CARPROFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARPROFEN (UNII: FFL0D546HO) (CARPROFEN - UNII:FFL0D546HO)

Available from:

Putney, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Carprofen Caplets are 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. CONTRAINDICATIONS: Carprofen Caplets should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

HOW SUPPLIED: 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
PUTNEY, INC.
----------
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 Caplets are 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-α-methyl-9H-carbazole-2-acetic acid. The empirical
formula is C
H CIN0 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 25º 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 NSAIDs, 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, indicating inhibition of acute (PMN
system) and chronic (synovial cell
system) infla