Regulatory product record
OTIZOLE
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- OTIZOLE
- DIN
- 02458888
- DPD drug code
- 94605
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- TOPICAL, OTIC
- Pharmaceutical form(s)
- SUSPENSION
- Ingredients
- PREDNISOLONE ACETATE (5 MG), POLYMYXIN B SULFATE (0.5293 MG), MICONAZOLE NITRATE (23 MG)
- Species (DPD record)
- CATS, DOGS
- Company
- CAN-VET ANIMAL HEALTH SUPPLIES LTD. (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 94605
- 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
Dose regimens0
No dose regimens recorded for this species selection.
Adverse effects600
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
- Vomiting539 reports
- Lack of efficacy - NOS498 reports
- Lethargy (see also Central nervous system depression in 'Neurological')398 reports
- Loss of hearing346 reports
- Diarrhoea296 reports
- Emesis283 reports
- Deafness269 reports
- Other abnormal test result NOS260 reports
- Anorexia254 reports
- Loss of hearing253 reports
- Elevated serum alkaline phosphatase (SAP)219 reports
- Elevated alanine aminotransferase (ALT)197 reports
Cat
- Vomiting183 reports
- Lack of efficacy - NOS150 reports
- Weight loss136 reports
- Lethargy (see also Central nervous system depression in 'Neurological')116 reports
- Anorexia113 reports
- Death by euthanasia109 reports
- Lethargy (see also Central nervous system depression in Neurological)108 reports
- Diarrhoea100 reports
- Not eating94 reports
- Decreased appetite91 reports
- Ataxia76 reports
- Anaemia NOS75 reports
Literature references30
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.
- The efficacy of a novel topical spray composed of sodium benzoate, alcohol and botanical oils for the treatment of Malassezia dermatitis in dogs - a split body, randomised, blinded study.
Study summary not available in the imported record. Open the original citation to review the study.
- Assessment of the mechanism of drug resistance in Trichophyton mentagrophytes in response to various substances.
Study summary not available in the imported record. Open the original citation to review the study.
- Immediate and residual antifungal activity of compounds used for whole body and adjuvant topical therapy against Microsporum canis: an in vitro study.
Study summary not available in the imported record. Open the original citation to review the study.
- Residual antibacterial activity of canine hair treated with topical antimicrobial sprays against Staphylococcus pseudintermedius in vitro.
Study summary not available in the imported record. Open the original citation to review the study.
- Use of itraconazole and either lime sulphur or Malaseb Concentrate Rinse ® to treat shelter cats naturally infected with Microsporum canis: an open field trial.
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.