Ciprodex

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Ciprodex is part of the drug class:

• Corticosteroids for local oral treatment

You should not use this medicine if you are allergic to ciprofloxacin or dexamethasone, or if you have:

• a viral infection affecting your ear canal, including herpes or chickenpox; or

• if you are allergic to any antibiotic similar to ciprofloxacin (Cipro), such as gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

To make sure this medicine is safe for you, tell your doctor if you have:

• severe ear pain; or

• hearing problems.

FDA pregnancy category C. It is not known whether ciprofloxacin and dexamethasone 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 ciprofloxacin and dexamethasone otic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Ciprofloxacin and dexamethasone should not be used on a child younger than 6 months old.

Avoid getting water in your ears while bathing or showering. Avoid swimming while you are treating an ear infection.

Avoid getting the medicine in your eyes.

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

Ciprofloxacin and dexamethasone combination ear drops is used to treat ear infections, such as acute otitis externa and acute otitis media. Otitis externa, also known as swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful. Otitis media is a middle ear infection in children who have a tube in their eardrum (known as tympanostomy) to prevent having too much fluid in the middle ear.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth. Dexamethasone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by ear infections.

This medicine is available only with your doctor's prescription.

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should be used only in the ear. Do not put it in the eyes or nose, and do not take it by mouth or inject it. If this medicine is swallowed by accident or gets in your eyes, call your doctor right away. .

It is important that the infected ear remain clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.

To use the ear drops:

• Wash hands thoroughly with soap and water
• Hold the bottle in your hands for 1 or 2 minutes to warm the medicine. Cold drops could cause you to become dizzy.
• Shake the bottle well before using it.
• Lie down on your side with your infected ear facing up.
• Drop the prescribed number of drops into the ear. Keep the ear tilted up for 60 seconds.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.
• For patients with middle ear infection with tubes: While the person getting the ear drops lies on their side, the person giving the drops should gently press the small projection in front of the outside opening of the ear 5 times in a pumping motion. This will allow the drops to pass through the tube and into the middle ear.
• For patients with outer ear infection (“swimmer's ear”): While the person getting the ear drops lies on their side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal.
• The person who just had the ear drops should stay on their side for at least one minute. Repeat the above steps if both ears are infected.
• When you have completed your course of therapy (usually 7 days), throw away any unused medicine.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if you or your child feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic dosage form (ear drops):
  • For middle ear infection:
    • Adults and children 6 months of age and older—4 drops into the affected ear(s) two times a day for 7 days.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For outer ear infection:
    • Adults, older adults, and children 6 months of age and older—4 drops into the affected ear(s) two times a day for 7 days.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Protect medicine away from light. Do not freeze.

If you or your child feel that your symptoms are not improve after 7 days, or if they have become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Call your doctor right away if you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with this medicine.

• It is used to treat ear infections.

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

• Follow how to use as you have been told by the doctor or read the package insert.
• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• For the ear only.
• Wash your hands before and after use.
• Warm suspension in hands 1 to 2 minutes before putting drops in ear.
• Shake well before use.
• Lie on your side with problem ear up.
• For children 3 years of age and older and adults, pull the outer ear outward and upward.
• For children younger than 3 years of age, pull the outer ear outward and downward.
• 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 or extra doses.

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.

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.

It is not likely that other drugs you take orally or inject will have an effect on Ciprodex 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.

Applies to ciprofloxacin / dexamethasone otic: otic suspension

Along with its needed effects, ciprofloxacin / dexamethasone otic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ciprofloxacin / dexamethasone otic:

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest
• unusual tiredness or weakness

Some side effects of ciprofloxacin / dexamethasone otic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Ear discomfort
• ear pain
• itching skin on the ear

• Bitter, sour, or unusual taste in the mouth
• ear congestion
• ear debris
• ear residue
• redness of the skin
• superimposed ear infection (second ear infection)