Ciprofloxacin/dexamethasone

Ciprofloxacin/dexamethasone
Combination of
Ciprofloxacin antibacterial
Dexamethasone anti-inflammatory corticosteroid
Clinical data
Trade names Ciprodex

Ciprofloxacin/dexamethasone (Ciprodex) is an antibiotic/steroid combination product in a sterile suspension. Ciprodex 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 influenza, Moraxella catarrhalis, and Pseudomonas aeruginosa. Dexamethasone acts as an anti-inflammatory corticosteroid.[1]

Ciprodex is indicated for use in the treatment of acute otitis media and acute otitis externa (swimmer’s ear) in ages 6 months and older. Ciprodex should be avoided in patients with a history of hypersensitivity to ciprofloxacin or other quinolones and should not be used to treat viral infections.

Ciprodex is typically given twice a day in each infected ear, 4 drops per ear, for as long as prescribed by the doctor (usually 7 days).[2]

Mechanism of action

Ciproflaxacin 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.[1]

Clinical trials

In clinical trials, the median time to cessation of ear pain in Ciprodex was 5 days in a sample population of 909 patients. 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. Ciprodex was noninferior to competitive products such as Cortisportin and ofloxacin.[3]

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.[4]

Phase II and III

Treatment-related adverse effects in AOE studies were determined in phase II and III trials. This includes ear pruritis, ear debris, superimposed ear infection, ear congestion, ear pain, and erythema. Similar effects were demonstrated in AOMT studies. Overall, Ciprodex was determined as a safe and well-tolerated drug for the treatment of AOE and AOMT. The proposed dosage for all patients was also effective and safe. Cure rates for pediatrics were slightly higher than adults in AOE studies.[4]

Drug interactions

Drug interactions have not been studied with Cirprodex.[2]

Commercialization

Ciprodex, owned by Alcon Laboratories, Inc., is protected by multiple patents and will be restricted from generic manufacturing until 2022.[5][6] Cirpodex is the number 1 topical antibiotic ear drop prescribed since 2007 by ENTs and pediatricians. There have been 18 million prescriptions filled for Ciprodex since 2003, making it the world leading marketed ear drops for AOE.[7] Ciprodex costs $162.35 for 7.5 mL of suspension.

In October 2015, Alcon sued Dr. Reddy’s Laboratories (DLR) for allegedly infringing on Ciprodex patents.[8]

References

  1. 1 2 http://www.alcon.ca/pdf/Product_pharma/Product_pharma_ciprodex_eng.pdf
  2. 1 2 http://www.ciprodex.com/
  3. ↑ "Otic Pharma Announces Positive Results from a Phase 2 Trial of FoamOtic Externa, Once-a-Day, Single Antibiotic, Steroid Free Product for Acute Otitis Externa (AOE)." US Official News. (January 7, 2015 Wednesday ): 742 words. LexisNexis Academic. Web. Date Accessed: 2015/12/07.
  4. 1 2 http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021537_Ciprodex_medr.PDF
  5. ↑ http://www.fda.gov/downloads/drugs/informationondrugs/ucm086233.pdf
  6. ↑ http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=021537&Product_No=001&table1=OB_Rx
  7. ↑ http://www.google.com/patents/US8846650
  8. ↑ "Alcon sues DRL over Ciprodex patent". Times of India. October 20, 2015.
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