NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (nitrofurantoin)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is indicated for the treatment of Urinary Tract Infection; Cystitis; Pyelonephritis; Perinephric Abscess.
Details
- Status
- Prescription
- First Approved
- 2004-03-22
- Routes
- ORAL
- Dosage Forms
- CAPSULE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) Approval History
What NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) Treats
4 indicationsNITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is approved for 4 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infection
- Cystitis
- Pyelonephritis
- Perinephric Abscess
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332781 | 2126175 // CTR grant U54GM1156 | Ph 4 | completed | Intravesical Gentamicin to Prevent Recurrent UTI |
| NCT05138822 results posted | 212943 | Ph 1 | completed | Safety, Tolerability, Pharmacokinetic and Microbiological Investigation of GSK3882347 in Female Participants With Urinary Tract Infections |
| NCT05274672 | 022-046 | Ph 4 | withdrawn | Role of Prophylactic Postoperative Antibiotics in HoLEP |
| NCT07186465 microbiome | MURA2024/339 Ref.2024/671 | Ph 4 | recruiting | Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis |
| NCT04959331 SCOUT | IJG-SCOUT-2021 | Ph 4 | completed | Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women. |
| NCT04502095 | I 573720 NCI-2020-04928, I 573720 | Ph 4 | completed | Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy |
| NCT05630833 EAGLE-J results posted | 214144 | Ph 3 | completed | A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis) |
| NCT06709196 REINFORCE | 2024-514312-27-00 2024-514312-27-00 | Ph 4 | recruiting | Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis |
| NCT05652374 GT RACING | 111802 NL76892.091.21 | Ph 4 | recruiting | Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study |
| NCT05519072 | 1889711-1 | Ph 4 | recruiting | Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA |
| NCT04187144 results posted | 212390 2020-000553-27 | Ph 3 | completed | Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) |
| NCT04020341 results posted | 204989 2018-001801-98 | Ph 3 | completed | A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) |
| NCT05600023 | Intracanal medication | Ph 4 | completed | The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste |
| NCT05254808 EXFOCY | NL75841.041.20 | Ph 3 | terminated | EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care |
| NCT03299387 INSTANT | 11-002887 | Ph 4 | withdrawn | INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI |
| NCT02727322 results posted | PRO15110557 | Ph 4 | completed | Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery |
| NCT01450800 STOPP UTI results posted | Pro00025269 3913577 | Ph 4 | completed | Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) |
| NCT00734968 results posted | 1108717 | Ph 4 | completed | Does Treatment With Macrobid Reduce Urinary Tract Infections in Patients Receiving a Sub-Urethral Sling for Incontinence |
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.
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) FDA Label Details
Indications & Usage
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is indicated for the treatment of Urinary Tract Infection; Cystitis; Pyelonephritis; Perinephric Abscess.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.