Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Delafloxacin is indicated for the treatment of acute bacterial skin and skin structure infections in adults caused by susceptible microorganisms. These include Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, the Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.

Community-Acquired Bacterial Pneumonia (CABP): Delafloxacin is also indicated for the treatment of community-acquired bacterial pneumonia in adults caused by susceptible microorganisms. These include Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

Delafloxacin works by inhibiting bacterial DNA topoisomerase IV and DNA gyrase (topoisomerase II). By blocking these enzymes, it disrupts bacterial DNA replication and prevents the relaxation of positive supercoils that normally occur during the DNA elongation process. This creates strain on the DNA and stops further elongation. Delafloxacin shows concentration-dependent bactericidal activity.

The antibacterial effect of delafloxacin is most closely associated with the ratio of the area under the concentration-time curve of free delafloxacin to the minimum inhibitory concentration (fAUC/MIC). Based on animal infection models, this relationship has been observed for Gram-positive organisms such as Staphylococcus aureus and Gram-negative organisms such as Escherichia coli.

Route of administration: Intravenous (IV) injection

Hepatic Impairment: No dosage adjustment of Delafloxacin is required in patients with hepatic impairment.

Renal Impairment: Dose adjustment is required in patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m²). In patients with severe renal impairment or end-stage renal disease (ESRD) with an eGFR below 15 mL/min/1.73 m², the intravenous vehicle sulfobutylether-β-cyclodextrin (SBECD) may accumulate. In such patients, serum creatinine should be monitored carefully. If serum creatinine increases, switching to oral Delafloxacin should be considered. Delafloxacin should be discontinued if eGFR falls below 15 mL/min/1.73 m².

With medicines: Delafloxacin Injection should not be administered through the same intravenous line with any solution containing multivalent cations, such as calcium or magnesium. It should also not be co-infused with other medications. With food and others: Not applicable.

Delafloxacin is contraindicated in patients with known hypersensitivity to delafloxacin or to any antibacterial drug in the fluoroquinolone class. Treatment should be discontinued immediately at the first sign of skin rash or any other evidence of a hypersensitivity reaction.

Common side effects: The most frequently reported side effects of Delaflox include nausea, diarrhea, headache, increased transaminase levels, and vomiting.

Available data on the use of Delafloxacin in pregnant women are limited and not sufficient to determine the drug-related risk of major birth defects or miscarriage. There are no available data on the presence of Delafloxacin in human milk, its effects on the breastfed infant, or its impact on milk production.

Fluoroquinolones have been linked to serious adverse reactions that may be disabling and potentially irreversible. Commonly reported reactions include tendinitis, tendon rupture, joint pain, muscle pain, peripheral neuropathy, and central nervous system effects such as hallucinations, anxiety, depression, insomnia, severe headache, and confusion. Delafloxacin should be discontinued immediately at the first sign or symptom of any serious adverse reaction.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in patients of all age groups. These events may occur within hours to days after starting treatment or even several months after completion of therapy, and they may affect both sides of the body. Delafloxacin should be stopped immediately if the patient develops tendon pain, swelling, inflammation, or rupture.

Peripheral neuropathy has also been reported with fluoroquinolones, including Delafloxacin. Cases of sensory or sensorimotor axonal polyneuropathy involving small and/or large axons have been observed, resulting in paresthesia, hypoesthesia, dysesthesia, and weakness. Delafloxacin should be discontinued promptly if symptoms of peripheral neuropathy occur.

Fluoroquinolones, including Delafloxacin, may increase the risk of psychiatric adverse reactions. These may include toxic psychosis, hallucinations, paranoia, depression, suicidal thoughts or behavior, delirium, disorientation, confusion, attention disturbances, anxiety, agitation, nervousness, insomnia, nightmares, and memory impairment. Treatment should be discontinued immediately if such symptoms develop.

Fluoroquinolones may also increase the risk of seizures, raised intracranial pressure (including pseudotumor cerebri), dizziness, and tremors. Delafloxacin should be stopped immediately if the patient experiences any of these symptoms.

Because fluoroquinolones have neuromuscular blocking activity, they may worsen muscle weakness in patients with myasthenia gravis. Delafloxacin should therefore be avoided in patients with a known history of myasthenia gravis.

Serious and sometimes fatal hypersensitivity reactions, including anaphylaxis, have been reported with fluoroquinolone therapy. Some of these reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, throat or facial swelling, shortness of breath, urticaria, and itching. Delafloxacin should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Delafloxacin. The severity may range from mild diarrhea to fatal colitis. An increased risk of aortic aneurysm and aortic dissection has been reported within two months after fluoroquinolone use, particularly in elderly patients.

Fluoroquinolones have also been associated with disturbances in blood glucose, including symptomatic hyperglycemia and hypoglycemia. These effects occur more commonly in diabetic patients receiving oral hypoglycemic agents or insulin. Careful monitoring of blood glucose is recommended in such patients. Severe hypoglycemia leading to coma or death has been reported with other fluoroquinolones. If hypoglycemia occurs, Delafloxacin should be discontinued immediately.

Delafloxacin may cause dizziness or lightheadedness. Patients should avoid driving, operating machinery, or performing activities requiring mental alertness or coordination until they know how the medicine affects them.

Children and Adolescents: The safety and effectiveness of Delafloxacin in individuals under 18 years of age have not been established. Therefore, its use is not recommended in children and adolescents below 18 years.

Geriatric Use: Elderly patients receiving fluoroquinolones are at a greater risk of developing serious tendon disorders, including tendon rupture. Delafloxacin should be prescribed with caution in older adults, particularly in those who are also taking corticosteroids. If any signs or symptoms of tendinitis or tendon rupture occur, Delafloxacin should be discontinued. In addition, cases of aortic aneurysm and aortic dissection have been reported within two months after fluoroquinolone use, especially in elderly patients. Therefore, Delafloxacin should be used with caution in this population

Management of Delafloxacin overdose should include careful observation and appropriate supportive treatment. Hemodialysis has been shown to remove approximately 19% of Delafloxacin and 56% of sulfobutylether-β-cyclodextrin following intravenous administration of Delafloxacin.

4-Quinolone antibacterial preparation.

Store at 20°C to 25°C, with permitted excursions between 15°C and 30°C, in a dry place protected from light. Keep all medicines out of the reach of children. The reconstituted vial may be stored either under refrigeration at 2°C to 8°C or at controlled room temperature of 20°C to 25°C for up to 24 hours. Do not freeze. After dilution in an intravenous bag, Delafloxacin may also be stored either under refrigeration at 2°C to 8°C or at controlled room temperature of 20°C to 25°C for up to 24 hours. Do not freeze.