PREVICOX- firocoxib tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merial, Inc.

INN (International Name):

FIROCOXIB

Composition:

FIROCOXIB 57 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Indications: PREVICOX (firocoxib) Chewable Tablets are indicated for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery in dogs. Contraindications: Dogs with known hypersensitivity to firocoxib should not receive PREVICOX.

Product summary:

How Supplied: PREVICOX 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 3 count, 10 count and 30 count blister packages and 60 count and 180 count bottles.

Authorization status:

New Animal Drug Application

Patient Information leaflet

PREVICOX- FIROCOXIB TABLET, CHEWABLE
Merial, Inc.
----------
INFORMATION FOR DOG OWNERS ABOUT
PREVICOX® (FIROCOXIB) CHEWABLE
TABLETS
PREVICOX Chewable Tablets are used for the control of pain and
inflammation due to osteoarthritis or
associated with soft-tissue and orthopedic surgery in your dog.
This summary contains important information about PREVICOX. You should
read this information
before you start giving your dog PREVICOX tablets and review it each
time your prescription is refilled.
This sheet is provided only as a summary and does not take the place
of instructions from your
veterinarian. Talk to your veterinarian if you do not understand any
of this information or you want to
know more about PREVICOX.
What is PREVICOX?
PREVICOX is a veterinary prescription non-steroidal anti-inflammatory
drug (NSAID) used to control
pain and inflammation due to osteoarthritis, or associated with
soft-tissue and orthopedic surgery in dogs.
Osteoarthritis is a painful condition caused by "wear and tear" of
cartilage and other parts of the joints
that may result in the following changes or signs in your dog:
•
Limping or lameness.
•
Decreased activity or exercise (reluctance to stand, climb stairs,
jump or run, or difficulty in
performing these activities).
•
Stiffness or decreased movement of joints.
PREVICOX is indicated for the control of postoperative pain and
inflammation following soft-tissue and
orthopedic surgeries (e.g. spays, cruciate ligament repair). Your
veterinarian may administer PREVICOX
before the procedure and recommend that the dog be treated for a few
days after going home.
What kind of results can I expect when my dog is on PREVICOX for
osteoarthritis?
While PREVICOX is not a cure for osteoarthritis, it can control the
pain and inflammation and improve
your dog's mobility.
•
Response varies from dog to dog, but improvement can be quite
dramatic.
•
In most dogs, improvement can be seen within days.
•
If PREVICOX is discontinued or not given as directed, your dog's pain
and inflammation may

Summary of Product characteristics

PREVICOX- FIROCOXIB TABLET, CHEWABLE
MERIAL, INC.
----------
PREVICOX (FIROCOXIB)
CHEWABLE TABLETS
_FOR ORAL USE IN DOGS ONLY._
_CAUTION:_ Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
_DESCRIPTION:_ PREVICOX (firocoxib) 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
C
H O S, and the molecular weight is 336.4. The structural formula is
shown below:
_PHARMACOKINETICS:_ The absolute bioavailability of PREVICOX
(firocoxib) 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 PREVICOX 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:_ PREVICOX (firocoxib) Chewable Tablets are indicated for
the control of pain and
inflammation associated with osteoarthritis and for the control of
postoperative 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 PREVICOX and other
treatment options before deciding to
use PREVICOX. Use the lowest effective dose for the shortest duration
consistent with individual
response. The recommended dosage of PREVICOX (firocoxib) for oral
administration in dogs is 2.27
mg/lb (5.0 mg/kg)