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Azo Gantanol (SULFAMETHOXAZOLE)
Azo Gantanol, also known as SULFAMETHOXAZOLE, is a sulfonamide antimicrobial drug developed by Monarch Pharms in 1973. It is a small molecule that has been approved to treat various bacterial infections, including respiratory, urinary, and ear infections. The drug is commercially available as a generic medication, with six manufacturers producing it. Key safety considerations include monitoring for potential allergic reactions and interactions with other medications. Azo Gantanol is off-patent, meaning it is no longer protected by patents.
At a glance
| Generic name | SULFAMETHOXAZOLE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Sulfonamide Antimicrobial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1973 |
Approved indications
- Acute exacerbation of chronic bronchitis
- Acute otitis media
- Aerobic Gram-Negative Bacillary Infection
- Aerobic Gram-Positive Cocci Infection
- Bacterial urinary infection
- Chlamydial conjunctivitis
- Escherichia coli urinary tract infection
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Chronic Bronchitis
- Infective otitis media
- Klebsiella cystitis
- Morganella Morganii Urinary Tract Infection
- Nocardiosis
- Pneumocystis Carinii Pneumonia Prevention
- Pneumocystosis jiroveci pneumonia
- Proteus urinary tract infection
- Shigellosis
- Streptococcus Pneumoniae Chronic Bronchitis
- Toxoplasmosis
Common side effects
- Agranulocytosis
- Aplastic anemia
- Fulminant hepatic necrosis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Hematologic
- Hemolytic anemia
- Megaloblastic anemia
- Thrombocytopenia
- Leukopenia
- Neutropenia
- Hypoprothrombinemia
Drug interactions
- pralatrexate
- trimethoprim
- warfarin
Key clinical trials
- A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial) (PHASE2)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Effects of Treatments on Atopic Dermatitis (PHASE2)
- Gram-Negative Bloodstream Infection Oral Antibiotic Therapy Trial (NA)
- Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients (PHASE4)
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Azo Gantanol CI brief — competitive landscape report
- Azo Gantanol updates RSS · CI watch RSS
- Pfizer portfolio CI