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AZ

azithromycin (Azimac)

✓ Approved

Beijing Holley-Cotec Pharma · Small Molecule · Small Molecule

What is azithromycin?

azithromycin is a small molecule developed by Beijing Holley-Cotec Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesAzimac
CompanyBeijing Holley-Cotec Pharma
Drug ClassSmall Molecule
RouteOral (PO)
StatusApproved

Therapeutic Indications

azithromycin is developed for 8 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Infections and infestationsLower respiratory tract infection✓ Approved
Infections and infestationsOtitis media✓ Approved
Infections and infestationsSinusitis✓ Approved
Infections and infestationsTonsillitis✓ Approved
Infections and infestationsUrinary tract infection✓ Approved

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Related Research Articles

PubMedBritish dental journal2026-09-19

Rethinking systemic adjuncts in periodontitis: a single centre acquisition cost comparison of antimicrobial and non-antimicrobial therapies.

Almanie Lina L, Neves Vitor C M VCM

Aims To compare National Health Service (NHS) acquisition costs of systemic antimicrobial regimens with emerging non-antimicrobial adjuncts in periodontal therapy and to model potential national financial implications.Methods A secondary acquisition cost comparison analysis was undertaken using three-year prescription data (2021-2024) from a service evaluation at Charles Clifford Dental Hospital. Antibiotic prescriptions were cross-referenced with clinical records to identify those issued for periodontitis. Direct acquisition costs were calculated using Sheffield Teaching Hospitals NHS Foundation Trust pricing.Results Of 643 antibiotic prescriptions, 445 (69.2%) were issued for periodontitis. Azithromycin accounted for 93.5% of periodontal prescriptions, whereas guideline-recommended amoxicillin plus metronidazole (A+M) represented 1.6%. Compared with A+M (£2.81 per course), azithromycin reduced acquisition costs by 55.16%. Non-antimicrobial adjuncts demonstrated substantially greater reductions depending on treatment duration, with metformin 500 mg achieving up to 91.46% reduction.Conclusions Non-antimicrobial systemic adjuncts demonstrate considerable direct cost advantages over traditional antimicrobial regimens. These findings highlight potential economic and antimicrobial stewardship benefits and support the need for formal cost-effectiveness analyses to inform future prescribing guidance.

PubMedAnnals of emergency medicine2026-09-18

Azithromycin is First-line Therapy for Atypical Coverage of Severe Community-Acquired Pneumonia.

Watson Haley D HD, Kooda Kirstin K

PubMedTherapeutic advances in infectious disease2026-09-18

Bacterial profile and antimicrobial resistance patterns of infected diabetic foot ulcers in low- and middle-income countries: a systematic review and meta‑analysis.

Awere-Duodu Aaron A, Kungu Frederick F, Atiase Yacoba Y, Donkor Eric S ES

Diabetic foot ulcers (DFUs) are often polymicrobial infections, necessitating antibiotic therapy. However, the high prevalence of antibiotic misuse and the growing issue of antibiotic resistance in low- and middle-income countries (LMICs) exacerbate the challenges in managing these ulcers, contributing to the risk of lower-limb amputations. This systematic review reported the bacterial profile and antibiotic resistance patterns associated with DFUs in LMICs. A systematic review and meta-analysis. A comprehensive search was conducted in PubMed, SCOPUS, and Web of Science to retrieve relevant articles, which were screened according to predefined selection criteria. Publication bias was assessed with a funnel plot and Egger's regression test. A meta-analysis was conducted in RStudio version 4.5.2, using the random-effects model. Meta-regression and sensitivity analysis were conducted to assess the sources of heterogeneity and robustness of the included studies, respectively. The most frequently isolated bacteria were Staphylococcus aureus (22.64%), Escherichia coli (12.37%), Pseudomonas aeruginosa (8.49%), Klebsiella pneumoniae (5.19%), P. mirabilis (4.61%), and Coagulase-negative Staphylococci (4.86%). The prevalence of key antibiotic-resistant bacteria was as follows: Methicillin-resistant S. aureus (38.65%), Extended-spectrum beta-lactamase (ESBL)-producing E. coli (50.74%), and ESBL-producing K. pneumoniae (41.54%). S. aureus demonstrated the highest resistance to penicillin (96.87% (93.30; 99.32)), azithromycin (76.42% (64.54; 86.65)), and cefoxitin (68.19% (46.83; 86.67)). E. coli showed the highest resistance to ampicillin (86.60% (77.14; 94.18)) and cotrimoxazole (69.27% (57.35; 80.18)). Pathogenic bacteria isolated from DFUs in LMICs exhibit high rates of antibiotic and multidrug resistance. Alternative therapies, such as phage therapy, should be explored as potential treatments for DFUs to mitigate the impact of antibiotic resistance and decrease the rate of diabetes-related amputations. Open Science Framework (OSF) registry, available at https://doi.org/10.17605/OSF.IO/DPX9F.

PubMedIDCases2026-09-17

Azithromycin-induced hepatocellular liver injury in a healthy young male: A case report.

Alharbi Ghaleb G, Al-Rasheedi Mabrouk M, Goresh Hind Khalid HK, Alharbi Faisal Abdullah FA et al.

Drug-induced liver injury (DILI) is an important and frequently under-recognized cause of acute hepatitis. Antibiotics represent one of the most commonly implicated drug classes. Azithromycin, a widely used macrolide antibiotic, is generally well tolerated; however, rare cases of idiosyncratic hepatotoxicity have been reported in the literature. This report describes a case of azithromycin-induced acute hepatocellular liver injury in a previously healthy 20-year-old male who developed jaundice, elevated aminotransferases, and hyperbilirubinemia within three days of initiating a standard three-day course of oral azithromycin 500 mg once daily (cumulative dose 1500 mg) prescribed for an upper respiratory tract infection. Biochemical analysis demonstrated a hepatocellular pattern of injury, confirmed by an R-value of 10.6 (ALT/ULN ÷ ALP/ULN), which exceeds the threshold of 5 required for this classification according to international guidelines. Viral hepatitis and autoimmune etiologies were excluded, and the patient specifically denied the use of dietary supplements, vitamins, bodybuilding or protein powders, and herbal remedies. Causality was assessed using the Roussel Uclaf Causality Assessment Method (RUCAM); on recalculation using the 2016 updated criteria, the score is 6, consistent with a probable causal relationship. The patient recovered fully with supportive care following prompt drug discontinuation, with normalization of liver function tests within eight weeks. This case highlights the importance of accurate biochemical classification of DILI, rigorous causality assessment, and heightened clinical vigilance when prescribing azithromycin even under standard guideline-recommended dosing regimens in young patients without pre-existing liver disease.

PubMedAmerican journal of infection control2026-09-17

"Prevalence and Risk Factors of Candidozyma auris Colonization Among Adult ICU Patients in India: Evaluation of a Real-Time PCR Screening Approach".

Dabi Kailash Chandra KC, Haridas Hitha H, Sayed Samrin Ejaz Hussain SEH, Talwar Vandana V et al.

Candidozyma (previously Candida) auris is a multidrug-resistant yeast linked to nosocomial outbreaks in Intensive care units (ICUs); colonization precedes invasive disease and drives transmission. We aimed to determine the prevalence of C. auris colonization among adult ICU patients using real-time PCR and to identify associated risk factors. A prospective study was conducted over 18 months (April-2023 to September-2024) in a tertiary-care adult ICU in India. Composite axilla/groin swabs were collected on Day 1 and Day 4 of ICU stay. Samples underwent enrichment broth culture, CHROMagar plating, VITEK 2 identification, and species-specific real-time PCR. Risk factors were evaluated by univariate analysis and multivariable logistic regression. Among 250 patients (500 swabs), colonization rose from 2.4% on Day 1 to 19.2% on Day 4. PCR showed 100% sensitivity and 98.24% specificity versus culture. Significant associations included urinary catheter use, bloodstream and respiratory infections, and prior exposure to meropenem, azithromycin, clarithromycin, and amikacin. In multivariable analysis, meropenem and azithromycin use on Day 1 independently predicted Day-4 colonization. C. auris colonization rose eightfold by Day 4; PCR detected more cases than culture, enabling faster infection-control responses. Prior meropenem and azithromycin exposure independently predicted Day-4 colonization, suggesting antimicrobial pressure may contribute, though confounding by illness severity cannot be excluded. These findings support PCR-based surveillance and targeted stewardship to limit transmission.

PubMedSexually transmitted diseases2026-09-17

Declining Fluoroquinolone Efficacy in Resistance-Guided Therapy for Mycoplasma genitalium: A Systematic Review and Meta-Analysis of Microbiological Cure.

Bordignon Albanir Laier AL, Grillo Felipe Lopes FL, Busanello André Rochinski AR, de Carvalho Newton Sérgio NS

Mycoplasma genitalium is an increasingly drug-resistant sexually transmitted infection, with widespread macrolide resistance rendering azithromycin frequently ineffective. Moxifloxacin, the main second-line treatment, is now threatened by fluoroquinolone resistance linked to the parC gene. Resistance-guided therapy, which tailors treatment to macrolide-resistance mutations detected after nucleic acid amplification testing, shows promise, but its pooled cure rate has not been quantified. Following a protocol registered in PROSPERO (CRD420251077720), we searched five databases for studies of resistance-guided therapy reporting cure (negative test-of-cure 14-90 days after treatment); 11 studies were eligible. Cure proportions were pooled with a random-effects Freeman-Tukey model with Hartung-Knapp adjustment and, as a co-primary approach, a generalized linear mixed model; we performed sensitivity analyses, a temporal meta-regression of moxifloxacin cure, and stratification by parC mutation. Pooled cure was 94.6% (95% confidence interval [CI] 92.4-96.4) and 93.9% (95% CI 91.7-95.5) across the two models, with no heterogeneity (I² = 0%) and robust in sensitivity analyses. However, moxifloxacin cure declined over time (odds ratio per calendar year 0.92; 95% CI 0.85-0.99; p = 0.033), driven by the parC S83I mutation (98% cure in wild-type versus 38% in mutants). In a modeled high-resistance Brazilian scenario (79% macrolide resistance), expected cure with empirical azithromycin fell to approximately 22%, versus approximately 93% with resistance-guided therapy. The evidence derives predominantly from a single center and a short-term surrogate outcome, with low-to-very-low certainty. Resistance-guided therapy achieves high short-term cure and should be prioritized over empirical therapy, yet its efficacy is time-limited and calls for parC-guided regimens as resistance evolves.

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