CIPRODEX (Page 3 of 4)

13.2 Animal Toxicology and/or Pharmacology

Guinea pigs dosed in the middle ear with CIPRODEX for one month exhibited no drug-related structural or functional changes of the cochlear hair cells and no lesions in the ossicles.

14 CLINICAL STUDIES

In a randomized, multicenter, controlled clinical trial, CIPRODEX 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 CIPRODEX compared to 79% for ofloxacin solution, 0.3%. Microbiological eradication rates for these patients in the same clinical trial were 91% for CIPRODEX compared to 82% for ofloxacin solution, 0.3%.

In 2 randomized multicenter, controlled clinical trials, CIPRODEX 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 CIPRODEX 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 CIPRODEX compared to 85% and 85%, respectively, for neo/poly/HC.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied:

CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension is a white-to off-white suspension supplied as follows: 7.5 mL fill in a DROP-TAINER® system. The DROP-TAINER system consists of a natural polyethylene bottle and natural plug, with a white polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

7.5 mL fill NDC 71205-309-75

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.

17 PATIENT COUNSELING INFORMATION

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

For Otic Use Only

Advise patients that CIPRODEX is for otic use (ears) only. This product must not be used in the eye.

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)].

DROP-TAINER is a trademark of Alcon.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320

T2019-37

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: February 2019

PATIENT INFORMATION 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:
1.
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
2.
outer ear canal infection (known as acute otitis externa or AOE)
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:
1.
are allergic to ciprofloxacin, quinolones, or any of the ingredients in CIPRODEX. See the end of this Patient Information leaflet for a complete list of ingredients in CIPRODEX.
2.
have an outer ear canal infection caused by certain viruses including the herpes simplex virus
3.
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:

1.
are pregnant or plan to become pregnant. It is not known if CIPRODEX will harm your unborn baby.
2.
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?

1.
Read the detailed Instructions for Use that come with CIPRODEX.
2.
Use CIPRODEX exactly as your doctor tells you to.
3.
CIPRODEX is for use in the ear only (otic use). Do not use CIPRODEX in the eye or inject CIPRODEX.
4.
Apply 4 drops of CIPRODEX into the affected ear 2 times a day for 7 days.
5.
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.
6.
Call your doctor right away if:
1.
you have fluid that continues to drain from your ear (otorrhea) after you have finished your treatment with CIPRODEX
2.
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:

1.
allergic reactions. Stop using CIPRODEX and call your doctor if you have any of the following signs or symptoms of an allergic reaction:
o hives (urticaria)
o trouble breathing
o swelling of your face, lips, mouth, or tongue
o dizziness, fast heartbeat, or pounding in your chest
o rash
o itching

The most common side effects of CIPRODEX include:

1.
ear discomfort
2.
ear pain
3.
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?

1.
Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
2.
Do not freeze CIPRODEX.
3.
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 use CIPRODEX in the eye. 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 preservativeInactive ingredients: acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 T2019-38 © Novartis
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: February 2019

Instructions for Use CIPRODEX (CI-PRO-DEX) (ciprofloxacin and dexamethasone) 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:

1.
Use CIPRODEX exactly as your doctor tells you to use it.
2.
CIPRODEX is for use in the ear only (otic use).Do not inject CIPRODEX or use CIPRODEX in the eye.
3.
Shake CIPRODEX well before each use.
4.
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?

wash
(click image for full-size original)

Step 1. Wash your hands with soap and water.

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.

warmFigure A

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.

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

sickFigure B

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.

eardropFigure C

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 tympanostomy:

1.
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.
2.
Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

tragus
(click image for full-size original)
Figure D

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

1.
Gently pull the outer ear lobe upward and backward (See Figure E). This will allow the drops of CIPRODEX to enter your ear canal.
2.
Remain on your side with the affected ear facing upward (See Figure B) for 1 minute.

up back
(click image for full-size original)
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?

1.
Store CIPRODEX at room temperature between 68°F to 77°F (20°C to 25°C).
2.
Do not freeze CIPRODEX.
3.
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.

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

Relabeled by:Proficient Rx LPThousand Oaks, CA 91320© Novartis

T2019-39

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