Neomycin, polymyxin b, and dexamethasone (ophthalmic route)


    Brand Name

    US Brand Name

    Maxitrol


    Description

    Neomycin, polymyxin B, and dexamethasone combination is used to treat eye infections and inflammation, including conjunctivitis and chronic anterior uveitis. It also prevents damage caused by chemicals, radiation, or foreign objects entering the eye.

    Neomycin and polymyxin B belong to the class of medicines known as antibiotics. They work 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 eye 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 neomycin, polymyxin B, and dexamethasone eye drops in children 2 years of age and older. Safety and efficacy have not been established in children younger than 2 years of age.

    Appropriate studies have not been performed on the relationship of age to the effects of neomycin, polymyxin B, and dexamethasone eye ointment 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 neomycin, polymyxin B, and dexamethasone eye drops and eye ointment 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.

    • Artemether
    • Desmopressin
    • Praziquantel
    • Rilpivirine
    • Rotavirus Vaccine, Live

    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
    • Alcuronium
    • Aldesleukin
    • Alfentanil
    • Amiodarone
    • Apalutamide
    • Aspirin
    • Atogepant
    • Atracurium
    • Avacopan
    • Balofloxacin
    • Bemiparin
    • Benzhydrocodone
    • Besifloxacin
    • Boceprevir
    • Buprenorphine
    • Bupropion
    • Carbamazepine
    • Ceritinib
    • Cholestyramine
    • Cidofovir
    • Ciprofloxacin
    • Cisatracurium
    • Clarithromycin
    • Cobicistat
    • Codeine
    • Colistimethate Sodium
    • Conivaptan
    • Cosyntropin
    • Cyclosporine
    • Dabrafenib
    • Daclatasvir
    • Darunavir
    • Decamethonium
    • Desogestrel
    • Dienogest
    • Dihydrocodeine
    • Diltiazem
    • Doxacurium
    • Doxorubicin

    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.

    • Alcuronium
    • Aminoglutethimide
    • Aprepitant
    • Atracurium
    • Auranofin
    • Bumetanide
    • Caspofungin
    • Fluindione
    • Fosaprepitant
    • Fosnetupitant
    • Gallamine
    • Hexafluorenium
    • Licorice
    • Metocurine
    • Netupitant
    • Ospemifene
    • Pancuronium
    • Rifapentine
    • Saiboku-To
    • 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    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:

    • Cataract or
    • Cornea (part of the eye) problems, history of or
    • Glaucoma or
    • Sclera (part of the eye) problems, history of—Use with caution. May make these conditions worse.
    • Cataract surgery, recent—May cause side effects to become worse.
    • Eye infection with pus—Use with caution. Dexamethasone may mask or enhance the infection.
    • Fungal eye infection or
    • Herpes simplex eye infection or
    • Smallpox eye infection or
    • Tuberculosis eye infection or
    • Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

    Proper Use

    Use this medicine only 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 too much medicine being absorbed into the body and the chance of side effects.

    To use the eye drops:

    • Wash your hands first with soap and water.
    • Shake the bottle well before each use.
    • Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space.
    • Let go of the eyelid and gently close your eye. Do not blink. Keep the eye closed and apply pressure to the inner corner of your eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
    • If you think you did not get the drop of medicine into your eye properly, use another drop.
    • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Keep the bottle tightly closed.

    To use the eye ointment:

    • Wash your hands first with soap and water.
    • Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Place a small amount (about 1/2 an inch) of ointment into this space.
    • Look down before closing your eye. Apply pressure to the inner corner of your eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
    • To keep the medicine as germ-free as possible, do not touch the tip of the tube to any surface (including the eye). Keep the tube tightly closed.

    To help clear up your infection completely, keep using this medicine for the full treatment time 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 eye infections:
      • For ophthalmic dosage form (eye drops):
        • Adults and children 2 years of age and older—Use one or two drops in the affected eye 4 to 6 times a day. Your doctor may tell you to use the drops more often during severe infections.
        • Children younger than 2 years of age—Use and dose must be determined by your doctor.
      • For ophthalmic dosage form (eye ointment):
        • Adults—Apply a small amount (about 1/2 an inch) into the eye 3 or 4 times a day.
        • Children—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

    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.

    This medicine may also be stored in the refrigerator or in a cool dry place.


    Precautions

    Your eye doctor will want to examine your eyes at regular visits to make sure this medicine is working properly and to check for unwanted effects, especially if you will be using this medicine for 10 days or longer.

    This medicine may cause blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous.

    If your symptoms do not improve within a few days or if they become worse, check with your eye doctor (ophthalmologist) right away.

    Check with your doctor right away if you have an eye injury, eye infection, or plan to have eye surgery.


    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:

    For eye drops and eye ointment

    Incidence not known

    • Blindness
    • blurred vision
    • change in vision
    • decreased vision
    • eye pain
    • headache
    • nausea or vomiting
    • slow wound healing

    For eye drops

    Incidence not known

    • Burning, dry, itching eyes
    • discharge, excessive tearing
    • eye redness, irritation, or pain
    • increase in blood flow to the whites of the eyes
    • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

    For eye ointment

    Incidence not known

    • Blurred vision or other change in vision
    • eye pain
    • redness of the eye
    • sensitivity of the eye to light
    • tearing in the eye

    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:

    For eye drops and eye ointment

    Incidence not known

    • Itching, redness, swelling, or other signs of eye or eyelid irritation

    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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