"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
Indigo Carmine (indigotindisulfonate) solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. The intravenous method is preferred because a 5 mL injection is sufficient.A lesser dosage in infants, children and underweight patients will prevent skin coloration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
PROTECT FROM LIGHT
Store at controlled room temperature 15°-30°C (59° -86°F).
Indigo Carmine (indigotindisulfonate) Injection
NDC 0517-0375-10...............5 mL ampules..............packaged in boxes of 10
AMERICAN REGENT LABORATORIES, INC. Shirley, NY 11967. Rev.7/98. FDA Rev date: n/a
Last reviewed on RxList: 10/20/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Indigo Carmine Information
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.