Ciprofloxacin and Dexamethasone

CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension contains the quinolone antimicrobial, ciprofloxacin hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of CIPRODEX contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.

Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1- cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C17H18FN3O3•HCl•H2O. The molecular weight is 385.82 and the structural formula is:

Figure 1: Structure of Ciprofloxacin

Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C22H29FO5. The molecular weight is 392.46 and the structural formula is:

Figure 2: Structure of Deamethasone

The following serious adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
• Potential for Microbial Overgrowth with Prolonged Use [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phases II and III clinical trials, a total of 937 patients were treated with CIPRODEX. This included 400 patients with acute otitis media with tympanostomy tubes and 537 patients with acute otitis externa. The reported adverse reactions are listed below:

The following adverse reactions occurred in 0.5% or more of the patients with non-intact tympanic membranes.

The following adverse reactions were each reported in a single patient: tympanostomy tube blockage; ear pruritus; tinnitus; oral moniliasis; crying; dizziness; and erythema.

The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic Membranes

The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

Postmarketing Experience

The following adverse reactions have been identified during post approval use of CIPRODEX. Because these reactions are reported voluntarily from a population of unknown size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.

CIPRODEX
(CI-PRO-DEX)
(ciprofloxacin and dexamethasone) otic suspension

What is CIPRODEX?

CIPRODEX is a prescription medicine used in the ear only (otic use) that contains 2 medicines, a quinolone antibiotic medicine called ciprofloxacin and a corticosteroid medicine called dexamethasone. CIPRODEX is used in adults and children 6 months of age or older to treat certain types of infections caused by certain germs called bacteria. These bacterial infections include:

• middle ear infection (known as acute otitis media) in people who have a tube in their eardrum known as a tympanostomy to prevent having too much fluid in the middle ear
• outer ear canal infection (known as acute otitis externa)

It is not known if CIPRODEX is safe and effective in children under 6 months of age.

Who should not use CIPRODEX?

Do not use CIPRODEX if you:

• are allergic to ciprofloxin, quinolones, or any of the ingredients in CIPRODEX. See the end of this Patient Information leaflet for a complete list of ingredients in CIPRODEX.
• 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?

Before using CIPRODEX, 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 will harm your unborn baby.
• are breastfeeding or plan to breastfeed. CIPRODEX can pass into your breast milk and may harm your baby. You and your doctor should decide if you will use CIPRODEX 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?

• Read the detailed Instructions for Use that come with CIPRODEX.
• Use CIPRODEX exactly as your doctor tells you to.
• CIPRODEX is for us e in the ear only (otic use). Do not inject CIPRODEX or use CIPRODEX in the eye.
• Apply 4 drops of CIPRODEX into the affected ear 2 times a day for 7 days.
• Do not stop using CIPRODEX unless your doctor tells you to, even if your symptoms improve.

If your symptoms do not improve after 7 days of treatment with CIPRODEX, call your doctor.

• Call your doctor right away if:
  • you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with CIPRODEX
  • you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with CIPRODEX

What are the possible side effects of CIPRODEX?

CIPRODEX may cause serious side effects, including:

• allergic reactions . Stop using CIPRODEX and call your doctor if you have any of the following signs or symptoms of an allergic reaction:
  • hives (urticaria)
  • swelling of your face, lips, mouth, or tongue
  • rash
  • itching
  • trouble breathing
  • dizziness, fast heartbeat, or pounding in your chest

The most common side effects of CIPRODEX include:

• ear discomfort
• ear pain
• ear itching (pruritus)

These are not all the possible side effects of CIPRODEX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CIPRODEX?

• Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze CIPRODEX.
• Keep CIPRODEX out of light.

Keep CIPRODEX and all medicines out of the reach of children.

General information about the safe and effective use of CIPRODEX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CIPRODEX for a condition for which it was not prescribed. Do not give CIPRODEX to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about CIPRODEX that is written for health professionals.

What are the ingredients in CIPRODEX?

Active ingredients : ciprofloxacin hydrochloride, dexamethasone, and benzalkonium chloride as a preservative

Inactive ingredients : boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate, edetate disodium, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH

Instructions for Use

CIPRODEX
(CI-PRO-DEX)
(ciprofloxacin and dexamethas one) otic suspension

Read this Instructions for Use that comes with CIPRODEX before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Important information about CIPRODEX:

• Use CIPRODEX exactly as your doctor tells you to use it.
• CIPRODEX is for use in the ear only (otic use). Do not inject CIPRODEX or use CIPRODEX in the eye.
• Shake CIPRODEX well before each use.
• Do not touch your ear, fingers or other surfaces with the tip of the CIPRODEX bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection.

How should I use CIPRODEX?

Step 1. Wash your hands with soap and water.

Figure A

Step 2. Warm the bottle of CIPRODEX by rolling the bottle between your hands for 1 to 2 minutes (See Figure A). Shake the bottle of CIPRODEX well.

Step 3. Remove the CIPRODEX cap. Put the cap in a clean and dry area. Do not let the tip of the bottle touch your ear, fingers or other surfaces.

Figure B

Step 4. Lie down on your side so that the affected ear faces upward (See Figure B).

Figure C

Step 5. Hold the bottle of CIPRODEX between your thumb and index finger (See Figure C). Place the tip of the bottle close to your ear. Be careful not to touch your fingers or ear with the tip of the bottle.

Step 6. Gently squeeze the bottle and let 4 drops of CIPRODEX fall into the affected ear. If a drop misses your ear, follow the instructions in Step 5 again.

Step 7. Stay on your side with the affected ear facing upward (See Figure B)

It is important that you follow the instructions below for your specific ear infection, to allow CIPRODEX to enter the affected part of your ear.

Step 8.

If you use CIPRODEX to treat a middle ear infection and you have a tube in your eardrum known as a tympanos tomy:

• Gently press the part of the ear known as the tragus (See Figure D) 5 times using a pumping motion (See Figure D). This will allow the drops of CIPRODEX to enter your middle ear.
• Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure D

If you use CIPRODEX to treat an outer ear canal infection:

• Gently pull the outer ear lobe upward and backward (See Figure E). This will allow the drops of CIPRODEX to enter your ear canal.
• Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

Figure E

Step 9. If your doctor has told you to use CIPRODEX in both ears, repeat steps 5-8 for your other ear.

Step 10. Put the cap back on the bottle and close it tightly.

Step 11. After you have used all of your CIPRODEX doses, there may be some CIPRODEX left in the bottle. Throw the bottle away.

How should I store CIPRODEX?

• Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze CIPRODEX.
• Keep CIPRODEX out of light.

Keep CIPRODEX and all medicines out of the reach of children.

If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for more information about CIPRODEX that is written for health professionals.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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 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 ciprofloxacin and dexamethasone, 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 ciprofloxacin and dexamethasone. 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 ciprofloxacin and dexamethasone.

Review Date: October 4, 2017

• Ciprofloxacin Hydrochloride and Dexamethasone
• Dexamethasone and Ciprofloxacin

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, otic:

Ciprodex: Ciprofloxacin 0.3% and dexamethasone 0.1% (7.5 mL) [contains benzalkonium chloride]

Acute otitis media: Treatment of acute otitis media in pediatric patients ≥6 months of age with tympanostomy tubes due to susceptible isolates of Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa.

Acute otitis externa: Treatment of acute otitis externa in pediatric patients ≥6 months of age and adults due to susceptible isolates of Staphylococcus aureus and Pseudomonas aeruginosa.

Refer to adult dosing.

Concerns related to adverse effects:

• Hypersensitivity: Severe and occasionally fatal hypersensitivity reactions, including anaphylaxis, have occurred with systemic fluoroquinolone therapy. Prompt discontinuation of drug should occur if skin rash or other symptoms of hypersensitivity arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection occurs, discontinue use and institute appropriate therapy.

• Tendon inflammation/rupture: There have been reports of tendon inflammation and/or rupture with systemic fluoroquinolones. Exposure following otic administration is substantially lower than with systemic therapy. Discontinue at first sign of tendon inflammation or pain.

Other warnings/precautions:

• Appropriate use: For otic use only; not intended for injection or ophthalmic use. Prior to instillation, suspension should be warmed in hands to prevent dizziness, which may occur following use of a cold solution.