UNITRO Hard gelatin capsule Ref.[115190] Active ingredients: Nitrofurantoin

Source: Health Products Regulatory Authority (ZA)  Publisher: AUROGEN SA (Pty) Ltd, Woodhill Office Park, Building 1, First Floor, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa

Pharmacodynamic properties

A 18.5 Urinary tract antiseptics
Pharmacotherapeutic group: antimicrobials for systemic use, Nitrofurantoin derivative
ATC code: J01XE01

Mechanism of action

Nitrofurantoin is an antibacterial medicine for specific urinary tract infections. Nitrofurantoin is a broad spectrum antibacterial medicine, 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

The nitrofurantoin macro crystals are specially formulated. The controlled crystal size is designed to control the speed of absorption and thus reduce the incidence of nausea. Clinical and animal studies indicate that Nitrofurantoin therapy decreases the likelihood of nausea in patients who might experience these symptoms on Nitrofurantoin therapy. This special formulation of Nitrofurantoin had not caused any decrease in antibacterial efficacy.

Absorption

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

Elimination

Anti-bacterial concentration are not achieved in plasma following ingestion of recommended doses because of rapid elimination, Maximum urinary excretion usually occurs 2-4 hours after administration of nitrofurantoin. Urinary medicine dose recoveries of about 40-45% are obtained. It has an elimination half-life of about 30 minutes.

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