February 22, 2017
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Ciprodex

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Ciprodex




Indications
Dosage
How Supplied

INDICATIONS

CIPRODEX is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:

  • Acute Otitis Media 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 in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

DOSAGE AND ADMINISTRATION

Important Administration Instructions

  • CIPRODEX is fo r otic use only, and not for ophthalmic use, or for injection.
  • Shake well immediately before use.

Dosage

For The Treatment Of Acute Otitis Media In Pediatric Patients (Age 6 Months And Older) With Tympanostomy Tubes

The recommended dosage regimen through tympanostomy tubes is as follows:

  • Four drops (equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg of ciprofloxacin and 0.14 mg of dexamethasone)) instilled into the affected ear twice daily for seven days.
  • The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.
  • The patient should lie with the affected ear upward, and then the drops should be instilled.
  • The tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear.
  • This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
  • Discard unused portion after therapy is completed.
For The Treatment Of Acute Otitis Externa (Age 6 Months And Older)

The recommended dosage regimen is as follows:

  • Four drops (equivalent to 0.14 mL of CIPRODEX, (consisting of 0.42 mg ciprofloxacin and 0.14 mg dexamethasone)) instilled into the affected ear twice daily for seven days.
  • The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension.
  • The patient should lie with the affected ear upward, and then the drops should be instilled.
  • This position should be maintained for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.
  • Discard unused portion after therapy is completed.

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

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.

NDC 0065-8533-02, 7.5 mL fill

Storage

Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature].

Avoid freezing. Protect from light.

Distributed by: Alcon Laboratories, Inc., Fort Worth, TX 76134 USA. Revised: Dec 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/21/2016

Indications
Dosage
How Supplied

Ciprodex - User Reviews

Ciprodex User Reviews

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