ADMINISTRATION ROUTES:
IV, PO
ALTERNATIVE NAMES:
Avelox
ICU INDICATIONS:
- Treatment of infections caused by susceptible organisms
PRESENTATION AND ADMINISTRATION:
IV:
400 mg in 250 mL solution (pre-mixed bag)
Remove from aluminium overwrap bag immediately before use. If stored at cool temperatures precipitation may occur – this will redissolve at room temperature. Do not use solution unless it is clear and free of precipitate. Administer over 60 minutes
Compatible with the following IV fluids:
0.9% saline, Hartmann's, 5%/10%/40% dextrose, Glucose and sodium chloride
Store at room temperature
Do not store below 8°C
PO:
Avelox 400 mg tablets
DOSAGE:
IV:
400 mg OD
PO:
400 mg OD
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose as in normal renal function
DOSAGE IN PAEDIATRICS:
IV:
10 mg/kg OD
PO:
10 mg/kg OD
Note: see WARNINGS
CLINICAL PHARMACOLOGY:
Moxifloxacin is a quinolone antibiotic. The bactericidal action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination. Moxifloxacin, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90%.
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections:
Aerobes, Gram-Positive:
- Staphylococcus aureus (methicillin-susceptible strains only)
- Streptococcus pneumoniae (including penicillin-resistant strains)
- Streptococcus pyogenes.
Aerobes, Gram-Negative:
- Haemophilus influenzae
- Haemophilus parainfluenzae
- Klebsiella pneumoniae
- Moraxella catarrhalis
Other Microorganisms:
- Chlamydia pneumoniae
- Mycoplasma pneumoniae
CONTRAINDICATIONS:
- Hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobials
WARNINGS:
THE SAFETY AND EFFECTIVENESS OF MOXIFLOXACIN IN CHILDREN, PREGNANT WOMEN, AND LACTATING WOMEN HAS NOT BEEN ESTABLISHED
QTc prolongation
Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. It should be avoided in patients with known QT prolongation, uncorrected hypokalaemia or patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.
Convulsions and neuropsychiatric complications
Convulsions have been reported in patients receiving quinolones. Quinolones may also cause central nervous system events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose.
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy.
Pseudomembranous Colitis
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including moxifloxacin, and may range in severity from mild to life-threatening.
Peripheral Neuropathy
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paraesthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones.
Tendon Effects
Ruptures of the shoulder, hand, achilles tendon or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones.
PRECAUTIONS:
General:
Prescribing moxifloxacin tablets and oral suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Laboratory Tests:
No tests in addition to usual ICU tests are indicated.
Drug/Laboratory Test Interactions:
None of note.
IMPORTANT DRUG INTERACTIONS IN ICU:
Antacids, Sucralfate, Metal Cations, Multivitamins
Quinolones form chelates with alkaline earth and transition metal cations. Oral administration of quinolones with antacids containing aluminium or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as (didanosine) chewable/buffered tablets or the paediatric powder for oral solution, may substantially interfere with the absorption of quinolones, resulting in systemic concentrations considerably lower than desired. Therefore, moxifloxacin should be taken at least 4 hours before or 8 hours after these agents.
ADVERSE REACTIONS:
Body as a Whole:
Headache, abdominal pain, injection site reaction, asthenia, moniliasis, pain, malaise, lab test abnormal (not specified), allergic reaction, leg pain, back pain, chest pain
Cardiovascular:
Palpitation, tachycardia, hypertension, peripheraloedema, QT interval prolonged
Central Nervous System:
Insomnia, nervousness, anxiety, confusion, somnolence, tremor, vertigo, paraesthesia
Gastrointestinal:
Vomiting, diarrhoea, abnormal liver function test, dyspepsia, dry mouth, constipation, oral moniliasis, anorexia, stomatitis, glossitis, flatulence, gastrointestinal disorder, GGTP increased
Haematological:
Prothrombin decrease (prothrombin time prolonged/International Normalised Ration (INR) increased), thrombocythemia, thrombocytopaenia, eosinophilia, leukopaenia
Metabolic and Nutritional:
Amylase increased, lactic dehydrogenase increased
Musculoskeletal:
Arthralgia, myalgia
Respiratory:
Dyspnoea
Dermatological:
Rash (maculopapular, purpuric, pustular), pruritus, sweating