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Nitrofurantoin

Generic Name
Nitrofurantoin
Brand Names
Furadantin, Macrobid, Macrodantin
Drug Type
Small Molecule
Chemical Formula
C8H6N4O5
CAS Number
67-20-9
Unique Ingredient Identifier
927AH8112L

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

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
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