NADA 140-441 and 140-913
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NADA 140-441 and 140-913 (supplemental); Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution (enrofloxacin); re: dosage frequency, indications, and limitations; June 19, 1997
Freedom of Information Summary
NADA 140-441 and 140-913
I. GENERAL INFORMATION:
NADA Numbers: 140-441 and 140-913
P.O. Box 390
Shawnee, Kansas 66201
Established name: enrofloxacin tablets and enrofloxacin injectable solution
Trade name: BAYTRIL® Antibacterial Tablets and BAYTRIL® Antibacterial Injectable Solution
Marketing status: prescription
Effect of the Supplement:
The supplement to NADA 140-441, for dogs and cats, provides for revisions to 21 CFR 520.812 as indicated below.
Conditions of use - (1) Amount. Administer orally at a rate to provide 5 to 20 mg/kg (2.27 to 9.07 mg/lb) of body weight, either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.
(2) Indications - Enrofloxacin tablets in dogs and cats for the management of diseases associated with bacteria susceptible to enrofloxacin. [This statement will replace section (2)(i) and (ii) as previously approved].
(3) Limitations - Treatment should be continued for at least 2 to 3 days beyond cessation of clinical signs, to a maximum of 30 days for both dogs and cats.
The supplement to NADA 140-913, for dogs, provides for revisions to 21 CFR 522.812 as indicated below.
(2) Indications - Enrofloxacin injectable solution in dogs for the management of diseases associated with bacteria susceptible to enrofloxacin.
II. INDICATIONS FOR USE
Baytril Antibacterial Tablets and Injectable Solution are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.
III. PRODUCT INFORMATION
A. Dosage form: 5.7 mg, 22.7 mg, and 68 mg enrofloxacin per tablet, and 22.7 mg per mL
B. Route of administration: Baytril Antibacterial Tablets for oral administration and Baytril Injectable Solution for intramuscular administration
C. Recommended dosage: The dose range of Baytril Antibacterial Tablets in dogs and cats is 5 to 20 mg/kg (2.27 to 9.07 mg/lb) of body weight, either as a single dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose of Baytril Injectable Solution for dogs is 2.5 mg/kg (1.13 mg/lb) as a single injection. The injectable dose should be followed by oral tablet treatment in 12 hours.
A. Clinical efficacy of the recommended minimum dosages have been established in dogs as indicated and referenced in the Freedom of Information Summaries for NADA 140-441 dated January 24, 1989, May 4, 1990, and October 29, 1990, and NADA 140-913 dated January 29, 1990.
B. The drugs distribute widely and reach adequate blood and tissue concentrations in the target animal species. Tissue concentration values are found in the approved labels, and are presented, or referenced, in the Freedom of Information Summaries associated with these approvals.
The wide distribution and activity of these drugs would indicate that the drugs
may be used in several conditions, and is evidenced by the wide range of
recommended conditions, indications, and limitations in clinical literature as
indicated in Table 1.
|Usage||11 mg/kg BID for 4 days; n = 6 adult dogs|
|Walker RD, Stein GE, Hauptman JG, et al. Pharmacokinetic evaluation of enrofloxacin administered orally to healthy dogs. Am J Vet Res 1992; 53:2315-2319.|
|-dosage of 11 mg/kg was required to maintain serum concentrations greater than the MIC90 of Pseudomonas aeruginosa for the entire dosing interval
- no adverse reactions observed
|Usage||100 dogs, 25 cats received 10 mg/kg/day, variable durations|
|Article/Journal Reference||vom Hove W, Lettow E, Opitz M. Experiences with the anti-infective enrofloxacin (Baytril) in pyodermas in dogs and cats. Kleintierpraxis 1992; 37:817-822.|
|Conclusions/Explanation||- authors recommend 10 mg/kg/day for bacterial dermatoses, for at least 3 weeks, to be adapted to individual cases
- dose was well-tolerated and can be safely administered over a period of several weeks
|Usage||5 mg/kg BID, dogs and cats|
|Article/Journal Reference||Aucoin D. Rational antimicrobial therapy in dermatitis. Proceedings of the 10th ESVD (European Soc. of Vet Derm) annual congress, Aalborg Denmark, 1993:116-125.|
|Conclusions/Explanation||- recommends increasing to this dose from 5 mg/kg SID if no
response is seen in 1 week
- also notes that once or twice daily dosing is possible, depending on the MIC of the pathogen
|Usage||5 - 7.5 mg/kg BID, dogs and cats|
|Article/Journal Reference||Rosychuk R. Management of Otitis Externa. VetClinNorthAmSmallAnimPract; 1994;24:921-951(1994).|
|Conclusions/Explanation||- this dose recommended for "enhanced effect [against Pseudomonas infections]"
- "pending culture and sensitivity data, the systemic antibiotic of choice"
|Usage||2.5 - 5 mg/kg BID, dogs|
|Article/Journal Reference||Mason I. Selection and use of antibacterial agents in canine pyoderma. Practice 1993; 15:29-34.|
|Conclusions/Explanation||- "in general, doses of antimicrobial agents are doubled for skin infections..."|
|Usage||5 mg/kg BID, dogs|
|Article/Journal Reference||Dorfman M, Barsanti J, Budsberg S. Enrofloxacin concentrations in dogs with normal prostate and dogs with chronic bacterial prostatitis. Am J Vet Res 1995; 56:386-389.|
|Conclusions/Explanation||- resulted in prostatic fluid and tissue concentrations exceeding the MIC of most pathogens that cause bacterial prostatitis|
|Usage||2.5 - 5.0 mg/kg q12-24h, dogs and cats|
|Article/Journal Reference||McKellar Q. Clinical relevance of the pharmacologic properties of fluoroquinolones. Supplement to Compendium on Continuing Education for the Practicing Veterinarian 1996, 18(2):14-21|