Simplera Otic Solution for Dogs, 1-mL

Simplera (florenicol, terbinafine, mometasone furoate) Otic Solution for Dogs

Simplera Otic Solution is a veterinary-prescribed medication designed to treat otitis externa (outer ear infections) in dogs. This single-dose, in-office treatment combines antibacterial, antifungal, and anti-inflammatory properties to address infections caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Drugs.com 

What Are the Benefits of Simplera Otic Solution?

• Comprehensive Treatment: Combines three active ingredients—florfenicol (antibacterial), terbinafine (antifungal), and mometasone furoate (anti-inflammatory)—to effectively target and eliminate common pathogens responsible for canine ear infections. 
  
• Single-Dose Convenience: Administered as a one-time dose by a veterinarian, simplifying the treatment process and ensuring compliance.
  Simplera
• Long-Lasting Effect: Provides up to 30 days of therapeutic effect, reducing the need for repeated applications and minimizing stress for both pets and owners. 
  

How to Use Simplera Otic Solution

Simplera should be administered by veterinary personnel. The typical procedure involves:

1. Preparation: Clean and dry the external ear canal before administering the product.
2. Dosage: Administer one dose (1 mL) per affected ear.
3. Application: Insert the tapered tip of the dropperette into the affected external ear canal and squeeze to instill the entire contents. Gently massage the base of the ear to allow distribution of the solution.

It's essential to verify that the tympanic membrane (eardrum) is intact prior to administration. Cleaning the ear after dosing may affect product effectiveness.  

What Are the Ingredients in Simplera Otic Solution?

• Active Ingredients per mL:

  • Florfenicol: 16.6 mg
  • Terbinafine: 14.8 mg (equivalent to 16.6 mg terbinafine hydrochloride)
  • Mometasone furoate: 2.2 mg

• Inactive Ingredients:

  • Purified water
  • Propylene carbonate
  • Propylene glycol
  • Ethyl alcohol
  • Polyethylene glycol

Are There Any Side Effects of Simplera Otic Solution?

While Simplera is generally well-tolerated, some dogs may experience:

• Ear discharge
• Head shaking
• Ataxia (loss of coordination)
• Hearing loss or signs of vestibular dysfunction

If any adverse reactions are observed, contact your veterinarian promptly.  

What Precautions Should Be Taken When Using Simplera Otic Solution?

• For Veterinary Use Only: Not for use in humans or cats.
• Eye Protection: Wear eye protection when administering Simplera, as splatter may occur if the dog shakes its head following administration.
• Tympanic Membrane Integrity: Do not use in dogs with known tympanic membrane perforation.
• Hypersensitivity: Contraindicated in dogs with known or suspected hypersensitivity to florfenicol, terbinafine hydrochloride, or mometasone furoate.
• Breeding and Pregnancy: The safe use of Simplera in dogs used for breeding purposes, during pregnancy, or in lactating bitches has not been evaluated. 
  

Simplera Frequently Asked Questions

1. What is Simplera Otic Solution used for?

Simplera is used to treat otitis externa in dogs caused by susceptible strains of yeast and bacteria. 

2. How long does the effect of Simplera last?

Simplera provides up to 30 days of therapeutic effect after a single administration.  

3. Can Simplera be used in cats?

No, Simplera is not approved for use in cats.  

4. What should I do if my dog shows side effects after using Simplera?

Contact your veterinarian promptly if any adverse reactions are observed.  

5. Is a prescription required for Simplera Otic Solution?

Yes, Simplera is a prescription medication and should be administered by veterinary personnel. 

Additional Resources

For more detailed information, refer to the FDA Approval Announcement for Simplera Otic Solution.