Ofloxacin
General Information
Fluoroquinolone
Restricted formulary antimicrobial: For details see OUH netFormulary
AWaRe antibiotic classification: 'Watch'. Use as per guidelines. All other indications to be discussed with Micro/ID.
For all information regarding interactions, contraception, pregnancy and breastfeeding and additional information, see BNF and Summary of Product Characteristics (SPC).
MHRA Drug Safety Updates
Fluoroquinolones, including ofloxacin are associated with disabling and potentially long-lasting or irreversible side effects. See Fluoroquinolone antibiotics - severe adverse effects
When using fluoroquinolones:
- DO NOT prescribe for:
- non-severe or self-limiting infections.
- mild to moderate infections (unless other antibiotics that are commonly recommended for these infections are considered inappropriate).
- DO read the Antimicrobial Guideline section: Fluoroquinolone antibiotics - severe adverse effects
- DO ensure penicillin allergies are properly clarified and consider de-labelling in appropriate patients to avoid the use of fluoroquinolones. See guidelines: Penicillin allergy assessment and overview and Penicillin allergy challenge and delabelling
- DO ensure all patients are given the MHRA fluoroquinolone patient leaflet (this is usually given to patients with their discharge and outpatient medications).
Standard dose
200mg-400mg po daily
Renal and hepatic impairment
Renal impairment
|
Creatinine Clearance (mL/min) |
Oral ofloxacin Dose |
|
Over 20 |
No dose adjustment |
|
10-20 |
200mg-400mg OD |
|
Less than 10 |
100mg-200mg OD |
|
HD/HDF/High Flux |
100mg-200mg OD Dialysed; give after dialysis |
|
PD |
100mg-200mg OD Not significantly dialysed |
Note: dose ranges use creatinine clearance, rather than eGFR.
Hepatic impairment
Severe hepatic dysfunction (e.g. cirrhosis of the liver with ascites): Dose should not exceed 400mg daily due to possible reduction of excretion.
Cases of fulminant hepatitis leading to liver failure (sometimes fatal) have been reported. In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
References
- Mylan. Ofloxacin 400 mg Tablets summary of product characteristics: Electronic Medicines Compendium [Internet]. Last revision date: 09/22 [cited 20/1/24]. Available from: https://www.medicines.org.uk/emc/product/8480/smpc
- The Renal Drug Database. Ofloxacin [Internet]. Laast reviews 09/9/19 [cited 20/1/24]. Available from: https://renaldrugdatabase.com/monographs/ofloxacin
- British Pharmaceutical Nutrition Group. Drug Administration via Enteral Feeding Tubes. 14 November 2023 [Internet]. 2023 [cited 2023 Nov 27]. Available from: https://www.medicinescomplete.com
- MHRA. Drug Safety update (January 2024) Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate. Accessed HERE
- MHRA. Drug Safety update (September 2023) Fluoroquinolone antibiotics: suicidal thoughts and behaviour. Accessed HERE
- MHRA. Drug Safety update (August 2023) Fluoroquinolone antibiotics: reminder of the risk of disabling and potentially long-lasting or irreversible side effects. Accessed HERE
- MHRA. Drug Safety update (December 2020) Systemic and inhaled fluoroquinolones: small risk of heart valve regurgitation; consider other therapeutic options first in patients at risk. Accessed HERE
- MHRA. Drug Safety update (March 2019) Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects. Accessed HERE
- MHRA. Drug Safety update (November 2018) Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; advice for prescribing in high-risk patients. Accessed HERE