Ciprofloxacin And Fluocinolone Acetonide

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to

• Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic use only. It is not for ophthalmic use, or for injection.

The recommended dosage regimen is as follows:

• Instill the contents of one single-dose vial 0.25 mL into the affected ear canal twice daily (approximately every 12 hours) for 7 days. Use this dosing for patients aged 6 months of age and older.
• Warm the solution by holding the vial in the hand for 1 to 2 minutes. This is to avoid dizziness, which may result from the instillation of a cold solution into the ear canal.
• The patient should lie with the affected ear upward, and then instill the medication.
• Pump the tragus 4 times by pushing inward to facilitate penetration of the medication into the middle ear.
• Maintain this position for 1 minute. Repeat, if necessary, for the opposite ear
  
  
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  INSTRUCTIONS FOR USE
  
  CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE
  
  (sip-roh-flok-suh-sin and floo-oh-SIN-oh-lone uh-SEET-oh-nide)
  
  Otic Solution

  Read this Instructions for Use that comes with Ciprofloxacin and Fluocinolone Acetonide Otic Solution 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 healthcare provider about your medical condition or treatment.

  Important information about Ciprofloxacin and Fluocinolone Acetonide Otic Solution

  :

  • Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for use in the ear only (otic use)
    . Do not inject Ciprofloxacin and Fluocinolone Acetonide Otic Solution or use Ciprofloxacin and Fluocinolone Acetonide Otic Solution in the eye.
  • Use Ciprofloxacin and Fluocinolone Acetonide Otic Solution exactly as your healthcare provider tells you to use it.

  How should I use Ciprofloxacin and Fluocinolone Acetonide Otic Solution?

  Step 1 .	You or your caregiver should wash their hands with soap and water.
  Step 2 .	Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any other object in the ear canal.
  Step 3 .	Remove Ciprofloxacin and Fluocinolone Acetonide Otic Solution from the protective foil pouch. Pull apart 1 single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution as shown, by tearing along the dotted lines (perforations) until it is fully separated.
  Step 4 .	Warm the dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution by holding the vial in your hand for 1 to 2 minutes .
  Step 5 .	Twist off the vial cap in the direction of the arrow as shown.
  Step 6 .	The person receiving Ciprofloxacin and Fluocinolone Acetonide Otic Solution should be on his/her side with the infected ear up as shown.
  Step 7 .	Hold the vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution in your hand and place the vial close to the ear. Let the entire dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution fall into the affected ear.
  Step 8 .	Gently press the part of the ear known as the tragus 4 times using a pumping motion as shown. This will allow the drops of Ciprofloxacin and Fluocinolone Acetonide Otic Solution to enter the middle ear.
  Step 9 .	Remain on your side with the affected ear facing upward for 1 minute .
  Step 10 .	If your healthcare provider has told you to use Ciprofloxacin and Fluocinolone Acetonide Otic Solution in both ears, repeat Steps 2-9 for the other ear.
  Step 11 .	Safely throw away Ciprofloxacin and Fluocinolone Acetonide Otic Solution vials after use.

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

  

  

  

  

  

  

  

  

  

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Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide

• Hypersensitivity
  : Discontinue use at the first appearance of a skin rash or any other sign of hypersensitivity. (
  
  
  5.1 Hypersensitivity Reactions

  Ciprofloxacin and Fluocinolone Acetonide Otic Solution should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.
  )
  
• Potential for Microbial Overgrowth:
  Prolonged use may result in the overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy. (
  
  
  5.2 Potential for Microbial Overgrowth with Prolonged Use

  Prolonged use of Ciprofloxacin and Fluocinolone Acetonide Otic Solution may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.
  )