Floxin Otic

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use extra eardrops to make up for a missed dose.

Ofloxacin otic may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• ear itching or pain
• change in taste
• dizziness

Some side effects can be serious. If you experience any of these symptoms, stop using ofloxacin otic call your doctor immediately:

• rash
• hives
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing

Ofloxacin otic may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

This medicine is for use only in the ears. Avoid getting the medicine in your eyes, mouth, and nose, or on your lips. Rinse with water if this medicine gets in or on these areas.

Do not use other ear medications unless your doctor tells you to.

It is not likely that other drugs you take orally or inject will have an effect on ofloxacin used in the ears. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

If you take too much Floxin Otic, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Floxin Otic is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Shake the medicine well just before each use.

You may warm the medicine before use by holding the bottle in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.

• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.

• Stay lying down or with your head tilted for at least 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.

• If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) four to five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.

Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have new symptoms.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after your treatment is finished.

An overdose of this medicine is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Use Floxin Otic as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the ear only.
• Wash your hands before and after use.
• Warm solution in hands 1 to 2 minutes before putting drops in ear.
• Lie on your side with problem ear up.
• For children younger than 3 years of age, pull the outer ear outward and downward.
• For children 3 years of age and older and adults, pull the outer ear outward and upward.
• Put drops in ear without touching dropper to ear. Stay on side for 5 minutes.
• Do not touch the container tip with your fingers or anything else.
• To gain the most benefit, do not miss doses.
• Use this medicine at the same time of day.
• Use as you have been told, even if your signs get better.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

1 to 12 years old:
-Usual dose: Instill 5 drops into the affected ear(s) 2 times a day
-Duration of therapy: 10 days

12 years and older:
-Usual dose: Instill 10 drops into the affected ear(s) 2 times a day
-Duration of therapy: 14 days

Comments:
-Patients should lie with the affected ear upward before administration. Once instilled, the tragus should be pumped inward 4 times, and the patient should remain in this position for at least 5 minutes.
-If both ears are affected, this procedure should be repeated for the opposite ear.

Uses:
-Treatment of acute otitis media in patients 1 to 12 years old with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae
-Treatment of chronic suppurative otitis media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, P aeruginosa, and S aureus

Data not available

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: Not assigned. Risk Summary: Use has not been associated with adverse events at doses used in this formulation.

Animal models have revealed evidence of decreased fetal weight, increased fetal mortality, and an increased frequency of fetal skeletal variations at high doses. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.