Ofloxacin Otic

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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 the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• Tell all of your health care providers that you take ofloxacin. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told. A second infection may happen.
• Very bad and sometimes deadly allergic reactions have rarely happened with other forms of this medicine as well as drugs like this one. Talk with the doctor.
• This medicine may cause harm if swallowed. If ofloxacin is swallowed, call a doctor or poison control center right away.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ofloxacin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ofloxacin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ofloxacin.

Review Date: October 4, 2017

• Floxin Otic Singles

• Floxin Otic

Otitis media, chronic suppurative (with perforated tympanic membranes): Otic: Instill 10 drops into affected ear(s) twice daily for 14 days

Otitis externa: Otic: Instill 10 drops into affected ear(s) once daily for 7 days

Tympanic membrane perforation, traumatic (off-label use): Otic: Instill 2 to 3 drops once daily until complete closure of perforation is confirmed (Jian-Yang 2016; Lou 2016). Additional data may be necessary to further define the role of ofloxacin in this condition.

>10%: Local: Application site reaction (≤17%)

1% to 10%:

Central nervous system: Paresthesia (1%), dizziness (≤1%), vertigo (≤1%)

Dermatologic: Pruritus (1% to 4%), skin rash (1%)

Gastrointestinal: Dysgeusia (7%)

<1% (Limited to important or life-threatening): Auditory disturbance (transient), diarrhea, fever, headache, hypertension, nausea, otorrhagia, psychiatric disturbance (transient), tinnitus, tremor, vomiting, xerostomia

You should not use this medicine if you are allergic to ofloxacin or similar antibiotics, such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), or norfloxacin (Noroxin).

FDA pregnancy category C. It is not known whether ofloxacin otic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

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.