Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: A. Menarini – Industrie Farmaceutiche Riunite – s.r.l., Via Sette Santi 3, 50131 Florence, Italy
Quofenix is indicated for the treatment of the following infections in adults:
when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended regimen of delafloxacin is 450 mg oral every 12 hours for a total duration of 5 to 14 days for ABSSSI and 5 to 10 days for CAP at the discretion of the physician. Delafloxacin tablets can be taken with or without food.
No dose adjustment is required. As per fluoroquinolone class patients aged over 60 years are at increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and 5.2).
No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2). Quofenix is not recommended in patients with ESRD.
No dosage adjustment is necessary (see section 5.2).
Quofenix is contraindicated in children and adolescents (see section 4.3).
Oral use.
Tablets should be swallowed and can be taken with or without food.
The patient should drink a sufficient amount of fluids while taking Quofenix.
The highest daily oral dose administered in clinical studies was 1600 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study. Treatment of overdose with delafloxacin should consist of observation and general supportive measures.
3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from light.
Laminated aluminium/aluminium foil blisters.
Pack sizes of 10, 20, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
This medicinal product may pose a risk to the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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