Description
Clotrimazole ear drops are used to treat fungus infections in the outer ear (fungal otitis externa or otomycosis). This medicine works by killing the fungus and preventing its growth.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of clotrimazole ear drops in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clotrimazole ear drops in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bedaquiline
- Colchicine
- Dihydroergotamine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Haloperidol
- Lisuride
- Meperidine
- Metergoline
- Methylergonovine
- Methysergide
- Mifepristone
- Nicergoline
- Nifedipine
- Paclitaxel
- Paclitaxel Protein-Bound
- Pimozide
- Roflumilast
- Tacrolimus
- Voriconazole
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Trimetrexate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Proper Use
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine should be used only in the ear. Do not put it into the eyes or nose, and do not take it by mouth. If this medicine is swallowed by accident or gets into your eyes, call your doctor right away.
This medicine comes with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use:
- Wash your hands before and after using this medicine.
- Gently clean any discharge (fluid) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any object in the ear canal.
- Remove the medicine from protective foil pouch. Pull apart 1 single-dose vial by tearing along the dotted lines until it is fully separated.
- Warm the vial in your hands for 1 to 2 minutes. Twist off the vial cap.
- Lie down or tilt your head so that the infected ear faces up. Gently pull the earlobe up and back to straighten the ear canal. Drop the medicine into the ear canal. Let the entire dose of the vial fall into the affected ear. Keep the ear facing up for 1 minute.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. Do not miss any doses.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For otic dosage form (ear drops):
- For ear canal infection:
- Adults—Instill one single-dose vial into the affected ear(s) 2 times a day, about 12 hours apart for 14 days.
- Children—Use and dose must be determined by your doctor.
- For ear canal infection:
Missed Dose
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Do not open the foil pouch until ready to use. Throw away unused vials 30 days after first opening the pouch.
Precautions
It is very important that a doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If your symptoms do not improve within 14 days, or if they become worse, check with your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Headache
Rare
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- continuing ringing or buzzing or other unexplained noise in the ears
- hearing loss
- pain at the application site
- ruptured eardrum
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-80008521
