Tobradex, Tobradex Ointment, Tobradex Suspension

It is used in the eye to prevent permanent damage, which may occur with certain eye problems .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Ointment


• 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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ophthalmic tobramycin and dexamethasone in children with use in other age groups.

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 ophthalmic tobramycin and dexamethasone in the elderly with use in other age groups.

Pregnancy

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

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.

• 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.

• Alcuronium


• Aldesleukin


• Atracurium


• Bupropion


• Cidofovir


• Cisatracurium


• Darunavir


• Dasatinib


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Etravirine


• Fazadinium


• Fosamprenavir


• Furosemide


• Gallamine


• Hexafluorenium


• Imatinib


• Ixabepilone


• Lapatinib


• Lysine


• Metocurine


• Mivacurium


• Nilotinib


• Pancuronium


• Pipecuronium


• Quetiapine


• Rapacuronium


• Rocuronium


• Romidepsin


• Succinylcholine


• Sunitinib


• Tacrolimus


• Temsirolimus


• Thalidomide


• Tubocurarine


• Vancomycin


• Vecuronium

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.

• Alatrofloxacin


• Alcuronium


• Aminoglutethimide


• Aprepitant


• Aspirin


• Atracurium


• Balofloxacin


• Caspofungin


• Cinoxacin


• Ciprofloxacin


• Cisplatin


• Clinafloxacin


• Cyclosporine


• Enoxacin


• Everolimus


• Fleroxacin


• Fluindione


• Flumequine


• Fosaprepitant


• Fosphenytoin


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Metocurine


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pancuronium


• Pefloxacin


• Phenobarbital


• Phenytoin


• Primidone


• Prulifloxacin


• Rifampin


• Rifapentine


• Ritonavir


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Saquinavir


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate


• Vecuronium


• Warfarin

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:

• Glaucomaa€”The dexamethasone in the eyedrops may cause glaucoma or make it worse if the eyedrops are used for a long time

• Herpes infection of the eye or


• Any other eye infection, including bacterial and fungala€”The dexamethasone in the eyedrops may make existing infections worse or cause new infections

Proper Use

For patients using the ophthalmic suspension (eye drops) form of this medicine:

• Always shake the container very well just before applying the eye drops.


• To use:
  
  
  
  • First, wash your hands. Tilt the 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 the eyes. Do not blink . Keep the eyes closed and apply pressure to the inner corner of the 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). Always keep the container tightly closed.
  
  
  
  

For patients using the ophthalmic ointment form of this medicine:

• To use:
  
  
  
  • First, wash your hands. Tilt the 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 . Squeeze a thin strip of ointment into this space . A 1/2-inch strip of ointment is usually enough. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the irritation.
  
  
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue. Do not wash the tip with water . Always keep the tube tightly closed.
  
  
  
  

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 ophthalmic ointment dosage form:
  
  
  
  • For eye disorders:
    
    
    
    • Adultsa€”Use about a 1/2-inch strip of ointment in the eye up to three or four times a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  


• For ophthalmic suspension (eye drops) dosage form:
  
  
  
  • For eye disorders:
    
    
    
    • Adultsa€”Use 1 or 2 drops in the eye every four to six hours. Your doctor may have you use the drops more frequently during the first day or two and will probably have you space the doses farther apart as the eye gets better.
    
    
    • Childrena€”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 you will be using this medicine for more than a few weeks, an ophthalmologist (eye doctor) should examine your eyes at regular visits to make sure it does not cause unwanted effects.

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 as soon as possible if any of the following side effects occur:

Less common

• Itching and swelling of eyelid


• Redness of eye

Rare

• Delayed wound healing


• Eye pain


• Gradual blurring or loss of vision

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.