FDA approves new Micotil label

Published on February 01, 2006
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The Food and Drug Administration has approved adding safety information to the label for Micotil, a treatment for respiratory disease in cattle and sheep, to assist in the response to a human exposure.

Elanco Animal Health had added warnings to this brand of tilmicosin injection after the accidental death of a cattleman. The latest label includes information from recent research on the mechanism of toxicity.

"The heart is the target of toxicity in laboratory and domestic animals given Micotil 300 by oral or parenteral routes," according to the label. "The primary cardiac effects are increased heart rate (tachycardia) and decreased contractility (negative inotropy). Cardiovascular toxicity may be due to calcium channel blockade."

The label lists research results from administering Micotil at various doses to mice, rats, dogs, monkeys, swine, cattle, and sheep.

"In dogs, intravenous calcium offset Micotil-induced tachycardia and negative inotropy, restoring arterial pulse pressure," according to the label. "Dobutamine partially offset the negative inotropic effects induced by Micotil in dogs. β-adrenergic antagonists, such as propranolol, exacerbated the negative inotropy of Micotil in dogs."

The complete text of the new label is available by calling (800) 428-4441 or through www.elanco.com, under Products.