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MACRODANTIN (NITROFURANTOIN, MACROCRYSTALLINE)
MACRODANTIN (generic name: NITROFURANTOIN, MACROCRYSTALLINE) is a Nitrofuran Antibacterial [EPC] drug developed by ALMATICA. It is currently FDA-approved for Enterobacter Cystitis, Enterococcus Urinary Tract Infection, Escherichia coli urinary tract infection.
MACRODANTIN is a small molecule that inhibits DNA, classified as an inhibitor. It is used to treat conditions such as urinary tract infections and nephrolithiasis, and is available in the form of nitrofurantoin monohydrate/macrocrystalline capsules.
At a glance
| Generic name | NITROFURANTOIN, MACROCRYSTALLINE |
|---|---|
| Sponsor | ALMATICA |
| Drug class | Nitrofuran Antibacterial [EPC] |
| Target | Mitochondrial pyruvate carrier 2, CDGSH iron-sulfur domain-containing protein 1, Glucose-6-phosphate 1-dehydrogenase |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Approved indications
- Enterobacter Cystitis
- Enterococcus Urinary Tract Infection
- Escherichia coli urinary tract infection
- Klebsiella cystitis
- Staphylococcus Aureus Urinary Tract Infection
- Staphylococcus Saprophyticus Urinary Tract Infection
Common side effects
- Nausea
- Headache
- Flatulence
Serious adverse events
- Peripheral neuropathy (severe or irreversible)
- Chronic pulmonary hypersensitivity reaction
- Acute pulmonary hypersensitivity reaction
- Subacute pulmonary hypersensitivity reaction
- Hepatitis
- Hepatic necrosis
- Chronic active hepatitis
- Cholestatic jaundice
- Pseudomembranous colitis
- Benign intracranial hypertension (pseudotumor cerebri)
Drug interactions
- Antacids containing magnesium trisilicate
- Uricosuric drugs (e.g., probenecid, sulfinpyrazone)
Key clinical trials
- A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncompli (Phase 3)
- Antibiotic Treatment for Intermittent Bladder Catheterisation: A Randomised Controlled Trial of Once Daily Prophylaxis (Phase 4)
- Comparison of Four Different Surgical Methods for the Treatment of Sacrococcygeal Pilonidal Sinus: a Randomized Controlled Trial (NA)
- A Randomized, Double-Blinded, Adaptive Phase 2 Study to Evaluate the Safety and Efficacy of Oral Omadacycline and Oral Nitrofurantoin in the Treatment of Female Adults With Cystitis (Phase 2)
- A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones (Phase 4)
- REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Pro (Phase 4)
- Does Prophylaxis With Macrobid Reduce the Incidence of Urinary Tract Infection in Patients Who Receive a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence: Randomized, Double Blinded (Phase 4)
- Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study (Phase 4)
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 |
|---|---|
| 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:
- MACRODANTIN CI brief — competitive landscape report
- MACRODANTIN updates RSS · CI watch RSS
- ALMATICA portfolio CI
Frequently asked questions about MACRODANTIN
What is MACRODANTIN?
MACRODANTIN (NITROFURANTOIN, MACROCRYSTALLINE) is a Nitrofuran Antibacterial [EPC] drug developed by ALMATICA, indicated for Enterobacter Cystitis, Enterococcus Urinary Tract Infection, Escherichia coli urinary tract infection.
What is MACRODANTIN used for?
MACRODANTIN is indicated for Enterobacter Cystitis, Enterococcus Urinary Tract Infection, Escherichia coli urinary tract infection, Klebsiella cystitis, Staphylococcus Aureus Urinary Tract Infection.
Who makes MACRODANTIN?
MACRODANTIN is developed and marketed by ALMATICA (see full ALMATICA pipeline at /company/almatica).
What is the generic name of MACRODANTIN?
NITROFURANTOIN, MACROCRYSTALLINE is the generic (nonproprietary) name of MACRODANTIN.
What drug class is MACRODANTIN in?
MACRODANTIN belongs to the Nitrofuran Antibacterial [EPC] class. See all Nitrofuran Antibacterial [EPC] drugs at /class/nitrofuran-antibacterial-epc.
What development phase is MACRODANTIN in?
MACRODANTIN is FDA-approved (marketed).
What are the side effects of MACRODANTIN?
Common side effects of MACRODANTIN include Nausea, Headache, Flatulence. Serious adverse events: Peripheral neuropathy (severe or irreversible), Chronic pulmonary hypersensitivity reaction, Acute pulmonary hypersensitivity reaction, Subacute pulmonary hypersensitivity reaction.
What does MACRODANTIN target?
MACRODANTIN targets Mitochondrial pyruvate carrier 2, CDGSH iron-sulfur domain-containing protein 1, Glucose-6-phosphate 1-dehydrogenase and is a Nitrofuran Antibacterial [EPC].
Related
- Drug class: All Nitrofuran Antibacterial [EPC] drugs
- Target: All drugs targeting Mitochondrial pyruvate carrier 2, CDGSH iron-sulfur domain-containing protein 1, Glucose-6-phosphate 1-dehydrogenase
- Manufacturer: ALMATICA — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Enterobacter Cystitis
- Indication: Drugs for Enterococcus Urinary Tract Infection
- Indication: Drugs for Escherichia coli urinary tract infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing