Quofenix

Posology The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion. Switch to delafloxacin 450 mg tablet orally every 12 hours is possible at the discretion of the physician. The total duration of treatment is 5 to 14 days for ABSSSI and 5 to 10 days for CAP.

Special populations Elderly No dose adjustment is required. 2). Renal impairment 3 No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min). 2). Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).

2). 3). Method of administration Intravenous use. 6.

85% respectively) which were mild to moderate in intensity. Tabulated list of adverse reactions The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 studies and in one CAP Phase 3 study classified by preferred term and System Organ Class, and by frequency.

Frequencies are defined as: very common (≥1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). g. 4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

8). 3). 6). Aortic dissection and aneurysm, and heart valve regurgitation/incompetence Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.

8). g. g. g. infective endocarditis). 4 The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities. Tendinitis and tendon rupture Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.

The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.

g. painful swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative treatment should be considered. g. immobilisation). 8). Peripheral neuropathy Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.

8). Central nervous system effects Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis.

1. Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product. Previous history of tendon disorders related to fluoroquinolone administration. 6). 2).