Ciprofloxacin/dexamethasone

Ciprofloxacin/dexamethasone
Combination of
CiprofloxacinAntibiotic
DexamethasoneCorticosteroid
Names
Trade namesCiprodex, others
Clinical data
Main usesAcute otitis media in those with tympanostomy tubes; acute otitis externa[1]
Side effectsEar pain, ear itchiness[1]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Routes of
use		Ear drop[1]
Typical dose4 drops BID x 7 days[2]
External links
AHFS/Drugs.comMonograph
MedlinePlusa607010
Legal
Legal status

Ciprofloxacin/dexamethasone, sold under the brand name Ciprodex among others, is a combination medication used to treat acute otitis media in those with tympanostomy tubes or acute otitis externa.[1] It may be used in those who are at least 6 months old.[1] It is used as an ear drop.[1]

Common side effects include ear pain and ear itchiness.[1] Other side effects may include anaphylaxis.[1] It contains the antibiotic, ciprofloxacin (0.3%) with the corticosteroid, dexamethasone (0.1%).[1] It is effective against a number of bacteria including Pseudomonas aeruginosa.[1]

The combination was approved for medical use in the United States in 2003.[1] It is available as a generic medication.[2] In the United Kingdom a 5 ml bottle costs the NHS about £6 as of 2021.[2] It costs about 63 USD in the United States as of 2023.[4]

Medical uses

It is indicated for use in the treatment of acute otitis media and acute otitis externa (swimmer's ear) in people aged six months and older.[1]

Dosage

It is generally used as 4 drops two times per day for 7 days.[2]

Interactions

Drug interactions have not been studied.[5]

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.[6]

It has 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.[6]

Society and culture

Ciprodex, owned by Alcon Laboratories, Inc., is protected by multiple patents and will be restricted from generic manufacturing until 2025.[7][8] There have been 18 million prescriptions filled for Ciprodex since 2003, making it the world leading marketed ear drops for AOE.

In October 2015, Alcon sued Dr. Reddy's Laboratories (DLR) for allegedly infringing on Ciprodex patents. A judge in the UK upheld the Alcon patent.[9]

Research

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.[10]

Phase II and III

Treatment-related adverse effects in AOE studies were determined in phase II and III trials. This includes ear pruritus, 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.[10]

References

  1. 1 2 3 4 5 6 7 8 9 10 11 12 13 "Ciprodex- ciprofloxacin and dexamethasone suspension/ drops". DailyMed. U.S. National Library of Medicine. 12 December 2019. Archived from the original on 24 January 2021. Retrieved 5 November 2020.
  2. 1 2 3 4 BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1242. ISBN 978-0857114105.
  3. ↑ Human Medicines Evaluation Division (14 January 2021). "Active substance: ciprofloxacin hydrochloride / dexamethasone acetate (ear drops, suspension)" (PDF). List of nationally authorised medicinal products. Europeans Medicines Agency. Archived (PDF) from the original on 30 June 2023. Retrieved 31 October 2021.
  4. ↑ "Ciprofloxacin / Dexamethasone". GoodRx. Archived from the original on 10 July 2021. Retrieved 25 May 2023.
  5. ↑ Novartis Pharmaceuticals Corporation. "Ciprodex Prescribing Information". US Food and Drug Administration. Archived from the original on 2018-08-23. Retrieved 2021-10-31.
  6. 1 2 "Product Monograph: Ciprodex" (PDF). Mississauga, Ontario: Alcon Canada Inc. 6 May 2004. Archived from the original (PDF) on 2016-03-04. Retrieved 2015-12-07.
  7. ↑ "Generic Drug Product Information & Patent Information". Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA/Center for Drug Evaluation and Research. Archived from the original on 4 March 2016.
  8. ↑ US 8846650, Wall GM, Conroy PJ, "Method of treating middle ear infections", published 18 June 2009, issued 30 September 2014, assigned to Novartis AG 
  9. ↑ "UK Judge Won't Invalidate Alcon's Glaucoma Treatment Patent". Law 360. 23 April 2021. Archived from the original on 12 July 2021. Retrieved 31 October 2021.
  10. 1 2 Smith T (7 August 2003). "Medical Officers Review of NDA 21-537: Ciprofloxacin 0.3% and 0.1% dexamethasone Otic Suspension" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 17 February 2017. Retrieved 31 October 2021.
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