Drugs List

Therapeutic Indications

Uses

Chronic pulmonary infection caused by P.aeruginosa in cystic fibrosis

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
Renal impairment - creatinine clearance below 20ml/minute
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Haemoptysis
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Predisposition to seizures
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
May reduce seizure threshold
Any concomitant bronchodilator should be used first
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)
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 changes in vision, taste, smell or hearing
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 discontinue therapy if signs of hepatotoxicity 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
Patient should report worrying psychological changes esp. suicidal thoughts
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
May affect results of some laboratory tests
Discontinue if peripheral neuropathy occurs
Discontinue if symptoms of hepatic disease occur
Bronchodilator therapy may be used to reduce bronchospasm
Avoid exposure to sunlight/UV rays during and for 2 days after treatment

Bronchospasm may occur after receiving treatment with nebulised levofloxacin. A short-acting inhaled bronchodilator given at least 15 minutes to 4 hours prior to subsequent doses may aid patients.

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 during pregnancy.

Use of levofloxacin during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of levofloxacin during pregnancy, however non-clinical studies have suggested there is a risk to the weight-bearing cartilage of the growing foetus.

Studies show levofloxacin crosses the placenta but the amounts crossing were small.

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 during breastfeeding.

Use of levofloxacin when breastfeeding is contraindicated by the manufacturer. The presence of levofloxacin in human breast milk is unknown, however, other fluoroquinolones are excreted in breast milk. At the time of writing there is limited published information regarding the use of levofloxacin during breastfeeding, however non-clinical studies have suggested a risk to the weight-bearing cartilage of the growing infant.

Side Effects

Abnormal breath sounds
Acute hepatic injury
Airway obstruction
Altered liver function tests
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anorexia
Anxiety
Arthralgia
Arthritis
Asthenia
Benign intracranial hypertension
Blood dyscrasias
Blood glucose disturbances
Bronchial hyperreactivity
Bronchospasm
Changes in bronchial secretions
Confusion
Constipation
Convulsions
Costochondritis
Cough
Decreased exercise tolerance
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dysgeusia
Dyskinesia
Dyspepsia
Dysphonia
Dyspnoea
Eosinophilia
Erythema multiforme
Extrapyramidal effects
Flatulence
Forced expiratory volume decreased
Fungal infection
Haemoptysis
Headache
Hearing loss
Hepatitis
Hyperbilirubinaemia
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hyposmia (transient)
Hypotension
Increase in alkaline phosphatase
Increase in serum ALT/AST
Insomnia
Jaundice
Leukocytoclastic vasculitis
Ligament rupture
Loss of vision(transient)
Muscle rupture
Myalgia
Nausea
Pain
Palpitations
Paraesthesia
Peripheral motor neuropathy
Peripheral sensory neuropathy
Photosensitivity
Pneumonitis
Prolongation of QT interval
Pruritus
Psychotic symptoms
Pyrexia
Rash
Reduced platelet count
Renal failure
Retching
Rhabdomyolysis
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Stiffness
Stomatitis
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Tinnitus
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Ventricular arrhythmias
Ventricular tachycardia
Vertigo
Visual disturbances
Vomiting
Vulvovaginal infections
Weight loss

Presentation

Nebuliser solution containing levofloxacin.

Drugs List

Therapeutic Indications

Uses

Chronic pulmonary infection caused by P.aeruginosa in cystic fibrosis

Dosage

Patients taking several inhaled respiratory therapies should receive their treatments in the following order: bronchodilators, dornase alfa, airway clearance techniques, levofloxacin nebuliser solution, inhaled steroids.

Adults

Additional Dosage Information

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
Renal impairment - creatinine clearance below 20ml/minute
Torsade de pointes

Precautions and Warnings

Family history of long QT syndrome
Haemoptysis
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Predisposition to seizures
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
May reduce seizure threshold
Any concomitant bronchodilator should be used first
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)
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 changes in vision, taste, smell or hearing
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 discontinue therapy if signs of hepatotoxicity 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
Patient should report worrying psychological changes esp. suicidal thoughts
Patients over 60 years are prone to tendon inflammation
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
May affect results of some laboratory tests
Discontinue if peripheral neuropathy occurs
Discontinue if symptoms of hepatic disease occur
Bronchodilator therapy may be used to reduce bronchospasm
Avoid exposure to sunlight/UV rays during and for 2 days after treatment

Bronchospasm may occur after receiving treatment with nebulised levofloxacin. A short-acting inhaled bronchodilator given at least 15 minutes to 4 hours prior to subsequent doses may aid patients.

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 during pregnancy.

Use of levofloxacin during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of levofloxacin during pregnancy, however non-clinical studies have suggested there is a risk to the weight-bearing cartilage of the growing foetus.

Studies show levofloxacin crosses the placenta but the amounts crossing were small.

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 during breastfeeding.

Use of levofloxacin when breastfeeding is contraindicated by the manufacturer. The presence of levofloxacin in human breast milk is unknown, however, other fluoroquinolones are excreted in breast milk. At the time of writing there is limited published information regarding the use of levofloxacin during breastfeeding, however non-clinical studies have suggested a risk to the weight-bearing cartilage of the growing infant.

Side Effects

Abnormal breath sounds
Acute hepatic injury
Airway obstruction
Altered liver function tests
Anaemia
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Anorexia
Anxiety
Arthralgia
Arthritis
Asthenia
Benign intracranial hypertension
Blood dyscrasias
Blood glucose disturbances
Bronchial hyperreactivity
Bronchospasm
Changes in bronchial secretions
Confusion
Constipation
Convulsions
Costochondritis
Cough
Decreased exercise tolerance
Depression
Diarrhoea
Dizziness
Dream abnormalities
Dysgeusia
Dyskinesia
Dyspepsia
Dysphonia
Dyspnoea
Eosinophilia
Erythema multiforme
Extrapyramidal effects
Flatulence
Forced expiratory volume decreased
Fungal infection
Haemoptysis
Headache
Hearing loss
Hepatitis
Hyperbilirubinaemia
Hyperhidrosis
Hypersensitivity reactions
Hypoglycaemia
Hyposmia (transient)
Hypotension
Increase in alkaline phosphatase
Increase in serum ALT/AST
Insomnia
Jaundice
Leukocytoclastic vasculitis
Ligament rupture
Loss of vision(transient)
Muscle rupture
Myalgia
Nausea
Pain
Palpitations
Paraesthesia
Peripheral motor neuropathy
Peripheral sensory neuropathy
Photosensitivity
Pneumonitis
Prolongation of QT interval
Pruritus
Psychotic symptoms
Pyrexia
Rash
Reduced platelet count
Renal failure
Retching
Rhabdomyolysis
Serum creatinine increased
Somnolence
Stevens-Johnson syndrome
Stiffness
Stomatitis
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Tinnitus
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Urticaria
Ventricular arrhythmias
Ventricular tachycardia
Vertigo
Visual disturbances
Vomiting
Vulvovaginal infections
Weight loss

Effects on Laboratory Tests

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

Mycobacterium tuberculosis growth may be inhibited by levofloxacin and so may give rise to false-negative results in 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: January 2020

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: Quinsair 240 mg nebuliser solution. Chiesi Limited. Revised February 2019.

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: 08 January 2020