Ciprofloxacin/dexamethasone (Ciprodex) is an antibiotic/steroid combination medication. It contains the synthetic broad-spectrum antibacterial agent, ciprofloxacin hydrochloride (0.3%), combined with the anti-inflammatory corticosteroid, dexamethasone (0.1%), in a sterile, preserved suspension for otic use. Ciprofloxacin, a fluoroquinolone antibiotic, has shown in vitro activity against many Gram-positive and Gram-negative bacteria including Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. Dexamethasone acts as an anti-inflammatory corticosteroid. Medical uses
Ciprodex is indicated for use in the treatment of acute otitis media and acute otitis externa (swimmers ear) in people aged six months and older. Mechanism of action
Ciprofloxacin functions as a bactericide by interfering with DNA gyrase, an enzyme with a key role in the synthesis of bacterial DNA. Dexamethasone is used in combination in order to aid in the reducing inflammatory responses that often accompany bacterial infection. Clinical trials
In clinical trials, the median time to cessation of ear pain in Ciprodex was five days in a sample population of 909 participants. However, the clinical trial failed to demonstrate any significant benefit of using the combination of active ingredients in Ciprodex over ciprofloxacin alone, in regards to ear pain. Ciprodex was superior to ciprofloxacin in regards to time to cessation of otorrhea. Phase I
The most reported adverse effects of phase I studies included headache, rhinitis, pain, dyspepsia, and dysmenorrhea. Investigators did not believe that any of these were directly treatment-related, as many of these events are considered symptoms or manifestations of the underlying illness.
Symptoms result from the release of histamine and other active substances by mast cells, and consist of redness (mainly due to vasodilation of the peripheral small blood vessels), swelling of the conjunctiva, itching, and increased production of tears. Bacterial
Bacterial conjunctivitis causes the rapid onset of conjunctival redness, swelling of the eyelid, and a sticky discharge. Typically, symptoms develop first in one eye, but may spread to the other eye within 2–5 days. Conjunctivitis due to common pus-producing bacteria causes marked grittiness or irritation and a stringy, opaque, greyish or yellowish discharge that may cause the lids to stick together, especially after sleep. Severe crusting of the infected eye and the surrounding skin may also occur. The gritty or scratchy feeling is sometimes localized enough that patients may insist that they have a foreign body in the eye.Common bacteria responsible for nonacute bacterial conjunctivitis are Staphylococcus, Streptococcus, and Haemophilus species. Less commonly, Chlamydia spp. may be the cause. Bacteria such as Chlamydia trachomatis or Moraxella spp. can cause a nonexudative but persistent conjunctivitis without much redness. Bacterial conjunctivitis may cause the production of membranes or pseudomembranes that cover the conjunctiva. Pseudomembranes consist of a combination of inflammatory cells and exudates and adhere loosely to the conjunctiva, while true membranes are more tightly adherent and cannot be easily peeled away. Cases of bacterial conjunctivitis that involve the production of membranes or pseudomembranes are associated with Neisseria gonorrhoeae, β-hemolytic streptococci, and Corynebacterium diphtheriae. C. diphtheriae causes membrane formation in conjunctiva of unimmunized children.