Brand Name

    US Brand Name

    Floxin


    Description

    Ofloxacin belongs to the family of medicines called antibiotics. Ofloxacin otic solution is used to treat infections of the ear canal. It also is used to treat infections of the middle ear in patients with nonintact tympanic membranes (holes or tubes in the eardrums).

    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

    Use is not recommended in infants younger than 1 year of age.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of otic ofloxacin in the elderly with use in other age groups.

    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.

    • Bepridil
    • Cisapride
    • Dronedarone
    • Levoketoconazole
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • 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.

    • Acarbose
    • Acecainide
    • Adagrasib
    • Albiglutide
    • Alfuzosin
    • Alogliptin
    • Alosetron
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amoxapine
    • Anagrelide
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Atazanavir
    • Azimilide
    • Azithromycin
    • Bedaquiline
    • Betamethasone
    • Bretylium
    • Budesonide
    • Buprenorphine
    • Bupropion
    • Buserelin
    • Canagliflozin
    • Ceritinib
    • Chloroquine
    • Chlorpromazine
    • Chlorpropamide
    • Cholera Vaccine, Live
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clofazimine
    • Clomipramine
    • Clothiapine

    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.

    • Aminolevulinic Acid
    • Didanosine
    • Lanthanum Carbonate

    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

    Ofloxacin eardrops comes with patient information and instructions (Medication Guide). Be sure to read these instructions before using the eardrops . If you have any questions, check with your doctor or health care professional.

    To use:

    • Hold the bottle in your hands for 1 or 2 minutes to warm up the solution before putting it in your ear. Otherwise, putting cold solution in your ear could cause you to become dizzy.
    • Wash your hands with soap and water.
    • Gently clean any discharge that can be removed easily from the outer ear, but do not insert any object or swab into the ear canal.
    • If you are using the eardrops for a middle ear infection—Drop the medicine into the ear canal. Then, gently press the tragus of the ear (see the diagram in the Medication Guide) four times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear.
    • If you are using the eardrops for an ear canal infection—Gently pull the outer ear up and back for adults (down and back for children) to straighten the ear canal. This will allow the eardrops to flow down into the ear canal.
    • Keep the ear facing up for about 5 minutes to allow the medicine to come into contact with the infection.
    • If both ears are being treated, turn over after 5 minutes, and repeat the application for the other ear.
    • 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.

    To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. 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 eardrops dosage form:
      • For ear infections:
        • Adults and teenagers (12 years of age and older)—Place 10 drops in each affected ear two times a day for ten to fourteen days, depending on the infection.
        • Children 1 to 12 years of age—Place 5 drops in each affected ear two times a day for ten days.
        • Children younger than 1 year of age—Use and dose must be determined by your doctor.

    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.


    Precautions

    If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

    Oral and systemic ofloxacin and other similar antibiotics have sometimes caused a severe allergic reaction. It is not known if otic ofloxacin may cause this reaction. However, stop using this medicine and check with your doctor immediately if you notice skin rash or itching, shortness of breath, or swelling of the face or neck.


    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

    • Burning, itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

    Check with your doctor as soon as possible if any of the following side effects occur:

    Less common

    • Dizziness

    Rare

    • Bleeding from the ear
    • fast heartbeat
    • fever
    • headache
    • ringing in the ear
    • runny or stuffy nose
    • sore throat

    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

    • Change in taste
    • earache
    • numbness or tingling

    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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