Patient information: uses, side effects, how to take - Ciprofloxacin and Dexamethasone
What is ciprofloxacin and dexamethasone otic suspension?
Ciprofloxacin and dexamethasone 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 and dexamethasone 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 and dexamethasone otic suspension is safe and effective in children under 6 months of age.
Who should not use ciprofloxacin and dexamethasone otic suspension?
Do not use ciprofloxacin and dexamethasone otic suspension if you:
- are allergic to ciprofloxacin, quinolones, or any of the ingredients in ciprofloxacin and dexamethasone otic suspension. See the end of this Patient Information leaflet for a complete list of ingredients in ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension?
Before using ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ciprofloxacin and dexamethasone passes into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension?
- Read the detailed Instructions for Use that come with ciprofloxacin and dexamethasone otic suspension.
- Use ciprofloxacin and dexamethasone otic suspension exactly as your doctor tells you to.
- Ciprofloxacin and dexamethasone otic suspension is for use in the ear only (otic use) . Do not use ciprofloxacin and dexamethasone otic suspension in the eye or inject ciprofloxacin and dexamethasone otic suspension.
- Apply 4 drops of ciprofloxacin and dexamethasone otic suspension into the affected ear 2 times a day for 7 days.
- Do not stop using ciprofloxacin and dexamethasone 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 and dexamethasone 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 and dexamethasone otic suspension
- you have fluid that drains from your ear 2 or more times within 6 months after you stop treatment with ciprofloxacin and dexamethasone otic suspension
What are the possible side effects of ciprofloxacin and dexamethasone otic suspension?
Ciprofloxacin and dexamethasone otic suspension may cause serious side effects, including:
allergic reactions. Stop using ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension include:
- ear discomfort
- ear pain
- ear itching (pruritus)
These are not all the possible side effects of ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension?
- Store ciprofloxacin and dexamethasone otic suspension at 20° to 25°C (68° to 77°F).
- Do not freeze ciprofloxacin and dexamethasone otic suspension.
- Keep ciprofloxacin and dexamethasone otic suspension out of light.
Keep ciprofloxacin and dexamethasone otic suspension and all medicines out of the reach of children.
General information about the safe and effective use of ciprofloxacin and dexamethasone otic suspension.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ciprofloxacin and dexamethasone otic suspension for a condition for which it was not prescribed. Do not give ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension that is written for health professionals.
What are the ingredients in ciprofloxacin and dexamethasone otic suspension?
Active ingredients: ciprofloxacin hydrochloride, dexamethasone, and benzalkonium chloride as a preservative
Inactive ingredients: boric acid, sodium chloride, hydroxyethyl cellulose, tyloxapol, acetic acid, sodium acetate trihydrate, edetate disodium, and water for injection. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
Sun Pharmaceutical Industries Limited
Baska Ujeti Road, Ujeti
Halol-389350, Gujarat, India.
For more information, call 1-800-818-4555.
This Patient Information has been approved by the U.S. Food and Drug Administration Revised. 12/2025
INSTRUCTIONS FOR USE
Ciprofloxacin (SIP-roe-FLOX-a-sin) and Dexamethasone (dex-a-meth-a-sone) Otic Suspension, USP
This “Instructions for Use” contains information on how to use ciprofloxacin and dexamethasone otic suspension.
Important Information You Need to Know Before Using Ciprofloxacin and Dexamethasone Otic Suspension.
Read this Instructions for Use that comes with ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension exactly as your doctor tells you to use it.
- Ciprofloxacin and dexamethasone otic suspension is for use in the ear only (otic use). Do not inject ciprofloxacin and dexamethasone otic suspension or use ciprofloxacin and dexamethasone otic suspension in the eye.
- Shake ciprofloxacin and dexamethasone otic suspension well before each use.
- Do not touch your ear, fingers, or other surfaces with the tip of the ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension?
Step 1. Wash your hands with soap and water (see Figure A).
Figure A
Step 2. Warm the bottle of ciprofloxacin and dexamethasone otic suspension by rolling the bottle between your hands for 1 to 2 minutes (see Figure B). Shake the bottle of ciprofloxacin and dexamethasone otic suspension well.
Figure B
Step 3. Remove the ciprofloxacin and dexamethasone otic suspension 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 C).
Figure C
Step 5. Hold the bottle of ciprofloxacin and dexamethasone 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 or ear with the tip of the bottle.
Figure D
Step 6. Gently squeeze the bottle and let 4 drops of ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension to enter the affected part of your ear.
Step 8.
If you use ciprofloxacin and dexamethasone otic suspension to treat a middle ear infection, and you have a tube in your eardrum known as a tympanostomy:
- Gently press the part of the ear known as the tragus (see Figure E) 5 times using a pumping motion (see Figure E). This will allow the drops of ciprofloxacin and dexamethasone 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 and dexamethasone 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 and dexamethasone 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 and dexamethasone 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 and dexamethasone otic suspension doses, there may be some ciprofloxacin and dexamethasone otic suspension left in the bottle. Throw the bottle away.
How should I store ciprofloxacin and dexamethasone otic suspension?
- Store ciprofloxacin and dexamethasone otic suspension at 20° to 25°C (68° to 77°F).
- Do not freeze ciprofloxacin and dexamethasone otic suspension.
- Keep ciprofloxacin and dexamethasone otic suspension out of light.
Keep ciprofloxacin and dexamethasone 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 and dexamethasone otic suspension that is written for health professionals.
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
Manufactured by:
Sun Pharmaceutical Industries Limited
Baska Ujeti Road, Ujeti
Halol-389350, Gujarat, India.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. ISS. 01/2026