PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID- peg-3350, sodium sulfate, sod

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)

Disponível em:

Teva Pharmaceuticals USA, Inc.

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is contraindicated in the following conditions: -   Gastrointestinal (GI) obstruction [see Warnings and Precautions (5.6)] -   Bowel perforation [see Warnings and Precautions (5.6)] -   Gastric retention -   Ileus -   Toxic colitis or toxic megacolon -   Hypersensitivity to any ingredient in PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution [see Warnings and Precautions (5.10)] Risk Summary There are no available data on PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution in pregnant women to inform a drug-associated risk for adverse developmental

Resumo do produto:

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution is supplied as a white to yellow free flowing powder with odor of lemon for reconstitution. Pouch A contains 100 grams of PEG 3350, NF; 7.5 grams of sodium sulfate, NF; 2.691 grams of sodium chloride, USP/NF; and 1.015 gram of potassium chloride, USP/NF: NDC 0093-9044-19. Pouch B contains 4.7 grams of Ascorbic acid; 5.9 grams of sodium ascorbate, USP/NF: NDC 0093-9043-19. Lemon flavor pack contains natural lemon flavor; maltodextrin and saccharin sodium. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, mixing container: NDC 0093-9045-19 PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, single-use inner carton: The inner carton contains three pouches labeled Pouch A, Pouch B and lemon flavor pack: NDC 0093-3560-19. PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution, single-use outer carton: Each outer carton contains 2 inner cartons, prescribing information and patient information and a mixing container with lid for reconstitution of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution: NDC 0093-3560-26 Storage Store carton/container at room temperature, between 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).When reconstituted, store upright and keep solution refrigerated. Use within 24 hours [see Dosage and Administration (2.1)] .

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM
ASCORBATE AND ASCORBIC ACID - PEG-3350, SODIUM SULFATE, SODIUM
CHLORIDE, POTASSIUM
CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium
Ascorbate, and Ascorbic
Acid for Oral Solution
(pol˝ ee eth´ i leen glye´ kol, soeˊ dee um sul' fate, soeˊ dee
um klor´ ide, poe tasˊee um klor´ ide, soeˊ
dee um a skor´ bate, as koreˊ bik as´ id for oral solution)
Read this Medication Guide and Instructions for Use before your
colonoscopy and again before you start
taking PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,
Sodium Ascorbate, and
Ascorbic Acid for Oral Solution.
What is the most important information I should know about PEG-3350,
Sodium Sulfate, Sodium
Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for
Oral Solution? PEG-3350,
Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate,
and Ascorbic Acid for Oral
Solution and other 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 Sulfate, Sodium
Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for
Oral Solution is higher if you:
•
have heart problems.
•
have kidney problems.
•
take water pills (diuretics), high blood pressure medicine, or
non-steroidal anti-inflammatory
drugs (NSAIDS).
Tell your healthcare provider right away if you have any of these
symptoms of serious loss of body fluid
(dehydration) while taking PEG-3350, Sodium Sulfate, Sodium Chloride,
Potassium Chloride, Sodium
Ascorbate, and Ascorbic Acid for Oral Solution:
•
vomiting
•
dizzin

Características técnicas

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE,
SODIUM ASCORBATE AND ASCORBIC ACID - PEG-3350, SODIUM SULFATE,
SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC
ACID
TEVA PHARMACEUTICALS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEG-3350, SODIUM
SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND
ASCORBIC
ACID FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR PEG-
3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM
ASCORBATE
AND ASCORBIC ACID FOR ORAL SOLUTION.
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM
ASCORBATE AND ASCORBIC ACID FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions, Aspiration: (5.7) 05/2021
INDICATIONS AND USAGE
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium
Ascorbate, and Ascorbic Acid for
Oral Solution is an osmotic laxative indicated for cleansing of the
colon as a preparation for colonoscopy in
adults (1)
DOSAGE AND ADMINISTRATION
Preparation and Administration:
Two doses of PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium
Chloride, Sodium Ascorbate, and
Ascorbic Acid for Oral Solution are required for a complete
preparation for colonoscopy, using a "Two-
Day" preferred method or "One-Day" alternative method dosing regimen.
(2.1)
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium
Ascorbate, and Ascorbic Acid
for Oral Solution must be reconstituted in water prior to ingestion.
(2.1)
Additional clear liquids must be consumed after each dose of PEG-3350,
Sodium Sulfate, Sodium
Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for
Oral Solution in both dosing
regiments. (2.1,5.1)
Do not take other laxatives while taking PEG-3350, Sodium Sulfate,
Sodium Chloride, Potassium
Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution. (2.1,
5.5)
Do not take oral medications within 1 hour of startin