CARPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

carprofen (UNII: FFL0D546HO) (carprofen - UNII:FFL0D546HO)

Available from:

BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Carprofen is indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. Carprofen should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

Carprofen caplets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per caplet. Each caplet size is packaged in bottles containing 60 or 180 caplets.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CARPROFEN- CARPROFEN TABLET
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
----------
COVETRUS
ANADA 200-498, Approved by FDA
CARPROFEN
CAPLETS
_NON-STEROIDAL ANTI-INFLAMMATORY DRUG_
FOR ORAL USE IN DOGS ONLY
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
Carprofen is a non-steroidal anti-inflammatory drug (NSAID) of the
propionic acid class that includes
ibuprofen, naproxen, and ketoprofen. Carprofen is the nonproprietary
designation for a substituted
carbazole, 6-chloro- -methyl-9H-carbazole-2-acetic acid.
The empirical formula is C
H ClNO and the molecular weight 273.72.
The chemical structure of carprofen is:
Carprofen is a white, crystalline compound. It is freely soluble in
ethanol, but practically insoluble in
water at 25°C.
CLINICAL PHARMACOLOGY:
Carprofen is a non-narcotic, non-steroidal anti-inflammatory agent
with characteristic analgesic and
antipyretic activity approximately equipotent to indomethacin in
animal models.
The mechanism of action of carprofen, like that of other NSAlDs, is
believed to be associated with the
inhibition of cyclooxygenase activity. Two unique cyclooxygenases have
been described in mammals.
The constitutive cyclooxygenase, COX-1, synthesizes prostaglandins
necessary for normal
gastrointestinal and renal function. The inducible cyclooxygenase,
COX-2, generates prostaglandins
involved in inflammation. Inhibition of COX-1 is thought to be
associated with gastrointestinal and renal
toxicity while inhibition of COX-2 provides anti-inflammatory
activity. The specificity of a particular
NSAID for COX-2 versus COX-1 may vary from species to species.
In an _IN VITRO_ study using canine
cell cultures, carprofen demonstrated selective inhibition of COX-2
versus COX-1.
Clinical relevance of these data has not been shown. Carprofen has
also been shown to inhibit the
release of several prostaglandins in two inflammatory cell systems:
rat polymorphonuclear leukocytes
(PMN) and human rheumatoid synovial cells, indica