CARPROFEN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARPROFEN (UNII: FFL0D546HO) (CARPROFEN - UNII:FFL0D546HO)

Available from:

Putney, Inc.

INN (International Name):

CARPROFEN

Composition:

CARPROFEN 50.0 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Carprofen Sterile Injectable Solution 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. CONTRAINDICATIONS: Carprofen Sterile Injectable Solution should not be used in dogs exhibiting previous hypersensitivity to carprofen.

Product summary:

HOW SUPPLIED: Carprofen Sterile Injectable Solution is supplied in 20-mL, amber, glass, sterile, multi-dose vials.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CARPROFEN- CARPROFEN INJECTION, SOLUTION
PUTNEY, INC.
----------
ANADA 200-522, Approved by FDA
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:
Carprofen Sterile Injectable Solution 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 CIN0 and molecular weight
273.72. The chemical structure of carprofen is:
Each mL of Carprofen Sterile Injectable Solution 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 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
releva