Important Considerations for Banamine Transdermal® Use

Veterinarians and those who raise food producing animals have legal and ethical obligations to use animal health products correctly. Farmers and veterinarians are required to first follow label directions. The recently FDA approved drug, Banamine Transdermal® is relatively easy to administer making the potential for its inappropriate use high. Work with your VCPR veterinarian in a legal and ethical manner to insure this product will perform for your cattle.

It appears there is good news: for some applications, an IV needle is no longer needed to deliver flunixin meglumine, the active ingredient found in Banamine® (manufactured by Merck Animal Health). Merck has a new product, Banamine Transdermal®, that is FDA approved for topical use in beef and dairy cattle. For those of you familiar with using Banamine®, do not substitute the dosing of Banamine® for the dosing of Banamine Transdermal®. Although the active ingredient is the same, the products are different!

Veterinarians and those who raise food producing animals have legal and ethical obligations to use animal health products correctly. Remember those BQA guidelines: carefully read and follow animal health product labels! Farmers and veterinarians are required to first follow label directions. Veterinarians working under an established veterinary-client-patient-relationship (VCPR) may use some FDA approved drugs in an extra-label-drug-use (ELDU) manner, but only when following the Animal Medicinal Drug Use Clarification Act (AMDUCA) decision tree.

Formulated to be given intravenously, Banamine® was involved in cases of violative residue levels in meat when the product was injected intramuscularly or subcutaneously. Banamine® is a non-steroidal anti-inflammatory drug used in cattle to control pyrexia associated with bovine respiratory disease, and fever and endotoxemia associated with acute bovine mastitis. Banamine® is to be given by a slow intravenous administration (1 -2 cc per 100 lbs. using the 50 mg/cc flunixin IV formulation) either once a day as a single dose or divided into two doses, administered at 12-hour intervals for up to 3 days.

Banamine Transdermal® is to be topically applied once, at a dose of 3 cc per 100 lbs. using the 50 mg/cc flunixin transdermal formulation. It may not be used in beef bulls intended for breeding, nor in suckling beef bulls. It’s not to be used in dairy bulls or dairy calves or female dairy cattle 20 months of age or older, including dry dairy cows. It is not to used in veal calves.

All of these ‘not for use’ statements occur because bull reproductive safety data was not established, and withdrawal periods have not been established for this product in pre-ruminating calves and milking cows.

Fever reduction

Banamine Transdermal® is a non-steroidal anti-inflammatory drug used to reduce fever associated with respiratory disease in weaned beef calves, beef cows, steers and heifers. The meat withdrawal time is eight days following the single application to the animal’s topline. The half-life is six hours, but Merck’s research data indicates its persistency is longer than that.

When used in combination with an antibiotic for the treatment of respiratory disease, a single application of Banamine Transdermal® to reduce fever may well be enough. Repeated doses of Banamine Transdermal® constitute ELDU by your VCPR veterinarian. The Food Animal Residue Avoidance Databank (FARAD) is unable to formulate a scientifically sound withdrawal time for multiple doses of Banamine Transdermal®.

The New Animal Drug Application for Banamine Transdermal® that was submitted to the FDA describes only single dose studies. The data regarding multiple administrations is lacking. Expected withdrawal times and side effects following repeated administration require studies evaluating chronic daily dosing of this medication.

Pain reduction

Banamine Transdermal® is also FDA approved, using a single topical dose, to reduce pain associated with foot rot in beef steers and heifers, beef bulls intended for slaughter and replacement dairy heifers under 20 months of age.

While a single dose may be enough to relieve acute pain, scientific data regarding its use to manage chronic pain is lacking along with the data needed to formulate good decisions regarding repeat dosing of Banamine Transdermal®. For field use, one application of Banamine Transdermal® will probably not provide the prolonged pain relief needed to manage long periods of lameness due to complicated cases of foot rot.

Early identification and diagnosis of lameness affords the best outcome. One dose of Banamine Transdermal® during early intervention for small, acute foot disease may be enough to successfully help relieve the pain these cattle are experiencing.

The label indication for pain relief is for foot rot only. Studies regarding Banamine Transdermal® use for relieving pain associated with dehorning and castrating were not done. The label explicitly states the product is not to be used on dairy calves, nor suckling beef bulls. The American Veterinary Medical Association, BQA and Dairy Farmers Assuring Responsible Management (Dairy-FARM) guidelines all agree that dehorning and castration must be performed in calves, less than 120 days of age.

Other drugs to relieve the chronic pain associated with dehorning and/or castration are needed. Meloxicam® is currently the analgesic drug of choice recommended for controlling the pain associated with these procedures. According to Dee Griffin, DVM, West Texas A&M University, Clinical Professor and the Director of the Texas A&M Veterinary Medical Center, “until Merck gets an approval for castration and or dehorning, the FDA has indicated ELDU of Meloxicam® is still acceptable with a VCPR.”

Additional considerations

Banamine Transdermal® is to be applied along the dry topline of cattle, from the withers to the tail head.  Do not treat cattle if the hide is wet or may get wet in six hours after administration, because effectiveness has not been evaluated under wet hide conditions.

Effectiveness was proven under ambient temperatures ranging from 2°F – 74°F at four locations in California, Kansas, Nebraska and Texas. The product was simply poured onto the topline, the hair was not parted nor other procedures done to promote skin application. The label indicates adsorption is better at warmer environmental temperatures; however, no dosing adjustment is needed when applying under cold conditions. Studies using the product on outwintered cattle in northern areas of the United States have not yet been reported.

Merck did examine the effect licking of the product, either by the animal itself or its herd mates, has on product efficacy. While those cattle who did not have the product removed by licking had better adsorption of the product than those who also ingested the product, no dosing adjustment is needed to compensate for possible lick-off.

Common sense is needed if one expects the product to perform as indicated. A five-weight feeder calf would need 15 cc applied to its topline, which in retrospect is not much volume. So, if you want it to work, don’t splash it on the side of the animal, or squirt it on one spot of a thick, dirty or wet hair coat, or apply it when rain or snow clouds looming on the horizon, unless cattle will be sheltered. Following BQA guidelines, effective animal restraint is always recommended. The Banamine Transdermal® label encourages humans applying the product wear protective eyewear.

Fascinating reading

There is more information regarding Banamine Transdermal® that is not covered in this article. So, grab a cup of coffee and do your homework. Read the label, product insert and online information. Work with your VCPR veterinarian in a legal and ethical manner to insure this product will perform for your cattle.

Written by: Sandy Stuttgen D.V.M., UW Extension Agriculture Educator, Taylor County.




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