MOXIFLOXACIN
Please note moxifloxacin is not licensed to treat tuberculosis in the UK.
DOSAGE
Adults: 400mg once a day (oral or intravenous).
WHO recommendations for MDR-TB short course regimen (safety of the higher doses not verified)
Weight <30kg: 400mg once a day
Weight 30-50kg: 600mg once a day
Weight >50Kg: 800mg once a day
Children:
10-15mg/kg once a day (oral)
Use 10mg/kg in children <6 moths old
PREPARATIONS
Oral: 400mg tablets.
Parenteral: 400mg/250mL solution for infusion.
DRUG LEVEL MONITORING
Indications for monitoring:
Target Level
Timing of sample:
Suggested Actions:
Frequency of Levels:
ADVERSE EFFECTS
COMMON:
Cardiovascular: QTc prolongation (more common in hypokalaemia, proarrhythmic conditions, in combination with other drugs that prolong the QT interval such as ondansetron).
Gastrointestinal: Nausea, vomiting, diarrhoea.
Hepatic: Transient increases in LFTs.
Other: Dizziness, headache.
SERIOUS:
Cardiovascular: QTc prolongation (rare; more common in hypokalaemia, and predisposing cardiac conditions).
Dermatological: Stevens-Johnson syndrome or toxic epidermal necrolysis (rare).
Haematological: (Uncommon) agranulocytosis, aplastic anaemia, haemolytic anaemia, thrombocytopaenia.
Hepatic: Acute hepatitis (rare).
Immunological: Anaphylaxis, immune hypersensitivity (uncommon).
Metabolic: Hypoglycaemia (in patients on hypoglycaemic drugs, uncommon).
Musculoskeletal: Tendon inflammation and rupture (see contra-indications below).
Neurological: Seizures: (Caution in patients with CNS disorders).
Renal: Renal impairment (rare).
Respiratory: Extrinsic allergic alveolitis (rare).
Other: Serum sickness (rare).
ADVERSE EFFECTS: MONITORING
ECG: Baseline, 2 weeks then every 3 months and after the addition of any new medication that is known to prolong QT.
LFTs, U&Es and FBC should be monitored sporadically throughout treatment. No specific frequency recommendations, please see generic monitoring guidelines for further information.
Blood glucose should be monitored regularly in patients with diabetes (risk of hypoglycaemia).
Routine tests as per generic MDR-TB treatment monitoring guidelines.
INTERACTONS
Antacids: Reduced absorption of moxifloxacin.
Anti-arrhythmics: Increased risk of ventricular arrhythmias with amiodarone or disopyramide.
Antidepressants: Increased risk of ventricular arrhythmias with tricyclics.
Antimalarials: Increased risk of ventricular arrhythmias with chloroquine, hydroxychloroquine, mefloquine, quinine.
Antipsychotics: Increased risk of ventricular arrhythmias with benperidol, droperidol, haloperidol, phenothiazines, pimozide and zuclopenthixol.
Antivirals: Increased risk of ventricular arrhythmias with saquinavir.
Beta-blockers: Increased risk of ventricular arrhythmias with sotalol.
Ciclosporin: Increased risk of nephropathy.
Erythromycin: Increased risk of ventricular arrhythmias when erythromycin given via intravenous route.
Iron: Reduced absorption of moxifloxacin.
NSAIDS: Possible increased risk of convulsions.
Pentamidine: Increased risk of ventricular arrhythmias.
Theophylline: Increased risk of convulsions. Reduce dose of theophylline and monitor levels.
Zinc: reduced absorption of moxifloxacin.
Drugs known to prolong the QT interval: use with caution in patients taking Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics.
This information is not inclusive of all drug interactions. Please discuss with a pharmacist.
CONTRA-INDICATIONS & CAUTIONS
Contraindications:
Hypersensitivity: To moxifloxacin or other quinolones.
Tendon Damage: Rarely reported but damage or rupture may occur within 48 hours of treatment and several months after stopping treatment. Increased risk in patients with a history of tendon disorders related to quinolone use, aged over 60 years, concomitant use of corticosteroids. Cease all quinolone treatment if tendinitis suspected.
Pregnancy: Avoid in pregnancy, animal studies have shown quinolones cause arthropathy.
Breast Feeding: Avoid, present in milk in animal studies.
Children: Moxifloxacin is contra-indicated in the UK for use in children or growing adolescents. Use in TB with caution. Arthropathy has developed in weight-bearing joints in young animals.
Cardiovascular: Due to the risk of QT prolongation with moxifloxacin, is should not be used in patients with congenital or documented acquired QT prolongation, clinically relevant bradycardia, clinically relevant heart failure with reduced left-ventricular ejection fraction, previous history of symptomatic arrhythmias, or electrolyte disturbances, particularly in uncorrected hypokalaemia.
Liver disease: Chronic liver disease; particularly Child Pugh severity score C and in those patients with transaminase levels 5 fold greater than the upper limit of normal. Consider using Levofloxacin as an alternative in these patients.
Concurrent use with other drugs that prolong the QT interval.
Cautions:
May impair performance of skilled tasks such as driving
Myasthenia Gravis: Risk of exacerbation.
G6PD deficiency: Risk of haemolytic reactions when treated with quinolones.
Sunlight: Risk of photosensitivity reaction.
Epilepsy/Seizure Activity: May induce convulsions in patients with or without history of convulsions, use with caution if epileptic or conditions predisposing seizures.
Liver Disease: Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported.
Serious bullous skin reactions: Risk of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Peripheral Neuropathy: Sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness.
LABORATORY INFORMATION
Please find up to date information at www.assayfinder.com regarding individual providers of drug level monitoring tests. Click on the provider to discover contact details. Turnaround time varies depending on the test and whether it is run locally or sent to an external lab. By contacting laboratories in advance, turnaround time can significantly be reduced.
Sample Type: Serum.
Volume Required: 2ml (min 0.1mL).
Sample Container: Plain glass or plastic (non SST).
Container Type: Any.
Availability: NS.
Turnaround Time: Telephoned same day if received 9am-3pm Mon-Fri if advanced warning given. Written confirmation report will be sent by 1st Class post.
The sample must be heat-treated before dispatch if HIV positive.
Please telephone at least one day in advance of the sample.
- Despite the lack of data establishing the safety and efficacy of fluoroquinolone use in children they continue to be used to treat MDR-TB in children of all ages in clinical practice. It is felt the benefit of treatment of MDR-TB outweighs the small potential risk of adverse reactions.
DOSAGE
Adults: 400mg once a day (oral or intravenous).
WHO recommendations for MDR-TB short course regimen (safety of the higher doses not verified)
Weight <30kg: 400mg once a day
Weight 30-50kg: 600mg once a day
Weight >50Kg: 800mg once a day
Children:
10-15mg/kg once a day (oral)
Use 10mg/kg in children <6 moths old
PREPARATIONS
Oral: 400mg tablets.
Parenteral: 400mg/250mL solution for infusion.
DRUG LEVEL MONITORING
Indications for monitoring:
- Known or suspected malabsorption.
- Poor treatment response.
Target Level
- Peak level: : 3-5mg/L
- Trough level: 0.3-0.7mg/L
Timing of sample:
- Peak – 2 hours post dose
- Repeat at 6 hours if suspect delayed absorption.
- Consider Trough levels only if suspect delayed absorption – taken immediately prior to a dose.
Suggested Actions:
- High Peak Level: Monitor for side effects and check ECG. If tolerated, consider continuing usual dose.
- Low Peak Level: Repeat serum levels at 2 hours and 6 hours post dose, and trough serum level (trough level may only be required if adult patients take >400mg once daily).
- Trough levels: a low trough level may confirm a low peak serum level, which may require an increase in moxifloxacin dose.
Frequency of Levels:
- No need for regular monitoring.
ADVERSE EFFECTS
COMMON:
Cardiovascular: QTc prolongation (more common in hypokalaemia, proarrhythmic conditions, in combination with other drugs that prolong the QT interval such as ondansetron).
Gastrointestinal: Nausea, vomiting, diarrhoea.
Hepatic: Transient increases in LFTs.
Other: Dizziness, headache.
SERIOUS:
Cardiovascular: QTc prolongation (rare; more common in hypokalaemia, and predisposing cardiac conditions).
Dermatological: Stevens-Johnson syndrome or toxic epidermal necrolysis (rare).
Haematological: (Uncommon) agranulocytosis, aplastic anaemia, haemolytic anaemia, thrombocytopaenia.
Hepatic: Acute hepatitis (rare).
Immunological: Anaphylaxis, immune hypersensitivity (uncommon).
Metabolic: Hypoglycaemia (in patients on hypoglycaemic drugs, uncommon).
Musculoskeletal: Tendon inflammation and rupture (see contra-indications below).
Neurological: Seizures: (Caution in patients with CNS disorders).
Renal: Renal impairment (rare).
Respiratory: Extrinsic allergic alveolitis (rare).
Other: Serum sickness (rare).
ADVERSE EFFECTS: MONITORING
ECG: Baseline, 2 weeks then every 3 months and after the addition of any new medication that is known to prolong QT.
LFTs, U&Es and FBC should be monitored sporadically throughout treatment. No specific frequency recommendations, please see generic monitoring guidelines for further information.
Blood glucose should be monitored regularly in patients with diabetes (risk of hypoglycaemia).
Routine tests as per generic MDR-TB treatment monitoring guidelines.
INTERACTONS
Antacids: Reduced absorption of moxifloxacin.
Anti-arrhythmics: Increased risk of ventricular arrhythmias with amiodarone or disopyramide.
Antidepressants: Increased risk of ventricular arrhythmias with tricyclics.
Antimalarials: Increased risk of ventricular arrhythmias with chloroquine, hydroxychloroquine, mefloquine, quinine.
Antipsychotics: Increased risk of ventricular arrhythmias with benperidol, droperidol, haloperidol, phenothiazines, pimozide and zuclopenthixol.
Antivirals: Increased risk of ventricular arrhythmias with saquinavir.
Beta-blockers: Increased risk of ventricular arrhythmias with sotalol.
Ciclosporin: Increased risk of nephropathy.
Erythromycin: Increased risk of ventricular arrhythmias when erythromycin given via intravenous route.
Iron: Reduced absorption of moxifloxacin.
NSAIDS: Possible increased risk of convulsions.
Pentamidine: Increased risk of ventricular arrhythmias.
Theophylline: Increased risk of convulsions. Reduce dose of theophylline and monitor levels.
Zinc: reduced absorption of moxifloxacin.
Drugs known to prolong the QT interval: use with caution in patients taking Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics.
This information is not inclusive of all drug interactions. Please discuss with a pharmacist.
CONTRA-INDICATIONS & CAUTIONS
Contraindications:
Hypersensitivity: To moxifloxacin or other quinolones.
Tendon Damage: Rarely reported but damage or rupture may occur within 48 hours of treatment and several months after stopping treatment. Increased risk in patients with a history of tendon disorders related to quinolone use, aged over 60 years, concomitant use of corticosteroids. Cease all quinolone treatment if tendinitis suspected.
Pregnancy: Avoid in pregnancy, animal studies have shown quinolones cause arthropathy.
Breast Feeding: Avoid, present in milk in animal studies.
Children: Moxifloxacin is contra-indicated in the UK for use in children or growing adolescents. Use in TB with caution. Arthropathy has developed in weight-bearing joints in young animals.
Cardiovascular: Due to the risk of QT prolongation with moxifloxacin, is should not be used in patients with congenital or documented acquired QT prolongation, clinically relevant bradycardia, clinically relevant heart failure with reduced left-ventricular ejection fraction, previous history of symptomatic arrhythmias, or electrolyte disturbances, particularly in uncorrected hypokalaemia.
Liver disease: Chronic liver disease; particularly Child Pugh severity score C and in those patients with transaminase levels 5 fold greater than the upper limit of normal. Consider using Levofloxacin as an alternative in these patients.
Concurrent use with other drugs that prolong the QT interval.
Cautions:
May impair performance of skilled tasks such as driving
Myasthenia Gravis: Risk of exacerbation.
G6PD deficiency: Risk of haemolytic reactions when treated with quinolones.
Sunlight: Risk of photosensitivity reaction.
Epilepsy/Seizure Activity: May induce convulsions in patients with or without history of convulsions, use with caution if epileptic or conditions predisposing seizures.
Liver Disease: Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported.
Serious bullous skin reactions: Risk of Stevens-Johnson syndrome or toxic epidermal necrolysis.
Peripheral Neuropathy: Sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness.
LABORATORY INFORMATION
Please find up to date information at www.assayfinder.com regarding individual providers of drug level monitoring tests. Click on the provider to discover contact details. Turnaround time varies depending on the test and whether it is run locally or sent to an external lab. By contacting laboratories in advance, turnaround time can significantly be reduced.
Sample Type: Serum.
Volume Required: 2ml (min 0.1mL).
Sample Container: Plain glass or plastic (non SST).
Container Type: Any.
Availability: NS.
Turnaround Time: Telephoned same day if received 9am-3pm Mon-Fri if advanced warning given. Written confirmation report will be sent by 1st Class post.
The sample must be heat-treated before dispatch if HIV positive.
Please telephone at least one day in advance of the sample.