Adult

Ofloxacin

Warning

General Information

Ofloxacin is a fluoroquinolone antibiotic.

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.

MHRA Warnings

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.

Pregnancy and breastfeeding

Pregnancy

Manufacturer states avoid use during pregnancy. Discuss choice of antibiotic with Micro/ID.

 

Breastfeeding

Caution. Discuss with pharmacy.

  • Use safer alternatives where possible.
  • If used, avoid breastfeeding for 4-6 hours post-dose if possible.
  • Avoid in infants with known G6PD deficiency due to the risk of haemolysis.
  • Use with caution in infants with epilepsy.
  • Monitor infant for gastro-intestinal disturbances and oral candida infection, especially if used in high doses, although these effects are unlikely to occur.

Notable interactions

The list below is not exhaustive. There are multiple interactions between ofloxacin and other medications. Ensure interactions are checked with the BNF and SPC. Discussion with a pharmacist is advised.

Key interactions:

NSAIDs: CAUTION. Taking NSAIDs at the same time as ofloxacin may induce convulsions in patients with or without a history of convulsions.

Theophylline: CAUTION. Taking theophylline at the same time as ofloxacin may induce convulsions in patients with or without a history of convulsions.

QT interval-prolongators: CAUTION: Use with caution in patients receiving other drugs known to prolong the QT interval or with other risk factors for QT interval prolongation.

Vitamin K antagonists: anticoagulant effect enhanced-monitor INR closely and within 3-5 days of starting ofloxacin.

The medications listed below reduce oral ofloxacin absorption. The ofloxacin SPC states take oral ofloxacin 2 hours before these medications. Consult the BNF and SPC for detailed guidance on administration:

  • magnesium and aluminium antacids,
  • sucralfate,
  • oral zinc or iron preparations,
  • didanosine chewable or buffered tablets.

Warnings

  • Ofloxacin may induce convulsions in patients with or without a history of convulsions; taking NSAIDs or theophylline at the same time as ofloxacin may also induce them.
  • Patients should be advised to avoid exposure to either extensive and/or strong sunlight or UV irradiation (e.g. tanning beds) during treatment with ofloxacin and for 48 hours after stopping ofloxacin.
  • Ofloxacin is not recommended in patients with a known history of myasthenia gravis. Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.  
  • Use with caution in G6PD deficiency.
  • Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with fluoroquinolones. Treatment should be immediately reviewed if skin and/or mucosal reactions occur.

Stewardship

Broad spectrum antibiotics such as ofloxacin carry a high risk of C.difficile infection. 

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
  • UK Teratology Information Service. Use of quinolones in pregnancy [Internet]. 2017 [cited 2023 Nov 27]. Available from: https://uktis.org/monographs/use-of-quinolones-in-pregnancy/
  • Specialist Pharmacy Service. Lactation safety information – ofloxacin [Internet]. Last update 19/9/20 [cited 20/1/24]. Available from: https://www.sps.nhs.uk/medicines/ofloxacin/
  • Briggs GG, Freeman RK, Tower CV, Forinash AB. Drugs in pregnancy and lactation. 11th ed. Philadelphia: Lippincott Williams and Wilkins; 2017.
  • 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

Editorial Information

Next review date: 01 Jan 2027