FDA records indicate that there are no current recalls for this drug.
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Colyte With Flavor Packs Recall
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Side Effects & Adverse Reactions
WARNINGS: Flavor packs are for use only in combination with the contents of the accompanying 4 liter container. No other additional ingredients (e.g., flavorings) should be added to the solution. Colyte with flavor packs should be used with caution in patients with severe ulcerative colitis.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE: Colyte with flavor packs is indicated for bowel cleansing prior to colonoscopy or barium enema X-ray examination.
History
There is currently no drug history available for this drug.
Other Information
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.
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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 mild 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 artificial orange powder, saccharin sodium, colloidal silicon dioxide. Each citrus berry flavor pack (3.22 g) contains hypromellose, artificial citrus berry powder, saccharin sodium, colloidal silicon dioxide. 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. Each pineapple flavor pack (3.22 g) contains hypromellose, artificial pineapple flavor powder, Magna Sweet™, saccharin sodium, colloidal silicon dioxide.
Sources
Colyte With Flavor Packs Manufacturers
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Alaven Pharmaceutical Llc
Colyte With Flavor Packs | Alaven Pharmaceutical Llc
DOSAGE AND ADMINISTRATION: Colyte with flavor packs can be administered orally or by nasogastric tube. Patients should fast at least 3 hours prior to administration. A one hour waiting period after the appearance of clear liquid stool should be allowed prior to examination to complete bowel evacuation. No foods except clear liquids should be permitted prior to examination after Colyte with flavor packs administration.
Oral: The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see PRECAUTIONS, Information for Patients). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 - 4 liters.
Nasogastric Tube: Colyte with flavor packs is administered at a rate of 20 - 30 mL per minute (1.2 - 1.8 L/hour).
Preparation of Colyte with flavor packs Solution:
To add flavor, tear open one flavor pack at the indicated marking and pour contents into the bottle BEFORE reconstitution. Discard unused flavor packs. SHAKE WELL to incorporate flavoring into the powder. Add tap water to FILL line. Replace cap tightly and mix or shake well until all ingredients have dissolved. (No other additional ingredients, e.g. flavorings, should be added to the solution.)
This preparation can be used with or without the flavor packs.Note: If not using flavor packs, omit steps one and two, above.
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