Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P)
Alaven Pharmaceutical LLC
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 3350 227.1 g in 3.785 L
PRESCRIPTION DRUG
New Drug Application
COLYTE- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM BICARBONATE, AND SODIUM SULFATE ANHYDROUS POWDER, FOR SOLUTION ALAVEN PHARMACEUTICAL LLC ---------- COLYTE WITH FLAVOR PACKS (PEG-3350 & ELECTROLYTES FOR ORAL SOLUTION) ONE GALLON FOR GASTROINTESTINAL LAVAGE RX ONLY DESCRIPTION: Colyte with flavor packs is a colon lavage preparation provided as water-soluble components for solution. In solution this preparation with one flavor pack delivers the following, in grams per liter. Polyethylene glycol 3350 60.00 Sodium chloride 1.46 Potassium chloride 0.745 Sodium bicarbonate 1.68 Sodium sulfate 5.68 Flavor ingredients 0.851 When dissolved in sufficient water to make 1 gallon, the final solution contains 125 mEq/L sodium, 10 mEq/L potassium, 20 mEq/L bicarbonate, 80 mEq/L sulfate, 35 mEq/L chloride and 18 mEq/L polyethylene glycol 3350. The reconstituted solution is isosmotic and has a mildly salty taste. This preparation can be used without the flavor packs and is administered orally or via nasogastric tube. Each orange flavor pack (3.22 g) contains hypromellose, natural and artifical orange powder, saccharin sodium, colloidal silicon dioxide. Each lemon lime flavor pack (3.22 g) contains, hypromellose, natural and artifical lemon lime powder, Prosweet Powder Natural, saccharin sodium, colloidal silicon dioxide. Each cherry flavor pack (3.22 g) contains hypromellose, artifical cherry powder, saccharin sodium, colloidal silicon dioxide. CLINICAL PHARMACOLOGY: Colyte with flavor packs cleanses the bowel by induction of diarrhea. The osmotic activity of polyethylene glycol 3350, in combination with the electrolyte concentration, results in virtually no net absorption or excretion of ions or water. INDICATIONS AND USAGE: Colyte with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. CONTRAINDICATIONS: Colyte is contraindicated in the following conditions: Gastrointestinal (GI) obstruction Bowel perforation Gastric retention Ileus Toxic colitis or Soma hati kamili