Ciprofloxacin/dexamethasone (Ciprodex) is an antibiotic/steroid combination medication. It contains the synthetic broad-spectrum antibacterial agent,

ciprofloxacin Ciprofloxacin is a fluoroquinolone antibiotic used to treat a number of bacterial infections. This includes bone and joint infections, intra abdominal infections, certain types of infectious diarrhea, respiratory tract infections, skin infec ...

hydrochloride (0.3%), combined with the anti-inflammatory

corticosteroid Corticosteroids are a class of steroid hormones that are produced in the adrenal cortex of vertebrates, as well as the synthetic analogues of these hormones. Two main classes of corticosteroids, glucocorticoids and mineralocorticoids, are involv ...

dexamethasone Dexamethasone is a glucocorticoid medication used to treat rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, eye pain following eye surgery, superior vena cav ...

(0.1%), in a sterile, preserved suspension for otic use. Ciprofloxacin, a

fluoroquinolone antibiotic A quinolone antibiotic is a member of a large group of broad-spectrum bacteriocidals that share a bicyclic core structure related to the substance 4-quinolone. They are used in human and veterinary medicine to treat bacterial infections, as well ...

, has shown ''in vitro'' activity against many

Gram-positive In bacteriology, gram-positive bacteria are bacteria that give a positive result in the Gram stain test, which is traditionally used to quickly classify bacteria into two broad categories according to their type of cell wall. Gram-positive bacte ...

and

Gram-negative bacteria Gram-negative bacteria are bacteria that do not retain the crystal violet stain used in the Gram staining method of bacterial differentiation. They are characterized by their cell envelopes, which are composed of a thin peptidoglycan cell wall ...

including ''

Staphylococcus aureus ''Staphylococcus aureus'' is a Gram-positive spherically shaped bacterium, a member of the Bacillota, and is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin. It is often positive ...

'', ''

Streptococcus pneumoniae ''Streptococcus pneumoniae'', or pneumococcus, is a Gram-positive, spherical bacteria, alpha-hemolytic (under aerobic conditions) or beta-hemolytic (under anaerobic conditions), aerotolerant anaerobic member of the genus Streptococcus. They are ...

'', ''

Haemophilus influenzae ''Haemophilus influenzae'' (formerly called Pfeiffer's bacillus or ''Bacillus influenzae'') is a Gram-negative, non-motile, coccobacillary, facultatively anaerobic, capnophilic pathogenic bacterium of the family Pasteurellaceae. The bacteria ...

'', ''

Moraxella catarrhalis ''Moraxella catarrhalis'' is a fastidious, nonmotile, Gram-negative, aerobic, oxidase-positive diplococcus that can cause infections of the respiratory system, middle ear, eye, central nervous system, and joints of humans. It causes the infec ...

'', and ''

Pseudomonas aeruginosa ''Pseudomonas aeruginosa'' is a common encapsulated, gram-negative, aerobic–facultatively anaerobic, rod-shaped bacterium that can cause disease in plants and animals, including humans. A species of considerable medical importance, ''P. aerugi ...

''. 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 (swimmer's ear) in people aged six months and older.

Mechanism of action

Ciprofloxacin functions as a bactericide by interfering with

DNA gyrase DNA gyrase, or simply gyrase, is an enzyme Enzymes () are proteins that act as biological catalysts by accelerating chemical reactions. The molecules upon which enzymes may act are called substrates, and the enzyme converts the substrat ...

, 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 Otitis media is a group of inflammatory diseases of the middle ear. One of the two main types is acute otitis media (AOM), an infection of rapid onset that usually presents with ear pain. In young children this may result in pulling at the ear, ...

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.

Phase II and III

Treatment-related adverse effects in AOE studies were determined in phase II and III trials. This includes ear

pruritus Itch (also known as pruritus) is a sensation that causes the desire or reflex to scratch. Itch has resisted many attempts to be classified as any one type of sensory experience. Itch has many similarities to pain, and while both are unpleasant ...

, 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.

Drug interactions

Drug interactions have not been studied with Ciprodex.

Commercialization

Ciprodex, owned by Alcon Laboratories, Inc., is protected by multiple patents and will be restricted from generic manufacturing until 2025. Ciprodex 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. 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.

References

External links

* {{DEFAULTSORT:Ciprofloxacin Dexamethasone Combination drugs Novartis brands