Regulatory product record
TOPAGEN
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
- TOPAGEN
- DIN
- 00602841
- DPD drug code
- 6528
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- TOPICAL
- Pharmaceutical form(s)
- SPRAY
- Ingredients
- GENTAMICIN (GENTAMICIN SULFATE) (0.57 MG), BETAMETHASONE (BETAMETHASONE VALERATE) (0.284 MG)
- Species (DPD record)
- DOGS
- Company
- INTERVET CANADA CORP (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 6528
- 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
Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia)
DogCatExtra-label (EXTRA_LABEL)2 source records · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia) — FDA-approved parenteral (dogs/cats); often extra-label by regimen
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Serious gram-negative aerobic infections / staphylococci when safer drugs lack susceptibility or empiric coverage is urgent (sepsis, soft tissue/orthopedic, bacteremia) — FDA-approved parenteral (dogs/cats); often extra-label by regimen
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Brucellosis combination protocol (with minocycline/doxycycline)
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Brucellosis combination protocol (with minocycline/doxycycline) — Extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — 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 effects403
Nephrotoxicity — worse than amikacin — Tubular necrosis; usually reversible if stopped early
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Ototoxicity — leans VESTIBULAR (vs amikacin's auditory) — May be irreversible
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neuromuscular blockade — Myasthenia gravis risk
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — 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
- Deafness2,101 reports
- Deafness1,427 reports
- Lack of efficacy - NOS1,260 reports
- Loss of hearing623 reports
- Temporary deafness489 reports
- Partial deafness384 reports
- Vomiting343 reports
- PR-EAR(S), LESION(S)321 reports
- Lack of efficacy - NOS298 reports
- Vomiting254 reports
- Partial deafness246 reports
- Lethargy (see also Central nervous system depression in 'Neurological')208 reports
Cat
- Ataxia77 reports
- Horner's syndrome73 reports
- Third eyelid protrusion58 reports
- Anorexia47 reports
- Not eating47 reports
- Anisocoria41 reports
- Head tilt - ear disorder41 reports
- Lethargy (see also Central nervous system depression in 'Neurological')41 reports
- Weight loss40 reports
- Vomiting35 reports
- Ataxia34 reports
- Vestibular disorder NOS33 reports
Monitoring1
Urine sediment + BUN/creatinine q2–3 days; serum levels if extended therapy (peak/trough); hearing/vestibular watch in cats
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications1
CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.
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
Gentamicin assay artifact: beta-lactams falsely lower stored-sample levels — freeze samples, draw at beta-lactam trough.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Same risk set as amikacin: renal disease, neonate/geriatric, dehydration/fever/sepsis, working dogs, sighthounds (reduce dose); rabbits contraindicated
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Gentamicin = vestibular ototoxicity; amikacin = auditory — either can do both, but the exam leans this way. Cats: vestibular sensitivity.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Once-daily dosing logic identical to amikacin (peaks drive kill; low troughs spare the kidney) — exceptions: neutropenia (q8h), renal impairment (extend interval + TDM).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Brucellosis protocol: gentamicin 5 mg/kg SC q24h weeks 1 & 4 + minocycline (or doxycycline) 25 mg/kg PO q24h × 4 weeks, repeated courses with serologic monitoring.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions5
Loop/osmotic diuretics (furosemide, torsemide, mannitol) — ↑ nephro/ototoxicity
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Other nephrotoxins (amphotericin B, cisplatin, polymyxin B, vancomycin) — Additive renal injury
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Cephalosporins — Possible additive nephrotoxicity (historical, cephaloridine/cephalothin era)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Beta-lactams — Synergy (Pseudomonas) — separate in vitro mixing; in-vivo inactivation in renal failure
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Neuromuscular blockers/anesthetics — Potentiated blockade
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics2
Class PK — As amikacin: extracellular distribution, renal elimination unchanged, negligible oral absorption
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — Short (~1–2 h small animals), prolonged in renal failure
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Category C / class C — last resort; fetal ototoxicity possible; milk passage.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 567–569; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 353–354 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references33
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.
- A Randomised Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Two-Dose Topical Terbinafine and Betamethasone Gel for the Treatment of Yeast (Malassezia pachydermatis) Otitis Externa in Dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Treatment of canine otitis externa: a randomized, double-blinded, clinical field study comparing the hydrocortisone aceponate monotherapy to a multi-agent reference product.
Study summary not available in the imported record. Open the original citation to review the study.
- Comparable organs weights and histopathological changes after administration of dexamethasone during pregnancy in rats.
Study summary not available in the imported record. Open the original citation to review the study.
- Inhibitory effect of the water-soluble retinoid X receptor partial agonist CAt-PMN on allergic conjunctivitis-like responses in mice.
Study summary not available in the imported record. Open the original citation to review the study.
- Pharmacokinetics and Anti-Inflammatory Effects of Intramuscular Betamethasone in Exercised Thoroughbred Horses.
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.