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Tilmicosin Phosphate

Detailed information about Tilmicosin Phosphate

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Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed. For the control of swine resp...

What it does:

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For the control of respiratory disease in cattle at high risk of developing B...

When it's needed:

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not appr...

Call your vet sooner if you notice:

  • Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

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Tilmicosin Phosphate

Tilmicosin Phosphate

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Elanco US Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Elanco US Inc.
Form: Aqueous Concentrate, Liquid, Type A Medicated Article, Type A medicated articles for use in the manufacture of Type B and Type C medicated feeds
Identifiers:
ANADA: 200596 ANADA: 200654 ANADA: 200655 ANADA: 200707 NADA: 140929 NADA: 141064 NADA: 141343 NADA: 141361 NDC Package: 23243-2395-4 NDC Package: 23243-7287-1 NDC Package: 49553-4161-1 NDC Package: 58198-0230-2 NDC Package: 58198-0470-1 NDC Package: 58198-0472-9 NDC Package: 86098-0004-1 NDC Product: 23243 NDC Product: 49553 NDC Product: 58198 NDC Product: 86098
Source metadata:

Warnings / Contraindications

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

  • High: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

No adverse-reaction rows are linked yet.

Source metadata:

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 36 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

Source metadata:

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
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Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Micotil™ 300 Pulmotil® 90 and Rumensin® 90 Pulmotil™ 90 Pulmotil™ AC Pulmotil™ and Monovet® Tilmovet® 90 and Rumensin® 90 Tilmovet® AC Tilmovet® and Monovet®
Catalog species: Both • FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Beef fed In confinement for slaughter, Dairy, Fed in confinement for slaughter, No use class stated or implied, Sheep
Rx/OTC: RX, VFD
Form/route: Aqueous Concentrate, Liquid, Type A Medicated Article, Type A medicated articles for use in the manufacture of Type B and Type C medicated feeds • Oral, Oral, in drinking water, Subcutaneous
Applications: ANADA 200-707 • NADA 140-929 • ANADA 200-655 • ANADA 200-654 • NADA 141-361 • NADA 141-064 • ANADA 200-596 • NADA 141-343
Documents: 28 (FOI: 18) • SPL: 8 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 0 • Cat 0
Case summaries: 0
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). (Contraindication, High)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200596 ANADA: 200654 ANADA: 200655 ANADA: 200707 NADA: 140929 NADA: 141064 NADA: 141343 NADA: 141361 NDC Package: 23243-2395-4 NDC Package: 23243-7287-1 NDC Package: 49553-4161-1 NDC Package: 58198-0230-2 NDC Package: 58198-0470-1 NDC Package: 58198-0472-9 NDC Package: 86098-0004-1 NDC Product: 23243 NDC Product: 49553 NDC Product: 58198 NDC Product: 86098
Package NDC Product NDC Form / Route Status
23243-2395-4 23243 -
23243-7287-1 23243 -
49553-4161-1 49553 -
58198-0230-2 58198 -
58198-0470-1 58198 -
58198-0472-9 58198 -
86098-0004-1 86098 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 20 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle … (Official, 2026-02-12)
  • usage: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For the control … (Official, 2026-02-12)
Recent Revisions
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
Tilmovet® AC
RX
Tilmicosin Phosphate
Aqueous Concentrate • Oral, in drinking water
Label highlights
Official documents
Huvepharma EOOD ANADA 200-707 Approved Feb 1, 2022
Micotil™ 300
RX
Tilmicosin Phosphate
Liquid • Subcutaneous
Label highlights
Official documents
Elanco US Inc. NADA 140-929 Approved Apr 24, 2020
Pulmotil™ and Monovet®
VFD
Monensin Tilmicosin Phosphate
Type A medicated articles for use in the manufacture of Type B and Type C medicated feeds • Oral
Label highlights
Official documents
Huvepharma EOOD ANADA 200-655 Approved Feb 24, 2020
Tilmovet® and Monovet®
VFD
Monensin Tilmicosin Phosphate
Type A medicated articles for use in the manufacture of Type B and Type C medicated feeds • Oral
Label highlights
Official documents
Huvepharma EOOD ANADA 200-654 Approved Feb 24, 2020
Pulmotil™ AC
RX
Tilmicosin Tilmicosin Phosphate
Aqueous Concentrate • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-361 Approved Oct 24, 2019
Pulmotil™ 90
VFD
Tilmicosin Phosphate
Type A Medicated Article • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-064 Approved Oct 23, 2019
Tilmovet® 90 and Rumensin® 90
VFD
Monensin Tilmicosin Phosphate
Type A Medicated Article • Oral
Label highlights
Official documents
Huvepharma EOOD ANADA 200-596 Approved Oct 3, 2019
Pulmotil® 90 and Rumensin® 90
VFD
Monensin Tilmicosin Phosphate
Type A Medicated Article • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-343 Approved Dec 4, 2018

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: No use class stated or implied
Composition / specifications
250 mg/mL
Swine
Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage

Administer in drinking water at a concentration of 200 mg tilmicosin per liter for 5 consecutive days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Beef • Dairy, excluding female breeding age animals • Sheep, No Use Class Stated Or Implied
Composition / specifications
300 mg tilmicosin/mL
Cattle
Indication
For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.
Dosage

Administer a single subcutaneous dose of 10 to 20 mg/kg body weight (1 to 2 mL/30 kg or 1.5 to 3 mL per 100 lbs.). Do not inject more than 10 mL per injection site.

Limitations
Sheep
Indication
For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica.
Dosage

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.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Fed in confinement for slaughter
Composition / specifications
Tilmovet®: 90.7 g/lb (200 g/kg) of tilmicosin (as tilmicosin phosphate); Monovet®: 90.7 g/lb of monensin
Cattle fed in confinement for slaughter
Indication

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

568 to 757 g/ton of Pulmotil™ and 5 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 5 grams to 40 grams monensin per ton on a 90% dry matter basis (5.6 to 44.4 grams per ton on a 100% dry matter basis) to provide 50 to 480 mg monensin/head/day.

Limitations
Indication

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

568 to 757 g/ton of Pulmotil™ and 10 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a
single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 10 grams to 40 grams monensin per ton on a 90% dry matter basis (11.1 to 44.4 g per ton on a 100% dry matter basis) to provide 0.14 to 0.42 mg monensin/lb bodyweight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Fed in confinement for slaughter
Composition / specifications
Tilmovet®: 90.7 g/lb (200 g/kg) of tilmicosin (as tilmicosin phosphate); Monovet®: 90.7 g/lb of monensin
Cattle fed in confinement for slaughter
Indication

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

568 to 757 g/ton of Tilmovet® and 5 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 5 grams to 40 grams monensin per ton on a 90% dry matter basis (5.6 to 44.4 grams per ton on a 100% dry matter basis) to provide 50 to 480 mg monensin/head/day.

Limitations
Indication

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

568 to 757 g/ton of Tilmovet® and 10 to 40 g/ton of Monovet®. To be fed continuously as the sole ration for a single, 14 day period at 568 grams to 757 grams tilmicosin per ton on a 100% dry matter basis (511.2 to 681.3 g per ton on a 90% dry matter basis) to provide 12.5 mg tilmicosin/kg of body weight/day and 10 grams to 40 grams monensin per ton on a 90% dry matter basis (11.1 to 44.4 g per ton on a 100% dry matter basis) to provide 0.14 to 0.42 mg monensin/lb bodyweight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied
Composition / specifications
250 mg tilmicosin/mL
Swine
Indication

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

For the control of swine respiratory disease (SRD) associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

Dosage
200 mg tilmicosin/L (200 ppm) for 5 consecutive days
Limitations
For use in swine only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not inject this product. Injection of tilmicosin has been shown to be fatal in swine and non-human primates, and may be fatal in horses and goats.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
Tilmicosin (as tilmicosin phosphate) 90.7 g per lb (200 g per kg)
Beef and non-lactating dairy cattle
Indication

For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

Tilmicosin (as tilmicosin phosphate): 568 to 757 grams per ton (100% dry matter basis) of Type C medicated feed.

Limitations

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product.

Swine
Indication
For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
Dosage

Tilmicosin (as tilmicosin phosphate): 181 to 363 grams per ton of Type C medicated feed.

Limitations

Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product.

FDA page: Open in Animal Drugs @ FDA

Species: Beef fed In confinement for slaughter
Composition / specifications
Tilmicosin phosphate &ndash; 90.7 g/lb</p>
<p>Monensin &ndash; 90.7 g/lb
Cattle (beef fed in confinement for slaughter)
Indication
For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
Dosage
Tilmicosin phosphate – 568 to 757 g/ton and monensin – 10 to 40 g/ton
Limitations
The safety of tilmicosin has not been established in cattle intended for breeding purposes. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with tilmicosin. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin and monensin are not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.
Indication
For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
Dosage
Tilmicosin phosphate – 568 to 757 g/ton and monensin – 5 to 40 g/ton
Limitations
The safety of tilmicosin has not been established in cattle intended for breeding purposes. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with tilmicosin. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin and monensin are not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves.

FDA page: Open in Animal Drugs @ FDA

Species: Fed in confinement for slaughter
Composition / specifications
Tilmicosin phosphate &ndash; 90.7 g/lb, Monensin &ndash; 90.7 g/lb
Cattle Fed in Confinement for Slaughter
Indication

For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

Dosage

Tilmicosin phosphate - 568 to 757 g/ton Monensin – 5 to 40 g/ton 100% dry matter basis 90% dry matter basis

Limitations
The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal.

Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

Indication

For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.


Dosage

Tilmicosin phosphate - 568 to 757 g/ton Monensin – 10 to 40 g/ton 100% dry matter basis 90% dry matter basis

Limitations
The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. For cattle fed in confinement for slaughter, feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Feed at a rate of 0.14 to 0.42 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary

    For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

    For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    To add Pasteurella multocida and Histophilus somni to the indication “For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni” in beef and non-lactating dairy cattle.
    To establish a dose range of 10 to 20 mg tilmicosin/kg body weight in beef and non-lactating dairy cattle for the treatment of BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica.

  • Summary
    To provide user safety information on the product labeling related to the mechanism of toxicity and medical intervention.
  • Summary
    This supplemental application provides for the addition of a new species, sheep.
  • Summary

    Deletes the following statements from the label: "A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal."

  • Summary

    Provides for the use of tilmicosin phosphate (Micotil® 300) in cattle for a new therapeutic claim.

  • Summary
    For the treatment of respiratory disease (BRD) associated with Pasteurella haemolytica in cattle.
  • EA 140-929
  • FONSI 140-929
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where
    active BRD has been diagnosed in at least 10% of the animals in the group.

    For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

    For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.


SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for a new indication for the control of swine respiratory disease (SRD) associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
  • Summary
    For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.
  • EA 141-361
  • FONSI 141-361
  • EA 141-361
  • FONSI 141-361
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    The supplemental NADA provides for the use of tilmicosin Type C medicated feeds by veterinary feed directive for the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and nonlactating dairy cattle where active BRD has been diagnosed in at least 10 percent of the animals in the group.
  • Summary
    To allow for use in female breeding swine for the existing indication “For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.”
  • Summary
    Changes to the label are 1) removal of the MIC chart; 2) additions to the Pharmacology section of the label; 3) additional CAUTION that discourages continuous use for more than 21 days and limits use of each VFD form to 90 days. Changes to the VFD are inclusion of the additional CAUTION like the label and 2) addition of a 90-day maximum for the expiration of the VFD.
  • Summary

    1. The addition of the following caution statement to labeling: “Caution: Do not allow horses or other equine access to feeds containing tilmicosin.”
    2. The codification under 21 CFR 556.735, of an acceptable daily intake (ADI) in man and a muscle tolerance for parent tilmicosin in swine muscle.

  • Summary

    PULMOTIL 90 is indicated for the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.

  • EA 141-064
  • FONSI 141-064
  • EA 141-064
  • FONSI 141-064
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    1) For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group. 2) For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

     1) For prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.
    2) For improved feed efficiency and control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pastuerella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni . For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica . For the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . For the control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Feed continuously for a single, 14-day period to provide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle intended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaughtered within 28 days of the last treatment with this drug product. Feed continuously as the sole ration for 21-day period, beginning approximately 7 days before an anticipated disease outbreak. The safety of tilmicosin has not been established in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. The safety of tilmicosin has not been established in cattle intended for breeding purposes. Tilmicosin is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed only to cattle being fed in confinement for slaughter. Feed continuously for 14 days to provide 12.5 mg tilmicosin/kg/head/day. Tilmicosin is not approved for use in calves intended to be processed for veal. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day).

Side Effects

No approved side-effect narrative is linked yet.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

No case-level openFDA reports are linked for this medication yet.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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