Moxifloxacin

Moxifloxacin [1 vial $246.42] ADMINISTRATION ROUTES:

IV, PO

ALTERNATIVE NAMES: Avelox

ICU INDICATIONS: 1. treatmentofinfectionscausedbysusceptibleorganisms

PRESENTATION AND ADMINISTRATION:

IV

400mg in 250ml solution (pre-mixed bag) Remove from aluminium overwrap bag immediately before us. temperatures precipitation may occur – this will redissolve at room temperature. Do not use solution unless it is clear and free of precipitate Administer over not less than 60 minutes Compatible with the following IV fluids:

Normal saline Glucose and sodium chloride Store at room temperature Do not store below 8°C

PO

Avelox 400mg tablets

DOSAGE:

IV:

400mg daily

PO:

Hartmanns

5%, 10% & 40% dextrose

400mg daily DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY: Dose as in normal renal function

DOSAGE IN PAEDIATRICS:

IV:

10mg/kg daily

PO:

10mg/kg daily Note: see WARNINGS

CLINICAL PHARMACOLOGY: Moxifloxacin is a quinolone antibiotic. 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%.

The bactericidal action of moxifloxacin results

Moxifloxacin

Version 30/08/2010

If stored at cool

301Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections. Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus pyogenes.

Aerobic Gram-Negative Microorganisms: Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis. Other Microorganisms: Chlamydia pneumoniae, Mycoplasma pneumoniae.

CONTRAINDICATIONS: 1. hypersensitivity to moxifloxacin or any member of the quinolone class of

antimicrobials

WARNINGS THE SAFETY AND EFFECTIVENESS OF MOXIFLOXACIN IN PEDIATRIC PATIENTS, ADOLESCENTS (<18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. QTc prolongation Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. The drug should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia and 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 (CNS) 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 paresthesias, 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.

Version 30/08/2010

302

Laboratory Tests:

No tests in addition to usual ICU tests are indicated

Drug/Laboratory Test Interactions:

None of note

IMPORTANT DRUG INTERACTIONS FOR THE ICU

Antacids, Sucralfate, Metal Cations, Multivitamins

Quinolones form chelates with alkaline earth and transition metal cations. Oral administration of quinolones with antacids containing aluminum 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 pediatric 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, peripheral edema, QT interval prolonged.

Central Nervous System:

Insomnia, nervousness, anxiety, confusion, somnolence, tremor, vertigo, paresthesia.

Digestive:

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/Internationl Normalized Ration (INR) increased), thrombocythemia, thrombocytopenia, eosinophilia, leukopenia. Metabolic and Nutritional: Amylase increased, lactic dehydrogenase increased.

Musculoskeletal:

Arthralgia, myalgia.

Respiratory:

Dyspnea.

Skin/Appendages:

Rash (maculopapular, purpuric, pustular), pruritus, sweating.