Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia
Complicated skin and soft tissue infections

Treatment of community acquired pneumonia (CAP) when other antibacterial treatment is considered inappropriate.

Treatment of complicated skin and skin structure infections (cSSSI) when other antibacterial treatment is considered inappropriate.

Administration

For intravenous infusion only.

Do not use if there are any visible particulate matter or if the solution is cloudy. At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended that moxifloxacin is only stored at room temperature.

Contraindications

Children under 18 years
Elevated serum transaminases - greater than 5 times upper limit of normal
Bradycardia
Breastfeeding
History of cardiac arrhythmias
History of tendon disorder secondary to quinolone use
Hypokalaemia
Left ventricular ejection fraction below lower limit of normal
Long QT syndrome
Pregnancy
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Torsade de pointes

Precautions and Warnings

Family history of G6PD deficiency
Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Predisposition to cardiac arrhythmia
Predisposition to seizures
Restricted sodium intake
Aortic aneurysm
Aortic dissection
Diabetes mellitus
Electrolyte imbalance
G6PD deficiency
History of psychiatric disorder
History of seizures
History of torsade de pointes
Myasthenia gravis
Psychiatric disorder
Reduced seizure threshold
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Not recommended for methicillin resistant staphylococci infections
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Consult national/regional policy on the use of anti-infectives
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 hepatic impairment symptoms occur monitor LFT & consider discontinuation
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor blood glucose closely in patients with diabetes mellitus
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.)
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
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 at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue in patients showing suicidal behaviour
Discontinue treatment if arrhythmias occur
Advise patient to avoid exposure to sunlight and UV rays during treatment

Elderly patients with renal impairment should be treated with caution if they are unable to maintain adequate fluid intake. Dehydration in these patients may increase the risk of renal failure.

Elderly patients may be more sensitive to moxifloxacin's QTc-prolonging effects. Special caution is required in this age group.

With or without ECG findings, treatment with moxifloxacin should be stopped if any signs or symptoms associated with cardiac arrhythmia occurring during the course of treatment. Female and elderly patients may be more sensitive to the effects of QT prolongation caused by moxifloxacin. Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias as they may have an increased risk of developing ventricular arrhythmias and cardiac arrest.

There is a risk of potentially fatal pseudomembranous colitis with broad spectrum antibiotics. It is important to consider this in patients suffering from severe, persistent diarrhoea. If pseudomembranous colitis is suspected, treatment with moxifloxacin should be stopped and appropriate treatment given. In these cases, drugs that inhibit peristalsis should not be administered.

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

Moxifloxacin is contraindicated during pregnancy.

Moxifloxacin has been shown to cross the human placenta.

At the time of writing there is insufficient information to assess the effects of moxifloxacin on the developing foetus. Animal studies indicate a potential risk of fetal cartilage damage.

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 14-17 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

Moxifloxacin is contraindicated during breastfeeding.

At the time of writing, there are no data available in breast feeding women.

The molecular weight, plasma protein binding and long elimination half-life suggest moxifloxacin will be excreted into breast milk. Preclinical data indicates small amounts of moxifloxacin are secreted in breast milk.

Other antibiotics should be used when possible.

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

Abnormal INR
Agranulocytosis
Allergic reaction
Amnesia
Anaemia
Anaphylaxis
Angina pectoris
Angioedema
Anxiety
Arrhythmias
Arthralgia
Arthritis
Asthenia
Atrial fibrillation
Attention disturbances
Cardiac arrest
Confusion
Decreased appetite
Dehydration
Depersonalisation
Depression (with risk of suicide)
Diarrhoea
Dizziness
Dream abnormalities
Dysaesthesia
Dyspepsia
Dysphagia
Dyspnoea
Elevated amylase levels
Emotional lability
Eosinophilia
Exacerbation of myasthenia gravis
Fatigue
Gamma glutamyl transferase (GGT) increased
Gastro-intestinal disturbances
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatitis
Hyperaesthesia
Hyperglycaemia
Hyperlipidaemia
Hypertension
Hyperuricaemia
Hypoaesthesia
Hypotension
Impaired co-ordination
Increase in alkaline phosphatase
Increase in serum transaminases
Injection site reactions
Jaundice
Leucopenia
Muscle cramps
Muscle rigidity
Muscle twitch
Muscle weakness
Myalgia
Nausea
Neutropenia
Oedema
Pain
Paraesthesia
Peripheral neuropathy
Prolongation of QT interval
Prothrombin time increased
Pseudomembranous colitis
Psychomotor hyperactivity
Psychotic reactions
Renal failure
Renal impairment
Seizures
Serum bilirubin increased
Serum creatinine increased
Skin reactions
Sleep disturbances
Smelling disturbances
Somnolence
Speech disturbances
Stevens-Johnson syndrome
Stomatitis
Superinfections
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocythaemia
Thrombocytopenia
Thrombophlebitis (localised)
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Vasculitis
Vasodilation
Ventricular tachyarrhythmias
Vertigo
Visual disturbances

Presentation

Solution for infusion containing moxifloxacin (as hydrochloride).

Drugs List

Therapeutic Indications

Uses

Community acquired pneumonia
Complicated skin and soft tissue infections

Treatment of community acquired pneumonia (CAP) when other antibacterial treatment is considered inappropriate.

Treatment of complicated skin and skin structure infections (cSSSI) when other antibacterial treatment is considered inappropriate.

Dosage

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Adults

Additional Dosage Information

Administration

For intravenous infusion only.

Do not use if there are any visible particulate matter or if the solution is cloudy. At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended that moxifloxacin is only stored at room temperature.

Contraindications

Children under 18 years
Elevated serum transaminases - greater than 5 times upper limit of normal
Bradycardia
Breastfeeding
History of cardiac arrhythmias
History of tendon disorder secondary to quinolone use
Hypokalaemia
Left ventricular ejection fraction below lower limit of normal
Long QT syndrome
Pregnancy
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Torsade de pointes

Precautions and Warnings

Family history of G6PD deficiency
Family history of long QT syndrome
Organ transplant recipients
Patients over 60 years
Predisposition to aortic aneurysm
Predisposition to aortic dissection
Predisposition to cardiac arrhythmia
Predisposition to seizures
Restricted sodium intake
Aortic aneurysm
Aortic dissection
Diabetes mellitus
Electrolyte imbalance
G6PD deficiency
History of psychiatric disorder
History of seizures
History of torsade de pointes
Myasthenia gravis
Psychiatric disorder
Reduced seizure threshold
Renal impairment

Correct electrolyte disorders before treatment
May exacerbate myasthenia gravis
Monitor for haemolysis in G6PD deficiency
Not recommended for methicillin resistant staphylococci infections
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Advise patient not to drive until they know how the medicine affects them
Consult national/regional policy on the use of anti-infectives
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 hepatic impairment symptoms occur monitor LFT & consider discontinuation
If rash develops, consider possibility of Stevens-Johnson Syndrome
Monitor blood glucose closely in patients with diabetes mellitus
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.)
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Discontinue if central nervous disturbances occur
Discontinue if psychiatric disturbances develop
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 at once if pseudomembranous colitis occurs
Discontinue if hypersensitivity reactions occur
Discontinue if peripheral neuropathy occurs
Discontinue if photosensitivity occurs
Discontinue in patients showing suicidal behaviour
Discontinue treatment if arrhythmias occur
Advise patient to avoid exposure to sunlight and UV rays during treatment

Elderly patients with renal impairment should be treated with caution if they are unable to maintain adequate fluid intake. Dehydration in these patients may increase the risk of renal failure.

Elderly patients may be more sensitive to moxifloxacin's QTc-prolonging effects. Special caution is required in this age group.

With or without ECG findings, treatment with moxifloxacin should be stopped if any signs or symptoms associated with cardiac arrhythmia occurring during the course of treatment. Female and elderly patients may be more sensitive to the effects of QT prolongation caused by moxifloxacin. Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias as they may have an increased risk of developing ventricular arrhythmias and cardiac arrest.

There is a risk of potentially fatal pseudomembranous colitis with broad spectrum antibiotics. It is important to consider this in patients suffering from severe, persistent diarrhoea. If pseudomembranous colitis is suspected, treatment with moxifloxacin should be stopped and appropriate treatment given. In these cases, drugs that inhibit peristalsis should not be administered.

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

Moxifloxacin is contraindicated during pregnancy.

Moxifloxacin has been shown to cross the human placenta.

At the time of writing there is insufficient information to assess the effects of moxifloxacin on the developing foetus. Animal studies indicate a potential risk of fetal cartilage damage.

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 14-17 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

Moxifloxacin is contraindicated during breastfeeding.

At the time of writing, there are no data available in breast feeding women.

The molecular weight, plasma protein binding and long elimination half-life suggest moxifloxacin will be excreted into breast milk. Preclinical data indicates small amounts of moxifloxacin are secreted in breast milk.

Other antibiotics should be used when possible.

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

Abnormal INR
Agranulocytosis
Allergic reaction
Amnesia
Anaemia
Anaphylaxis
Angina pectoris
Angioedema
Anxiety
Arrhythmias
Arthralgia
Arthritis
Asthenia
Atrial fibrillation
Attention disturbances
Cardiac arrest
Confusion
Decreased appetite
Dehydration
Depersonalisation
Depression (with risk of suicide)
Diarrhoea
Dizziness
Dream abnormalities
Dysaesthesia
Dyspepsia
Dysphagia
Dyspnoea
Elevated amylase levels
Emotional lability
Eosinophilia
Exacerbation of myasthenia gravis
Fatigue
Gamma glutamyl transferase (GGT) increased
Gastro-intestinal disturbances
Haemolytic anaemia
Hallucinations
Headache
Hearing disturbances
Hepatic impairment
Hepatitis
Hyperaesthesia
Hyperglycaemia
Hyperlipidaemia
Hypertension
Hyperuricaemia
Hypoaesthesia
Hypotension
Impaired co-ordination
Increase in alkaline phosphatase
Increase in serum transaminases
Injection site reactions
Jaundice
Leucopenia
Muscle cramps
Muscle rigidity
Muscle twitch
Muscle weakness
Myalgia
Nausea
Neutropenia
Oedema
Pain
Paraesthesia
Peripheral neuropathy
Prolongation of QT interval
Prothrombin time increased
Pseudomembranous colitis
Psychomotor hyperactivity
Psychotic reactions
Renal failure
Renal impairment
Seizures
Serum bilirubin increased
Serum creatinine increased
Skin reactions
Sleep disturbances
Smelling disturbances
Somnolence
Speech disturbances
Stevens-Johnson syndrome
Stomatitis
Superinfections
Syncope
Tachycardia
Taste disturbances
Tendinitis
Tendon rupture
Thrombocythaemia
Thrombocytopenia
Thrombophlebitis (localised)
Torsades de pointes
Toxic epidermal necrolysis
Tremor
Vasculitis
Vasodilation
Ventricular tachyarrhythmias
Vertigo
Visual disturbances

Effects on Laboratory Tests

Moxifloxacin may cause false negative results in Mycobacterium spp. culture tests by suppressing mycobacterial growth.

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 2017

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: Avelox 400mg/250ml solution for infusion. Bayer plc. Revised September 2018.

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 November 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed). Record 191- Moxifloxacin
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: 08 August 2017
Last accessed: 13 November 2017