tobramycin injection / Generic mfg. - LARVOL DELTA

Alembic Pharmaceuticals Ltd… said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. (The Hindu Business Line) - "The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing...Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added."

ANDA • Infectious Disease • Ocular Inflammation

BEAT CF DSA B - Adjunct antibiotics: BEAT CF: Pulmonary Exacerbations Treatment Platform - Adjunct Antibiotics Domain (ANZCTR) - P=N/A | N=500 | Terminated | Sponsor: University of Sydney | N=5000 ➔ 500 | Recruiting ➔ Terminated

Enrollment change • HEOR • Trial termination • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Characteristics, treatment, and lung function outcomes of pulmonary exacerbations in cystic fibrosis: insights from the BEAT-CF cohort. (PubMed, Eur Respir J) - "The pattern and magnitude of lung function impairment during PERITs is similar among those receiving and not receiving modulator therapy. This underscores the continued need for evidence to help clinicians balance treatment burden against the risk of irreversible loss of lung function."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Changes in Medicaid claims for chronic medications for cystic fibrosis (NACFC 2025) - "Background: Several published reports have described changes in chronic medications for cystic fibrosis (CF) after the initiation of elexacaftortezacaftor-ivacaftor (ETI)...Prescriptions for inhaled tobramycin were difficult to differentiate from prescriptions for IV tobramycin, so we have not yet included tobramycin in our analysis... Prescriptions for dornase alfa and inhaled aztreonam decreased after the introduction of ETI, but to a greater extent than recorded in the CFFPR (approximately 15% and 25%, respectively). These results support the use of claims data to complement CFFPR analyses and prospective studies to understand changes in chronic CF medications use after ETI. Our analysis is limited by the inability to examine only people with CF, to determine if people with CF took the medications that were prescribed, or whether changes in medications occurred via shared decision-making with the CF care team."

Medicaid • Reimbursement • US reimbursement • Cystic Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Musculoskeletal Diseases • Orthopedics

Personalized tobramycin dosing in children with cystic fibrosis: an AUC24-guided approach. (PubMed, Antimicrob Agents Chemother) - "Multicenter prospective observational study of children with CF aged 0-19 years receiving IV tobramycin who had ≥1 serum concentration measured...A fully individualized approach (available at https://www.kidscalc.org/) improved target attainment in all children. CFTR modulators had a negligible effect on tobramycin PK."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • CFTR

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Sep 2025 ➔ Aug 2026 | Trial primary completion date: Sep 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Infectious Disease • Musculoskeletal Diseases • Orthopedics

A case report of late-onset central toxic keratopathy following femtosecond laser-assisted in situ keratomileus. (PubMed, BMC Ophthalmol) - "Early and correct differentiation between CTK and DLK could lead to a good prognosis. Corneal confocal microscopy is helpful in diagnosis. A reduction in the use of corticosteroids and antibiotics led to further ocular amelioration. Moreover, this treatment should actively promote corneal epithelial repair, and in the future, the use of vitamin C in the early stage of the disease can be considered."

Journal • Keratitis • Ocular Inflammation • Ophthalmology • Pain

Calcineurin Inhibitors Not Always to Blame: Case of Inhaled Tobramycin Nephrotoxicity in Lung Transplant (ISHLT 2025) - "Bronchoscopy cultures grew Serratia marcescens on POD 16 which was treated with intravenous (IV) cefepime and meropenem...However, with increased congestion and cough, oral levofloxacin started POD 170...A serum tobramycin trough level was elevated at 4.1 µg/mL, more than twice the recommended trough for IV tobramycin (<1-2 µg/mL). ITS was stopped POD 260, levels POD 263 and 265 decreased to 1.5 µg/mL and 1.0 µg/mL respectively and renal function started to improve.Summary Renal dysfunction with ITS is thought to be minimal, but this case demonstrates systemic absorption and supratherapeutic trough levels, which contributed to drug accumulation and AKI in a LT recipient. Evaluating trough tobramycin levels while on ITS should be considered in LT pts with declining renal function and repeat levels may be considered as drug clearance may be prolonged."

Clinical • Acute Kidney Injury • Cough • Infectious Disease • Interstitial Lung Disease • Nephrology • Pneumonia • Respiratory Diseases • Transplantation

Relationship between Sputum Bacterial Load and Lung Function in Children with Cystic Fibrosis Receiving Tobramycin. (PubMed, Respir Med) - "A greater reduction in total sputum P. aeruginosa bacterial load (live+dead) was associated with improved lung function (FEV1) in children with CF receiving tobramycin."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Effectiveness of Single-Stage Debridement with High-Dose Medullary Antibiotic Injection for Treating Osteomyelitis (AAOS 2025) - "The surgical technique included local debridement and medullary debridement using a reamer irrigator, with injection of 30 mL of calcium sulfate in the canal using a french tube and a tumi syringe, mixed with 9g of Vancomycin and 3.6g of Tobramycin... Surgical debridement and high dose antibiotic injection can be an effective and safe way to treat Cierny stage III and IV osteomyelitis. The surgeon must be vigilant for renal function postoperatively when injecting antibiotics in the medullary canal."

Acute Kidney Injury • Infectious Disease • Inflammation • Nephrology • Renal Disease

SYSTEMIC ACCUMULATION OF TOBRAMYCIN INHALATION (SATIN) STUDY (SCCM 2025) - "Introduction: The relationship between intravenous tobramycin and acute kidney injury (AKI) has been established in previous studies. Currently, the package insert does not report nephrotoxicity from inhaled tobramycin but does suggest obtaining levels if given with other nephrotoxic agents. However, our data suggests a statistically significant risk of renal injury that increases by 17% with each additional accumulating dose of inhaled tobramycin. As data is lacking for inhaled tobramycin dose adjustments, we recommend frequent monitoring with troughs and dose re-evaluation for safe and effective regimens."

Acute Kidney Injury • Genetic Disorders • Immunology • Infectious Disease • Nephrology • Non‐Cystic Fibrosis Bronchiectasis • Pneumonia • Renal Disease • Respiratory Diseases

INHALED VERSUS IV TOBRAMYCIN FOR EMPIRIC GRAM-NEGATIVE COVERAGE IN VENTILATOR-ASSOCIATED PNA (SCCM 2025) - "There was no significant difference in treatment success between INHt and IVt for empiric treatment of VAP. Further research is warranted to establish the role of aerosolized antibiotics in the treatment of VAP."

Gram negative • Acute Kidney Injury • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases

Tobramycin Pharmacokinetics in Pediatric Patients With Primary Ciliary Dyskinesia. (PubMed, Pediatr Pulmonol) - "No difference in tobramycin elimination rate constant was found between patients with PCD and those with CF. Clinical outcomes were not significantly different between groups. Although not statistically significant, a lower tobramycin dose was observed in patients with PCD."

Journal • PK/PD data • Retrospective data • Acute Kidney Injury • Cystic Fibrosis • Genetic Disorders • Immunology • Nephrology • Otorhinolaryngology • Pediatrics • Pulmonary Disease • Renal Disease • Respiratory Diseases

Inhaled versus intravenous tobramycin therapy for empiric double Gramnegative coverage in pneumonia A single health system retrospective cohort study (ASHP 2024) - No abstract available

Gram negative • Retrospective data • Infectious Disease • Pneumonia • Respiratory Diseases

Real-word effectiveness of a Pseudomonas aeruginosa eradication protocol in children with cystic fibrosis (NACFC 2024) - "Eradication of new-onset P. aeruginosa infection with the use of 28 days of tobramycin inhaled solution (TIS) is recommended [1] and was found to be successful in 92% of cases 1 month after treatment and remained successful in 66% of cases at the final visit [2]...Step 1 consists of nebulized intravenous tobramycin 80 mg twice daily for 28 days and oral ciprofloxacin 40 mg/kg per day for 21 days... Our findings suggest that CHUSJ clinic multistage protocol for eradicating P. aeruginosa in people with CF is unconventional but effective. Our overall success rate compares with published data [2, 3]. Nonetheless, patient advocacy is required to facilitate access to recommended medication."

Clinical • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pediatrics • Respiratory Diseases

SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Sound Pharmaceuticals, Incorporated | Enrolling by invitation ➔ Completed | N=80 ➔ 40

Enrollment change • Trial completion • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Does Local Aqueous Tobramycin Injection Reduce Open Fracture-Related Infection Rates? (PubMed, J Orthop Trauma) - "Local aqueous tobramycin injection at the time of definitive internal fixation of open extremity fractures was associated with a significant reduction in fracture-related infection rates when administered as an adjunct to intravenous antibiotics, even after controlling for potential confounding variables."

Journal • Infectious Disease • Musculoskeletal Diseases • Orthopedics

Intravenous Tobramycin Inhalation for Patients With Advanced Bronchiectasis With Pseudomonas aeruginosa Infection in Home Medical Care: A Report of Two Cases. (PubMed, Cureus) - "We describe two cases of advanced bronchiectasis with Pseudomonas aeruginosa infection treated with inhaled tobramycin in a home setting, demonstrating clinical effectiveness. Using commercially available empty eye drop containers to prepare an aseptic inhalation solution and nebulizers easily usable at home, our experience suggests that this could be a viable therapeutic alternative in home medical care."

Journal • Metastases • Bronchiectasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Nephrotoxicity as a Complication of Inhaled Tobramycin for Pseudomonas Pneumonia: A Case Series (ATS 2024) - "Acute renal failure and nephrotoxicity has been well documented in intravenous use of tobramycin; however inhaled tobramycin has been believed to avoid this as it works topically rather than systemically. Inhaled tobramycin may be absorbed systemically more than initially believed and lead to severe side effects such as renal failure. Caution should be used in vulnerable populations, with consideration of frequent renal function monitoring and serum tobramycin levels."

Clinical • Acute Kidney Injury • Bronchiectasis • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Infectious Disease • Lung Cancer • Nephrology • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor

Assay Interference Causing Persistently Elevated Vancomycin Levels Ultimately Leading to Treatment Failure and Fatal Outcome (ATS 2024) - "Patient received Bebtelovimab (monoclonal antibody) for COVID-19. Transtrachial aspiration (TTA) culture grew Pseudomonas aeruginosa, and the patient was started on intravenous (IV) aztreonam, metronidazole, doxycycline and vancomycin...Patient eventually deteriorated clinically, and due to persistently high vancomycin levels, the antibiotic regimen was switched to inhaled Tobramycin, IV Micafungin and IV Ceftriaxone... The implementation of therapeutic drug monitoring is widely accepted and is a customary approach in the administration of vancomycin, with the primary objective of optimizing patient outcomes while minimizing the potential for toxicity. It is crucial to consider that assay interference can result in inaccurately elevated vancomycin levels. Clinicians should maintain a high level of suspicion if persistently higher vancomycin levels cannot be accounted for by renal function or other causes, especially if the patient continues to clinically deteriorate."

Asthma • Cardiovascular • Congestive Heart Failure • Dermatology • Diabetes • Heart Failure • Hypertension • Immunology • Infectious Disease • Metabolic Disorders • Musculoskeletal Diseases • Novel Coronavirus Disease • Obesity • Orthopedics • Pulmonary Disease • Respiratory Diseases • Septic Shock

A comparison of aminoglycoside antibiotic serum concentrations collected by peripheral veins and peripherally inserted central catheters in adults with cystic fibrosis. (PubMed, Pediatr Pulmonol) - "Tobramycin serum samples collected by PICC appear to be similar in value to PV collections. Collecting aminoglycoside levels by PICC rather than PV may reduce patient discomfort and improve quality of life. Additional multicenter studies are needed to confirm these results."

Journal • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Necessity of Tobramycin trough Levels in Once Daily Iv-Treatment in Patients with Cystic Fibrosis. (PubMed, Klin Padiatr) - "Our data show that elevated tobramycin TLs are rare but cannot be excluded, so determination of tobramycin TLs is still recommended for safety."

Journal • Chronic Kidney Disease • Cystic Fibrosis • Diabetes • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Metabolic Disorders • Pulmonary Disease • Renal Disease • Respiratory Diseases

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Massachusetts General Hospital | N=300 ➔ 600

Enrollment change • Infectious Disease • Musculoskeletal Diseases • Orthopedics

Comparison of tobramycin concentrations via peripheral and central blood draws in children with cystic fibrosis (NACFC 2023) - " We performed a retrospective chart review for children with CF aged 6 and older admitted to Children’s Healthcare of Atlanta for a pulmonary exacerbation and who received IV tobramycin between April 1, 2020, and May 25, 2022... When comparing venipuncture and PICC serum tobramycin levels, we did not find a statistically significant difference. Although our patient groups were small, we did not see an impact on doses required to reach therapeutic peak levels and AUC goals between groups, thus no clinically significant difference was found. We plan to move toward using PICC draws whenever feasible."

Clinical • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Mood Disorders • Psychiatry • Pulmonary Disease • Respiratory Diseases