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Ciprofloxacin and fluocinolone (otic)

Generic name: ciprofloxacin and fluocinolone (otic) [SIP-roe-FLOX-a-sin-and-FLOO-oh-SING-oh-lone]
Brand name: Otovel
Form of dosage: otic solutions (0.3% to 0.25%)
Drug class: otic steroids with anti-infectives

What is Ciprofloxacin and fluocinolone (otic)?

Ciprofloxacin treats infections that are caused by bacteria with an antibacterial. Fluocinolone reduces the effects of chemicals that cause inflammation in the body. The combination medicine Ciprofloxacin and Fluocinolone (for the ears) is used to treat middle-ear infections, also known as otitis media. Children who have tubes in their ears and are at least six months old can use ciprofloxacin. This medication guide does not list all possible uses for fluocinolone and ciprofloxacin.

Side effects of Ciprofloxacin and fluocinolone (otic)

If you experience any of the following symptoms, seek emergency medical attention: hives or rash; itching or dizziness; a fast or pounding pulse; difficulty breathing; swelling on your face, lips, or tongue; or throat.

Ciprofloxacin or fluocinolone can cause serious side effects. If you experience:

  • At any sign of skin inflammation or infection, even minor ones need to be addressed immediately.
  • If you notice any new symptoms or worsening of the infection, please contact us.
  • This medicine can cause ear drainage to continue for up to 6 months after the last dose.

Some of the common side effects associated with ciprofloxacin or fluocinolone include:

  • Itching, swelling, or pain in the ear
  • Problems with balance
  • Scar tissue on the part of the ear.

There may be other side effects. Call your physician immediately if experiencing side effects; for FDA reporting purposes call them directly on 1-800-FDA-1088.

Warnings

Carefully follow all instructions printed on your medication package or label. Be sure to inform your healthcare provider of all relevant details relating to medical conditions, allergies and medicines you are currently taking.

Before you take this drug

If you have an allergy to fluocinolone or ciprofloxacin, or you suffer from:

  • A viral disease that affects your ear canal. This includes chickenpox.
  • An ear infection caused fungus.
  • An allergy to any antibiotic that is similar to ciprofloxacin, such as gatifloxacin or Tequin

Inform your physician of any allergies or medical conditions you are living with. Children younger than six months should not receive fluocinolone or ciprofloxacin. Tell your doctor if you are pregnant or breastfeeding a child.

How to take Ciprofloxacin and fluocinolone (otic)?

Do not alter the instructions on your prescription. Use this medication only as directed. Do not exceed the recommended dose or use it for longer than recommended. Take it only by mouth. Otic medicines are only to be used in the ears. Read all of the available information, such as medication guides and instructions. If any queries arise, speak with either your physician or pharmacist directly. Before using this medication, wash your hands. Use a tissue to gently clean any ear discharge from the outer ear. Holding the vial for 1 to 2 minutes will warm up the medicine. Cold ear drops may cause dizziness in children, especially those with ear tubes.

How to use the eardrops:

  • If you are lying down, tilt your head upward with your ear up. When giving the medicine to a young child, gently pull your ear back or pull downward on the earlobe.
  • Drop the correct amount of drops in your ear by holding the dropper upside-down over your ear.
  • For at least one minute, lie down with your head tipped back. Use a piece of cotton to block the ear canal and prevent the medication from draining.
  • Avoid touching the tip of the dropper or placing it directly into your ears. It could become contaminated. Do not use soap or water to wash the tip. Instead, wipe it with a tissue.

If your doctor has instructed you to use this medicine in both of your ears, then only apply it to the ear that is affected. In case any medication comes into contact with the eyes, rinse with plenty of water immediately to clear away. Do not stop taking the medicine before it is completely cleared. You may experience improvement in your symptoms before the infection has completely resolved. You may increase your chances of a second infection resistant to anti-biotics if you skip doses. If your symptoms don't improve within 7 days or you experience new symptoms, call your doctor. The plastic vials are enough to make one dose. After one use, throw away the vial, even if it still contains some medicine. Store away from moisture, heat and light at room temperature. To prevent contamination, keep unopened vials inside the foil pouch. Use the medicine immediately after opening a vial. After opening the foil pouch, you must use your vials within 7 days.

Details on dosage

Adult dose for otitis media:

Instilled in the affected ear canal twice a day, every 12 hours
Duration of treatment: 7 days
Comments:
The vial should be heated in your hands for 1 to 2 minutes before administration. This will prevent the dizziness that can occur when a cold solution is injected into the ear canal.
Once the tragus has been instilled into the patient, it should be pumped four times inward, and the patient should then remain in this position for a minimum of one minute.
Use: Treatment for acute otitis with a tympanostomy tube due to Haemophilus fluoride, Moraxella catarrhalis (Moraxella), Pseudomonas aureus (Staphylococcus aeruginosa), Staphylococcus aeruginosa, and/or Streptococcus pneumoniae

Usual paediatric dose for otitis media:

Ciprofloxacin 0,75 mg and fluocinolone 0,0625 mg were instilled two times per day (every twelve hours) into the affected ear canal.
Duration of treatment: 7 days
Comments:
The vial should be heated in your hands for between 1 and 2 minutes before administration. This will help to prevent the dizziness that can occur when a cold solution is injected into the ear canal.
Once the tragus has been instilled into the patient, it should be pumped four times inward, and the patient should then remain in this position for a minimum of one minute.
Use: Treatment for AOMT caused by H. Influenzae, P. Aeruginosa (including S. Pneumoniae), M. Catarrhalis, and/or S. Aureus.

What happens if I miss the dose?

As soon as you recall taking an overdue dose, take it immediately; otherwise if your next scheduled dosage is approaching fast enough to pass without incident, simply skip it altogether.You should not take extra medicine to compensate for a missed dose.

What happens if I overdose?

Overdoses of fluocinolone and ciprofloxacin are not dangerous. Should anyone accidentally swallow medication, seek emergency medical assistance immediately or call Poison Help immediately at 1-800-222-1222.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Other drugs that you may take orally or even inject are unlikely to have any effect on the fluocinolone and ciprofloxacin used in your ears. Many drugs interact with each other. Inform your healthcare provider about any medicines you are taking, including over-the-counter and prescription medicines, vitamins, and herbal supplements.