Nadifloxacin Gel

Overview

Nadifloxacin is a topical fluoroquinolone antibiotic that works by inhibiting the enzyme DNA gyrase, which plays a crucial role in bacterial DNA synthesis and replication. By blocking this process, nadifloxacin prevents bacterial multiplication.

In addition to its therapeutic antibacterial activity, nadifloxacin also demonstrates sebostatic (oil-reducing) and anti-inflammatory effects, contributing to improved clinical outcomes in patients.

Pharmacokinetics

• After a single topical application of 10 g of Nadifloxacin 1% cream on normal human skin, the highest plasma concentration observed was 107 ng/mL, with an elimination half-life of 19.4 hours.

• About 0.09% of the administered dose was excreted in urine within 48 hours post-dosing.

• In a repeated administration study, when 5 g of Nadifloxacin 1% cream was applied twice daily for 7 days, the plasma concentration reached steady state on Day 5.

• The peak plasma concentration was 4.1 ng/mL, measured 8 hours after the final dose, with an elimination half-life of 23.2 hours.

• Urinary excretion rate increased to 0.16% on Day 7.

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