Gatifloxacin (Ophthalmic Route)

Ophthalmic gatifloxacin works by killing bacteria.

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 and children under 1 year of age. In children older than 1 year of age, this medicine is not expected to cause different side effects or problems than it does in adults.

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. Although there is no specific information comparing use of gatifloxacin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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.

• Cisapride


• Dronedarone


• Mesoridazine


• 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


• Acetohexamide


• Acetophenazine


• Ajmaline


• Alosetron


• Amiodarone


• Amitriptyline


• Amoxapine


• Asenapine


• Azimilide


• Benfluorex


• Bretylium


• Chlorpromazine


• Chlorpropamide


• Clomipramine


• Desipramine


• Disopyramide


• Dofetilide


• Dothiepin


• Doxepin


• Droperidol


• Encainide


• Erythromycin


• Ethopropazine


• Flecainide


• Fluphenazine


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibutilide


• Iloperidone


• Imipramine


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Lapatinib


• Lidocaine


• Lofepramine


• Metformin


• Methadone


• Methotrimeprazine


• Mexiletine


• Miglitol


• Moricizine


• Nilotinib


• Nortriptyline


• Opipramol


• Paliperidone


• Pazopanib


• Perphenazine


• Pipotiazine


• Pirmenol


• Prajmaline


• Prednisone


• Procainamide


• Prochlorperazine


• Promazine


• Promethazine


• Propafenone


• Propiomazine


• Protriptyline


• Quinidine


• Ranolazine


• Recainam


• Sematilide


• Sotalol


• Tedisamil


• Telavancin


• Tetrabenazine


• Thiethylperazine


• Tocainide


• Tolazamide


• Tolbutamide


• Trifluoperazine


• Triflupromazine


• Trimeprazine


• Trimipramine


• Troglitazone

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.

• Digoxin


• Probenecid

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:

• Allergy to gatifloxacin or


• Allergy to any part of the medicinea€”serious allergic reactions can occur

Proper Use

To use gatifloxacin ophthalmic solution (eye drops):

• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink . Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• If you think you did not get the drop of medicine into your eyes 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). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using ophthalmic gatifloxacin for the full time of treatment, even if your symptoms have disappeared. If you stop using this medicine to soon your symptoms may return. 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 ophthalmic solution dosage form:
  
  
  
  • For bacterial conjunctivitis:
    
    
    
    • Adults and children 1 year of age and oldera€”Days 1 and 2: Put one drop in the affected eye(s) every two hours while awake. Do not put drops in more than 8 times a day. Days 3 through 7: Put one drop in the affected eye(s) every 4 hours while awake. Do not put drops in more than 4 times a day.
    
    
    • Infants and children up to 1 year of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Precautions

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor .

Stop using these eye drops and contact your doctor at the first sign of a rash or an allergic reaction .

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:

More common

• Eye irritation


• Eye pain


• Eye redness

Less common

• Bloody eye


• Decrease in vision


• Swelling of the membrane covering the white part of 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:

More Common

• Blurry vision


• Discharge from eyes


• Itching eyes


• Stringy mucus secretions


• Swelling of eye, eyelid, or inner lining of eyelid


• Watering eyes

Less common

• Bad, unusual or unpleasant (after) taste


• Change in taste


• Dry eye


• Headache

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.