Florfenicol/Terbinafine/Mometasone: Otic

What is florfenicol/terbinafine/mometasone otic?

Florfenicol/ terbinafine/mometasone otic (brand names: Claro®, Simplera®) is a long-acting, topical ear medication used to treat the itching and inflammation associated with susceptible bacterial (Staphylococcus pseudintermedius) and/or yeast (Malassezia pachydermatis) ear infections in dogs. It contains a combination of anti-bacterial (Florfenicol), anti-fungal (Terbinafine) and steroid anti-inflammatory (Mometasone) ingredients. 

Florfenicol/terbinafine/betamethasone otic is labeled for use in dogs. It is not intended for use in cats.

If this medication is used for any other purpose other than that described above, it is considered “off-label use.” “Off label” means the drug is being used in a way that has not been reviewed or approved by the FDA or Health Canada. In these instances, follow your veterinarian’s directions and cautions as they may be significantly different from those on the label or this handout.

How do I give my pet florfenicol/terbinafine/mometasone otic?

Florfenicol/ terbinafine/mometasone otic should only be administered by a veterinary professional. 

• This medication requires one application to each affected ear. Florfenicol/terbinafine/mometasone otic is labeled to be effective for up to 30 days in the control of otitis externa (ear infections).

Precautions for humans exposed to florfenicol/terbinafine/mometasone otic:

• Humans with known hypersensitivity to any of the medicines found in this product should not handle it.
• Pregnant and nursing women should use caution when handling.
• In case of accidental human skin exposure: wash areas immediately.
• In case of accidental human ingestion: contact your physician immediately.
• In case of accidental eye exposure: flush eyes thoroughly with water for at least 15 minutes.

This medication will take effect quickly, in about 1 to 2 hours, but its effects may not be noticeable for a few days.

What if I miss giving my pet the medication?

Florfenicol/terbinafine/mometasone otic is usually given by veterinary personnel as a single-dose medication, without requiring further doses to be given at home. If the ear infection is not resolving, additional testing is usually recommended to identify underlying physical and/or environmental causes. 

Are there any potential side effects from florfenicol/terbinafine/mometasone otic?

Florfenicol/terbinafine/betamethasone may cause the following side effects:

• redness or discomfort at the site of application

The following reactions are less likely to occur but are more serious; if noted, contact your veterinarian immediately:

• worsening or severe redness or discomfort at the site of application or on the ear flap
• ear discharge
• infections that do not respond to treatment, do not appear to be healing, or are getting worse
• loss of appetite, persistent vomiting, or diarrhea
• sudden hearing loss
• progressive ear pain
• head tilt, walking in circles, loss of balance or abnormal eye movements
• discharge or changes in the appearance of the eye
• development of sores around the mouth
• increased thirst (e.g., frequent drinking of large quantities of water) and/or frequent urination)
• weight loss
• nausea or vomiting

Other side effects may occur. If you notice anything unusual, contact your veterinarian immediately. This medication contains a corticosteroid drug (mometasone) that, when applied to the ears, may have effects on other parts of the body. 

Drug sensitivities can develop over time with repeated exposure. Your pet may have no reaction after the first few doses but may develop a sensitivity later. It is important to watch for signs of an allergic reaction over the entire course of treatment.

The effects of this medication are long-lived, meaning they may last for multiple weeks, although the effects can be longer in pets with liver or kidney disease. 

Are there any risk factors for this medication?

This medication should NOT BE USED in pets who:

• are allergic to it
• have a confirmed or suspected ruptured ear drum
• are pregnant, nursing, or used for breeding

This medicine should be USED WITH CAUTION in pets who:

• have recurring ear infections
• have impaired liver function
• have certain types of liver disease

Are there any drug interactions I should be aware of?

There are no documented drug interactions for this medication; however, cleaning the ears within 30 days of application can reduce its effectiveness.

Be sure to tell your veterinarian about any medications (including vitamins, supplements, or herbal therapies) that your pet is taking before starting any new treatment.

Is any monitoring needed with this medication?

At home, monitor for any side effects, such as those noted above. If side effects occur, discontinue the medication, and contact your veterinarian.

Follow your veterinarian’s recommendations regarding:

• when will your animal need to be rechecked
• what tests may need to be performed prior to and during treatment with this drug

How do I store florfenicol/terbinafine/mometasone otic?

You will not need to store this medicine at home, because it is administered by veterinary personnel.

What should I do in case of emergency?

If you suspect an adverse reaction to the medication, call your veterinary office immediately. If they are not available, follow their directions in contacting an emergency facility.