NITROFURANTOIN Tablet Ref.[7492] Active ingredients: Nitrofurantoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Dr Reddys Laboratories (UK) Limited, 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, nitrofurantoin derivatives
ATC code: J01XE01

Mechanism of action

Nitrofurantoin is a broad spectrum antibacterial agent, active against the majority of urinary pathogens. The wide range of organisms sensitive to the bactericidal activity include:

Escherichia coli
Enterococcus Faecalis
Klebsiella Species
Enterobacter Species
Staphylococcus Species e.g. S. Aureus, S. Saprophyticus, S. Epidermidis
Citrobacter Species

Clinically most common urinary pathogens are sensitive to nitrofurantoin. Most strains of Proteus and Serratia are resistant. All Pseudomonas strains are resistant.

Pharmacokinetic properties

Absorption

Orally administered nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Blood concentrations at therapeutic dosages are usually low.

Elimination

Maximum urinary excretion usually occurs 2-4 hours after administration of nitrofurantoin. Urinary drug dose recoveries of about 40-45% are obtained. It has an elimination half-life of about 30 minutes.

Preclinical safety data

Carcinogenic effect of nitrofurantoin in animal studies was observed. However, human data and extensive use of nitrofurantoin over 50 years do not support such suggestion.

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