Description
Ciprofloxacin and dexamethasone combination ear drops is used to treat ear infections, such as acute otitis externa and acute otitis media. Otitis externa, also known as swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful. Otitis media is a middle ear infection in children who have a tube in their eardrum (known as tympanostomy) to prevent having too much fluid in the middle ear.
Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth. Dexamethasone 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.
This product is available in the following dosage forms:
- Suspension
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 Ciprodex® 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 Ciprodex® ear drops to treat outer ear canal infection in the elderly.
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
- Artemether
- Bepridil
- Cisapride
- Desmopressin
- Dronedarone
- Fezolinetant
- Flibanserin
- Levoketoconazole
- Lomitapide
- Mesoridazine
- Pimozide
- Piperaquine
- Praziquantel
- Rilpivirine
- Rotavirus Vaccine, Live
- 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.
- Abametapir
- Acalabrutinib
- Acarbose
- Acecainide
- Adagrasib
- Albiglutide
- Aldesleukin
- Alfentanil
- Alfuzosin
- Alogliptin
- Alosetron
- Alprazolam
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atogepant
- Atorvastatin
- Avacopan
- Avapritinib
- Azathioprine
- Azimilide
- Azithromycin
- Balofloxacin
- Bedaquiline
- Bemiparin
- Bendamustine
- Benzhydrocodone
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
- Alcuronium
- Aminoglutethimide
- Aminolevulinic Acid
- Amlodipine
- Aprepitant
- Atracurium
- Auranofin
- Caspofungin
- Chloroquine
- Diclofenac
- Dutasteride
- Fluindione
- Fosaprepitant
- Fosnetupitant
- Fosphenytoin
- Gallamine
- Hexafluorenium
- Lanthanum Carbonate
- Licorice
- Mavacamten
- Metocurine
- Netupitant
- Ospemifene
- Pancuronium
- Phenytoin
- Probenecid
- Rifapentine
- Ropinirole
- Ropivacaine
- Saiboku-To
- Sildenafil
- Vecuronium
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. .
It is important that the infected ear remain clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.
To use the ear drops:
- Wash hands thoroughly with soap and water
- Hold the bottle in your hands for 1 or 2 minutes to warm the medicine. Cold drops could cause you to become dizzy.
- Shake the bottle well before using it.
- Lie down on your side with your infected ear facing up.
- Drop the prescribed number of drops into the ear. Keep the ear tilted up for 60 seconds.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.
- For patients with middle ear infection with tubes: While the person getting the ear drops lies on their side, the person giving the drops should gently press the small projection in front of the outside opening of the ear 5 times in a pumping motion. This will allow the drops to pass through the tube and into the middle ear.
- For patients with outer ear infection (“swimmer's ear���): While the person getting the ear drops lies on their side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal.
- The person who just had the ear drops should stay on their side for at least one minute. Repeat the above steps if both ears are infected.
- When you have completed your course of therapy (usually 7 days), throw away any unused medicine.
To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you or your child 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 middle ear infection:
- Adults and children 6 months of age and older—4 drops into the affected ear(s) two times a day for 7 days.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For outer ear infection:
- Adults, older adults, and children 6 months of age and older—4 drops into the affected ear(s) two times a day for 7 days.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For middle ear infection:
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
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Protect medicine away from light. Do not freeze.
Precautions
If you or your child feel that your symptoms are 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, 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:
Incidence not known
- Cough
- difficulty with swallowing
- dizziness
- fast heartbeat
- hives, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- tightness in the chest
- unusual tiredness or 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:
Less common
- Ear discomfort
- ear pain
- itching skin on the ear
Rare
- Bitter, sour, or unusual taste in the mouth
- ear congestion
- ear debris
- ear residue
- redness of the skin
- superimposed ear infection (second ear infection)
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.
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