Description
Ciprofloxacin and fluocinolone acetonide combination ear drops is used to treat middle ear infections (also called otitis media) in children 6 months of age and older with tympanostomy tubes.
Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria causing the infection. Fluocinolone acetonide is a steroid medicine that is used to relieve the redness, itching, and swelling caused by ear infections.
This medicine is available only with your doctor's prescription.
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Otovel® ear drops in children. However, safety and efficacy have not been established in children younger than 6 months of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Otovel® ear drops in the elderly.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Agomelatine
- Bepridil
- Cisapride
- Desmopressin
- Dronedarone
- Fezolinetant
- Flibanserin
- Levoketoconazole
- Lomitapide
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Tizanidine
- Ziprasidone
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.
- Acalabrutinib
- Acarbose
- Acecainide
- Adagrasib
- Albiglutide
- Alfentanil
- Alfuzosin
- Alogliptin
- Alosetron
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atorvastatin
- Avapritinib
- Azathioprine
- Azimilide
- Azithromycin
- Bedaquiline
- Bemiparin
- Bendamustine
- Benzhydrocodone
- Betamethasone
- Bosutinib
- Bretylium
- Brigatinib
- Budesonide
- Buprenorphine
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.
- Aceclofenac
- Aminolevulinic Acid
- Amlodipine
- Chloroquine
- Diclofenac
- Dutasteride
- Lanthanum Carbonate
- Phenytoin
- Probenecid
- Rifapentine
- Ropinirole
- Ropivacaine
- Sildenafil
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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Caffeine
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Fungal ear infections in the outer ear or
- Viral ear infections (including herpes simplex virus) in the outer ear—Should not be used in patients with these conditions.
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 come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine should be used only in the ear. Do not put it in the eyes or nose, and do not take it by mouth or inject it. If this medicine is swallowed by accident or gets in your eyes, call your doctor right away.
To use the ear drops:
- Wash hands thoroughly with soap and water.
- Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any other object in the ear canal.
- Remove the medicine from the foil pouch. Do not open the foil pouch until you are ready to use it.
- Pull apart 1 single dose vial. Hold the vial in your hands for 1 or 2 minutes to warm the medicine. Cold drops could cause you to become dizzy.
- Lie down on your side with your infected ear facing up.
- Twist off the vial cap to open. Drop the entire contents of one vial and pump the tragus 4 times.
- Keep the ear tilted up for 1 minute.
- If necessary, use another vial for the other ear and repeat the same steps.
- Throw away the opened vials after use.
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 acute otitis media with tympanostomy tubes:
- Adults and children 6 months of age and older—0.25 milliliter (1 vial) two times a day for 7 days. Each dose should be 12 hours apart.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For acute otitis media with tympanostomy tubes:
Missed Dose
If you miss a dose of this medicine, take 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. Do not double doses.
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.
Upon opening the foil pouch, use the vials within 7 days.
Precautions
If you or your child feel that your symptoms do not improve after 7 days, or if they have become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, loss of consciousness, or any swelling of your hands, face, or mouth while you are using this medicine.
Call your doctor right away if you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with this medicine.
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:
Rare
- Change in hearing
- ear drainage
- earache or pain in the ear
- fever
- loss of balance
Incidence not known
- Chest pain or discomfort
- cold, clammy, pale skin
- confusion
- dizziness
- fast heartbeat
- hearing loss
- hives or welts, itching, or skin rash
- hoarseness
- irregular heartbeats
- irritation
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of consciousness
- redness of the skin
- ringing or buzzing or other unexplained noise in the ears
- trouble breathing or swallowing
- weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Change in taste
- feeling of warmth
- headache
- loss of taste
- redness of the face, neck, arms, and occasionally, upper chest
- tingling in the ears
- white patches in the mouth or throat or on the tongue
- white patches with diaper rash
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-20425892
