FDA records indicate that there are no current recalls for this drug.
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Micotil 300 Recall
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Side Effects & Adverse Reactions
Warnings:
Human Warnings: Not for human use. Injection of this drug in humans has been associated with fatalities. Keep out of reach of children. Do not use in automatically powered syringes. Exercise extreme caution to avoid accidental self-injection. In case of human injection, consult a physician immediately and apply ice or cold pack to injection site while avoiding direct contact with the skin. Emergency medical telephone numbers are 1-800-722-0987 or 1-800-428-4441. Avoid contact with eyes.
Note To the Physician: The cardiovascular system is the target of toxicity and should be monitored closely. Cardiovascular toxicity may be due to calcium channel blockade. In dogs, administration of intravenous calcium offset Micotil-induced tachycardia and negative inotropy (decreased contractility). 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.
Epinephrine potentiated lethality of Micotil in pigs. This antibiotic persists in tissues for several days.
Residue Warnings: Animals intended for human consumption must not be slaughtered within 42 days of the last treatment. Not for use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Not for use in lactating ewes producing milk for human consumption.
For Subcutaneous Use in Cattle and Sheep Only. Do Not Use in Automatically Powered Syringes.
Legal Issues
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FDA Safety Alerts
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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
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History
There is currently no drug history available for this drug.
Other Information
Micotil® is a solution of the antibiotic tilmicosin. Each mL contains 300 mg of tilmicosin, USP as tilmicosin phosphate in 25% propylene glycol, phosphoric acid as needed to adjust pH and water for injection, Q.S. Tilmicosin, USP is produced semi-synthetically and is in the macrolide class of antibiotics.
Sources
Micotil 300 Manufacturers
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Elanco
Micotil 300 | Elanco
Inject Subcutaneously in Cattle and Sheep Only. In cattle, administer a single subcutaneous dose of 10 to 20 mg/kg of body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs). In sheep greater than 15 kg, administer a single subcutaneous dose of 10 mg/kg of body weight (1 mL/30 kg or 1.5 mL per 100 lbs).
Do not inject more than 10 mL per injection site.
If no improvement is noted within 48-hours, the diagnosis should be reevaluated.
For cattle and sheep, injection under the skin in the neck is suggested. If not accessible, inject under the skin behind the shoulders and over the ribs.
Note: Swelling at the subcutaneous site of injection may be observed.
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