INDICATIONS AND IMPORTANT SAFETY INFORMATION
What is CIPRODEX® Otic?
CIPRODEX® Otic is a prescription ear drop used to treat certain types of infections caused by certain germs called bacteria:
middle ear infection (known as acute otitis media) in children at least 6 months of age who have a tube in their eardrum known as a tympanostomy tube
outer ear canal infection (known as acute otitis externa) in adults and in children at least 6 months of age. It is not known if CIPRODEX® Otic is safe and effective in children under 6 months of age.
IMPORTANT SAFETY INFORMATION
Who should not use CIPRODEX® Otic?
Do not use CIPRODEX® Otic if you:
are allergic to ciprofloxacin (the active ingredient in CIPRODEX® Otic), other quinolone antibiotics, or any of the ingredients in CIPRODEX® Otic. See the Patient Information leaflet in the full prescribing information for a complete list of ingredients.
have an outer ear canal infection caused by certain viruses including the herpes simplex virus
have an ear infection caused by a fungus
What should I tell my doctor before using CIPRODEX® Otic?
Tell your doctor about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if CIPRODEX® Otic will harm your unborn baby.
are breastfeeding or plan to breastfeed. CIPRODEX® Otic can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use CIPRODEX® Otic or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use CIPRODEX® Otic?
Read the detailed Instructions for Use that come with CIPRODEX® Otic.
Use CIPRODEX® Otic exactly as your doctor tells you to.
CIPRODEX® Otic is for use in the ear only.
Do not inject CIPRODEX® Otic or use CIPRODEX® Otic in the eye.
Apply 4 drops of CIPRODEX® Otic into the affected ear 2 times a day for 7 days.
stop using CIPRODEX® Otic unless your doctor tells you to, even if your symptoms improve. If your symptoms do not improve after 7 days of treatment with CIPRODEX® Otic, call your doctor.
Call your doctor right away if:
you have fluid that continues to drain from your ear after you have finished your treatment with CIPRODEX® Otic
you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with CIPRODEX® Otic
What are the possible side effects of CIPRODEX® Otic?
CIPRODEX® Otic may cause serious side effects, including:
The most common side effects of CIPRODEX® Otic include
ear discomfort, ear pain, and ear itching.
These are not all the possible side effects of CIPRODEX® Otic. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to FDA. Visit
, or call
Keep CIPRODEX® Otic and all medicines out of the reach of children.
For additional information on CIPRODEX® Otic, please
for the full Prescribing Information.