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 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 + mometasone otic is labeled for use in dogs. It is not intended for use in cats. 

Use of this medication for any other purpose other than that described above is considered off label (extra label). Many drugs are commonly prescribed for off-label use in veterinary medicine. “Off label” means the drug is being used in a way that has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) or Health Canada. In these instances, follow your veterinarian’s directions and cautions carefully, as they may be significantly different from those on the label.

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.
• Humans with known hypersensitivity to any of the medicines found in this product should not handle it.
• Use caution handling this medication if you are pregnant or nursing.
• 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. Florfenicol + terbinafine + mometasone otic is labeled to be effective for up to 30 days in the control of otitis externa (ear infections).

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 recommended to identify underlying physical or environmental causes.

Are there any potential side effects?

Florfenicol + terbinafine + mometasone otic may cause the following side effects:

• Redness or discomfort at the site of application

Serious adverse reactions may occur. If any of the following signs develop, stop giving florfenicol + terbinafine + mometasone otic may and 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 (frequent drinking of large quantities of water) or frequent urination
• Weight loss
• Nausea or vomiting

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 and notify your veterinarian if you have any concerns. 

Other side effects may occur. This medication contains a corticosteroid drug (mometasone) that, when applied to the ears, may have effects on other parts of the body. If you notice anything unusual, contact your veterinarian immediately. This long-acting medication should last for multiple weeks, although effects may last longer in pets with liver or kidney disease. It is labeled to be effective for up to 30 days in the control of otitis externa (ear infections).

Are there any risk factors for this medication?

DO NOT USE forfenicol + terbinafine + mometasone otic in:

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

USE WITH CAUTION in:

• Pets with recurring ear infections
• Pets with impaired liver function
• Pets with 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?

• Your veterinarian will let you know when and how they want to reassess your pet to ensure the medication is working and not causing side effects.
• At home, monitor for any side effects such as those noted above. If any occur, stop using the medication and contact your veterinarian.

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. Be prepared to provide information about the product and your pet’s weight and symptoms. Report any adverse effects to the FDA or Health Canada.