CARPROVET- carprofen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Carprofen (UNII: FFL0D546HO) (Carprofen - UNII:FFL0D546HO)

Available from:

Dechra Veterinary Products

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Carprovet 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. CONTRAINDICATIONS: Carprovet should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

HOW SUPPLIED: Carprovet 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. Carprovet 25 mg, 60 caplets NDC-17033-362-60, Carprovet 25 mg, 180 caplets NDC-17033-362-18 Carprovet 75 mg, 60 caplets NDC-17033-367-60, Carprovet 100 mg, 180 caplets NDC-17033-367-18 Carprovet 100 mg, 60 caplets NDC-17033-361-60, Carprovet 100 mg, 180 caplets NDC-17033-361-18 Approved by FDA under ANADA # 200-397

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CARPROVET- CARPROFEN TABLET
DECHRA VETERINARY PRODUCTS
----------
CARPROVET
(CARPROFEN TABLETS)
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: Carprovet (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
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 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) an