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Halflytely (Polyethylene Glycol 3350) - Indications and Dosage

 
 



INDICATIONS AND USAGE

HalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for bowel cleansing prior to colonoscopy.

DOSAGE AND ADMINISTRATION

HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered orally. Ideally, the patient should only consume clear liquids (no solid food, no milk) prior to HalfLytely and Bisacodyl Tablets Bowel Prep Kit administration. No antacids should be given for at least one hour before beginning the regimen.

Oral administration:    Swallow all four bisacodyl delayed release tablets with water (do NOT chew or crush). The first bowel movement should occur in approximately 1-6 hours after taking the bisacodyl delayed release tablets. Wait for a bowel movement (or maximum of 6 hours) then drink the solution at a rate of 1 (8 oz) glass every 10 minutes (approximately 8 glasses). Drink ALL of the solution. Rapid drinking of each portion is preferred to drinking small amounts continuously. A watery bowel movement should occur in approximately 1 hour after drinking the solution.

The recommended regimen is to consume clear liquids only (no solid food, no milk) the day of the preparation, take all four bisacodyl delayed release tablets at noon, following the first bowel movement or a maximum of 6 hours, begin drinking the solution.

Preparation of the solution:    The solution is prepared by filling the container to the 2 liter mark with water, cap the bottle and shake to dissolve ingredients. Dissolution is facilitated by using lukewarm water. The reconstituted solution may be refrigerated and should be used within 48 hours. All reconstituted solutions are clear and colorless.

HOW SUPPLIED

HalfLytely and Bisacodyl Tablets Bowel Prep Kit is available in Lemon-Lime flavor. Each foil lined blister pack contains 4 (5 mg each) bisacodyl delayed release tablets for ingestion prior to drinking of the solution. Each disposable bottle contains powder for oral administration as a solution following reconstitution.

Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains:

One pack bisacodyl delayed release tablets:    Four (5 mg each) bisacodyl delayed release tablets.

One 2 liter bottle of HalfLytely® (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution):    polyethylene glycol 3350 210 g, sodium bicarbonate 2.86 g, sodium chloride 5.60 g, potassium chloride 0.74 g, and 1.0 g lavoring ingredient (if applicable). When made up to 2 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.

All reconstituted solutions are clear and colorless.

STORAGE:    Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). When reconstituted, you may keep solution refrigerated. Use within 48 hours.

Lemon-Lime HalfLytely and Bisacodyl Tablets

Bowel Prep Kit                                          NDC 52268-502-01

Distributed by Braintree Laboratories, Inc.

Braintree, MA 02185                                                  H 5/04

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