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:

Boehringer Ingelheim Animal Health USA Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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
Boehringer Ingelheim Animal Health USA 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 do

Summary of Product characteristics

PREVICOX- FIROCOXIB TABLET, CHEWABLE
BOEHRINGER INGELHEIM ANIMAL HEALTH USA 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 d