Regulatory product record
FIROKARE CHEWABLE TABLETS
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- FIROKARE CHEWABLE TABLETS
- DIN
- 02559528
- DPD drug code
- 106266
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET (CHEWABLE)
- Ingredients
- FIROCOXIB (227 MG)
- Species (DPD record)
- DOGS
- Company
- FELIX PHARMACEUTICALS PVT. LTD. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 106266
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)Rule-based (RULE_BASED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications3
OA pain/inflammation; post-op orthopedic pain
DogOn-label (ON_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: OA pain/inflammation; post-op orthopedic pain — Authorized
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
OA pain/inflammation
HorseOn-label (ON_LABEL)1 source record · View provenance
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: OA pain/inflammation — Authorized
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pyrexia/pain (limited study data)
CatExtra-label (EXTRA_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Pyrexia/pain (limited study data) — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens6
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects182
Vomiting, anorexia — Most common (~4%, ~2% resp.)
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Periportal hepatic fatty change — Juvenile/puppy chronic dosing studies
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Oral ulcers, facial skin lesions, renal papillary necrosis — At/above labeled dose or duration
HorseNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
The safety and effectiveness of firocoxib tablets was established in a relative bioavailability study comparing firocoxib tablets and firocoxib oral paste. Therefore, additional field studies were not performed to support the effectiveness of firocoxib tablets. In controlled field studies, 127 horses (ages 3 to 37 years) were evaluated for safety when given firocoxib oral paste at a dose of 0.045 mg/lb (0.1 mg/kg) orally once daily for up to 14 days. The following adverse reactions were observed. Horses may have experienced more than one of the observed adverse reactions during the study. Table 1: Adverse Reactions Seen in U.S. Field Studies with firocoxib oral paste: In these field trials, firocoxib oral paste was safely used concomitantly with other therapies, including vaccines, anthelmintics, and antibiotics. The safety data sheet (SDS) contains more detailed occupational safety information. Adverse Reactions Firocoxib n=127 Active Control n=125 Abdominal pain 0 1 Diarrhea 2 0 Excitation 1 0 Lethargy 0 1 Loose stool 1 0 Polydipsia 0 1 Urticaria 0 1
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Vomiting2,519 reports
- Anorexia1,326 reports
- Elevated blood urea nitrogen (BUN)1,078 reports
- Diarrhoea932 reports
- Elevated creatinine807 reports
- Elevated serum alkaline phosphatase (SAP)791 reports
- Death786 reports
- Elevated alanine aminotransferase (ALT)715 reports
- Depression699 reports
- Death by euthanasia692 reports
- Lethargy (see also Central nervous system depression in 'Neurological')547 reports
- Other abnormal test result NOS424 reports
Cat
- Accidental exposure23 reports
- Vomiting18 reports
- Anorexia9 reports
- Elevated alanine aminotransferase (ALT)6 reports
- Anaemia NOS4 reports
- Death4 reports
- Elevated blood urea nitrogen (BUN)4 reports
- Elevated creatinine4 reports
- Lethargy (see also Central nervous system depression in 'Neurological')4 reports
- Depression3 reports
- Hyperphosphataemia3 reports
- Agitation2 reports
Monitoring1
Baseline + periodic physical exam, CBC, liver/renal function, electrolytes, urinalysis
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications3
Puppies <7 months old or <7 lb — serious adverse reactions incl. death reported above label dose; cannot be accurately dosed under 7 lb
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Horses with a hypersensitivity to firocoxib should not receive Firocoxib Tablets for Horses.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions7
Pre-existing renal/hepatic/cardiovascular disease, dehydration, hypotension, concurrent diuretics; avoid NSAID/corticosteroid combos
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Manufacturer overdose hotline exists (877-217-3543) — reflects a relatively new-drug adverse-effect profile still being characterized.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Not FDA-approved for cats — use is extra-label with limited safety data.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
For use in horses only. Do not use in horses intended for human consumption. Keep Firocoxib Tablets for Horses in a secure location out of reach of dogs, cats, and other animals to preventaccidental ingestion or overdose.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Horses should undergo a thorough history and physical examination before initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data before and periodically during administration of any NSAID. Clients should be advised to observe for signs of potential drug toxicity and be given a Client Information Sheet with each prescription. See Information for Owner or Person Treating Horse section of this package insert. Treatment with Firocoxib Tablets for Horses should be terminated if signs such as inappetence, colic, abnormal feces, or lethargy are observed. As a class, cyclooxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity.Sensitivity to drug-associated adverse events varies with the individual patient. Horses that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached or avoided.NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects mayresult in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since many NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of Firocoxib Tablets for Horses with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. The concomitant use of protein bound drugs with Firocoxib Tablets for Horses has not been studied in horses. The influence of concomitant drugs that may inhibit the metabolism of Firocoxib Tablets for Horses has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The safe use of Firocoxib Tablets in Horses less than one year in age, horses used for breeding, or in pregnant or lactating mares has not been evaluated. Consider appropriate washout times when switching from one NSAID to another NSAID or corticosteroid.
Species not recordedOn-label (ON_LABEL)United States2 source records · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions6
ACE inhibitors — Reduced antihypertensive effect
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Aspirin, corticosteroids, other NSAIDs — ↑ GI toxicity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Fluconazole — Possible ↑ firocoxib levels
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Furosemide, nephrotoxic drugs — ↓ diuretic effect / ↑ nephrotoxicity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Highly protein-bound drugs — Possible displacement
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics7
Bioavailability — ~38% (dog, chewable tab); ~79–100% (horse); ~54–70% (cat)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — 96–98%
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — 6–8h (dog); 9–12h (cat); 30–40h (adult horse); 11h (foal); 6.7h (calf)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Hepatic — dealkylation + glucuronidation (dog); decyclopropylmethylation (horse)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Biliary/fecal (dog); renal (horse)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
No data in breeding/pregnant/lactating dogs or horses; adverse effects not specifically reported. Use cautiously.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 523–525; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 352–355 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references20
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Long-Term Firocoxib Use in Horses.
Study summary not available in the imported record. Open the original citation to review the study.
- Solar dermatitis in a cynomolgus macaque (Macaca fascicularis).
Study summary not available in the imported record. Open the original citation to review the study.
- Single-dose enflicoxib versus a 7-day course of firocoxib for postoperative pain control in dogs undergoing orthopaedic surgery: A multicentre, randomised, masked, non-inferiority study.
Study summary not available in the imported record. Open the original citation to review the study.
- Gastroscopic Evaluation of Gastric Mucosa in Horses Treated With Flunixin Meglumine or High-Dose Firocoxib: A Descriptive Pilot Study.
Study summary not available in the imported record. Open the original citation to review the study.
- Periovulatory administration of therapeutic and supratherapeutic doses of firocoxib does not impair induced ovulation or follicular dynamics in mares treated with a GnRH analogue.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.