FIROCOXIB FOR DOGS- firocoxib tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FIROCOXIB (UNII: Y6V2W4S4WT) (FIROCOXIB - UNII:Y6V2W4S4WT)

Available from:

Pegasus Laboratories, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Firocoxib Chewable Tablets for Dogs are indicated for the control of pain and inflammation associated with osteoarthritis and for the control of post-operative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs. Dogs with known hypersensitivity to firocoxib should not receive Firocoxib Chewable Tablets for Dogs.

Product summary:

Firocoxib Chewable Tablets for Dogs is available as round, beige to tan, half-scored tablets in two strengths, containing 57 mg or 227 mg firocoxib.  Each tablet strength is supplied in 60 count and 180 count bottles.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

FIROCOXIB FOR DOGS- FIROCOXIB TABLET, CHEWABLE
PEGASUS LABORATORIES, INC.
----------
FIROCOXIB CHEWABLE TABLETS FOR DOGS
FIROCOXIB CHEWABLE TABLETS FOR DOGS
For oral use in dogs only.
_CAUTION: _Federal law restricts this drug to use by or on the order
of a licensed
veterinarian.
_DESCRIPTION:_
Firocoxib Chewable Tablets for
Dogs belongs to the coxib class of non-narcotic,
non-steroidal anti-inflammatory drugs. Firocoxib is a
white crystalline compound described chemically as
3-(cyclopropylmethoxy)-4-(4-(methylsulfonyl)phenyl)-
5,5-dimethylfuranone. The empirical formula is
C17H20O5S, and the molecular weight is 336.4. The
structural formula is shown below:
_PHARMACOKINETICS:_
The absolute bioavailability of Firocoxib Chewable Tablets for Dogs is
approximately 38%
when administered as a 5 mg/kg oral dose to fasted adult dogs.
Firocoxib is rapidly
cleared from the blood via hepatic metabolism and fecal excretion
(CLsystemic = ~0.4
L/hr/kg). Despite
a high level of plasma protein binding (96%), firocoxib exhibits a
large volume of
distribution (Vd of total drug = ~4.6 L/kg) and a terminal elimination
half life of 7.8
hours (%CV = 30%). The oral drug absorption process is highly variable
among
subjects. Co-administration of firocoxib with food delays drug
absorption (Tmax from 1
to 5 hours) and decreases peak concentrations (Cmax from 1.3 to 0.9
mcg/mL).
However, food does not affect the overall oral bioavailability at the
recommended dose.
_INDICATIONS:_
Firocoxib Chewable Tablets for Dogs are indicated for the control of
pain and
inflammation associated with osteoarthritis and for the control of
λ
post-operative pain and inflammation associated with soft-tissue and
orthopedic surgery
in dogs.
_DOSAGE AND ADMINISTRATION:_
Always provide the Client Information Sheet with prescription.
Carefully consider the
potential benefits and risks of Firocoxib Chewable Tablets for Dogs
and other treatment
options before deciding to use Firocoxib Chewable Tablets for Dogs.
Use the lowest
effective dose for the shortest duration