Regulatory product record
ITRAFUNGOL
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
- ITRAFUNGOL
- DIN
- 02316811
- DPD drug code
- 80231
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- ITRACONAZOLE (10 MG)
- Species (DPD record)
- CATS
- Company
- VIRBAC AH, INC. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 80231
- 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.
Indications2
Blastomycosis (often drug of choice unless severe hypoxemia present), histoplasmosis, dermatophytosis, Malassezia dermatitis, nasal aspergillosis
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Blastomycosis (often drug of choice unless severe hypoxemia present), histoplasmosis, dermatophytosis, Malassezia dermatitis, nasal aspergillosis — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dermatophytosis (often first choice), cryptococcosis, blastomycosis
CatExtra-label (EXTRA_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Dermatophytosis (often first choice), cryptococcosis, blastomycosis — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens7
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 effects205
Anorexia — Most common, often 2nd month of treatment
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Hepatotoxicity (↑ALT) — ~10% at 10 mg/kg/day, ~5% at 5 mg/kg/day
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Ulcerative skin lesions/vasculitis, limb edema — ~7% at high dose
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
GI effects, hepatotoxicity, depression — Dose-related
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Rare: erythema multiforme, toxic epidermal necrolysis — Rare, serious
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · 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
- Lack of efficacy - NOS8 reports
- Lethargy (see also Central nervous system depression in Neurological)6 reports
- Fever5 reports
- Lethargy (see also Central nervous system depression in 'Neurological')5 reports
- Cough4 reports
- Diarrhoea4 reports
- Elevated serum alkaline phosphatase (SAP)4 reports
- Other abnormal test result NOS4 reports
- Polyuria4 reports
- Abnormal radiograph finding3 reports
- Anxiety3 reports
- Death by euthanasia3 reports
Cat
- Lack of efficacy - NOS94 reports
- Vomiting83 reports
- Lethargy (see also Central nervous system depression in 'Neurological')59 reports
- Not eating58 reports
- Elevated alanine aminotransferase (ALT)56 reports
- Weight loss55 reports
- Elevated total bilirubin44 reports
- Decreased appetite43 reports
- Elevated liver enzymes40 reports
- Diarrhoea32 reports
- Anorexia31 reports
- Lack of efficacy (fungi) - NOS29 reports
Monitoring1
Baseline + periodic liver enzymes; trough level 0.5–1 mcg/mL if monitored
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications1
Azole hypersensitivity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions4
Hepatic impairment, achlorhydria; reduced cardiac function (negative inotrope); African Grey parrots extremely sensitive
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Never substitute compounded bulk-powder capsules — documented poor/erratic absorption; use the commercial capsule or oral solution.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Give capsules with food to maximize absorption (oral solution doesn't need food).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Considered more effective and fewer endocrine side effects than ketoconazole, but significantly more expensive.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
H2-blockers, PPIs, antacids — ↓ absorption (needs acidic environment) — separate dosing
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cyclosporine, digoxin — ↑ levels — monitor closely
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Ivermectin — ↑ neurotoxicity risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cisapride — Contraindicated combination (human) — arrhythmia risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Benzodiazepines, corticosteroids, calcium channel blockers — ↑ levels via CYP inhibition
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics6
Bioavailability — Highly food-dependent — ~50% fasted, ~100% fed (capsules)
CatHorseNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Horse · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — Very high
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — ~7h (dog, approved formulation); ~20h (cat)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Extensive hepatic — active metabolite (hydroxyitraconazole)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Elimination — Hepatic/biliary
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Maternotoxic, fetotoxic, teratogenic in lab animals at 5–20x labeled doses. Human FDA category C. Enters milk.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 680–682; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 418–420 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references14
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.
- Eyelid Verrucous Sporotrichosis Caused by Sporothrix Brasiliensis Mimicking Cutaneous Leishmaniasis and Complicated by Drug-Drug Interaction.
Study summary not available in the imported record. Open the original citation to review the study.
- Biogenic Silver Nanoparticle: In vitro antifungal activity against Sporothrix brasiliensis.
Study summary not available in the imported record. Open the original citation to review the study.
- Ozonized sunflower oil as an integrative therapy for feline sporotrichosis: a randomized clinical trial.
Study summary not available in the imported record. Open the original citation to review the study.
- The black aspergilli (Aspergillus niger complex) and their role in human, animal, and plant diseases.
Study summary not available in the imported record. Open the original citation to review the study.
- Chromosome-level genome and transcriptome analysis of Trichophyton verrucosum reveals pathogenicity mechanisms and antifungal response.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.