ROVERA- carprofen tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Vicar Operating, Inc.

INN (שם בינלאומי):

carprofen

הרכב:

carprofen 25 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION

סממני תרפויטית:

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

leaflet_short:

Rovera 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.

מצב אישור:

New Animal Drug Application

מאפייני מוצר

ROVERA- CARPROFEN TABLET
VICAR OPERATING, INC.
----------
ROVERA
(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
Rovera (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)
and chronic (synov