Florfenicol + Terbinafine + Betamethasone Otic

What is florfenicol + terbinafine + betamethasone otic?

Florfenicol + terbinafine + betamethasone otic (brand name Osurnia®) 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), antifungal (terbinafine), and steroid anti-inflammatory (betamethasone) ingredients.

Florfenicol + terbinafine + betamethasone otic is labeled for use in dogs. It is not intended for use in cats. Use of this medication for any 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 + betamethasone otic?

• Florfenicol + terbinafine + betamethasone otic should only be administered by a veterinary professional.
• This medication comes as 1 mL tubes for individual application.
• This medication requires two applications to each ear, one week apart. It is important to follow this dosing schedule for this medication to be effective.
• Do not clean the ear canal for 45 days after the initial administration to allow the gel to contact the ear canal. Cleaning the ear may decrease effectiveness.
• Prevent your dog or other animals from licking or scratching the area for at least 20 to 30 minutes after application.
• Humans with known hypersensitivity to any of the medicines found in this product should not handle it.
• Use caution when handling this product if you are pregnant and 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.

What if I miss giving my pet the medication?

If you miss a treatment, arrange to have the treatment applied as soon as you remember and then continue with the regular dosing schedule. However, if it is almost time for the next treatment, skip the missed treatment and resume the regular treatment schedule. Do not give the pet two treatments at once.

Are there any potential side effects from florfenicol + terbinafine + betamethasone otic?

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

• Redness or discomfort at the site of application
• Nausea or vomiting

Serious adverse reactions may occur. If any of the following signs develop, stop giving florfenicol + terbinafine + betamethasone 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

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 (betamethasone) 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.

Are there any risk factors for this medication?

DO NOT USE florfenicol + terbinafine + betamethasone 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. 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, discontinue the medication, and contact your veterinarian.

How do I store florfenicol + terbinafine + betamethasone 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.