Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

• Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae,Moraxella catarrhalis, and Pseudomonas aeruginosa.
• Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa.

Otic Suspension: Each mL of ciprofloxacin and dexamethasone otic suspension USP, contains ciprofloxacin hydrochloride USP 0.3% (equivalent to 3 mg ciprofloxacin base) and dexamethasone USP, 0.1% equivalent to 1 mg dexamethasone.

• Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.
• Use of this product is contraindicated in viral infections of the external canal, including herpes simplex infections and fungal otic infections.

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

• Hypersensitivity Reactions [see Warnings and Precautions ( 5.1)]

• Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions ( 5.2)]

Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of this product.

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP, contains the quinolone antimicrobial, ciprofloxacin hydrochloride USP, combined with the corticosteroid, dexamethasone USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension contains ciprofloxacin hydrochloride USP (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone USP, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, sodium acetate, sodium chloride, tyloxapol and water for injection. 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 C 17H 18FN 3O 3·HCl·H 2O. The molecular weight is 385.82 g/mol 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 C 22H 29FO 5. The molecular weight is 392.46 g/mol and the structural formula is:

Figure 2: Structure of Dexamethasone

In a randomized, multicenter, controlled clinical trial, ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in the per protocol analysis in 86% of AOMT patients compared to 79% for ofloxacin solution, 0.3%, dosed 2 times per day for 10 days. Among culture positive patients, clinical cures were 90% for ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension compared to 82% for ofloxacin solution, 0.3%. 

In 2 randomized multicenter, controlled clinical trials, ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension dosed 2 times per day for 7 days demonstrated clinical cures in 87% and 94% of per protocol evaluable AOE patients, respectively, compared to 84% and 89%, respectively, for otic suspension containing neomycin 0.35%, polymyxin B 10,000 units/mL, and hydrocortisone 1.0% (neo/poly/HC). Among culture positive patients clinical cures were 86% and 92% for ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension compared to 84% and 89%, respectively, for neo/poly/HC. Microbiological eradication rates for these patients in the same clinical trials were 86% and 92% for ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension compared to 85% and 85%, respectively, for neo/poly/HC.

How Supplied:

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension USP, is white to off-white suspension supplied as follows: 7.5 mL fill in 10 mL low density polyethylene bottle. The packaging system consists of a 10 mL low density polyethylene plastic squeeze bottle, a natural low density polyethylene dropper tip and a high density polyethylene tamper evident screw cap for dropper bottle.

7.5 mL fill, NDC 68071-3804-7

Storage:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Avoid freezing. Protect from light.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

For Otic Use Only

Advise patients that ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for otic use (ears) only. This product must not be used in the eye[see Dosage and Administration ( 2.2)]. 

Administration Instructions

Instruct patients to warm the bottle in their hand for one to two minutes prior to use and shake well immediately before using [see Dosage and Administration ( 2.1, 2.2)].

 Allergic Reactions

Advise patients to discontinue use immediately and contact their physician, if rash or allergic reaction occurs [ see Warnings and Precautions ( 5.1)].

Avoid Contamination of the Product

Advise patients to avoid contaminating the tip with material from the ear, fingers, or other sources [see Instructions for Use].

Duration of Use

Advise patients that it is very important to use the eardrops for as long as their doctor has instructed, even if the symptoms improve [see Patient Information].

Protect from Light

Advise patients to protect the product from light [see How Supplied/Storage and Handling ( 16)].

Unused Product

Advise patients to discard unused portion after therapy is completed [see Dosage and Administration ( 2.2)].

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension 

What is ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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. Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 or AOM) 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 or AOE)

It is not known if ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is safe and effective in children under 6 months of age.

Who should not use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension? 

Do not use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension if you:

• are allergic to ciprofloxacin, quinolones, or any of the ingredients in ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. See the end of this Patient Information leaflet for a complete list of ingredients in ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
• 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 ciprofloxacin 0.3% and dexamethasone 0.1%otic suspension?

Before using ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, tell your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension passes into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

• Read the detailed  Instructions for Use that come with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
• Use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension exactly as your doctor tells you to.
• Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for use in the ear only (otic use). Do not use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension in the eye or inject ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
• Apply 4 drops of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension into the affected ear 2 times a day for 7 days.
• Do not stop using ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension unless your doctor tells you to, even if your symptoms improve. If your symptoms do not  improve after 7 days of treatment with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension, 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
  • you have fluid that drains from your ear  2 or more times within 6 months after you stop treatment with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension

What are the possible side effects of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension? 

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension may cause serious side effects, including:

• allergic reactions. Stop using ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension and call your doctor or go to the nearest emergency room 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension include:

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

These are not all the possible side effects of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension. 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

• Store ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
• Keep ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension out of light.

Keep ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension and all medicines out of the reach of children.

General information about the safe and effective use of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet . Do not use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension for a condition for which it was not prescribed.Do not give ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension that is written for health professionals.

What are the ingredients in ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

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

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

For more information, call at 1-888-375-3784

This Patient Information has been approved by the U.S. Food and Drug Administration

R X Only 

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension 

This “Instructions for Use” contains information on how to use Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension

Important Information You Need to Know Before UsingCiprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension 

Read this Instructions for Use that comes with ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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.

• Use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension exactly as your doctor tells you to use it. 
• Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is for use in the ear only (otic use).Do not inject ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension or use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension in the eye.
• Shake ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension well before each use.
• Do not touch your ear, fingers, or other surfaces with the tip of the ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension bottle. You may get bacteria on the tip of the bottle that can cause you to get another infection.

How should I use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

Figure A

Step 1.Wash your hands with soap and water (see Figure A). 

Step 2.Warm the bottle of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension by rolling the bottle between your hands for 1 to 2 minutes (see Figure B). Shake the bottle of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension well.

Figure B

Step 3.Remove the ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension cap. Put the cap in a clean and dry area. Do notlet the tip of the bottle touch your ear, fingers or other surfaces.

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

Figure C

Step 5. Hold the bottle of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension between your thumb and index finger ( see Figure D). Place the tip of the bottle close to your ear. Be careful not to touch your fingers orear with the tip of the bottle.

Figure D  

Step 6.Gently squeeze the bottle and let 4 drops of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 C).

It is important that you follow the instructions below for your specific ear infection, to allow ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension to enter the affected part of your ear.

Step 8. If you use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension to treat a middle ear infection, and you have a tubein your eardrum known as a tympanostomy:

• Gently press the part of the ear known as the tragus (See Figure E) 5 timesusing a pumping motion ( see Figure E). This will allow the drops of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension to enter your middle ear.

• Remain on your side with the affected ear facing upward ( see Figure C) for 1 minute.

Figure E

If you use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension to treat an outer ear canal infection:

• Gently pull the outer ear lobe upward and backward ( see Figure F). This will allow the drops of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension to enter your ear canal.
• Remain on your side with the affected ear facing upward ( see Figure C) for 1 minute.

Figure F

Step 9. If your doctor has told you to use ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension in both ears, repeat steps 5 to 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension doses, there may be some ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension left in the bottle. Throw the bottle away.

How should I store ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension?

• Store ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension at room temperature between 68⁰F to 77⁰F (20⁰C to 25⁰C).
• Do not freeze ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension.
• Keep ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension out of light.

  Keep ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension 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 ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension that is written for health professionals.

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

R X Only 

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India