RIMADYL STERILE- carprofen injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zoetis Inc.

INN (Kansainvälinen yleisnimi):

Carprofen

Koostumus:

Carprofen 50 mg in 1 mL

Antoreitti:

SUBCUTANEOUS

Prescription tyyppi:

PRESCRIPTION

Käyttöaiheet:

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

Tuoteyhteenveto:

Rimadyl Injectable is supplied in 20-mL, amber, glass, sterile, multi-dose vials.

Valtuutuksen tilan:

New Animal Drug Application

Valmisteyhteenveto

RIMADYL STERILE- CARPROFEN INJECTION, SOLUTION
ZOETIS INC.
----------
RIMADYL
RIMADYL
(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
Rimadyl Injectable 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
CINO and molecular weight 273.72.
The chemical structure of carprofen is:
Each mL of Rimadyl Injectable 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
®
®
15
12
2
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