[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.309]

[Page 106]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.309  Carprofen.

    (a) Specifications. Each caplet or chewable tablet contains 25, 75, 
or 100 milligrams of carprofen.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use in dogs--(1) Amount. 1 milligram per pound of 
body weight twice daily. Caplets and chewable tablets are scored and 
dosage should be calculated and given in half-caplet or half-chewable 
tablet increments.
    (2) Indications for use. For the relief of pain and inflammation 
associated with osteoarthritis in dogs.
    (3) Limitations. The safe use of carprofen in pregnant dogs, dogs 
used for breeding purposes, or in lactating bitches has not been 
established. As a class, cyclo-oxygenase inhibitory nonsteroidal anti-
inflammatory drugs (NSAID's) may be associated with gastrointestinal and 
renal toxicity. Patients at greatest risk for renal toxicity are those 
on concomitant diuretic therapy, or those with renal, cardiovascular, 
and/or hepatic dysfunction. Because many NSAID's possess the potential 
to induce gastrointestinal ulceration, avoid or closely monitor 
concomitant use of carprofen with other anti-inflammatory drugs, such as 
corticosteroids and NSAID's. Carprofen treatment was not associated with 
renal toxicity or gastrointestinal ulceration in safety studies of up to 
10 times the dose in dogs. Do not use in dogs with bleeding disorders 
(e.g., Von Willebrand's disease). Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999]