Formulary
Delafloxacin: Indications, Dosing, Side Effects and Interactions
Delafloxacin clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Delafloxacin: Indications, Dosing, Side Effects and Interactions
Delafloxacin clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Acute bacterial skin and skin structure infections**
- **Adult** (By Intravenous Infusion): 300 mg every 12 hours for 5-14 days, to be given over 60 minutes, switch from intravenous to oral route when clinically appropriate.
- **Adult** (By Mouth): 450 mg twice daily for 5-14 days.
Cautions
Important safety information For all quinolones With systemic use or when used by inhalation: The CSM has warned that quinolones may induce convulsions in patients with or without a history of convulsions; taking NSAIDs at the same time may also induce them. Tendon damage With systemic use or when used by inhalation: Tendon damage (including rupture) has been reported rarely in patients receiving quinolones. Tendon rupture may occur within 48 hours of starting treatment; cases have also been reported several months after stopping a quinolone. Healthcare professionals are reminded that: quinolones are contra-indicated in patients with a history of tendon disorders related to quinolone use; patients over 60 years of age are more prone to tendon damage; the risk of tendon damage is increased by the concomitant use of corticosteroids; if tendinitis is suspected, the quinolone should be discontinued immediately. MHRA/CHM advice: Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients (November 2018) With systemic use or when used by inhalation: The MHRA advises that benefit-risk should be assessed and other therapeutic options considered before using fluoroquinolones in patients at risk of aortic aneurysm and dissection. Factors that increase the risk of aortic aneurysm and dissection include: family history of aneurysm disease; pre-existing aortic aneurysm and/or aortic dissection; other risk factors or conditions predisposing to aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behet's disease, hypertension, and known atherosclerosis). Patients (particularly the elderly and those at risk) and their carers should be informed about rare events of aortic aneurysm and dissection, and advised to seek immediate medical attention if sudden-onset severe abdominal, chest, or back pain develops. MHRA/CHM advice: Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects (March 2019) With systemic use or when used by inhalation: Disabling, long-lasting, or potentially irreversible adverse reactions affecting musculoskeletal and nervous systems have been reported very rarely with fluoroquinolone antibiotics. Healthcare professionals are advised to inform patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and CNS effects, and to contact their doctor immediately. Fluoroquinolones should not be prescribed for non-severe or self-limiting infections, or non-bacterial conditions. Unless other commonly recommended antibiotics are inappropriate, fluoroquinolones should not be prescribed for some mild to moderate infections, such as acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease, and ciprofloxacin or levofloxacin should not be prescribed for uncomplicated cystitis. Fluoroquinolones should be avoided in patients who have previously had serious adverse reactions. Use of fluoroquinolones with corticosteroids should also be avoided as it may exacerbate fluoroquinolone-induced tendinitis and tendon rupture. Fluoroquinolones should be prescribed with caution in patients older than 60 years and in patients with renal impairment or solid-organ transplants as they are at a higher risk of tendon injury. MHRA/CHM advice: Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk (December 2020) With systemic use or when used by inhalation: A European review of worldwide data found an increased risk of heart valve regurgitation associated with systemic and inhaled fluoroquinolones. A case-control study suggested a two-fold increased relative risk with current oral fluoroquinolone use compared with amoxicillin or azithromycin use. Healthcare professionals are advised that fluoroquinolones are authorised for use in serious, life-threatening bacterial infections, and should only be used after careful benefit-risk assessment and consideration of other therapeutic options in patients with the following risk factors: congenital or pre-existing heart valve disease; connective tissue disorders (e.g. Marfan syndrome or Ehlers-Danlos syndrome); other risk factors or conditions predisposing to heart valve regurgitation (e.g. hypertension, Turner's syndrome, Behet's disease, rheumatoid arthritis, and infective endocarditis). Patients should be advised to seek immediate medical attention if they experience a rapid onset of shortness of breath (especially when lying down flat in bed), swelling of the ankles, feet, or abdomen, or new-onset heart palpitations. MHRA/CHM advice: Fluoroquinolone antibiotics: reminder of the risk of disabling and potentially long-lasting or irreversible side effects (August 2023) With systemic use or when used by inhalation: The risk of disabling and potentially long-lasting or irreversible adverse reactions affecting different, sometimes multiple, body systems resulted in the introduction of restrictions and precautions for fluoroquinolone antibiotics in 2019. However, a study of prescribing data has found no evidence that these measures changed fluoroquinolone prescribing patterns in primary care, and the MHRA has continued to receive reports of such reactions. Healthcare professionals are reminded to be alert to this risk and to continue to follow the advice issued in 2019 (see above). MHRA/CHM advice: Fluoroquinolone antibiotics: suicidal thoughts and behaviour (September 2023) With systemic use or when used by inhalation: Fluoroquinolones can cause psychiatric side-effects, including depression and psychosis, even after the first dose. In rare cases, these can lead to thoughts or attempts of suicide, and have been associated with the completed suicide of a patient without a history of psychiatric disorders. Fluoroquinolones can also worsen existing psychiatric symptoms and treatment should be stopped immediately if such side-effects, including new or worsening depression or psychosis, occur. Healthcare professionals are advised to counsel patients or their carers to: inform their healthcare professional if they are prescribed a fluoroquinolone and have pre-existing depression or psychosis; be alert to any changes in mood or behaviour, even after treatment has stopped for some time, and to inform friends and family about the risk and signs of psychiatric side-effects associated with fluoroquinolones-medical advice should be sought if these occur; stop taking the fluoroquinolone and seek immediate medical advice if suicidal thoughts or behaviour develop. MHRA/CHM advice: Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate (January 2024) With systemic use or when used by inhalation: Following a review of the effectiveness of current measures to reduce the identified risk of disabling and potentially long-lasting or irreversible adverse reactions, the MHRA has further restricted the use of fluoroquinolones. These adverse reactions, which may affect multiple body systems including musculoskeletal, nervous, psychiatric and sensory systems, have been reported in patients irrespective of their age and potential risk factors, and may last for months or years; the updated reporting incidence suggested a minimum frequency of between 1 and 10 per 10 000 patients. In addition to advice issued in 2019 and 2023 (see above), healthcare professionals are advised that fluoroquinolones should only be used when other commonly recommended antibiotics are inappropriate i.e. in situations where: there is resistance to other first-line antibiotics recommended for the infection; other first-line antibiotics are contra-indicated in an individual patient; other first-line antibiotics have caused side-effects that required treatment to be stopped; treatment with other first-line antibiotics has failed. Patients should be advised to stop fluoroquinolone treatment at the first sign of a serious musculoskeletal, neurological or psychiatric side effect and to contact their doctor immediately (see Patient and carer advice ).
Contraindications
When used by inhalation History of tendon disorders related to quinolone use With intravenous use History of tendon disorders related to quinolone use With oral use History of tendon disorders related to quinolone use
Side effects
Common or very common Appetite decreased; arthralgia; asthenia; constipation; diarrhoea; dizziness; dyspnoea; eye discomfort; eye disorders; fever; fungal infection; gastrointestinal discomfort; headache; myalgia; nausea; QT interval prolongation; skin reactions; sleep disorders; taste altered; tinnitus; vision disorders; vomiting Uncommon Altered smell sensation; anaemia; anxiety; arrhythmias; chest pain; confusion; cough; depression; drowsiness; dry eye; eosinophilia; eye inflammation; flatulence; hallucination; hearing impairment; hepatic disorders; hyperglycaemia; hyperhidrosis; hypersensitivity; hypoglycaemia; hypotension; leucopenia; muscle weakness; neutropenia; pain; palpitations; peripheral neuropathy (sometimes irreversible); pseudomembranous enterocolitis; renal impairment; seizure; sensation abnormal; stomatitis; tendon disorders; thrombocytopenia; tremor; vertigo Rare or very rare Agranulocytosis; angioedema; arthritis; coordination abnormal; gait abnormal; haemolytic anaemia; hypoglycaemic coma; idiopathic intracranial hypertension; memory impairment; myasthenia gravis aggravated; pancreatitis; pancytopenia; photosensitivity reaction; polyneuropathy; psychotic disorder; severe cutaneous adverse reactions (SCARs); suicidal behaviours; syncope; vasculitis Frequency not known Heart valve incompetence; increased risk of aortic aneurysm (more common in elderly); increased risk of aortic dissection (more common in elderly); rhabdomyolysis Side-effects, further information The drug should be discontinued if neurological, psychiatric, tendon disorders or hypersensitivity reactions (including severe rash) occur. For more information regarding the safety of fluoroquinolones, please see Important Safety Information. Side-effects For delafloxacin Common or very common Hypertransaminasaemia Uncommon Alopecia; auditory hallucinations; chills; dry mouth; dry throat; flushing; gastrointestinal disorders; haematuria; hypertension; increased risk of infection; local swelling; muscle spasms; myositis; oral disorders; peripheral oedema; seasonal allergy; sweat changes; wound complications Rare or very rare Paranoia Frequency not known Intracranial pressure increased; toxic psychosis
Pregnancy
With intravenous use or oral use or when used by inhalation: Avoid in pregnancy-shown to cause arthropathy in animal studies; safer alternatives are available.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Renal impairment
Avoid in end-stage renal disease. M With intravenous use: Monitor serum creatinine in patients with moderate to severe renal impairment as intravenous vehicle may accumulate-if serum creatinine increases, consider switching to oral formulation (no dose adjustment required). M With oral use: Caution in severe renal impairment-monitor renal function. M Dose adjustments With intravenous use: Reduce dose to 200 mg every 12 hours if creatinine clearance is less than 30 mL/min; alternatively, consider switching to oral formulation (no dose adjustment required). M See Prescribing in renal impairment .
Medicinal forms
Tablet,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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