Gemifloxacin

What it is and how it works

Gemifloxacin inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes required for DNA replication, transcription and repair, producing rapid bactericidal activity. It has enhanced activity against Streptococcus pneumoniae, including penicillin- and macrolide-resistant strains, as well as Haemophilus influenzae, Moraxella catarrhalis and atypical respiratory pathogens.

Indications

Community-acquired pneumonia of mild to moderate severity and acute bacterial exacerbation of chronic bronchitis, when other antibacterials considered appropriate are unsuitable.

Dosage and administration (summary)

Oral, 320 mg once daily, usually for 5 days (acute exacerbation of chronic bronchitis) or 5–7 days (community-acquired pneumonia); dose reduction is required in severe renal impairment.

Contraindications

Hypersensitivity to fluoroquinolones, history of tendon disorders related to quinolone use, children and adolescents, pregnancy and breastfeeding, and known QT prolongation or concomitant QT-prolonging drugs.

Warnings and precautions

Fluoroquinolones can cause disabling and potentially irreversible adverse reactions including tendinitis and tendon rupture, peripheral neuropathy and CNS effects, and may exacerbate myasthenia gravis; they also carry risks of aortic aneurysm or dissection, QT prolongation, dysglycaemia and Clostridioides difficile infection. Rash is relatively frequent with gemifloxacin, particularly in women under 40 and with courses longer than 7 days; treatment should be stopped if rash develops.

Pregnancy

Avoid in pregnancy.

Storage and supply

Store below 25 °C, protected from light and moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.