NOVOX- carprofen tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Vedco, Inc.

INN (International Name):

carprofen

Composition:

carprofen 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Novox 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. Novox should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

Novox chewable tablets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per tablet. Each tablet size is packaged in bottles containing 30, 60, or 180 tablets.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

NOVOX- CARPROFEN TABLET, CHEWABLE
VEDCO, INC.
----------
ANADA 200-595, Approved by FDA
NOVOX
(CARPROFEN)
CHEWABLE TABLETS
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:
Novox
(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-α-methyl-9H-carbazole-2-acetic acid.
The empirical formula is
C
H CINO and the molecular weight is 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 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 (