Regulatory product record
SIMPLERA
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
- SIMPLERA
- DIN
- 02555670
- DPD drug code
- 104442
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- OTIC
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- MOMETASONE FUROATE (2.2 MG), FLORFENICOL (16.6 MG), TERBINAFINE HYDROCHLORIDE (16.6 MG)
- Species (DPD record)
- DOGS
- Company
- VETOQUINOL N A INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 104442
- 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.
Indications11
BRD (Mannheimia, Pasteurella, Histophilus); footrot (label)
CattleOn-label (ON_LABEL)1 source record · View provenance
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: BRD (Mannheimia, Pasteurella, Histophilus); footrot (label) — Authorized (Nuflor label)
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Respiratory disease (label)
SwineOn-label (ON_LABEL)1 source record · View provenance
- Swine · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Respiratory disease (label) — Authorized
- Swine · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Susceptible infections when avoiding chloramphenicol's myelotoxicity (the design logic — no human aplastic-anemia link)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible infections when avoiding chloramphenicol's myelotoxicity (the design logic — no human aplastic-anemia link) — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Susceptible infections when avoiding chloramphenicol's myelotoxicity (the design logic — no human aplastic-anemia link) — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dermatophytosis, Malassezia dermatitis (adjunct), nasal aspergillosis (adjunct with topical therapy)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Dermatophytosis, Malassezia dermatitis (adjunct), nasal aspergillosis (adjunct with topical therapy) — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Dermatophytosis, Malassezia dermatitis (adjunct), nasal aspergillosis (adjunct with topical therapy) — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis nixiFLOR™ is indicated for treatment of bovine respiratory disease (BRD) associated withand, and control of BRD-associated pyrexia in beef and non-lactating dairy cattle.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens15
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 effects617
Anorexia, ↓water intake, diarrhea, injection-site reactions (trim loss) — Cattle label events
CattleNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cat retinopathy/blindness (overdose) — Dose-discipline consequence
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Painful IM — Route effect
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Transient anorexia/fever — Occasional
CattleNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cattle · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Vomiting, inappetence, diarrhea — Most common
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — 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 - NOS1,930 reports
- Lack of efficacy - NOS1,897 reports
- Deafness896 reports
- Lack of efficacy - NOS814 reports
- Vomiting563 reports
- Vomiting546 reports
- Vomiting535 reports
- Ear discharge455 reports
- Ear discharge451 reports
- Ataxia438 reports
- Head tilt - ear disorder435 reports
- Ataxia434 reports
Cat
- Ataxia357 reports
- Ataxia356 reports
- Ataxia306 reports
- Horner's syndrome242 reports
- Horner's syndrome242 reports
- Anorexia189 reports
- Anorexia187 reports
- Horner's syndrome174 reports
- Third eyelid protrusion165 reports
- Third eyelid protrusion165 reports
- Anorexia160 reports
- Head tilt - ear disorder151 reports
Monitoring2
Clinical response; injection sites; cats: vision/neuro signs (retinopathy early); withdrawal compliance
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Baseline liver enzymes, periodic if long-term
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications7
IV route; veal/breeding cattle (manufacturer); hypersensitivity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Hypersensitivity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Precautions Do not use in dogs with known tympanic membrane perforation (see). Klentz is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions Do not use in dogs with known tympanic membrane perforation (see). CLARO is contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions19
Not for lactating dairy (US label era); prolonged dosing = marrow-class watch (theoretical)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
The F-for-NO₂ swap is the whole drug: chloramphenicol spectrum without the human aplastic-anemia handler risk — which is exactly why it could become a cattle label workhorse while chloramphenicol got food-animal-banned.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cat precision rule: 22 mg/kg q12h works, ~20 mg/kg retinopathy territory — thin margin, compounding-grade care.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Resflor Gold pairs the antibiotic with flunixin in one shot — convenient, but remember you're also giving an NSAID (withdrawal + contraindication inheritance).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Active/chronic liver disease, significant renal impairment (manufacturer does not recommend use)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
50S competitors (erythromycin/lincosamides/chloramphenicol) — Antagonism
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Warfarin (class) — Effect ↑
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cyclosporine — May ↑ cyclosporine elimination (↓ levels) — opposite direction from azoles
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Rifampin — ↑ terbinafine clearance
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Beta-blockers, MAOIs (amitraz, selegiline), SSRIs, TCAs — Shared CYP2D6 pathway — potential interaction
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics11
Mechanism — 50S ribosome (chloramphenicol-class) with F– replacing the NO₂ group → retains spectrum, loses the human aplastic-anemia linkage
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cats — Retinotoxicity at overdose — the feline caution unique among species
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Withdrawals — Route-dependent (IM shorter than SC; SR longest)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Bioavailability — >46% (dog); ~31% (cat)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — >99% (human data)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations2
Do not give to veal calves or breeding-age cattle (manufacturer restriction) — fetal/testicular phenicol effects.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 526–528 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
No overt teratogenicity in rabbit/rat studies at high doses, but not established as safe. Human FDA category B; manufacturer recommends against use while nursing (7x plasma levels in milk).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 1100–1101; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 792–793 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references31
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.
- Effect of using mannan-oligosaccharides and β-glucans as feed additives on growth, biochemical parameters, and immunity of Salmonella enterica serovar Enteritidis-challenged turkey.
Study summary not available in the imported record. Open the original citation to review the study.
- Discontinuation of prophylactic antimicrobial use in calves restores susceptibility in bovine respiratory pathogens.
Study summary not available in the imported record. Open the original citation to review the study.
- Single-Cell-Derived Rabbit mAb-Based Immunoassay for Simultaneous Detection of Florfenicol and Florfenicol Amine.
Study summary not available in the imported record. Open the original citation to review the study.
- Timing of florfenicol administration determines the protective efficacy of an Actinobacillus pleuropneumoniae live attenuated vaccine in pigs.
Study summary not available in the imported record. Open the original citation to review the study.
- Actinobacillus pleuropneumoniae in Korea (2015-2025): serovar distribution, toxin gene profiles, antimicrobial resistance, and identification of an apxIICA-deficient serovar 15 profile.
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.