Drug Database
OF

ofloxacin (Floxin Otic)

✓ Approved

Daiichi Sankyo Company Limited · Small Molecule · Small Molecule

What is ofloxacin?

ofloxacin is a small molecule developed by Daiichi Sankyo Company Limited. It is approved for therapeutic indications via others or topical.

Drug Profile

Brand NamesFloxin Otic
CompanyDaiichi Sankyo Company Limited
Drug ClassSmall Molecule
RouteOthers, Topical
StatusApproved
Sources: ClinicalTrials.gov, Daiichi Sankyo Company Limited

Therapeutic Indications

ofloxacin is developed for 4 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsOtitis externa✓ Approved
Infections and infestationsOtitis media✓ Approved
Ear and labyrinth disordersExternal ear inflammation✓ Approved
Ear and labyrinth disordersMiddle ear inflammation✓ Approved

Related Research Articles

PubMedVeterinary dermatology2026-08-25

A Randomised Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Two-Dose Topical Terbinafine and Betamethasone Gel for the Treatment of Yeast (Malassezia pachydermatis) Otitis Externa in Dogs.

Baks Zorica Zivkovic ZZ, Heinz Hope Baird HB, Grundke Stephan S, Thompson Caryn C et al.

Otitis externa (OE) with Malassezia pachydermatis overgrowth with limited bacterial involvement is common in dogs. Treatment with products containing antibiotics is unnecessary and not consistent with judicious use of antimicrobials. To evaluate the efficacy and safety of an otic gel containing 1% terbinafine and 0.1% betamethasone acetate for the treatment of yeast-predominant canine OE. 239 privately owned dogs were enrolled. Inclusion criteria were an otitis index score (OTIS3) of ≥ 6 and yeast-predominance on ear swab cytological evaluation. Dogs received either the study product containing terbinafine and betamethasone (TBG) or placebo (saline) on Day (D) 0 and D7. Follow-up visits were on D7, D14, D28 and D45. Clinical success was defined as an OTIS3 score ≤ 3 on D45. Overall clinical response (by the veterinary surgeon and owner) and yeast cytological count reduction also were assessed. Safety was evaluated based on clinical assessments, haematological and clinical chemical analysis, urinalysis and adverse events. The treatment success was significantly higher in the treated group compared to the placebo group (62.9% versus 20.0%, p < 0.0001). Dogs receiving TBG had a treatment response described as 'excellent' or 'good' by 61.9% and 71.1% of veterinary surgeons and owners, respectively. The safety evaluation demonstrated that the otic gel was safe. Efficacy and safety of an otic gel for the treatment of canine OE associated with Malassezia pachydermatis were demonstrated.

PMID 42638346
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PubMedFrontiers in medicine2026-08-25

Comparison of common pharmacological strategies for post-photorefractive keratectomy pain management: a systematic review and network meta-analysis.

Yan Xin X, Lei Shiqi S, Yi Jiasheng J, Hu Lifen L et al.

To systematically evaluate the comparative efficacy and safety of common pharmacological strategies for managing post-photorefractive keratectomy (PRK) eye pain through a network meta-analysis, providing evidence-based guidance for clinical medication. Randomized controlled trials (RCTs) were systematically retrieved from Cochrane Library, Web of Science, PubMed, and EMbase (from inception to November 15, 2025). Using R Studio, we conducted a network meta-analysis to assess differences in Visual Analogue Scale (VAS) scores and adverse events across pharmacological interventions. SUCRA (Surface Under the Cumulative Ranking) values were calculated to determine the relative ranking of interventions, while accounting for heterogeneities in administration timing and dosage. A total of 28 studies were included, involving 2,797 patients. In route-stratified analyses, Ofloxacin (SUCRA = 0.84) and Proparacaine (0.76) were the top-ranked topical agents for analgesia, while Codeine combined with Acetaminophen (0.71) ranked highest among systemic agents. The exploratory combined network yielded identical top-three rankings, though these cross-route comparisons are susceptible to transitivity violations. Notably, effect sizes for most interventions relative to placebo spanned the line of no effect. Regarding safety, Diclofenac (SUCRA = 0.81), Ketorolac (0.70), and Nepafenac (0.53) demonstrated the optimal profiles. The highest numbers of adverse events occurred with Pregabalin (39 cases), Fentanyl (20 cases), and Codeine combined with Acetaminophen (13 cases); however, safety conclusions remain limited as only seven studies reported highly heterogeneous adverse event data. Ofloxacin demonstrates superior relative efficacy for pain control following PRK, while Diclofenac offers the most favorable safety profile. Clinicians should synthesize these comparative findings with individual patient profiles to optimize drug selection, ensuring a balanced approach between effective pain relief and minimized adverse risks. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251238092, CRD420251238092.

PMID 42638662
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PubMedMaterials & design2026-08-22

Biodistribution and transport of intratympanically administered drugs in the inner ear using a porcine ex-vivo chamber model.

Moazzam Farimah F, Holdsclaw Samuel S, Yu Fengyi F, Titus Rachel Maria RM et al.

Effective pharmacotherapy for hearing loss remains a significant challenge because of the blood-labyrinth barrier, which limits systemic drug access and often necessitates local intratympanic (IT) administration. However, the distribution of drugs after IT injection between the vestibular system and cochlea is unclear. Although the round window membrane is the main recognized entry route, in this study, we explored alternative pathways, namely the oval window (OW) and the thin apical otic capsule, using an ex vivo porcine model to assess their permeability to different solvent vehicles. We demonstrated that the route of entry is critically on the solvent composition and additives; in particular, reconstituting dexamethasone-fluorescein in dimethyl sulfoxide enhanced permeability through the OW by 42-fold compared to that with methanol, establishing the OW as a pathway for this solvent type rather than the RWM. Furthermore, we identified the thin apical otic capsule as a third drug-entry route in young pigs. Surgical sealing of this pathway in vivo, which reduces perilymph drug levels, underscores its importance in human translational studies. In summary, we developed a robust ex vivo multi-barrier model integrated with FluidSim to predict the inner ear drug biodistribution.

PMID 42631265
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PubMedIranian journal of microbiology2026-08-21

Phenotypic and molecular characterization of virulence-associated enzymes in Malassezia spp. isolated from companion animals in northern Iran.

Barmachi Nima Niaee NN, Bayat Mansour M, Haghdoost Nakisa Sohrabi NS, Ghorbaniyekta Batool B et al.

Malassezia spp. are lipid-dependent yeasts that colonize the skin of humans and animals and may act as opportunistic pathogens. This study aimed to characterize virulence-associated enzymes and their encoding genes in Malassezia spp. isolated from companion animals in northern Iran. A total of 300 clinical samples were collected from dogs and cats with dermatological or otic lesions. Species identification was performed using ITS-based PCR. Multiplex PCR was used to detect LIP, PLB, and KER genes. Enzymatic activity was evaluated using the Pz index. Statistical analyses included Chi-square and Spearman's correlation tests (p < 0.05). Eighty isolates were identified as Malassezia pachydermatis (87.5%) and Malassezia nana (12.5%). LIP, PLB, and KER genes were detected in 90%, 62.5%, and 50% of isolates, respectively. Strong enzymatic activity (Pz ≤ 0.69) was observed in 41.2% of isolates. A significant association was found between the presence of the PLB gene and phospholipase activity. Malassezia pachydermatis was the predominant species. Virulence-associated genes were associated with higher enzymatic activity, supporting their role in pathogenic potential.

PMID 42625939
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PubMedCureus2026-08-20

Clinical Profile of Children With Typhoid and Paratyphoid Fever and Antimicrobial Susceptibility Testing Patterns of the Bacterial Isolates: A Cross-Sectional Study.

Behera Chinmay Kumar CK, Jain Mukesh K MK, Singh Anupama A, Singh Abhipsa A et al.

Background and objectives Typhoid and paratyphoid fevers in children are global health concerns due to antimicrobial resistance (AMR) among their pathogens (i.e., Salmonella typhi and Salmonella paratyphi). We conducted this study to determine the symptoms of typhoid and paratyphoid fevers in children and assess the antimicrobial susceptibility testing (AST) patterns of S. typhi and S. paratyphi isolates in our hospital. Methods This cross-sectional study was conducted from July 2023 to June 2025 at Kalinga Institute of Medical Sciences (KIMS), Bhubaneswar, India. All pediatric patients (under 18 years) admitted during the indicated timeframe with fever were screened. The study included participants with a positive blood culture for S. typhi or S. paratyphi. Patients who reported having any additional bacteria were not included. We noted the participants' age, sex, symptoms, and length of hospitalization. Blood samples were collected to determine AST results for the bacterial isolates. We presented our findings using an upset plot, jitter plots, and chord diagrams. We used the VITEK 2 system to perform AST. We used R software (version 4.6.1) for data analysis. Results Our study population comprised 328 participants (men: 171, 52.13%; women: 157, 47.87%). The median age of the participants was 8.63 (5.98-11.52) years. Typhoid and paratyphoid fevers were seen in 264 (80.49%) and 64 (19.51%) patients, respectively. The causative organisms were S. typhi and S. paratyphi A, respectively. The median hospitalization length was 7.5 (5.0-10.3) days. The most common symptoms were fever (328, 100%), followed by cough (157, 47.87%), followed by altered bowel movements (126, 38.41%), abdominal pain (89, 27.13%), coated tongue (71, 21.65%), vomiting (66, 20.12%), and loss of appetite (47, 14.33%). The S. typhi isolates demonstrated the highest sensitivity to chloramphenicol (261, 98.86%), followed by azithromycin (256, 96.97%), imipenem (241, 91.29%), cotrimoxazole (251, 95.08%), and meropenem (249, 94.32%). Levofloxacin (177, 67.05%) was the most resistant drug, followed by ciprofloxacin (161, 60.98%) and ofloxacin (127, 48.11%) for the 264 S. typhi isolates. None of the isolates showed resistance to azithromycin or chloramphenicol. The S. paratyphi A isolates demonstrated maximum sensitivity towards meropenem (57, 89.06%), followed by imipenem (55, 85.94%), chloramphenicol (54, 84.38%), and cotrimoxazole (51, 79.69%). Ciprofloxacin (47, 73.44%), followed by ofloxacin (42, 65.63%) and levofloxacin (41, 64.06%), were the most resistant drugs among the 64 S. paratyphi A isolates. Conclusion Most participants had typhoid fever. S. paratyphi A was the causative organism of paratyphoid fever in the remaining 64 participants. Fever, cough, abnormal bowel motions, abdominal pain, coated tongue, vomiting, and appetite loss were the most prevalent symptoms. For the S. typhi isolates, azithromycin, cotrimoxazole, imipenem, meropenem, and chloramphenicol were the most effective treatment options. Similarly, the best therapies for the S. paratyphi A isolates were imipenem, meropenem, cotrimoxazole, and chloramphenicol. Both isolates exhibited the highest level of resistance to quinolones, including levofloxacin, ciprofloxacin, and ofloxacin.

PMID 42621584
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PubMedJournal of clinical microbiology2026-08-20

MIC-based tuberculosis drug susceptibility testing using Sensititre MYCOTB: a diagnostic accuracy meta-analysis.

D Daniel Raj DR, G Mukesh Kumar MK, Singh Jitendra J, Ali Sabir S et al.

Accurate drug susceptibility testing (DST) is crucial for designing effective regimens for multidrug-resistant (MDR) and pre-extensively drug-resistant tuberculosis (pre-XDR TB). Sensititre MYCOTB enables simultaneous determination of minimum inhibitory concentrations (MICs) for multiple drugs, but its diagnostic performance varies across studies. This meta-analysis evaluated the diagnostic performance of Sensititre MYCOTB for key MDR and pre-XDR TB drugs. The protocol was registered in PROSPERO (CRD420251230599). PubMed, Cochrane, Google Scholar, Scopus, ONOS, Web of Science, ScienceDirect, and registries were systematically searched for studies published between 2010 and 2025. Studies comparing the Sensititre MYCOTB with reference DST for Mycobacterium tuberculosis complex (MTBC) were included. Bias assessment and pooled diagnostic accuracy estimates were generated. Fourteen studies, including 1,728 isolates, were analyzed. Rifampicin and isoniazid demonstrated high sensitivity (0.976 [95% CI: 0.94-0.99] and 0.977 [95% CI: 0.95-0.99]) and specificity (0.958 [95% CI: 0.84-0.98] and 0.957 [95% CI: 0.83-0.99], respectively) with low heterogeneity. Amikacin, kanamycin, and ofloxacin demonstrate good diagnostic accuracy, with high specificity (>0.98 [95% CI]). Moderate diagnostic accuracy was observed for ethambutol, streptomycin, ethionamide, and rifabutin. Cycloserine, moxifloxacin, and para-aminosalicylic acid showed inconsistent performance despite excellent specificity (>0.97 [95% CI]). Sensitivity analysis partially improved pooled sensitivity for moxifloxacin 0.801 (95% CI: 0.585-0.924) and para-aminosalicylic acid 0.76 (95% CI: 0.518-0.894), whereas cycloserine remained at 0.436 (95% CI: 0.190-0.725), although heterogeneity persisted. Sensititre MYCOTB DST demonstrates high diagnostic accuracy for MDR-TB and pre-XDR-TB drugs, while caution is required with cycloserine, moxifloxacin, and para-aminosalicylic acid. These findings support the integration of MIC-based testing into clinical decision-making.

PMID 42623427
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