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CONTRIBUTOR(S): Vetstream Ltd, Linda Horspool, Fear Free,

Medication: Terbinafine

Medication: Terbinafine

Your dog has been prescribed terbinafine as part of a combination product for the treatment of otitis externa or as oral tablets (not approved for veterinary use) for the treatment of cutaneous and systemic fungal infections in dogs.

Key points:
• Anti-fungal agent.
• Do not use in dogs weighing less than 1.2 kg (ear gel, Europe & UK) or 4 kg (ear drops solution, Europe & UK) as safety has not been established.
• Do not use in dogs younger than 2 months old (ear gel, Europe & UK).
• Do not use in pregnant, lactating or breeding animals.
• Do not use oral products in dogs with active or chronic liver disease or impaired kidney function.
• Do not use ear products in dogs with generalized demodicosis (demodectic mange).
• Do not use ear products if your dog’s eardrum is perforated.
• Combination product contains a corticosteroid and should be used with care in in dogs with a suspected or confirmed endocrine disorder (eg diabetes mellitus, hypothyroidism).
• Dosage: one dose of long-acting ear solution or two doses at 7 days intervals.

This information sheet is designed to help answer commonly asked questions and help you give the medication safely and effectively to your pet. It does not contain all available information for this medication. If you have other questions or need more information, contact your veterinarian or pharmacist. Always follow the dosing instructions provided by your veterinarian. 

Name, Brand names, Class of medication and Storage

Name
  • Terbinafine.
Brand name
  • Claro® (otic solution) (US).
  • Lamisil® (for use in humans) (Europe & UK, US).
  • Neptra® (ear drops solution) (Europe & UK).
  • Osurnia® (ear gel) (Europe & UK, US).
  • DuOtic™ (ear gel) (US)
Class of medication
  • Allylamine antifungal agent.
Storage
  • Ear drops solution: store at room temperature (15-30°C; 59-86°F).
  • Ear gel: store in a refrigerator (2- 8°C; 36-46°F).
  • Tablets: store below 25°C or 75°F. Protect from light.

Why has my dog been prescribed terbinafine?

Your veterinarian has prescribed terbinafine for the treatment of:

  • Acute otitis externa (external ear disease) and acute flare-ups of recurrent otitis externa associated with Staphylococcus pseudointermedius and Malassezia pachydermatis.
  • Cutaneous and systemic fungal infections like Malassezia dermatitis and dermatophytosis (ringworm) where systemic therapy is needed and licensed drugs are not suitable.

How is the medication given?

Combination products for treating otitis externa (external ear disease) in dogs are available for in-clinic application of one tube per affected ear. The otic drops solution (also contains florfenicol and mometasone furoate, Neptra® or Claro®) is a single dose. The otic gel (also contains betamethasone acetate and/or florfenicol, DuOtic® or Osurnia®) is administered as two doses at an interval of 7 days.

Terbinafine is either given orally as a tablet or granules for systemic (whole body) treatment or topically as a cream, gel or spray. Terbinafine tablets or granules should be given with food, especially if vomiting is a problem.

Are there any side-effects or drug interactions?

Ear treatment

Wet ears or clear discharge can be observed after treatment.

Ear product application may be followed by vocalization, head shaking and application site pain. Because ear infections can be painful, your veterinarian may recommend pain medication as part of the treatment plan and sedation for administration of the drops or gel formulations. Other signs reported very rarely include eye disorders (like irritation, conjunctivitis, corneal ulcer and keratoconjunctivitis sicca / dry eye), ear discharge, ear irritation and pain, vomiting, head shaking, vomiting, internal ear disorder / head tilt, ataxia, vocalization, corneal ulcer, keratoconjunctivitis sicca, nystagmus, tympanic rupture, and facial paralysis.

Deafness or impaired hearing, usually temporary, have been reported in dogs.

Compatibility with ear cleaners has not been demonstrated.

Other treatment routes

Studies in veterinary patients are limited. Vomiting, diarrhea, excessive panting and increased liver enzymes may be seen following oral administration.

There are little or no data on interactions after oral terbinafine administration to dogs. Many other drugs are removed from the body via the same inactivation pathway as terbinafine and there is potential for a drug interaction – examples include like selegiline (an MAO inhibitor); clomipramine (a tricyclic antidepressant), and fluoxetine (a selective serotonin reuptake inhibitor). Terbinafine may facilitate the removal of cyclosporine (an immune-modulator used in the treatment of allergy and immune-mediated diseases as well as allergy) from the body making the cyclosporine less effective. Concurrent use of cimetidine (an antacid) will increase the amounts of terbinafine by slowing its removal from the body.

How long will my dog need to receive this medication?

The ear drops solution is applied once in-clinic by your veterinarian. The ear gel is applied twice in-clinic by your veterinarian with 7 days between doses. The maximum clinical response may not be seen until 28 days after the single dose treatment and 21 days after the second ear gel dose. Your dog’s ears should be cleaned prior to initial treatment and not repeated until 28-45 days after the first application (varies between products).

The tablets are given once daily (20-40 mg/kg) on a week on/week off schedule and are best given with food.

How should I dispose of this medication if I don’t use it all?

Dispose of any terbinafine safely – do not flush down the toilet or sink. Ask your veterinary team if they take back medication for disposal. Do not save terbinafine for future use or give to other pets.

What if I miss a dose or give an extra dose?

For oral tablets, if it is suspected that any of the dose has been lost or if vomiting occurs within 2 hours of oral administration, re-dose with another full dose. If you miss a dose, give the dose as soon as possible but do not double up a dose. Make sure the dose given doesn’t exceed the total recommended amount in any 24-hour period.

My dog is unwell, should I still give the drug?

Contact your veterinarian if you think that your dog has experienced hearing loss (possibly associated with eardrum rupture), head tilt, loss of balance or other neurological signs after ear treatment.

If your pet is unwell, contact your veterinarian for advice.

What should I do if this medication is accidentally given to another pet or taken by a human?

Terbinafine should only be given to the dog that it has been prescribed for:

  • Do not use in cats – use has not been evaluated and is associated with neurological signs in this species.
  • Do not use ear products in dogs with generalized demodicosis (demodectic mange).
  • Do not use ear products if your dog’s eardrum is perforated.
  • Do not use in dogs weighing less than 1.2 kg (ear gel) or 4 kg (ear drops solution) as safety has not been established.
  • Do not use in dogs younger than 2 months old (ear gel).
  • Do not use oral products in dogs with active or chronic liver disease or impaired kidney function.
  • Serious eye irritation can result if the ear medication accidentally gets into your eyes (eg when your dog shakes its head) or your dog’s eyes during or just after application.
  • Do not use in breeding, pregnant or lactating dogs.
  • Ear products may cause eye injury and irritation in humans. In case of accidental ocular exposure, flush the eyes thoroughly with water for 10 to 15 minutes. If symptoms develop, seek medical advice and show the package leaflet or the label to the physician.

If tablets are accidentally consumed by a human, speak to your primary care physician or poison control center.

Will my dog need to be monitored while on terbinafine?

Before and during oral treatment with terbinafine tablets, blood tests may be taken to monitor complete blood count (CBC), kidney and liver function tests when terbinafine is prescribed systemically.

Further information

If you have any concerns, further information on terbinafine can be found on the package insert and the following websites:

Europe & UK

USA

Always follow the recommended dosage and contact your veterinary team or pharmacist if you have any questions regarding your dog’s medication.

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