Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)
Affordable Pharmaceuticals, LLC
polyethylene glycol 3350
polyethylene glycol 3350 420 g in 4 L
ORAL
PRESCRIPTION DRUG
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is contraindicated in the following conditions: - Gastrointestinal (GI) obstruction, ileus, or gastric retention - Bowel perforation - Toxic colitis or toxic megacolon - Known allergy or hypersensitivity to any component of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution [see How Supplied/Storage and Handling ( 16)] Animal reproduction studies have not been conducted with PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. It is also not known whether PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution can cause fetal harm when administered to a pregnant woman or can affect reproductive
In powdered form, for oral administration as a solution following reconstitution. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is available in a disposable jug in powdered form containing: Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution: 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. Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (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. Lemon-Lime Flavor PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution NDC 10572-302-01
New Drug Application Authorized Generic
polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride powder, for solution Affordable Pharmaceuticals, LLC ---------- Medication Guide PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution (PEG-3350, so- DEE-um klor-IDE, so-DEE-um bi-CAR-bon-ate and po-TASS-ee-um klor-IDE for oral solution) Read this Medication Guide before you start taking PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution? PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: • abnormal heartbeats that can cause death • seizures. This can happen even if you have never had a seizure. • kidney problems Your chance of having fluid loss and changes in body salts with PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is higher if you: • have heart problems • have kidney problems • take water pills or non-steroidal anti-inflammatory drugs (NSAIDS) Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution: • vomiting that prevents you from keeping down the solution • dizziness • urinating less often than normal • headache See Section "What are the possible side effects of PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution” for more information about side effects. What is PEG-3350, sodium chloride, s Прочитать полный документ
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE- POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE POWDER, FOR SOLUTION AFFORDABLE PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION. POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE FOR ORAL SOLUTION INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Aspiration: ( 5.7) 05/2021 INDICATIONS AND USAGE PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater ( 1) DOSAGE AND ADMINISTRATION PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution, supplied as a powder, must be reconstituted with water before its use ( 2.1, 5.8) On day prior to colonoscopy, instruct patients to: Eat a light breakfast or have clear liquids (avoid red and purple liquids) ( 2.2). Early in the evening prior to colonoscopy, fill container containing PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution powder with lukewarm water to 4 liter fill line ( 2.2). After capping container, shake vigorously several times ( 2.2). Instruct patients to consume water or clear liquids during and after bowel preparation up until 2 hours before time of colonoscopy ( 2.3). ADULTS: Drink at a rate of 240 mL (8 oz.) every 10 minutes, until 4 liters are consumed or rectal effluent is clear. For nasogastric tube (NGT), rate is 1.2 to 1.8 liters per hour ( 2.3) PEDIATRIC PATIENTS (AGED 6 MONTHS OR GREATER): Прочитать полный документ