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Halflytely And Bisacodyl Bowel Prep With Flavor Packs Recall
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Uses
HalfLytely and Bisacodyl Tablet Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.
History
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Other Information
HalfLytely and Bisacodyl Tablet Bowel Prep Kit consists of PEG-3350, an osmotic laxative and bisacodyl, a stimulant laxative. Each HalfLytely and Bisacodyl Tablet Bowel Prep Kit [Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablet] consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and one 5 mg bisacodyl, delayed-release tablet.
- Bisacodyl delayed-release tablet: Each pink, round, enteric coated bisacodyl delayed-release tablet (stamped “BRA”) contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.40. Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax. The bisacodyl delayed-release tablet is administered orally prior to drinking the HalfLytely solution [see Dosage and Administration (2)].
- HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.86 grams of sodium bicarbonate, 5.6 grams of sodium chloride, 0.74 grams of potassium chloride and 1 gram of flavoring ingredient (if applicable). Flavor Packs are available in Cherry, Lemon-Lime, Orange and Pineapple. This preparation can be used without the addition of a Flavor Pack. When dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless. The HalfLytely solution is administered orally after taking the one bisacodyl delayed-release tablet [see Dosage and Administration (2)].
Sources
Halflytely And Bisacodyl Bowel Prep With Flavor Packs Manufacturers
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Braintree Laboratories, Inc.
Halflytely And Bisacodyl Bowel Prep With Flavor Packs | Braintree Laboratories, Inc.
The recommended HalfLytely and Bisacodyl Tablet Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy is as follows:
No solid food or milk (clear liquids only) should be consumed on the day of the preparation. Take one 5 mg bisacodyl delayed-release tablet with water. Do NOT chew or crush the tablet. No antacids should be taken within one hour of taking the bisacodyl delayed-release tablet. Prepare the HalfLytely solution according to the instructions on the kit. Add flavor pack of choice (if applicable) to the 2 liter container. No additional ingredients (other than flavor packs provided) should be added to the solution. Prepare the HalfLytely solution by filling the container to the 2 liter mark with water. Cap the container. Shake to dissolve the powder. Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes. Drink all of the solution. If you have abdominal distention or discomfort, stop drinking the HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms improve. Consume only clear liquids after taking the HalfLytely solution until your colonoscopy.
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