Tilmicosin

Indications

Micotil is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida and Histophilus somni and for the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . Micotil is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica .

Dosage and Administration

Follow instructions for activation of the shroud before first usage. Inject Subcutaneously in Cattle and Sheep Only. See Safe Handling Practices, Contraindications, and Warnings prior to use. 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.

Contraindications

Do not use in automatically powered syringes, single-use syringes, or other delivery devices not specified in the labeling. Do not administer intravenously to cattle or sheep. Intravenous injection in cattle or sheep will be fatal. Do not use in lambs less than 15 kg body weight. Do not administer to animals other than cattle or sheep. Injection of tilmicosin has been shown to be fatal in swine and non-human primates. Death following exposure to tilmicosin injection has been reported to FDA/CVM in goats, rabbits, pheasants, pigs, dogs, deer, cats, alpacas and horses.

Warnings

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. Administer only with a tube-fed safety syringe. Do not use in automatically powered syringes, single-use syringes, or other delivery devices. Contact Elanco at 1-800-428-4441, or your distributor, for a tube-fed safety syringe for use with this product. Solo Para Uso Subcutáneo en Ganado Vacuno y Ovino. Administrar únicamente con una jeringa de seguridad con tubo. No administrar con jeringas accionadas automáticamente, jeringas de un solo uso u otros dispositivos de aplicación. Contactar a Elanco al 1-800-428-4441, o al distribuidor, para obtener una jeringa de seguridad con tubo para usar con este producto. Triangle l Triangle 2

Precautions

The effects of tilmicosin on bovine and ovine reproductive performance, pregnancy and lactation have not been determined. Intramuscular injection will cause a local reaction which may result in trim loss of edible tissue at slaughter.

Adverse Reactions

The following adverse reactions have been reported post-approval: In cattle: injection site swelling and inflammation, lameness, collapse, anaphylaxis/anaphylactoid reactions, decreased food and water consumption, and death. In sheep: dyspnea and death. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Description

Micotil (tilmicosin injection) 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.

Storage

Store at or below 86°F (30°C). Protect from direct sunlight. Use within 84 days of first puncture. Store upright between product dispensing. Disconnect and clean dosing equipment for storing as per manufacturer’s instructions. Conservar a 86 °F (30 °C). Proteger de la luz solar directa. Usar dentro de los 84 días de la primera punción. Guardar en posición vertical entre cada suministro del producto. Desconectar y limpiar el dispositivo de dosificación para el almacenamiento según las instrucciones del fabricante.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming tilmicosin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.