OSTIFEN- carprofen injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

MWI/VetOne

INN (שם בינלאומי):

carprofen

הרכב:

carprofen 50 mg in 1 mL

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION

סממני תרפויטית:

OstiFen Injection 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.

leaflet_short:

OstiFen Injection is supplied in 20 mL and 50 mL, amber, glass, sterile, multi-dose vials.

מצב אישור:

Abbreviated New Animal Drug Application

מאפייני מוצר

OSTIFEN- CARPROFEN INJECTION, SOLUTION
MWI/VETONE
----------
Approved by FDA under ANADA # 200-520
VETone
OSTIFEN
INJECTION
(CARPROFEN)
STERILE INJECTABLE SOLUTION
50 MG/ML
NON-STEROIDAL ANTI-INFLAMMATORY DRUG
FOR SUBCUTANEOUS USE IN DOGS ONLY
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
OstiFen Injection is a sterile solution containing carprofen, a
non-steroidal anti-
inflammatory drug (NSAID) of the propionic acid class that includes
ibuprofen,
naproxen, and ketoprofen. Carprofen is the non-proprietary 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:
Each mL of OstiFen Injection contains 50.0 mg carprofen, 30.0 mg
arginine, 88.5 mg
glycocholic acid, 169.0 mg lecithin, 10.0 mg benzyl alcohol, 6.17 mg
sodium hydroxide,
with additional sodium hydroxide and hydrochloric acid as needed to
adjust pH, and
water for injection.
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
®
TM
™
15
12
2
1
2
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.