Formulary
Ofloxacin: Indications, Dosing, Side Effects and Interactions
Ofloxacin clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 17 min read
Ofloxacin: Indications, Dosing, Side Effects and Interactions
Ofloxacin clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Local treatment of infections**
- **Child** (To The Eye): 1-17 years Apply every 2-4 hours for the first 2 days, then reduced to 4 times a day for maximum 10 days treatment.
- **Adult** (To The Eye): Apply every 2-4 hours for the first 2 days, then reduced to 4 times a day for maximum 10 days treatment.
**Urinary-tract infections**
- **Adult** (By Mouth): 200-400 mg daily for 3 days, preferably taken in the morning.
**Complicated urinary-tract infections,Acute pyelonephritis,Lower respiratory-tract infections**
- **Adult** (By Mouth): 400 mg daily, preferably taken in the morning, increased if necessary to 400 mg twice daily for 7-10 days, dose increased for severe or complicated infections.
- **Adult** (By Intravenous Infusion): 200 mg twice daily, increased if necessary to 400 mg twice daily, dose increased for severe or complicated infections, to be given over at least 30 minutes for each 200 mg.
**Prostatitis**
- **Adult** (By Mouth): 200 mg twice daily for 14 or 28 days based on clinical assessment.
**Complicated skin and soft-tissue infections**
- **Adult** (By Mouth): 400 mg twice daily for 7-10 days.
- **Adult** (By Intravenous Infusion): 400 mg twice daily, to be given over at least 30 minutes for each 200 mg.
**Gonococcal urethritis,Gonococcal cervicitis**
- **Adult** (By Mouth): 400 mg for 1 dose.
**Uncomplicated genital chlamydial infection,Non-gonococcal urethritis,Non-gonococcal cervicitis**
- **Adult** (By Mouth): 400 mg daily for 7 days, dose may be taken as a single daily dose or in divided doses.
**Pelvic inflammatory disease**
- **Adult** (By Mouth): 400 mg twice daily for 14 days.
**Local treatment of infections for ofloxacin**
- **Child 1-17 years** (To the eye): Apply every 2-4 hours for the first 2 days, then reduced to 4 times a day for maximum 10 days treatment.
Cautions
Important safety information For all quinolones With systemic use or when used by inhalation in adults: 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. With systemic use in children: 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 in adults: 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. Tendon damage With systemic use in children: 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; 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 in adults: 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: Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients (November 2018) With systemic use in children: 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 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 in adults: 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: 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 in children: 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 mild to moderate infections. 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 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 in adults: 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: Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk (December 2020) With systemic use in children: 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 in adults: 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: reminder of the risk of disabling and potentially long-lasting or irreversible side effects (August 2023) With systemic use in children: 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 in adults: 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: suicidal thoughts and behaviour (September 2023) With systemic use in children: 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 in adults: 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 ). MHRA/CHM advice: Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate (January 2024) With systemic use in children: 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 signs 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 (in adults); 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 (in adults) 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 ofloxacin Uncommon With intravenous use Increased risk of infection (in adults) With oral use Increased risk of infection (in adults) Rare or very rare With intravenous use Bronchospasm (in adults); enterocolitis (in adults); enterocolitis haemorrhagic (in adults); hot flush (in adults); movement disorders (in adults) With oral use Bronchospasm (in adults); delirium (in adults); enterocolitis (in adults); enterocolitis haemorrhagic (in adults); hot flush (in adults); movement disorders (in adults) Frequency not known When used by eye (topical) Face oedema; oropharyngeal swelling; tongue swelling With intravenous use Alveolitis allergic (in adults); bone marrow failure (in adults); ligament rupture (in adults); muscle rupture (in adults); myopathy (in adults); nephritis acute interstitial (in adults); self-endangering behaviour (in adults) With oral use Alveolitis allergic (in adults); bone marrow failure (in adults); ligament rupture (in adults); muscle rupture (in adults); myopathy (in adults); nephritis acute interstitial (in adults); self-endangering behaviour (in adults)
Interactions
**Severe interactions:**
- Vitamin K antagonists Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with ofloxacin in combination with a vitamin K antagonist (e.g.
**Other interactions (10):**
- Antacids, Sucralfate, Metal Cations Co-administered magnesium/aluminum antacids, sucralfate zinc or iron preparations and didanosine chewable/buffered tablets can reduce absorption of ofloxacin.
- Therefore, ofloxacin should be taken 2 hours before such preparations.
- Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of ofloxacin were found with theophylline in a clinical study.
- However, a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, nonsteroidal anti-inflammatory drugs, or other agents, which...
- In case of convulsive seizures, treatment with ofloxacin should be discontinued.
- Probenecid, cimetidine, furosemide, and methotrexate Probenecid decreased the total clearance of ofloxacin by 24%, and increased AUC by 16%.
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. Pregnancy For ofloxacin When used by eye: Manufacturer advises use only if benefit outweighs risk (systemic quinolones have caused arthropathy in animal studies).
Breast feeding
With intravenous use or oral use in adults: Amount probably too small to be harmful but manufacturer advises avoid. When used by eye: Manufacturer advises avoid.
Hepatic impairment
With intravenous use or oral use in adults: Manufacturer advises caution. Dose adjustments With intravenous use or oral use in adults: Manufacturer advises maximum 400 mg daily in hepatic failure (risk of decreased elimination).
Renal impairment
Dose adjustments With intravenous use or oral use in adults: Usual initial dose, then use half normal dose if creatinine clearance 20-50 mL/minute; 100 mg every 24 hours if creatinine clearance less than 20 mL/minute. See Prescribing in renal impairment .
Medicinal forms
Solution,Tablet,Drops
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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