FIROCOXIB tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FELIX PHARMACEUTICALS PRIVATE LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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 Firocoxib.

Product summary:

Firocoxib is available as round, brownish yellow to pale brown, 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. 1 Willoughby DA, Moore AR and Colville-Nash PR. COX-1, COX-2, and COX-3 and the future treatment of chronic inflammatory disease. Lancet 2000; 355: 646-648. 2 Smith, et al., Pharmacological Analysis of Cyclo-oxygenase-1 in Inflammation. Proc. Natl. Acad. Sci. USA, Pharmacology 1998; 95: 13313-13318. 3 Jones CJ and Budsberg SC. Physiologic characteristics and clinical importance of the cyclooxygenase isoforms in dogs and cats. JAVMA 2000; 217(5): 721-729. 4 Zhang, et al., Inhibition of Cyclo-oxygenase-2 Rapidly Reverses Inflammatory Hyperalgesia and Prostaglandin E2 Production. JPET 1997; 283: 1069-1075. 5 Jones and Budsberg, pp. 721-729. 6 Zhang, et al., pp. 1069-1075. 7 Chandrasekharan NV, Dai H, et al. COX-3, a cyclooxygenase-1 variant inhibited by acetaminophen and other analgesic/antipyretic drugs: Cloning, structure and expression. Proc. Natl. Acad. Sci. USA, 2002; 99(21): 13926-13931. 8 Data on file with NADA # 141-230. Distributed by: Felixvet Inc., 1300 NW Briarcliff Parkway, Suite 100, Kansas City, Missouri 64116 Made in India Neutral Code No. MP/DRUGS/25/90/2020 Rev. December 2023 Approved by FDA under ANADA # 200-755

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

FIROCOXIB- FIROCOXIB TABLET, CHEWABLE
FELIX PHARMACEUTICALS PRIVATE LIMITED
----------
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:
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 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
Firocoxib with food delays drug absorption (T
from 1 to 5 hours) and decreases
17
20
5
λ
max
peak concentrations (C
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 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 Firocoxib and other treatment options
before deciding to
use Firocoxib. Use the lowest effective dose for the shortest duration
consistent with
individual response. The recommended dosage of Firocoxib for oral
administration in
dogs is 2.27 mg/lb (5.0 mg/kg) body weight once daily as ne