COLYTE- peg-3350 and electrolytes powder, for solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) (POLYETHYLENE GLYCOL 3350 - UNII:G2M7P15E5P), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20), SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)

Disponible desde:

Meda Pharmaceuticals

Designación común internacional (DCI):

POLYETHYLENE GLYCOL 3350

Composición:

POLYETHYLENE GLYCOL 3350 240 g in 4 L

Vía de administración:

NASOGASTRIC

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Colyte® with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination. Colyte is contraindicated in the following conditions: Colyte® (co-light) with Flavor Packs (peg-3350 & electrolytes for oral solution) Read this Instructions for Use before you start taking Colyte. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. How should I take Colyte? Colyte can be taken with or without a flavor pack. If you use a flavor pack, complete Steps 1 through 8. If you do not use a flavor pack, throw away the flavor packs and complete Steps 4 through 8. Step 1:  Remove the cap from the Colyte bottle. Step 2:  Tear open 1 flavor pack of your choice and pour contents into the Colyte bottle. Throw away the unused flavor pack. Step 3:  Replace the cap on the Colyte bottle. Shake the Colyte bottle well to mix the contents of the flavor pack into the powder. Step 4:  Remove the cap from the Colyte bottle.

Resumen del producto:

Colyte® with flavor packs is supplied in 4 liter bottles with an attached package containing flavor packs. Each 4 liter bottle contains polyethylene glycol 3350 240 g, sodium chloride 5.84 g, potassium chloride 2.98 g, sodium bicarbonate 6.72 g, sodium sulfate (anhydrous) 22.72 g. This preparation is supplied in powdered form, for oral administration as a solution. Colyte® with flavor packs     4 liter     NDC 0037-6820-04 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). KEEP RECONSTITUTED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION. CL-682004-0X1     Rev. 05/2021 Manufactured for: MEDA Somerset, New Jersey 08873-4120 © 2021 Viatris Inc.

Estado de Autorización:

New Drug Application

Información para el usuario

COLYTE- PEG-3350 AND ELECTROLYTES POWDER, FOR SOLUTION
Meda Pharmaceuticals
----------
MEDICATION GUIDE
Colyte® (co-light) with Flavor Packs
(peg-3350 & electrolytes for oral solution)
Read this Medication Guide before you start taking Colyte. This
information does not take the place of
talking to your healthcare provider about your medical condition or
your treatment.
What is the most important information I should know about Colyte?
Colyte 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 risk of having fluid loss and changes in body salts with Colyte
is higher if you:
•
have heart problems
•
have kidney problems
•
take water pills (diuretics) 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 Colyte:
•
vomiting
•
dizziness
•
urinating less often than normal
•
headache
See “What are the possible side effects of Colyte?” for more
information about side effects.
What is Colyte?
Colyte is a prescription medicine used to clean the colon before a
colonoscopy or barium enema X-ray
examination. Colyte cleans your colon by causing you to have diarrhea.
Cleaning your colon helps your
healthcare provider see the inside of your colon more clearly during
your colonoscopy or barium enema X-
ray examination.
It is not known if Colyte is safe and effective in children.
Who should not take Colyte?
Do not take Colyte if your healthcare provider has told you that you
have:
•
a blockage in your intestine (bowel obstruction)
•
an opening in the wall of your stomach or intestine (bowel
perforation)
•
problems with food and fluid emptying from your stomach (gastric
retention)
•
a very dilated intestine (toxic megacolon)
•
a

Ficha técnica

COLYTE- PEG-3350 AND ELECTROLYTES POWDER, FOR SOLUTION
MEDA PHARMACEUTICALS
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4 LITERS
FOR GASTROINTESTINAL LAVAGE
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 added 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 0.805
When dissolved in sufficient water to make 4 liters, 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 lemon lime flavor pack (3.22 g) contains, hypromellose, natural
and artificial lemon
lime powder, Prosweet
Powder Natural, saccharin sodium, colloidal silicon dioxide.
Each cherry flavor pack (3.22 g) contains hypromellose, artificial
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
•
•
•
WARNINGS
Colyte with flavor packs should be used with caution in patients with
severe ulcerative
colitis.
PRECAUTIONS
GENERAL
Patients with impaired gag reflex, unconscious or semiconscious
patients and patients
prone to regurgitation or aspiration should be observed during the
administrat