"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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.
The recommended adult oral dose is 240 mL (8 fl. oz.) every 10 minutes (see PRECAUTIONS, PATIENT INFORMATION). Lavage is complete when fecal discharge is clear. Lavage is usually complete after the ingestion of 3 - 4 liters (3 – 4 quarts).
Colyte with flavor packs is administered at a rate of 20 - 30 mL per minute (1.2 - 1.8 L/hour).
Preparation of Colytewith flavor packs Solution:
This preparation can be used with or without the flavor packs.
- 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 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.)
Note: If not using flavor packs, omit steps one and two above.
Colyte with flavor packs is supplied in 1 gallon bottles with an attached package containing flavor packs. Each 1 gallon bottle contains polyethylene glycol 3350 227.10 g, sodium chloride 5.53 g, potassium chloride 2.82 g, sodium bicarbonate 6.36 g, sodium sulfate (anhydrous) 21.50 g. Each preparation is supplied in powdered form, for oral administration as a solution.
Colyte with flavor packs 1 gallon NDC 68220-133-01
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
KEEP RECONSTITUED SOLUTION REFRIGERATED. USE WITHIN 48 HOURS. DISCARD UNUSED PORTION.
Manufactured for: Meda Pharmaceuticals Inc., Somerset, NJ, USA. Manufactured by: Kremers Urban Pharmaceuticals Inc., Seymour, IN 47274, For Medical Inquiries, Call toll-free 1-888-317-0001. NDC 68220-133-01. Rev 08/ 2013
Last reviewed on RxList: 8/29/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional CoLyte Information
CoLyte - User Reviews
CoLyte User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.