Simplera Otic Solution for Dogs, 1-mL

Single-Dose Ear Infection Treatment for Dogs

Product Description

SIMPLERA Otic Solution is a veterinarian-administered, single-dose ear treatment for dogs with otitis externa caused by susceptible bacteria and yeast. Its triple-action formula combines antibacterial, antifungal, and anti-inflammatory agents to help relieve infection and inflammation for up to 30 days. The convenient single-use dropperette supports treatment compliance while reducing the need for repeated at-home ear medication by pet owners.

Benefits

• Triple-Action Formula: Combines florfenicol, terbinafine, and mometasone to target bacteria, yeast, and inflammation associated with canine otitis externa.
• Convenient Single Dose: Single-use dropperette eliminates daily ear medication routines, improving compliance for dogs and their owners during treatment.
• Long-Lasting Relief: A single administered dose is designed to provide therapeutic effect for approximately 30 days after treatment.
• Vet-Controlled Treatment: Administration by veterinary professionals helps ensure proper dosing, ear evaluation, and appropriate patient selection before use.
• Clinically Proven Results: Field study demonstrated 72.5% treatment success compared with 11.1% in the vehicle control group.

Variants

1 mL single-dose dropperette

Ingredients

Composition Table

Other Ingredients

Purified water, propylene carbonate, propylene glycol, ethyl alcohol, polyethylene glycol.

How to Use

Recommended-Usage Chart

Product Preparation

• Prepare Dropperette: Remove the cap, reverse it onto the tip, twist to break the seal, then attach the applicator nozzle.
• Shake Before Use: Shake the dropperette well before administration to ensure proper mixing of the suspension components.

Dosage & Administration Instructions

• Ear Preparation: Clean and dry the external ear canal thoroughly before administering the solution to improve treatment effectiveness.
• Membrane Verification: Confirm the tympanic membrane (eardrum) is intact before administration to reduce the risk of complications.
• Single Dose Use: Insert the dropperette tip into the ear canal and instill the entire 1 mL contents.
• Massage Ear Base: Gently massage the base of the ear after administration to help distribute the solution.
• Prevent Head Shaking: Hold the dog after application to minimize shaking and reduce the risk of splatter exposure.
• Veterinary Prescription: This medication is restricted for use by a licensed veterinarian or on their order only.

Disclaimer: This dosage information is provided by the manufacturer. Always consult your veterinarian before administering or adjusting any supplement for your pet.

Additional Information

Precautions

• Dogs Only: Product is intended for dogs only and should not be used in cats due to reported adverse reactions.
• Membrane Integrity: Do not use in dogs with known tympanic membrane perforation because of the risk of complications.
• Liver Caution: Use carefully in dogs with poor liver function, as systemic effects may happen.
• Eye Protection: Use eye protection during administration and try to minimize dog head shaking to avoid accidental eye exposure.
• Breeding Safety: The safety has not been evaluated in breeding dogs, pregnant dogs, or lactating females.

Possible Side Effects

• Ear Discomfort: Reported reactions include ear discharge, pain, irritation, and persistent head shaking after administration.
• Balance Issues: Vestibular signs such as ataxia, head tilt, or nystagmus have been reported in treated dogs.
• Hearing Changes: Deafness or internal ear disorders have been reported during post-approval adverse event monitoring.
• Eye Reactions: Corneal ulcers and eye irritation may occur from splatter exposure if the dog shakes its head.
• Digestive Signs: Vomiting has been reported in some dogs following treatment during adverse event monitoring.

Storage Information

• Room Temperature: Store between 20°C and 25°C with permitted excursions between 15°C and 30°C.
• Original Packaging: To maintain integrity, keep the product in its original blister packaging until use
• Child Safety: Keep this medication stored away from children to prevent accidental exposure or ingestion.

Shipping & Return

We offer ground, express, priority, and international delivery; see our shipping policy for details.

For return instructions or product concerns, please refer to our detailed refund policy. 

Prescription items are NON-RETURNABLE and NON-REFUNDABLE.

Frequently Asked Questions

Q1: What conditions does SIMPLERA treat in dogs?

Ans: SIMPLERA is used to treat otitis externa in dogs caused by certain yeasts, like Malassezia pachydermatis, and bacteria, including Staphylococcus pseudintermedius. It contains antibacterial, antifungal, and anti-inflammatory agents to tackle infection and inflammation at the same time in affected ears.

Q2: How long does one dose of SIMPLERA last?

Ans: A single administered dose of SIMPLERA is designed to provide therapeutic effectiveness for approximately 30 days. Cleaning the ear after treatment may reduce product effectiveness, so veterinarians typically recommend avoiding additional ear cleaning unless specifically instructed during the treatment period.

Q3: Can pet owners administer SIMPLERA at home?

Ans: SIMPLERA should be administered by veterinary personnel only because federal law restricts its use to licensed veterinarians or their order. Proper ear examination and confirming an intact tympanic membrane are required before administration to ensure safe and appropriate treatment.

Q4: Is SIMPLERA safe for cats or other pets?

Ans: SIMPLERA is intended for use in dogs only and should not be used in cats. Adverse events have been reported following extra-label use in cats, including neurological and ear-related complications, which is why the product labeling specifically contraindicates feline use.

Q5: What should I monitor after my dog receives SIMPLERA?

Ans: Dog owners should watch for signs like ear pain, irritation, vomiting, head shaking, head tilt, incoordination, or eye discharge after treatment. If any unusual symptoms appear, it’s a good idea to contact a veterinarian right away to assess the dog and decide on the right care.

References

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