NOVOX- carprofen tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Vedco, Inc.

INN (Међународно име):

carprofen

Састав:

carprofen 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION

Терапеутске индикације:

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

Резиме производа:

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

Статус ауторизације:

Abbreviated New Animal Drug Application

Карактеристике производа

NOVOX - CARPROFEN TABLET
VEDCO, INC.
----------
Approved by FDA under ANADA # 200-498
NOVOX
(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:
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-∝-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
®
®
15
12
2
1
2
3
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
i