Drugs List

Therapeutic Indications

Uses

Acute bacterial sinusitis when other treatment inappropriate
Acute exacerbation of chronic bronchitis when other treatment inappropriate
Chronic bacterial prostatitis: treatment
Community acquired pneumonia when other treatment inappropriate
Complicated skin and soft tissue infections: other treatment inappropriate
Complicated urinary tract infections
Inhalation anthrax
Pyelonephritis
Uncomplicated lower urinary tract infection

Contraindications

Children under 18 years
Breastfeeding
Epileptic disorder
History of seizures
History of tendon disorder secondary to quinolone use
Long QT syndrome
Myasthenia gravis
Pregnancy
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
Predisposition to seizures
Aortic aneurysm
Aortic dissection
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
G6PD deficiency
History of psychiatric disorder
History of torsade de pointes
Psychosis
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Contains sunset yellow (E110) - may cause allergic reaction
Perform ECG before and during treatment
Consider pseudomembranous colitis if patient presents with severe diarrhoea
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 serum electrolytes
Reduce dose in patients with creatinine clearance below 51ml/min
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 new visual problems and symptoms
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 patient to stop therapy & contact Dr if hypersensitivity signs occur
Advise patients to report muscle pain/tenderness/weakness
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
Discontinue treatment if DRESS is suspected
Discontinue treatment if Stevens-Johnson syndrome is confirmed
Discontinue treatment if toxic epidermal necrolysis is confirmed
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Prolonged use may result in superinfection with non-susceptible organisms
Suspend treatment if Stevens-Johnson syndrome is suspected
Suspend treatment if toxic epidermal necrolysis is suspected
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if symptoms of hepatic disease occur
Discontinue in patients showing suicidal behaviour
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Avoid exposure to sunlight/UV rays during and for 2 days after treatment

Methicillin-resistant S. aureus (MRSA) are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin.

There is an increased risk of aortic aneurysm and dissection following treatment with levofloxacin. Use levofloxacin 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

Levofloxacin is contraindicated in pregnancy.

The manufacturer suggests in the absence of human data levofloxacin is contraindicated in pregnancy because of the risk to the weight-bearing cartilage of the growing foetus. Studies show levofloxacin crosses the placenta but the amounts crossing were small. Reproductive studies in animals did not raise specific concerns. Animal data has shown a risk of cartilage damage leading to arthropathy in the weight-bearing joints of growing organisms.

Briggs suggests levofloxacin should be used with caution if used in pregnancy, especially in the first trimester. Available evidence for other members of this class suggests risk of major malformation is low but cannot be excluded. Safer alternatives are usually available. Schaefer suggests the use of a quinolone antibiotic is not grounds for termination of pregnancy but a detailed foetal ultrasonograph may be considered.

Lactation

Levofloxacin is contraindicated in breastfeeding.

The manufacturer suggests in the absence of human data levofloxacin is contraindicated in breastfeeding because of the risk to the weight-bearing cartilage of the growing infant. Levofloxacin is excreted into breast milk.

Side Effects

Abdominal pain
Acute hepatic failure
Acute renal failure
Aggravation of porphyria
Agitation
Agranulocytosis
Anaphylactic shock
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Benign intracranial hypertension
Bronchospasm
Confusion
Constipation
Convulsions
Depression
Diarrhoea
Dizziness
Dream abnormalities
Drowsiness
Dysgeusia
Dyskinesia
Dyspepsia
Dyspnoea
Eosinophilia
Erythema multiforme
Exacerbation of myasthenia gravis
Extrapyramidal effects
Flatulence
Fungal superinfection
Haemolytic anaemia
Haemorrhagic diarrhoea
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatitis
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Leukocytoclastic vasculitis
Ligament rupture
Muscle rupture
Muscle weakness
Myalgia
Nausea
Nervousness
Neutropenia
Nightmares
Pain
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral motor neuropathy
Peripheral sensory neuropathy
Photosensitivity
Pneumonitis
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Psychotic reactions
Pyrexia
Rash
Rhabdomyolysis
Serum bilirubin increased
Serum creatinine increased
Severe mucocutaneous skin reactions
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon disorder
Tendon rupture
Thrombocytopenia
Tinnitus
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Ventricular arrhythmias
Vertigo
Visual disturbances
Vomiting

Presentation

Tablets containing levofloxacin as levofloxacin hemihydrate.

Drugs List

Therapeutic Indications

Uses

Acute bacterial sinusitis when other treatment inappropriate
Acute exacerbation of chronic bronchitis when other treatment inappropriate
Chronic bacterial prostatitis: treatment
Community acquired pneumonia when other treatment inappropriate
Complicated skin and soft tissue infections: other treatment inappropriate
Complicated urinary tract infections
Inhalation anthrax
Pyelonephritis
Uncomplicated lower urinary tract infection

Dosage

Tablets containing levofloxacin may be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. The same dosage can be used given the bioequivalence of the parenteral and oral forms.

Adults

Patients with Renal Impairment

Contraindications

Children under 18 years
Breastfeeding
Epileptic disorder
History of seizures
History of tendon disorder secondary to quinolone use
Long QT syndrome
Myasthenia gravis
Pregnancy
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
Predisposition to seizures
Aortic aneurysm
Aortic dissection
Cardiac disorder
Diabetes mellitus
Electrolyte imbalance
G6PD deficiency
History of psychiatric disorder
History of torsade de pointes
Psychosis
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Contains sunset yellow (E110) - may cause allergic reaction
Perform ECG before and during treatment
Consider pseudomembranous colitis if patient presents with severe diarrhoea
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 serum electrolytes
Reduce dose in patients with creatinine clearance below 51ml/min
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 new visual problems and symptoms
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 patient to stop therapy & contact Dr if hypersensitivity signs occur
Advise patients to report muscle pain/tenderness/weakness
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
Discontinue treatment if DRESS is suspected
Discontinue treatment if Stevens-Johnson syndrome is confirmed
Discontinue treatment if toxic epidermal necrolysis is confirmed
May cause convulsions
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Prolonged use may result in superinfection with non-susceptible organisms
Suspend treatment if Stevens-Johnson syndrome is suspected
Suspend treatment if toxic epidermal necrolysis is suspected
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue if symptoms of hepatic disease occur
Discontinue in patients showing suicidal behaviour
Advise to avoid antacids/mineral supplements 2 hours before or after dose
Avoid exposure to sunlight/UV rays during and for 2 days after treatment

Methicillin-resistant S. aureus (MRSA) are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin.

There is an increased risk of aortic aneurysm and dissection following treatment with levofloxacin. Use levofloxacin 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

Levofloxacin is contraindicated in pregnancy.

The manufacturer suggests in the absence of human data levofloxacin is contraindicated in pregnancy because of the risk to the weight-bearing cartilage of the growing foetus. Studies show levofloxacin crosses the placenta but the amounts crossing were small. Reproductive studies in animals did not raise specific concerns. Animal data has shown a risk of cartilage damage leading to arthropathy in the weight-bearing joints of growing organisms.

Briggs suggests levofloxacin should be used with caution if used in pregnancy, especially in the first trimester. Available evidence for other members of this class suggests risk of major malformation is low but cannot be excluded. Safer alternatives are usually available. Schaefer suggests the use of a quinolone antibiotic is not grounds for termination of pregnancy but a detailed foetal ultrasonograph may be considered.

Lactation

Levofloxacin is contraindicated in breastfeeding.

The manufacturer suggests in the absence of human data levofloxacin is contraindicated in breastfeeding because of the risk to the weight-bearing cartilage of the growing infant. Levofloxacin is excreted into breast milk.

Side Effects

Abdominal pain
Acute hepatic failure
Acute renal failure
Aggravation of porphyria
Agitation
Agranulocytosis
Anaphylactic shock
Angioedema
Anorexia
Anxiety
Arthralgia
Asthenia
Benign intracranial hypertension
Bronchospasm
Confusion
Constipation
Convulsions
Depression
Diarrhoea
Dizziness
Dream abnormalities
Drowsiness
Dysgeusia
Dyskinesia
Dyspepsia
Dyspnoea
Eosinophilia
Erythema multiforme
Exacerbation of myasthenia gravis
Extrapyramidal effects
Flatulence
Fungal superinfection
Haemolytic anaemia
Haemorrhagic diarrhoea
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatitis
Hyperglycaemia
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
Leucopenia
Leukocytoclastic vasculitis
Ligament rupture
Muscle rupture
Muscle weakness
Myalgia
Nausea
Nervousness
Neutropenia
Nightmares
Pain
Palpitations
Pancreatitis
Pancytopenia
Paraesthesia
Peripheral motor neuropathy
Peripheral sensory neuropathy
Photosensitivity
Pneumonitis
Prolongation of QT interval
Pruritus
Pseudomembranous colitis
Psychotic reactions
Pyrexia
Rash
Rhabdomyolysis
Serum bilirubin increased
Serum creatinine increased
Severe mucocutaneous skin reactions
Smelling disturbances
Somnolence
Stevens-Johnson syndrome
Stomatitis
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon disorder
Tendon rupture
Thrombocytopenia
Tinnitus
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Ventricular arrhythmias
Vertigo
Visual disturbances
Vomiting

Effects on Laboratory Tests

In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific methods.

Levofloxacin may inhibit growth of Mycobacterium tuberculosis and, may give false-negative results in the bacteriological diagnosis of tuberculosis.

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: November 2022

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: Evoxil 250mg film-coated tablets. Beacon Pharmaceuticals Ltd. Revised June 2020.
Summary of Product Characteristics: Evoxil 500mg film-coated tablets. Beacon Pharmaceuticals Ltd. Revised June 2020.

MHRA Drug Safety Update March 2019
Available at: https://www.mhra.gov.uk
Last accessed: 25 November 2022

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 November 2022