Ciprofloxacin Ear Drops

• If you have an allergy to ciprofloxacin or any other part of this medicine (ciprofloxacin ear drops).
• 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.

This medicine may interact with other drugs or health problems.

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 (ciprofloxacin ear drops) 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 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 1 minute.
• Do not touch the container tip to the skin.

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.
• Very bad ear pain.
• Very bad ear irritation.

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:

• Headache.
• Itching.
• Short-term pain after use.

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.

Ciprofloxacin Otic Solution is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.

Ciprofloxacin Otic Solution is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.

Ciprofloxacin Otic Solution 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin Otic Solution is a sterile, preservative-free solution for otic use. Each single use container of Ciprofloxacin Otic Solution delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.

Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3•HCl•H2O, and molecular weight is 385.82.

The chemical structure of ciprofloxacin hydrochloride is:

Directions for Use

Patients should be advised that Ciprofloxacin Otic Solution is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.

Ciprofloxacin Otic Solution should be given 2 times each day (about 12 hours apart) in each infected ear.

Ciprofloxacin Otic Solution should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on Ciprofloxacin Otic Solution:

• Wash their hands before use.
  
• Warm the container in their hands for at least one minute prior to use to minimize dizziness that may result from the instillation of a cold solution into the ear canal. Twist off and discard top of container.
  
• Lie with the affected ear upward and then instill the contents of one container into the ear. Maintain this position for at least one minute to facilitate penetration of the drops into the ear.
  
• Repeat, if necessary, for the opposite ear.
• Discard used container.
• Store unused containers in pouch to protect from light.

Hypersensitivity

Patients should be advised to immediately discontinue Ciprofloxacin Otic Solution at the first appearance of a skin rash or any other sign of hypersensitivity [see Section 5.1 Warnings and Precautions].

Ciprofloxacin Otic Solution is:
Distributed by:
Xspire Pharma
P.O. Box 1724
Madison, MS 39130.

Manufactured by:
The Ritedose Corporation
Columbia, SC 29203 USA