis "...
NuLYTELY is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater.
DOSAGE AND ADMINISTRATION
NuLYTELY, supplied as a powder, must be reconstituted with water before its use; it is not for direct ingestion [see WARNINGS AND PRECAUTIONS]. The 4 liter reconstituted NuLYTELY solution contains: 420 grams of polyethylene glycol (PEG) 3350, 5.72 grams of sodium bicarbonate, 11.2 grams of sodium chloride, and 1.4 grams of potassium chloride. NuLYTELY may be used with or without one of the supplied flavor packs.
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.
- If adding a NuLYTELY flavor pack, pour the contents of the 2 gram flavor powder (i.e., cherry, lemon-lime, orange or pineapple) into the container prior to reconstitution. No additional flavorings should be added. Discard unused flavor packs. The NuLYTELY flavor packs are for use only in combination with the contents of the accompanying 4 liter container.
- Early in the evening prior to colonoscopy, fill the supplied container containing the NuLYTELY powder (and if applicable, a flavor 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.
The following is the recommended dose of reconstituted NuLYTELY solution for adults and pediatric patients ≥ 6 months. 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 up to 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 2030 mL per minute (1.2 – 1.8 liters per hour).
- Pediatric Patients ≥ 6 Months: Pediatric patients should drink 25 mL/kg/hour until the stool is watery, clear, and free of solid matter. If pediatric patients are unable to drink the reconstituted NuLYTELY solution, the solution may be given by nasogastric (NGT).
NGT administration is at the rate of 25 mL/kg/hour.
The first bowel movements should occur approximately one hour after the start of NuLYTELY administration. Continue drinking until the watery stool is clear and free of solid matter.
Dosage Forms And Strengths
For oral solution: One 4 liter jug with powder for reconstitution with water.
Each 4 liter jug contains: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 and flavoring ingredients 2g. 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.
Storage And Handling
In powdered form, for oral administration as a solution following reconstitution.
NuLYTELY is available in a disposable jug in powdered form containing:
NuLYTELY with Flavor Packs: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g (optional). 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. Each jug has an attached package containing 4 flavor packs (optional); one each 2.0g: Cherry, Lemon-Lime, Orange and Pineapple flavoring, in powdered form, for the addition of ONE pack by the pharmacist prior to dispensing.
Lemon-Lime Flavor NuLYTELY: polyethylene glycol 3350 420 g, sodium bicarbonate 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g and flavoring ingredients 2.0 g. 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.
Store at 25oC (77oF); excursions permitted to 15-30oC (59-86°F) [see USP Controlled Room Temperature]. When reconstituted, keep solution refrigerated. Use within 48 hours. Discard unused portion.
Keep out of reach of children.
NuLYTELY with Flavor Packs NDC 52268-400-01
Lemon-Lime Flavor NuLYTELY NDC 52268-302-01
Braintree Laboratories, Inc. Braintree, MA 02185, USA. Revised 9/2013
Last reviewed on RxList: 10/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional NuLytely Information
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