MACRODANTIN (nitrofurantoin, macrocrystalline) · ALMATICA
Macrodantin is a nitrofuran antibacterial indicated for the treatment of urinary tract infections caused by susceptible strains of *Escherichia coli*, enterococci, *Staphylococcus aureus*, and certain strains of *Klebsiella* and *Enterobacter* species. It is not indicated for the treatment of pyelonephritis or perinephric abscesses due to its limited tissue distribution; the drug concentrates primarily in the urine. When prescribing, clinicians should balance Macrodantin's potentially lower eradication rates against the advantage of reduced systemic toxicity and a lower risk of developing antimicrobial resistance compared to agents with broader tissue distribution.
How MACRODANTIN Works
Nitrofurantoin utilizes a unique, multi-targeted mechanism of action. It is reduced by bacterial flavoproteins into highly reactive intermediates that attack and inactivate bacterial ribosomal proteins and other macromolecules. This results in the simultaneous inhibition of vital biochemical processes, including protein synthesis, aerobic energy metabolism, DNA/RNA synthesis, and cell wall synthesis. This broad-based attack is bactericidal in the urine and makes the development of bacterial resistance difficult, as multiple simultaneous mutations would be required for survival.
Details
- Status
- Prescription
- First Approved
- 1970-06-05
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MACRODANTIN Approval History
What MACRODANTIN Treats
3 indicationsMACRODANTIN is approved for 3 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Pyelonephritis
- Perinephric Abscess
MACRODANTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MACRODANTIN FDA Label Details
Indications & Usage
FDA Label (PDF)Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.