"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"...
Serious adverse events have not been reported in healthy subjects with dosages up to 5 times the normal clinical dose (maximum dose investigated).
High doses of manganese can have negative inotropic and vasodilatory effects as well as effects on heart rhythm and conduction because of calcium antagonism.
Treatment of an overdose should be symptomatic and directed towards the support of vital functions. There is no antidote to this contrast medium.
Mangafodipir and its metabolites are dialysable whereas manganese is not dialysable because of protein binding (see also Pharmacokinetic properties under CLINICAL PHARMACOLOGY).
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and lactation.
Severely reduced liver function (Child - Pugh class C), especially severe obstructive hepatobiliary disease.
Severely reduced renal function.
Last reviewed on RxList: 3/3/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Teslascan 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.