OFLOXIN Film-coated tablet Ref.[50389] Active ingredients: Ofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Quinolone antibacterials, Fluoroquinolones
ATC code: J01MA01

Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both gram negative and gram positive organisms. It is active after oral administration. It inhibits bacterial DNA replication by blocking DNA topo-isomerases, in particular DNA gyrase.

Therapeutic doses of ofloxacin are devoid of pharmacological effects on the voluntary or autonomic nervous systems.

Microbiological results indicate that the following pathogens may be regarded as sensitive: Staphylococcus aureus (including methicillin resistant staphylococci), Staphylococcus epidermidis, Neisseria species, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Hafnia, Proteus (indole-negative and indole-positive strains), Haemophilus influenzae, Chlamydiae, Legionella, Gardnerella.

Variable sensitivity is shown by Streptococci, Serratia marcescens, Pseudomonas aeruginosa and Mycoplasmas.

Anaerobic bacteria (e.g. Fusobacterium species, Bacteroides species, Eubacterium species, Peptococci, Peptostreptococci) are normally resistant.

5.2. Pharmacokinetic properties

Ofloxacin is almost completely absorbed after oral administration. Maximal blood levels occur 1-3 hours after dosing and the elimination half-life is 4-6 hours. Ofloxacin is primarily excreted unchanged in the urine.

In renal insufficiency the dose should be reduced.

No clinically relevant interactions were seen with food and no interaction was found between ofloxacin and theophylline.

5.3. Preclinical safety data

Not applicable.

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