Ciprofloxacin/dexamethasone

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Ciprofloxacin/dexamethasone
Ciprodex.png
Combination of
Ciprofloxacin antibacterial
Dexamethasone anti-inflammatory corticosteroid
Clinical data
Trade names Ciprodex
AHFS/Drugs.com Professional Drug Facts
MedlinePlus a607010
Routes of
administration
Auricular
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

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.

Contents

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. [3]

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. [1]

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. [3]

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.[ citation needed ]

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 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. [4]

Drug interactions

Drug interactions have not been studied with Ciprodex. [5]

Commercialization

Ciprodex, owned by Alcon Laboratories, Inc., is protected by multiple patents and will be restricted from generic manufacturing until 2025. [6] [7] Ciprodex is the number 1 topical antibiotic ear drop prescribed since 2007 by ENTs and pediatricians.[ citation needed ] There have been 18 million prescriptions filled for Ciprodex since 2003, making it the world leading marketed ear drops for AOE.[ citation needed ]

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. [8]

Related Research Articles

<span class="mw-page-title-main">Ciprofloxacin</span> Fluoroquinolone antibiotic

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 infections, typhoid fever, and urinary tract infections, among others. For some infections it is used in addition to other antibiotics. It can be taken by mouth, as eye drops, as ear drops, or intravenously.

<span class="mw-page-title-main">Otitis media</span> Inflammation of the middle ear

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, increased crying, and poor sleep. Decreased eating and a fever may also be present. The other main type is otitis media with effusion (OME), typically not associated with symptoms, although occasionally a feeling of fullness is described; it is defined as the presence of non-infectious fluid in the middle ear which may persist for weeks or months often after an episode of acute otitis media. Chronic suppurative otitis media (CSOM) is middle ear inflammation that results in a perforated tympanic membrane with discharge from the ear for more than six weeks. It may be a complication of acute otitis media. Pain is rarely present. All three types of otitis media may be associated with hearing loss. If children with hearing loss due to OME do not learn sign language, it may affect their ability to learn.

<span class="mw-page-title-main">Pharyngitis</span> Inflammation of the back of the throat

Pharyngitis is inflammation of the back of the throat, known as the pharynx. It typically results in a sore throat and fever. Other symptoms may include a runny nose, cough, headache, difficulty swallowing, swollen lymph nodes, and a hoarse voice. Symptoms usually last 3–5 days, but can be longer depending on cause. Complications can include sinusitis and acute otitis media. Pharyngitis is a type of upper respiratory tract infection.

<span class="mw-page-title-main">Dexamethasone</span> Corticosteroid medication

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 cava syndrome, and along with antibiotics in tuberculosis. In adrenocortical insufficiency, it may be used in combination with a mineralocorticoid medication such as fludrocortisone. In preterm labor, it may be used to improve outcomes in the baby. It may be given by mouth, as an injection into a muscle, as an injection into a vein, as a topical cream or ointment for the skin or as a topical ophthalmic solution to the eye. The effects of dexamethasone are frequently seen within a day and last for about three days.

<span class="mw-page-title-main">Prednisolone</span> Chemical compound (steroid medication)

Prednisolone is a corticosteroid, a steroid hormone used to treat certain types of allergies, inflammatory conditions, autoimmune disorders, and cancers. Some of these conditions include adrenocortical insufficiency, high blood calcium, rheumatoid arthritis, dermatitis, eye inflammation, asthma, and multiple sclerosis. It can be taken by mouth, injected into a vein, used topically as a skin cream, or as eye drops. It differs from the similarly named prednisone in having a hydroxyl at the 11th carbon instead of a ketone.

<span class="mw-page-title-main">Ofloxacin</span> Antibiotic to treat bacterial infections

Ofloxacin is a quinolone antibiotic useful for the treatment of a number of bacterial infections. When taken by mouth or injection into a vein, these include pneumonia, cellulitis, urinary tract infections, prostatitis, plague, and certain types of infectious diarrhea. Other uses, along with other medications, include treating multidrug resistant tuberculosis. An eye drop may be used for a superficial bacterial infection of the eye and an ear drop may be used for otitis media when a hole in the ear drum is present.

<span class="mw-page-title-main">Ear pain</span> Pain in the ear

Ear pain, also known as earache or otalgia, is pain in the ear. Primary ear pain is pain that originates from the ear. Secondary ear pain is a type of referred pain, meaning that the source of the pain differs from the location where the pain is felt.

Burow's solution is an aqueous solution of aluminium triacetate. It is available in the U.S. as an over-the-counter drug for topical administration, with brand names including Domeboro, Domeboro Otic, Star-Otic, and Borofair. The preparation has astringent and antibacterial properties and may be used to treat a number of skin conditions, including insect bites and stings, rashes caused by poison ivy and poison sumac, swelling, allergies, and bruises. However, its main use is for treatment of otitis, including otomycosis.

<span class="mw-page-title-main">Tobramycin</span> Chemical compound

Tobramycin is an aminoglycoside antibiotic derived from Streptomyces tenebrarius that is used to treat various types of bacterial infections, particularly Gram-negative infections. It is especially effective against species of Pseudomonas.

<span class="mw-page-title-main">Moxifloxacin</span> Antibiotic

Moxifloxacin is an antibiotic, used to treat bacterial infections, including pneumonia, conjunctivitis, endocarditis, tuberculosis, and sinusitis. It can be given by mouth, by injection into a vein, and as an eye drop.

<span class="mw-page-title-main">Ear drop</span> Form of medication placed in ears

Ear drops are a form of topical medication for the ears used to treat infection, inflammation, impacted ear wax and local anesthesia. They are commonly used for short-term treatment and can be purchased with or without a prescription. Before using ear drops, refer to the package insert or consult a health professional for the amount of drops to use and the duration of treatment.

<span class="mw-page-title-main">Otitis externa in animals</span>

Otitis externa is an inflammation of the outer ear and ear canal. Animals are commonly prone to ear infection, and this is one of the most common manifestations of allergy in dogs. In dogs, those breeds with floppy ears are more prone, since air flow is limited and a warm, moist environment built up, which is conducive to infection. The external ear in animals is longer and deeper than in humans, which makes it easier for infection or wax to build up or be hard to remove. Complete ear canal inspection requires the use of an otoscope by a veterinarian.

<span class="mw-page-title-main">Loteprednol</span> Pharmaceutical drug

Loteprednol is a topical corticosteroid used to treat inflammations of the eye. It is marketed by Bausch and Lomb as Lotemax and Loterex.

<span class="mw-page-title-main">Hydrocortisone aceponate</span> Chemical compound

Hydrocortisone aceponate is a veterinary corticosteroid that is used in form of creams for the treatment of various dermatoses. It is an ester of hydrocortisone (cortisol) with acetic acid and propionic acid.

<span class="mw-page-title-main">Nepafenac</span> NSAID analgesic and anti-inflammatory drug

Nepafenac, sold under the brand name Nevanac among others, is a nonsteroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop 0.1% solution (Nevanac) or 0.3% solution (Ilevro). It is used to treat pain and inflammation associated with cataract surgery. Nepafenac is a prodrug of amfenac, an inhibitor of COX-1 and COX-2 activity.

Tobramycin/dexamethasone, sold under the brand name Tobradex, is a fixed-dose combination medication in the form of eye drops and eye ointment, marketed by Alcon. The active ingredients are tobramycin and dexamethasone. It is prescribed for the treatment of pink eye in combination with bacterial infections.

Antipyrine and benzocaine ear drops is a medication for the treatment of ear pain caused by otitis media. It combines antipyrine, an NSAID, and benzocaine, a local anaesthetic in order to treat ear pain, alongside hydroxyquinoline sulfate, an antiseptic and preservative. Its trade names include Auralgan, Aurodex, Auroto, among others, and is abbreviated as A/B otic drops.

<span class="mw-page-title-main">Otitis externa</span> Inflammation of the ear canal

Otitis externa, also called swimmer's ear, is inflammation of the ear canal. It often presents with ear pain, swelling of the ear canal, and occasionally decreased hearing. Typically there is pain with movement of the outer ear. A high fever is typically not present except in severe cases.

<span class="mw-page-title-main">Finafloxacin</span> Chemical compound

Finafloxacin (Xtoro) is a fluoroquinolone antibiotic. In the United States, it is approved by the Food and Drug Administration to treat acute otitis externa caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus.

References

  1. 1 2 "Ciprodex- ciprofloxacin and dexamethasone suspension/ drops". DailyMed. U.S. National Library of Medicine. 12 December 2019. Retrieved 5 November 2020.
  2. 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.
  3. 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.
  4. 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.
  5. Novartis Pharmaceuticals Corporation. "Ciprodex Prescribing Information". US Food and Drug Administration.
  6. "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.
  7. US 8846650,Wall GM, Conroy PJ,"Method of treating middle ear infections",published 18 June 2009,issued 30 September 2014, assigned to Novartis AG
  8. "UK Judge Won't Invalidate Alcon's Glaucoma Treatment Patent". Law 360. 23 April 2021.