Understanding the Pulmotil label – conditions for use

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In an ongoing series, Marilyn Corbin, DVM, PhD and Elanco technical consultant explains the conditions for use of FDA’s recent approval of Pulmotil (tilmicosin) in cattle. Part one of the series focused on the veterinarian’s role and the process for implementing a Veterinary Feed Directive (VFD) order, a requirement for feeding Pulmotil. In this edition, Corbin explains the Pulmotil label and how the label impacts the use of the product. “It’s important for veterinarians to understand these label conditions as they work with their clients to help them understand how to appropriately use Pulmotil as a new Bovine Respiratory Disease in-feed control therapy.”

What are the label indications for Pulmotil in cattle?

Pulmotil is now approved 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 percent of the animals in the group.

In general, how is the Pulmotil label different from other typical antimicrobial product labels?

Pulmotil is an innovative BRD therapy for groups of cattle in the early stages of a BRD outbreak that provides 14 days of sustained in-feed therapy, a practice that reduces stress associated with cattle handling. To help ensure food safety, the FDA has specified requirements for the use of Pulmotil, including the VFD and use only in groups of cattle where at least 10 percent of the cattle have been diagnosed with BRD. There are also limitations on which injectable antibiotics can be used prior to or during Pulmotil administration.

What is the need for these additional requirements on the label?

As growing concerns about the development of antimicrobial resistance in humans from use of antibiotics in food animal production continue to impact regulatory policy, more conservative conditions for use are becoming part of the labeling requirements and/or cautions. It is also important to understand that as part of the FDA drug approval process, a risk assessment is completed and product use requirements are determined based on the risks identified. 

Pulmotil belongs to the macrolide class of antibiotics, which is an important class of antibiotics for the treatment of food-borne illness in humans, specifically those illnesses caused by Campylobacter. Concern over the potential for macrolide antibiotic resistance development with Campylobacter resulted in cautions for Pulmotil use in general, and its use in conjunction with other injectable macrolide antibiotics. These cautions are not based on efficacy issues; they are based on food safety concerns. By following its established microbial food-safety risk protocol, the FDA has determined that the conditions of use and label caution statements enable Pulmotil to be safely used in cattle feed with minimal potential of public health risk.

Consumer safety and confidence is important to all stakeholders in the beef supply chain. Judicious use of antibiotics in food animal production enhances animal health, continues to help protect the technologies we use to care for cattle, and helps provide a safe, wholesome and affordable food supply.

What are the specific requirements for Pulmotil use based on the risk assessment?

The following conditions are part of the assessment that allowed the FDA to conclude that use of tilmicosin in cattle feed would not result in a significant risk of development of macrolide resistance in food-borne Campylobacter:

  • Active BRD has been diagnosed in at least 10 percent of the animals
  • 14 consecutive day treatment
  • Administration during the first 45 days of the production period
  • Intended for treatment of groups of affected animals, not individual animals
  • Pulmotil use should not occur concurrently with or following administration of an injectable macrolide
  • Pulmotil use should not occur within 3 days following administration of a non-macrolide injectable BRD therapy
  • Severe clinically ill cattle should be individually treated with an alternative non-macrolide therapy

What is Elanco doing to communicate Pulmotil cattle label requirements?

We will initiate a comprehensive educational outreach program with veterinarians, feed advisors/nutritionists and feed suppliers prior to the commercial introduction of Pulmotil to the market.  This initiative also will include sharing the results of the commercial trials currently underway and a training program for fulfilling the requirements of a VFD order. In the meantime, we ask that you become familiar with the Pulmotil label and encourage you to contact your Elanco technical consultant if you have any questions or need additional information.

The label contains complete use information, including cautions and warnings. Always read, understand and follow the label and use directions.

Feeds containing tilmicosin must be withdrawn 28 days prior to slaughter.

Caution: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive issued by a licensed veterinarian in the course of the veterinarian’s professional practice.

For the control of Bovine Respiratory Disease (BRD) in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10 percent of the animals in the group:  Feed continuously for a single, 14-day period at 568 to 757 g/ton of tilmicosin (100 percent DM basis) in a Type C medicated feed as the sole ration to provide 12.5 mg/kg of body weight/hd/d.

Pulmotil® is a trademark for Elanco’s brand of tilmicosin.
© 2012 Elanco Animal Health.

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