Drugs List

Therapeutic Indications

Uses

Acute exacerbation of chronic bronchitis
Community acquired pneumonia
Complicated urinary tract infections
Epididymo-orchitis
Non-gonococcal urethritis / cervicitis
Pelvic inflammatory disease
Prostatitis
Pyelonephritis
Skin and soft tissue infections
Uncomplicated gonorrhoea
Uncomplicated lower urinary tract infection

Contraindications

Children under 18 years
Breastfeeding
G6PD deficiency
Galactosaemia
History of seizures
History of tendon disorder secondary to quinolone use
Long QT syndrome
Pregnancy
Reduced seizure threshold
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Aortic aneurysm
Aortic dissection
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of psychiatric disorder
History of torsade de pointes
Lactose intolerance
Myasthenia gravis
Psychiatric disorder
Renal impairment
Severe hepatic impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Reduce dose in patients with creatinine clearance below 50ml/min
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Contains lactose
Consider monitoring ECG in patients at risk of QT prolongation
Diabetic control may need adjustment
Discontinue at first sign of pain/inflammation of limb(possible tendonitis)
Discontinue treatment if patient develops seizures
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs of superinfection with non-susceptible organisms
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report any changes in vision, taste, smell or hearing
Advise patient to report mucosal/skin reactions (blistering or peeling)
Advise patient to report signs of neuropathy
Advise patient to report signs of tendinitis
Advise patient to report tiredness, mood, memory or sleep disturbances
Advise patient to rest affected limb if tendonitis occurs
Advise patient to seek medical advice if joint aches or pain occur
Advise patients to report muscle pain/tenderness/weakness
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Consider pseudomembranous colitis if patient presents with diarrhoea
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
May cause anaphylactic / anaphylactoid reactions
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Prolonged use may result in infection due to resistant organisms
Transplant patients are prone to tendon inflammation
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if anaphylactoid reaction occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue in patients showing suicidal behaviour
Course of treatment should not exceed 2 months
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Avoid excessive exposure to sunlight or sunlamps

There is an increased risk of aortic aneurysm and dissection following treatment with ofloxacin. Use ofloxacin only after careful benefit risk assessment in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and or aortic dissection, or in the presence of other risk factors or conditions predisposing for aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arthritis, Behcet's disease, hypertension, known atherosclerosis.)

Disabling, long-lasting and potentially irreversible adverse reactions mainly affecting musculoskeletal and nervous systems have been reported with quinolone and fluoroquinolone antibiotics. Treatment should be discontinued at the first signs of a serious adverse reaction such as tendinitis, pain or inflammation.

Pregnancy and Lactation

Pregnancy

Ofloxacin is contraindicated during pregnancy.

The manufacturer does not recommend using ofloxacin during pregnancy.

Based on limited amount of human data, the use of fluoroquinolones in the first trimester of pregnancy has not been associated with an increased risk of major malformations or other adverse effects on pregnancy outcome.

Ofloxacin has been shown to cause arthropathy in immature animals. Reproduction studies in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal development. Animal studies do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.

Schaefer (2015) suggests quinolones should only be used in case of complicated infections resistant to the antibiotics of choice in pregnancy. Ciprofloxacin and norfloxacin have a relatively large amount of documented experience. Even the first trimester use of a quinolone antibiotic is not an indication for termination of pregnancy, but detailed foetal ultrasonography can be offered.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ofloxacin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking ofloxacin.

Quinolones have been shown to cause arthropathy in animal studies.

Ofloxacin is excreted into breast milk in concentrations similar to those in maternal serum. Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to ofloxacin in breast milk.

Schaefer (2015) suggests as a rule, a standard antibiotic with a lower potential for risk can be substituted for the use of quinolones.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acute generalised exanthematous pustulosis
Acute hepatic failure
Acute hepatic injury
Acute renal failure
Aggravation of porphyria
Agitation
Agranulocytosis
Anaemia
Anaphylactoid reaction
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Antibiotic-associated colitis
Anxiety
Arthralgia
Arthritis
Blood disorders
Blood sugar changes
Bone marrow depression
Bronchospasm
Cholestatic jaundice
Confusion
Constipation
Convulsions
Cough
Depression
Diarrhoea
Dizziness
Dyskinesia
Dyspepsia
Dyspnoea
Enterocolitis
Eosinophilia
Erythema multiforme
Exfoliative dermatitis
Extrapyramidal effects
Eye irritation
Flatulence
Fungal infection
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hearing loss
Hepatitis
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Increases in hepatic enzymes
Interstitial nephritis
Leucopenia
Ligament rupture
Muscle rupture
Myalgia
Nasopharyngitis
Nausea
Neuropathy
Nightmares
Pain
Pancreatitis
Paraesthesia
Photosensitivity
Pneumonitis
Pruritus
Pseudomembranous colitis
Psychotic reactions
Pyrexia
Rash
Rhabdomyolysis
Serum bilirubin increased
Serum creatinine increased
Skin necrosis
Sleep disturbances
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocytopenia
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Uveitis
Vasculitis
Ventricular arrhythmias
Vertigo
Visual disturbances
Vomiting
Weakness

Presentation

Oral formulations of ofloxacin.

Drugs List

Therapeutic Indications

Uses

Acute exacerbation of chronic bronchitis
Community acquired pneumonia
Complicated urinary tract infections
Epididymo-orchitis
Non-gonococcal urethritis / cervicitis
Pelvic inflammatory disease
Prostatitis
Pyelonephritis
Skin and soft tissue infections
Uncomplicated gonorrhoea
Uncomplicated lower urinary tract infection

Dosage

Adults

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Breastfeeding
G6PD deficiency
Galactosaemia
History of seizures
History of tendon disorder secondary to quinolone use
Long QT syndrome
Pregnancy
Reduced seizure threshold
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Aortic aneurysm
Aortic dissection
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of psychiatric disorder
History of torsade de pointes
Lactose intolerance
Myasthenia gravis
Psychiatric disorder
Renal impairment
Severe hepatic impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Reduce dose in patients with creatinine clearance below 50ml/min
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Contains lactose
Consider monitoring ECG in patients at risk of QT prolongation
Diabetic control may need adjustment
Discontinue at first sign of pain/inflammation of limb(possible tendonitis)
Discontinue treatment if patient develops seizures
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor blood glucose closely in patients with diabetes mellitus
Monitor for signs of superinfection with non-susceptible organisms
Monitor serum electrolytes
Advise patient to report any blurred vision or any other eye symptoms
Advise patient to report any changes in vision, taste, smell or hearing
Advise patient to report mucosal/skin reactions (blistering or peeling)
Advise patient to report signs of neuropathy
Advise patient to report signs of tendinitis
Advise patient to report tiredness, mood, memory or sleep disturbances
Advise patient to rest affected limb if tendonitis occurs
Advise patient to seek medical advice if joint aches or pain occur
Advise patients to report muscle pain/tenderness/weakness
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Consider pseudomembranous colitis if patient presents with diarrhoea
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
May cause anaphylactic / anaphylactoid reactions
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Prolonged use may result in infection due to resistant organisms
Transplant patients are prone to tendon inflammation
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if anaphylactoid reaction occurs
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue in patients showing suicidal behaviour
Course of treatment should not exceed 2 months
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Avoid excessive exposure to sunlight or sunlamps

There is an increased risk of aortic aneurysm and dissection following treatment with ofloxacin. Use ofloxacin only after careful benefit risk assessment in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and or aortic dissection, or in the presence of other risk factors or conditions predisposing for aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arthritis, Behcet's disease, hypertension, known atherosclerosis.)

Disabling, long-lasting and potentially irreversible adverse reactions mainly affecting musculoskeletal and nervous systems have been reported with quinolone and fluoroquinolone antibiotics. Treatment should be discontinued at the first signs of a serious adverse reaction such as tendinitis, pain or inflammation.

Pregnancy and Lactation

Pregnancy

Ofloxacin is contraindicated during pregnancy.

The manufacturer does not recommend using ofloxacin during pregnancy.

Based on limited amount of human data, the use of fluoroquinolones in the first trimester of pregnancy has not been associated with an increased risk of major malformations or other adverse effects on pregnancy outcome.

Ofloxacin has been shown to cause arthropathy in immature animals. Reproduction studies in rats and rabbits did not reveal any evidence of teratogenicity, impairment of fertility or impairment of peri- and post-natal development. Animal studies do not entirely exclude the risk of damage to the cartilage of joints in the growing subject.

Schaefer (2015) suggests quinolones should only be used in case of complicated infections resistant to the antibiotics of choice in pregnancy. Ciprofloxacin and norfloxacin have a relatively large amount of documented experience. Even the first trimester use of a quinolone antibiotic is not an indication for termination of pregnancy, but detailed foetal ultrasonography can be offered.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ofloxacin is contraindicated during breastfeeding.

The manufacturer does not recommend breastfeeding whilst taking ofloxacin.

Quinolones have been shown to cause arthropathy in animal studies.

Ofloxacin is excreted into breast milk in concentrations similar to those in maternal serum. Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to ofloxacin in breast milk.

Schaefer (2015) suggests as a rule, a standard antibiotic with a lower potential for risk can be substituted for the use of quinolones.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acute generalised exanthematous pustulosis
Acute hepatic failure
Acute hepatic injury
Acute renal failure
Aggravation of porphyria
Agitation
Agranulocytosis
Anaemia
Anaphylactoid reaction
Anaphylaxis
Angioedema
Angioneurotic oedema
Anorexia
Antibiotic-associated colitis
Anxiety
Arthralgia
Arthritis
Blood disorders
Blood sugar changes
Bone marrow depression
Bronchospasm
Cholestatic jaundice
Confusion
Constipation
Convulsions
Cough
Depression
Diarrhoea
Dizziness
Dyskinesia
Dyspepsia
Dyspnoea
Enterocolitis
Eosinophilia
Erythema multiforme
Exfoliative dermatitis
Extrapyramidal effects
Eye irritation
Flatulence
Fungal infection
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hearing loss
Hepatitis
Hot flushes
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Increases in hepatic enzymes
Interstitial nephritis
Leucopenia
Ligament rupture
Muscle rupture
Myalgia
Nasopharyngitis
Nausea
Neuropathy
Nightmares
Pain
Pancreatitis
Paraesthesia
Photosensitivity
Pneumonitis
Pruritus
Pseudomembranous colitis
Psychotic reactions
Pyrexia
Rash
Rhabdomyolysis
Serum bilirubin increased
Serum creatinine increased
Skin necrosis
Sleep disturbances
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocytopenia
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Uveitis
Vasculitis
Ventricular arrhythmias
Vertigo
Visual disturbances
Vomiting
Weakness

Effects on Laboratory Tests

Determination of opiates in urine may give false positive results during treatment with ofloxacin. The use of more specific methods may be necessary to confirm positive opiate screens.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: January 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Ofloxacin 200mg tablets. Generics UK T/A Mylan. Revised March 2016.
Summary of Product Characteristics: Ofloxacin 400mg tablets. Generics UK T/A Mylan. Revised March 2016.
Summary of Product Characteristics: Tarivid 400 mg tablets. Sanofi. Revised November 2017.

MHRA Drug Safety Update March 2019
Available at: https://www.mhra.gov.uk
Last accessed: 20 May 2019

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 January 2019

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ofloxacin. Last revised: 31 October 2018
Last accessed: 04 January 2018