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Halflytely (Polyethylene Glycol 3350) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Each HalfLytely® and Bisacodyl Tablets Bowel Prep Kit (Polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed release tablets) consists of:

One pack of 4 bisacodyl delayed release tablets:    Each pink, round, enteric coated delayed release tablet (stamped "BRA") contains 5 mg bisacodyl, USP (C22 H19 NO4); MW=361.40. Inactive ingredients: 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, confections sugar, kaolin USP, sucrose NF, opalux pink, beeswax, carnuba wax.

The bisacodyl delayed release tablets are administered orally prior to drinking the solution.

One 2 liter bottle of HalfLytely® (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution):    A white powder for reconstitution containing 210 g polyethylene glycol 3350, 2.86 g sodium bicarbonate, 5.6 g sodium chloride, 0.74 g potassium chloride and 1.0 g flavoring ingredient (if applicable). When dissolved in water to a volume of 2 liters, the solution is isosmotic. The solution is administered orally as a gastrointestinal lavage in combination with four bisacodyl delayed release tablets. All solutions are clear and colorless.

CLINICAL PHARMACOLOGY

HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces a diarrhea which cleanses the bowel. Bisacodyl is a contact stimulant laxative. After being hydrolyzed by intestinal brush border enzymes and colonic bacteria, its active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2 methane (BHPM) acts directly on the colonic mucosa to produce peristalsis throughout the large intestine.

The osmotic activity of polyethylene glycol 3350 and electrolytes result in virtually no net absorption or excretion of ions or water.

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