Regulatory product record
ISADERM GEL
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- ISADERM GEL
- DIN
- 02427850
- DPD drug code
- 91235
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- TOPICAL
- Pharmaceutical form(s)
- GEL
- Ingredients
- FUSIDIC ACID (5 MG), BETAMETHASONE (BETAMETHASONE VALERATE) (1 MG)
- Species (DPD record)
- DOGS
- Company
- DECHRA VETERINARY PRODUCTS A/S (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 91235
- 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.
Dose regimens1
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.
Dose calculation
Species: Species not recorded. Results use the source regimens shown below.
- Review the source route shown below.
- Enter patient weight and its unit.
- For volume, optionally enter a matching label concentration.
Source route: Route not specified
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
- Source regimen: Not available in this source
- Source formulation
- Not specified in this source
- Dose basis
- Not specified in this source
Indication: Not specified in this source field
Manual verification required — this source did not state a per-weight dose this calculator can compute from.
SPL section 34068-7 (DOSAGE & ADMINISTRATION SECTION)
Adverse effects209
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
- Deafness1,427 reports
- Lack of efficacy - NOS1,260 reports
- Vomiting254 reports
- Partial deafness246 reports
- Ear discharge187 reports
- Lethargy (see also Central nervous system depression in 'Neurological')180 reports
- Loss of hearing176 reports
- Diarrhoea140 reports
- Other abnormal test result NOS125 reports
- Head shake - ear disorder121 reports
- Behavioural disorder NOS115 reports
- Head tilt - ear disorder97 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
- Vestibular disorder NOS33 reports
- Deafness31 reports
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
Precautions2
WARNINGS: The use of OTOMAX ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g., geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX ointment immediately and flush the ear canal thoroughly with a nonototoxic solution. Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
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
PRECAUTIONS: Identification of infecting organisms should be made either by microscopic roll smear evaluation or by culture as appropriate. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. If overgrowth of nonsusceptible bacteria, fungi, or yeasts occur, or if hypersensitivity develops, treatment should be discontinued and appropriate therapy instituted. Administration of recommended doses of OTOMAX ointment beyond 7 days may result in delayed wound healing. Avoid ingestion. Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects. Use of corticosteroids, depending on dose, duration, and specific steroid, may result in endogenous steroid production inhibition following drug withdrawal. In patients presently receiving or recently withdrawn from corticosteroid treatments, therapy with a rapidly-acting corticosteroid should be considered in especially stressful situations. Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references38
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.