Ciprofloxacin and Fluocinolone

• If you have an allergy to ciprofloxacin and fluocinolone or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Chickenpox, herpes infection, or viral infection of the ear.
• If you have a fungal infection of the ear.

This is not a list of all drugs or health problems that interact with ciprofloxacin and fluocinolone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

• For the ear only.
• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• Wash 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 1 minute.
• Throw away any part of opened vial not used after use.

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• A fast heartbeat.
• A heartbeat that does not feel normal.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Fluid draining from the ear.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store unused containers in foil pouch until use.
• Throw away any part of opened pouch that is not used after 7 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• Antibiotic, Fluoroquinolone
• Antibiotic, Otic
• Antibiotic/Corticosteroid, Otic
• Corticosteroid, Otic

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

1% to 10%:

Connective tissue disorder (excessive granulation tissue; 1%)

Local: Application site discharge (otorrhea: 5%)

Frequency not defined: Infection: Bacterial superinfection

<1% (Limited to important or life-threatening): Auricular edema, candidiasis, dizziness, dysgeusia, equilibrium disturbance, eustachian tube congestion, exfoliation of skin, flushing, hypersensitivity reaction, hypoacusis, otalgia, otic infection, paresthesia, pruritus of ear, tinnitus, tympanic membrane disease, tympanostomy tube blockage (device occlusion)