Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) / Novartis - LARVOL DELTA

Safety of Nebulized Ciprodex for Postoperative Management of Tracheal Resection. (PubMed, Laryngoscope) - "The incidence of side effects related to the use of nebulized Ciprodex is felt to be minimal in post-TR/CTR. Although Ciprodex may have the potential to treat granulation tissue in the airway, further studies are needed to verify its efficacy and safety."

Journal • Allergy • Dermatology • Musculoskeletal Pain • Pediatrics

Assessing National Trends and Perceived Safety of Off-Label Ciprofloxacin-Dexamethasone Use by Pediatric Otolaryngologists. (PubMed, Laryngoscope) - "Our findings (26.6% response rate) suggest that off-label CPD is commonly used by pediatric otolaryngologists, many of whom reported feeling that the benefits of off-label CPD outweigh the risks. Our results establish a baseline for future efforts to assess the efficacy and safety of off-label CPD and to improve its accessibility."

Journal • Allergy • Otorhinolaryngology • Pediatrics

Otologic safety of intratympanic N-acetylcysteine in an animal model. (PubMed, Int J Pediatr Otorhinolaryngol) - "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."

Journal • Preclinical • Otorhinolaryngology

Off-Label Use of Ciprofloxacin/Dexamethasone Drops in the Pediatric Upper Airway: Case Presentation and Review of Adverse Effects. (PubMed, Ann Otol Rhinol Laryngol) - "This is the first reported pediatric case of increased blood glucose levels associated with intranasal steroid suspensions, to the best of our knowledge. Counseling families on precise dose administration and potential endocrine disturbances is critical when prescribing these medications for off-label use in infants and small children, particularly among patients with underlying endocrine disorders such as diabetes."

Adverse events • Journal • Review • Diabetes • Endocrine Disorders • Metabolic Disorders • Otorhinolaryngology • Pediatrics • Type 1 Diabetes Mellitus

"Lol after my FQ anaphylaxis I scratched my cornea and got Rxd ciprodex eye drops and the pharmacist made me fill my epi pen and have it in hand and put the drops in in front of her at the counter 🤣 no issues luckily!" (@TheIDApprentice)

Iron Pill-Induced Chemical Laryngitis. (PubMed, Ann Otol Rhinol Laryngol) - "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...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."

Journal • Dysphonia • Otorhinolaryngology • Respiratory Diseases

Manipulating the Microbiome in IBD by Antibiotics and FMT (clinicaltrials.gov) - P=N/A; N=28; Completed; Sponsor: Shaare Zedek Medical Center; Active, not recruiting ➔ Completed; Phase classification: P4 ➔ PN/A

Clinical • Phase classification • Trial completion • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Transplantation • Ulcerative Colitis

Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa (clinicaltrials.gov) - P3; N=499; Completed; Sponsor: Exela Pharma Sciences, LLC.; Recruiting ➔ Completed

Clinical • Trial completion • Otorhinolaryngology

Expert Technique: Pediatric Tracheal Surgery. (PubMed, World J Pediatr Congenit Heart Surg) - "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."

Clinical • Journal • Pediatrics

FORTE Raises Question of Excessive Treatment in Myeloma (Medscape) - "The FORTE study, presented at the recent American Society of Hematology (ASH) virtual meeting, compared giving 12 months of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (KRd) plus transplant to KRd alone in patients with newly diagnosed multiple myeloma. MedPage Today has brought together three expert leaders in the field...Al-Ola Abdallah, MD, for a virtual roundtable discussion to discuss whether positive results should mean adding more potentially toxic and expensive treatments to standard of care, in this fourth of five exclusive roundtable episodes."

Video

Rising Costs of Otic Drops: Review of a National Database. (PubMed, Laryngoscope) - "Otic drop prices have been volatile, with overall price increases higher than overall inflation. Drug pricing is not transparent, making it difficult for prescribers and patients alike to be cost conscious when choosing the best therapy. We outline six factors that contribute to high US medication prices and also highlight two examples of otic drops that underwent significant price fluctuation during the studied period."

Journal • Otorhinolaryngology

Manipulating the Microbiome in IBD by Antibiotics and FMT (clinicaltrials.gov) - P4; N=28; Active, not recruiting; Sponsor: Shaare Zedek Medical Center; Trial completion date: Dec 2019 ➔ Jan 2021

Clinical • Trial completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Transplantation • Ulcerative Colitis

"Why is Ciprodex from @Novartis $220 AFTER @UHC insurance? It's an antibiotic drop - the pill form is like $5. Wtf?" (@TechJeffE)

Reimbursement

Manipulating the Microbiome in IBD by Antibiotics and FMT (clinicaltrials.gov) - P4; N=28; Active, not recruiting; Sponsor: Shaare Zedek Medical Center; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Crohn's disease • Gastric Cancer • Immunology • Inflammatory Bowel Disease

N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media (clinicaltrials.gov) - P4; N=30; Not yet recruiting; Sponsor: St. Paul's Hospital, Canada; Trial completion date: Jan 2020 ➔ Jun 2021; Trial primary completion date: Jan 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Biosimilar • Immunology

Pediatric Tracheal Surgery: A 25-year Review of Slide Tracheoplasty and Tracheal Resection. (PubMed, Ann Thorac Surg) - "Slide tracheoplasty and tracheal resection are effective operative strategies for infants and children with tracheal stenosis including patients with lung agenesis/hypoplasia. We recommend simultaneous repair of intracardiac anomalies and pulmonary artery sling."

Clinical • Journal

"$260 for literal drops of ciprodex otic solution? Trying to make a killing before it goes generic? @Novartis" (@sseip)

".@SunPharma_Live files #Patent #lawsuit against @Novartis seeking a declaratory judgment that #pharmaceuticals listed in its #ANDA do not infringe any Novartis patents related to Ciprodex. @RivkinRadler @Freeborn_Peters https://t.co/0XyjEPZXWe" (@UniCourtInc)

ANDA • Corporate lawsuit

"@Novartis heya the #ciprodex savings card is down on your site. $300 for ear drops? Can ya help out?" (@NurseNikki82)

N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media (clinicaltrials.gov) - P4; N=0; Withdrawn; Sponsor: St. Paul's Hospital, Canada; N=30 ➔ 0; Trial completion date: Jun 2021 ➔ Nov 2019; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Jun 2021 ➔ Nov 2019

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal

Manipulating the Microbiome in IBD by Antibiotics and FMT (clinicaltrials.gov) - P4; N=28; Active, not recruiting; Sponsor: Shaare Zedek Medical Center; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Dec 2017 ➔ Dec 2018

Clinical • Trial completion date • Trial primary completion date