FIROX- firocoxib tablet, chewable

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Norbrook Laboratories Limited

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION

Indikasjoner:

Firox (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. Dogs with known hypersensitivity to firocoxib should not receive Firox.

Produkt oppsummering:

Firox 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. Manufactured for: Norbrook Laboratories Limited, Newry, BT35 6QQ, Co. Down, Northern lreland.www.norbrook.com 1-866-591-5777 Approved by FDA under ANADA # 200-722 Firox™ is a trademark of Norbrook Laboratories Limited Rev. 11/2022 Norbrook ®

Autorisasjon status:

Abbreviated New Animal Drug Application

Preparatomtale

FIROX- FIROCOXIB TABLET, CHEWABLE
NORBROOK LABORATORIES LIMITED
----------
FIROX™ (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:
Firox (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-di-
methyIfuranone. The
empirical formula is C
H
0 S, and the molecular weight is 336.4. The structural
formula is shown at right:
PHARMACOKINETICS:
The absolute bioavailability of Firox (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 Firox 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:
Firox (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
17
20 5
λ
potential benefits and risks of Firox and other treatment options
before deciding to use
Firox.
Use the lowest effective dose for the shortest duration consistent
with individual
response. The recommended dosage of Firox (firocoxib) for oral
administration in dogs
is 2.27 mg/lb (5.0 mg/kg) body wei