Overview
Nitrofurantoin is a nitrofuran antibiotic used to treat uncomplicated urinary tract infections. Nitrofurantoin is converted by bacterial nitroreductases to electrophilic intermediates which inhibit the citric acid cycle as well as synthesis of DNA, RNA, and protein. This drug is more resistant to the development of bacterial resistance because it acts on many targets at once. Nitrofurantoin is a second line treatment to trimethoprim/sulfamethoxazole. Nitrofurantoin was granted FDA approval on 6 February 1953.
Background
Nitrofurantoin is a nitrofuran antibiotic used to treat uncomplicated urinary tract infections. Nitrofurantoin is converted by bacterial nitroreductases to electrophilic intermediates which inhibit the citric acid cycle as well as synthesis of DNA, RNA, and protein. This drug is more resistant to the development of bacterial resistance because it acts on many targets at once. Nitrofurantoin is a second line treatment to trimethoprim/sulfamethoxazole. Nitrofurantoin was granted FDA approval on 6 February 1953.
Indication
Nitrofurantoin is indicated to treat acute uncomplicated urinary tract infections.
Associated Conditions
- Acute Cystitis
- Urinary Tract Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/02/07 | Phase 3 | Not yet recruiting | |||
2024/12/09 | Phase 3 | Not yet recruiting | NICHD Global Network for Women's and Children's Health | ||
2024/11/29 | Phase 4 | Recruiting | |||
2024/07/24 | Phase 4 | Not yet recruiting | Shalamar Institute of Health Sciences | ||
2024/04/29 | Phase 4 | Recruiting | |||
2024/03/27 | Phase 4 | Recruiting | Women and Infants Hospital of Rhode Island | ||
2022/12/15 | Phase 4 | Recruiting | |||
2022/11/30 | Phase 3 | Completed | |||
2022/10/31 | Phase 4 | Completed | |||
2022/08/29 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
A-S Medication Solutions | 50090-0866 | ORAL | 25 mg in 1 1 | 6/20/2012 | |
A-S Medication Solutions | 50090-0866 | ORAL | 75 mg in 1 1 | 6/20/2012 | |
Lifestar Pharma LLC | 70756-410 | ORAL | 25 mg in 1 1 | 3/24/2023 | |
DIRECT RX | 61919-458 | ORAL | 100 mg in 1 1 | 1/12/2023 | |
REMEDYREPACK INC. | 70518-0265 | ORAL | 25 mg in 1 1 | 1/4/2024 | |
REMEDYREPACK INC. | 70518-0265 | ORAL | 75 mg in 1 1 | 1/4/2024 | |
NuCare Pharmaceuticals,Inc. | 68071-4535 | ORAL | 25 mg in 1 1 | 3/15/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-4535 | ORAL | 75 mg in 1 1 | 3/15/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-2647 | ORAL | 100 mg in 1 1 | 2/24/2022 | |
Teva Pharmaceuticals USA, Inc. | 0480-3470 | ORAL | 25 mg in 1 1 | 12/18/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AA PHARMA NITROFURANTOIN TABLET 50 mg | SIN00439P | TABLET | 50 mg | 4/27/1988 | |
AA PHARMA NITROFURANTOIN TABLET 100 mg | SIN00290P | TABLET | 100 mg | 4/21/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Nitrofurantoin Tablets | 国药准字H23020313 | 化学药品 | 片剂 | 6/19/2020 | |
Nitrofurantoin Tablets | 国药准字H42021643 | 化学药品 | 片剂 | 9/14/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H34020837 | 化学药品 | 片剂(肠溶) | 8/7/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H32021810 | 化学药品 | 片剂 | 8/17/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H12020426 | 化学药品 | 片剂 | 8/27/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H22024813 | 化学药品 | 片剂(肠溶) | 5/22/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H42021549 | 化学药品 | 片剂 | 6/17/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H20064736 | 化学药品 | 片剂 | 3/31/2022 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H61021835 | 化学药品 | 片剂 | 12/11/2020 | |
Nitrofurantoin Enteric-coated Tablets | 国药准字H41020591 | 化学药品 | 片剂 | 7/15/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
UROSINA CAP | N/A | N/A | N/A | 12/28/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NITROFURANTOIN MLABS nitrofurantoin 50 mg capsule bottle pack | 299382 | Medicine | A | 12/21/2018 | |
NITROFURANTOIN MLABS nitrofurantoin 100 mg capsule bottle pack | 299387 | Medicine | A | 12/21/2018 | |
MACRODANTIN 100mg Capsule | 60065 | Medicine | A | 5/29/1997 | |
URODANTIN nitrofurantoin 100 mg capsule bottle pack | 299381 | Medicine | A | 12/21/2018 | |
NITRODANTIN nitrofurantoin 100 mg capsule bottle pack | 299386 | Medicine | A | 12/21/2018 | |
URODANTIN nitrofurantoin 50 mg capsule bottle pack | 299384 | Medicine | A | 12/21/2018 | |
Nitrofurantoin BNM nitrofurantoin 100 mg hard capsule blister pack | 346712 | Medicine | A | 10/8/2021 | |
NITRODANTIN nitrofurantoin 50 mg capsule bottle pack | 299380 | Medicine | A | 12/21/2018 | |
MACRODANTIN 50mg capsules | 60064 | Medicine | A | 5/29/1997 | |
NITROFURANTOIN EM nitrofurantoin 100 mg capsule blister | 319274 | Medicine | A | 10/22/2020 |