CARPROFEN- 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.

INN (International Name):

CARPROFEN

Composition:

CARPROFEN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

Carprofen Caplets 25 mg – Each light orange, convex tablet debossed with "G" on one side and bisected on the other side with "33" on the left and "11" on the right of the bisect. Carprofen Caplets 75 mg – Each light orange, convex tablet debossed with "G" on one side and bisected on the other side with "33" on the left and "22" on the right of the bisect. Carprofen Caplets 100 mg – Each light orange, convex tablet debossed with "G" on one side and bisected on the other side with "33" on the left and "33" on the right of the bisect.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CARPROFEN- CARPROFEN TABLET
PUTNEY, INC.
----------
CARPROFEN CAPLETS
25 MG, 75 MG AND 100 MG
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. The chemical name for carprofen,
a substituted carbazole, is 6-
chloro- alpha-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 shown
above.
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 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 ce