Regulatory product record
DUOTIC
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
- DUOTIC
- DIN
- 02556529
- DPD drug code
- 104521
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- OTIC
- Pharmaceutical form(s)
- GEL
- Ingredients
- BETAMETHASONE ACETATE (1 MG), TERBINAFINE (10 MG)
- Species (DPD record)
- DOGS
- Company
- DECHRA LTD (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 104521
- 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
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
BETAVET is indicated for the control of pain and inflammation associated with osteoarthritis in horses.
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 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 effects408
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
↑ Liver enzymes — Possible, more with continuous high-dose vs. pulse dosing
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
Facial pruritus — Reported
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- 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
Lethargy — Case report
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- 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
Adverse reactions reported during a field study of 239 horses of various breeds which had been administered either BETAVET (n=119) or a saline control (n=120) are summarized in Table 1. One BETAVET treated horse was removed from the study for onset of acute non-weight bearing lameness on Day 4. Treatment for presumed joint sepsis was instituted immediately, but the horse was eventually euthanized several weeks later due to a thromboembolic event associated with prolonged intravenous catheter placement. One BETAVET treated horse developed bilateral forelimb lameness on Day 8, with snow packed in the shoes and poor hoof conformation noted by the investigator. The horse was diagnosed with laminitis. Radiographs showed no abnormalities, and the horse was sound shortly after shoeing changes were implemented. Table 1. Adverse Reactions Adverse Reaction Number (%) of BETAVETtreatedhorses Number (%)of saline treatedhorses Acute joint effusionand/or local injection site swelling (within 2 days of injection) 18 (15%) 16 (13%) Increased lameness(within the first 5 days) 8 (6.7%) 10 (8.3%) Loose stool 7 (5.9%) 10 (8.3%) Increased heat in joint 3 (2.5%) 6 (5%) Depression 7 (5.9%) 2 (1.6%) Agitation/anxiety 5 (4.2%) 3 (2.5%) Delayed swelling of treated joint (5 or moredays after injection) 3 (2.5%) 4 (3.3%) Inappetance 4 (3.4%) 3 (2.5%) Dry stool 2 (1.7%) 0 (0%) Excessive sweating 1 (0.8%) 0 (0%) Acute non-weightbearing lameness 1 (0.8%) 0 (0%) Laminitis 1 (0.8%) 0 (0%)
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- 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
- Lack of efficacy - NOS1,930 reports
- Vomiting563 reports
- Ear discharge455 reports
- Ataxia438 reports
- Head tilt - ear disorder435 reports
- Head shake - ear disorder383 reports
- Corneal ulcer353 reports
- Deafness346 reports
- Lethargy (see also Central nervous system depression in 'Neurological')344 reports
- Behavioural disorder NOS315 reports
- Nystagmus313 reports
- Loss of hearing264 reports
Cat
- Ataxia356 reports
- Horner's syndrome242 reports
- Anorexia187 reports
- Third eyelid protrusion165 reports
- Head tilt - ear disorder151 reports
- Anisocoria143 reports
- Not eating124 reports
- Vestibular disorder NOS116 reports
- Nystagmus110 reports
- Falling103 reports
- Lethargy (see also Central nervous system depression in 'Neurological')103 reports
- Head shake - ear disorder89 reports
Monitoring1
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
Contraindications3
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
BETAVET is contraindicated in horses with hypersensitivity to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis.
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 perforation (see). Do not use in dogs with a hypersensitivity to terbinafine or corticosteroids.
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
Precautions7
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
Comparatively few drug interactions vs. azole antifungals — doesn't work through CYP3A/steroidogenesis pathway, so it's often better tolerated in animals on multiple other medications.
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 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Veterinary doses are much higher than human doses (30–40 mg/kg vs. human ~3–6 mg/kg) — do not extrapolate from human dosing.
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 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pulse dosing in cats (1 week on, 3 weeks off) can be as effective as continuous dosing with fewer GI/hepatic side effects.
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 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not use in horses intended for human consumption. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroids in pregnant animals, the possible benefits to the pregnant animal should be weighed against potential hazards to its developing embryo or fetus. Human Warnings: Not for use in humans. For use in animals only. Keep this and all medications out of the reach of children. Consult a physician in the case of accidental human exposure.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Interactions3
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
Pharmacokinetics7
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
Half-life — 8.6h (dog); 8.1h (cat)
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
Metabolism — Hepatic (CYP2D6-shared pathway)
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
Elimination — Hepatic
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
Pregnancy / lactation considerations1
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 references22
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.
- Clinical safety and efficacy of a single-dose gentamicin, posaconazole and mometasone furoate otic suspension for treatment of canine otitis externa.
Study summary not available in the imported record. Open the original citation to review the study.
- One percent of the clinical dose used for antenatal steroid therapy is sufficient to induce lung maturation when administered directly to the preterm ovine fetus.
Study summary not available in the imported record. Open the original citation to review the study.
- Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Study summary not available in the imported record. Open the original citation to review the study.
- Antenatal corticosteroids: a reappraisal of the drug formulation and dose.
Study summary not available in the imported record. Open the original citation to review the study.
- The duration of fetal antenatal steroid exposure determines the durability of preterm ovine lung maturation.
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.