Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.

Start Date29 Nov 2019

Sponsor / Collaborator

St. Paul's Hospital (Grey Nuns) of Saskatoon

NCT02216071 / CompletedPhase 3

A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa

The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Start Date20 Jul 2014

Sponsor / Collaborator

Exela Pharma Sciences LLC

NCT01994642 / TerminatedPhase 3

A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Acute Bacterial Otitis Media in Children With Patent Tympanostomy Tubes

The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.

Start Date01 Nov 2013

Sponsor / Collaborator

Par Pharmaceutical, Inc.

[+1]

100 Clinical Results associated with Ciprofloxacin/Dexamethasone

100 Translational Medicine associated with Ciprofloxacin/Dexamethasone

100 Patents (Medical) associated with Ciprofloxacin/Dexamethasone

Literatures (Medical) associated with Ciprofloxacin/Dexamethasone

01 Oct 2023·International journal of pediatric otorhinolaryngology

Otologic safety of intratympanic N-acetylcysteine in an animal model

Article

Author: Chan, Ching Yee ; Daniel, Sam J ; Wurzba, Sabrina Daniela Silva ; Conley, Stephen F ; Grenier, Karl ; Sayegh, Joseph ; Salameh, Samer ; Linn, David T ; Partain, Matthew P

OBJECTIVE:

N-acetylcysteine (NAC) is an anti-oxidant and mucolytic effective against bacterial biofilms, making it useful in the treatment of chronically discharging ears that are unresponsive to traditional treatment methods. The objective of this study was to evaluate the otologic safety of intratympanic NAC combined with Ciprodex® in an animal model.

METHODS:

Baseline distortion product otoacoustic emissions (DPOAE) and auditory brainstem response (ABR) measurements were performed for both ears on thirteen guinea pigs from the animal care research facilities of the McGill University Health Center. This was followed by intratympanic administration of control solution (Ciprofloxacin 0.3%/Dexamethasone 0.1%) to the left ear and experimental solution (1.25% NAC/Ciprofloxacin 0.3%/Dexamethasone 0.1%) to the right ear. Three additional intratympanic injections were performed over the next fourteen days. DPOAE and ABR measurements were repeated 3-4 weeks after the initial procedure. Outcome measures included differences in DPOAE and ABR thresholds after intervention, clinical evidence of vestibular dysfunction and histological evidence of ototoxicity.

RESULTS:

There were no significant differences in the ABR thresholds and DPOAE results of the control and experimental ears at baseline and after intervention. There was neither clinical manifestation of vestibular dysfunction nor histological evidence of ototoxicity.

CONCLUSION:

Our study suggests that intratympanic 1.25% NAC with ciprofloxacin and dexamethasone is safe in guinea pigs and support its potential use in the treatment of chronically discharging ears. Further studies in humans are required to analyze its efficacy relative to conventional treatments.

LEVEL OF EVIDENCE:

Animal Research.

01 Jan 2023·The Annals of otology, rhinology, and laryngologyQ4 · MEDICINE

Iron Pill-Induced Chemical Laryngitis

Q4 · MEDICINE

Article

Author: Bishop, Ryan ; Sethia, Rishabh ; Matrka, Laura ; Gordian-Arroyo, Adlin

Objective::

To discuss the presentation and management of pill-induced chemical laryngitis by illustrating a rare case.

Methods::

We report a unique case of a patient with iron pill-induced laryngitis.

Results::

A 71-year-old male presented for evaluation of dysphonia. Five weeks prior, the patient had reportedly aspirated an iron pill. The pill was lodged in his throat for several hours before being coughed up, soft but still intact. Since that event, the patient noted complete voice loss and in clinic was found to have a very breathy and asthenic voice. Stroboscopy revealed aperiodicity with severe false fold compression and significant ulceration of the infraglottic region associated with thick exudate. Vocal folds were mobile but atrophic, with overlying crusted secretions. A sensory deficit was suspected based on scope tolerance. The patient was treated with nebulized ciprodex and humidified air with some improvement in mucosal crusting but had persistent glottic insufficiency and dysphonia, prompting bilateral hyaluronic acid injection.

Conclusions::

Pill-induced laryngitis is an extremely rare phenomenon. While typically associated with bisphosphonates, this condition should be considered in any patient presenting with dysphonia and history of aspiration of a pill, including iron supplements. Regardless of the inciting medication, pill-induced laryngitis may be treated with humidified air, nebulized steroids, and antibiotics. Injection augmentation of the vocal folds may be made considered when glottic insufficiency and weak cough contribute to the presentation.

01 May 2021·World journal for pediatric & congenital heart surgery

Expert Technique: Pediatric Tracheal Surgery

Article

Author: Wiedermann, Joshua P. ; Backer, Carl L. ; Stephens, Elizabeth H. ; Dearani, Joseph A.

Substantial improvements in techniques of tracheal surgery for children have occurred in the past 20 years. Precise preoperative imaging with computed tomography clearly defines the anatomy for surgical planning and is assisted by on-the-table needle localization. The use of cardiopulmonary bypass greatly facilitates creation of an airtight, widely patent trachea. The use of Ciprodex as a postoperative nebulizer has significantly decreased granulation tissue along the suture line. Most important has been the adoption of slide tracheoplasty as the procedure of choice.

News (Medical) associated with Ciprofloxacin/Dexamethasone

26 Mar 2024

·www.pharmaceutical-technology.com

Amneal gains FDA greenlight to develop Ciprodex generic for ear infections

Amneal aims to develop an affordable, complex, high-value product for bacterial ear infections. Credits: goodlux/Shutterstock.com. Amneal Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for its ciprofloxacin and dexamethasone otic suspension, a generic drug of Novartis ’ Ciprodex (ciprofloxacin/dexamethasone), for the treatment of ear infections. With the FDA approval, the New Jersey-based pharma company will develop an affordable, complex, and high-value product that reflects the “diversification of [the] business” and its evolving portfolio, said Amneal’s generics executive vice-president Andy Boyer in the 25 March press release. An approved ANDA allows a sponsor to manufacture and market a safe and effective generic product at a lower cost than the brand-name product it references. Ciprodex is designed to prevent bacterial DNA replication and the growth of new bacteria via the antibiotic ciprofloxacin. It suppresses inflammation by inhibiting the synthesis of cytokines associated with inflammation. As per its label, the drug is indicated to treat infections caused by susceptible isolates of the designated microorganisms in acute otitis media (AOM) and acute otitis externa (AOE) in patients aged six months and older. Novartis reported a 62% rise in net income in 2023, increasing from $6.04bn to $8.6bn on constant currencies. See Also: J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction Takeda’s ADZYNMA gains Japanese approval for cTTP treatment Amneal is among several companies marketing generics of Novartis’ combination ear drop medication. India-based Dr Reddy’s launched its Ciprodex generic after receiving FDA approval in August 2020.

Drug ApprovalFast TrackQualified Infectious Disease Product

25 Mar 2024

·www.biospace.com

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

- Product references branded Ciprodex - Represents another complex, high value new product BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, and is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to staphylococcus aureus and pseudomonas aeruginosa. “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics. “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.” The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%). For full prescribing information, see package insert located here. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company. Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including recent events affecting the financial services industry; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Drug Approval

01 Sep 2021

·www.biospace.com

Dexamethasone Injectables to Remain Top Choice for Addressing Rising Cases of Inflammatory Conditions

COVID-19 Outbreak Fuelled Dexamethasone Demand, Overall Sales to Total US$ 46.9 Bn by 2031 Fact.MR survey on Dexamethasone market offers detailed analysis on the key growth drivers and trends affecting the demand in terms of administration route, application and distribution channel. It also highlights various strategies adopted by key market players to gain a competitive edge in the dexamethasone market. Fact.MR – A Market Research and Competitive Intelligence Provider: As per the latest Fact.MR analysis, the global dexamethasone market is set to witness strong growth in the next ten years. Expansion of global antiviral market will have a profound impact on Dexamethasone sales. Fact.MR presents a positive growth outlook for the dexamethasone market with antiviral market set to surpass US$ 46.9 billion by 2031. Robust expansion of the dexamethasone market can be attributed to the increasing prevalence of various diseases such as allergic disorders, skin conditions, cancer, breathing disorders, ulcerative colitis, arthritis and COVID-19. Owing to its anti-inflammatory and immunosuppressant properties, dexamethasone is being increasingly prescribed to treat a wide range of diseases. Sales of dexamethasone skyrocketed during the COVID-19 pandemic as it was found effective in the treatment of some cases of novel coronavirus. Around 2.8 million orders were released in June 2020 after the University of Oxford researchers found dexamethasone effective against symptoms affecting COVID-19 patients. In September 2020, the World Health Organization (WHO) prescribed the use of dexamethasone for the treatment of patients with severe and critical COVID-19. Similarly on August 4, the Food and Drug Administration (FDA) approved an abbreviated new drug application for dexamethasone sodium phosphate injection to treat critically ill COVID-19 patients. Injectable segment dominates the dexamethasone market. They are preferred in hospital emergency wards for treating variety of diseases. Considering this, injectable segment is expected to remain dominant as route of administration through the forecast period. The U.K leads the dexamethasone market with a healthy market share. As per National Health Services (NHS), in June 2020, the U.K government had stockpiled around 200,000 courses of the drug after it showed promising results against COVID-19. “Consistent drug approvals by regulating bodies and increasing manufacturing of will continue to drive the market during the forecast period,” says the Fact.MR analyst. For More Information On How To Improve Your Dexamethasone Market Footprint, Request A Sample Here Key Takeaways from Dexamethasone Market Survey The U.K leads the dexamethasone market as a result of governmental support and increase in manufacturing of generic drug dexamethasone for treating COVID-19. China is expected to offer lucrative growth opportunities for the manufacturers of dexamethasone as majority of raw material comes from the country. With highly developed healthcare sector and presence of leading drug manufacturers, the U.S is set to emerge as a leading market for dexamethasone. The injectable segment leads the dexamethasone market as it is being preferred for its quick action in the treatment of various diseases. Based on application, the COVID-19 segment is anticipated to continue its dominance in the dexamethasone market. Key Drivers Increasing prevalence of various disorders such as chronic obstructive lung diseases and arthritis is driving the dexamethasone market. Advent of COVID-19 pandemic bolstered the sales of dexamethasone products. Involvement of governments to tackle the rising cases of diseases like COVID-19 and cancer is positively impacting the demand for dexamethasone. Expansion of pharmaceutical sector will offer lucrative opportunities to the manufacturers of dexamethasone. Rising awareness regarding the use of dexamethasone also aids in the growth of the market. Key Restraints Development of vaccines will decrease the demand for dexamethasone products. Side effects associated with dexamethasone is restraining the growth of the market. Ask Your Dexamethasone Market Related Questions & Get Customized Reports Competitive Landscape Key companies operating in the dexamethasone market are focusing on developing new products. They have adopted various organic and inorganic strategies such as mergers and acquisitions, advanced product development and collaborations to gain a competitive edge in the market. In August 2020, Dr. Reddy’s Laboratories announced the first-to-market launch of the generic version of Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) in the U.S. The Ciprodex is indicated for the treatment of infections caused by the susceptible isolates of the designated microorganism in the specific conditions of Acute Otitis Media (AOM in pediatric and Acute Otitis Externa (AOE) in pediatric, adult and elderly patients. In August 2020, Fera Pharmaceuticals announced the launch of Dexamethasone 4 mg tablets USP in unit dose packaging. In March 2021, the U.S Food and Drug Administration (FDA) approved isatuximab-irfc (sarclisa) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received 1 to 3 lines of therapy. Some of the prominent players operating in the Dexamethasone market profiled by Fact.MR are: Allergan plc Alcon, Pfizer Inc. Morepan laboratories Ltd. Zydus Cadila, Aspen Cadila Pharmaceuticals GLS Pharma Ltd Hikma Pharmaceuticals PLC Merck and Co, Inc. Xspire Pharma, LLC Taro Pharmaceutical Industries Ltd Pragma Pharmaceuticals, LLC Trotwood Pharma Limited Wellona pharma Wokhardt, Sandoz AG. AdvaCare Pharma. More Insights on the Global Dexamethasone Sales Outlook Fact MR provides an unbiased analysis of dexamethasone market, presenting historical demand data (2016-2020) and forecast statistics for the period from 2021-2031. The study divulges compelling insights on the demand for dexamethasone with a detailed segmentation on the basis of: Route of administration Nasal Ophthalmic Otic Topical Oral Injectable Application Rheumatoid arthritis Psoriasis Eczema Pulmonary diseases COVID-19 Distribution channel Hospital pharmacies Online pharmacies Retail stores Key Questions Covered in the Dexamethasone Sales Outlook Report The report offers insight into dexamethasone demand outlook for 2021-2031 The market study also highlights projected sales growth for dexamethasone market between 2021 and 2031 Dexamethasone market survey identifies key growth drivers, restraints, and other forces impacting prevailing trends and evaluation of current market size and forecast and technological advancements within the industry Dexamethasone market share analysis of the key companies within the industry and coverage of strategies such as mergers & acquisitions, joint ventures, collaborations or partnerships, and others Explore Fact.MR’s Coverage on the Healthcare Domain Rheumatoid Arthritis Stem Cell Therapy Market - Over the forecast period, the global market for rheumatoid arthritis therapeutics is expected to grow moderately. Over the forecast period, the allogeneic mesenchymal stem cell segment is expected to lead the global rheumatoid arthritis stem cell therapy market. As the most accessible channel, hospitals are expected to account for a sizable portion of the global rheumatoid arthritis stem cell therapy market. Medical Ventilators Market - The non-invasive ventilators segment is expected to account for a sizable portion of the medical ventilators market. According to projections, the company will account for more than half of the total medical ventilators market. This is due to its increasing use in homecare and critical care units. The major factor driving intense competition among market players in the global medical ventilators market is the development and launch of technologically advanced innovative products based on patient needs. Medical Oxygen Systems Market - Growing healthcare spending, improved medical facilities, and rapid technological advancements have all contributed to an increase in demand for medical oxygen systems around the world. Because of anatomic changes and muscle loss, the elderly have less pulmonary reserve and cough strength. As a result, they are at a high risk of developing lung disorders and other breathing issues. This has resulted in an increase in demand for medical oxygen systems in recent years. About Fact.MR Market research and consulting agency with a difference! That’s why 80% of Fortune 1,000 companies trust us for making their most critical decisions. We have offices in US and Dublin, whereas our global headquarter is in Dubai. While our experienced consultants employ the latest technologies to extract hard-to-find insights, we believe our USP is the trust clients have on our expertise. Spanning a wide range – from automotive & industry 4.0 to healthcare & retail, our coverage is expansive, but we ensure even the most niche categories are analyzed. Reach out to us with your goals, and we’ll be an able research partner. Contact: Mahendra Singh US Sales Office: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 E: sales@factmr.com Source: Fact.MR

Generic DrugCell TherapyVaccineAcquisitionCollaborate

100 Deals associated with Ciprofloxacin/Dexamethasone

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ciprofloxacin/Dexamethasone	S01CA01 S03CA01 S02CA06	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute otitis media	US	Sandoz, Inc.	18 Jul 2003
Otitis Externa	US	Sandoz, Inc.	18 Jul 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Otitis Media	NDA/BLA	DK	Alcon AG	-
Otitis Media	NDA/BLA	FR	Alcon AG	-
Otitis Media	NDA/BLA	DE	Alcon AG	-
Otitis Media	NDA/BLA	IT	Alcon AG	-
Otitis Media	NDA/BLA	ES	Alcon AG	-
Otitis Media	NDA/BLA	GB	Alcon AG	-
Eye Diseases	Phase 3	US	-	-
Eye Diseases	Phase 3	EU	-	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02216071 (CTgov)	Phase 3	Acute otitis externa	499	Ciprodex® (Ciprodex®, RLD)	pohuzcvgxo(ugzozoocmj) = faptkduole kfbscjfngh (xdbawwxsqa, qkfpehjkmq - upxhxfpblg) View more	-	28 May 2021
				Dexamethasone 0.1%) Sterile Otic Suspension (EXL CDOS)	pohuzcvgxo(ugzozoocmj) = rsuxzouqed kfbscjfngh (xdbawwxsqa, ztutqdfhpl - bxivvjrybk) View more

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