CARPROFEN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

BUTLER ANIMAL HEALTH SUPPLY, LLC dba COVETRUS NORTH AMERICA

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Carprofen 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.

Product summary:

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

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CARPROFEN- CARPROFEN INJECTION, SOLUTION
BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA
----------
COVETRUS
Approved by FDA under ANADA # 200-520
CARPROFEN
INJECTION
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:
Carprofen 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 Carprofen 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
have been described in mammals.
The constitutive cyclooxygenase, COX-1,
synthesizes prostaglandins necessary for normal gastrointestinal and
renal function.
®
15
12
2
1
2
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
sel