Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
FIROCOXIB (UNII: Y6V2W4S4WT) (FIROCOXIB - UNII:Y6V2W4S4WT)
FELIX PHARMACEUTICALS PRIVATE LIMITED
ORAL
PRESCRIPTION
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.
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
Abbreviated New Animal Drug Application
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 Leggi il documento completo