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Floxsafe: The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in this section.
Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions: Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin.
Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest. The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded.
If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Hypersensitivity/allergic reactions: Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
Severe liver disorders: Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin. Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Serious bullous skin reactions: Cases of bullous skin reactions like Stevens Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Patients predisposed to seizures: Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders or in the presence of other risk factors which may predispose to seizures or lower the seizure threshold. In case of seizures, treatment with moxifloxacin should be discontinued and appropriate measures instituted.
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
Psychiatric reactions: Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self injurious behaviour such as suicide attempts. In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Antibiotic-associated diarrhoea incl. colitis: Antibiotic-associated diarrhoea (AAD) and antibiotic associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Patients with myasthenia gravis: Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Tendon inflammation, tendon rupture: Tendon inflammation and rupture (especially Achilles tendon), sometimes bilateral, may occur with quinolone therapy including moxifloxacin, even within 48 hours of starting treatment and have been reported up to several months after discontinuation of therapy. The risk of tendinitis and tendon rupture is increased in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin, rest the affected limb(s) and consult their doctor immediately in order to initiate appropriate treatment (e.g. immobilisation) for the affected tendon.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Dysglycemia: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. In diabetic patients, careful monitoring of blood glucose is recommended.
Prevention of photosensitivity reactions: Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Patients with glucose-6-phosphate dehydrogenase deficiency: Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.
Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Patients with pelvic inflammatory disease: For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with Moxifloxacin 400 mg film-coated tablets is not recommended.
Pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Patients with special cSSSi: Clinical efficacy of intravenous moxifloxacin in the treatment of severe burn infections, fasciitis and diabetic foot infections with osteomyelitis has not been established.
Interference with biological tests: Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results in samples taken from patients currently receiving moxifloxacin.
Patients with MRSA infections: Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started.
Patients with renal impairment: Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Effects on ability to drive and use machines: No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute, transient loss of vision, or acute and short lasting loss of consciousness. Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Use in Children: Due to adverse effects on the cartilage in juvenile animals the use of moxifloxacin in children and adolescents <18 years is contraindicated.
Floxsafe IV: To prevent the development of drug-resistant bacteria, it is desirable that moxifloxacin is used for a therapeutically minimum period after the confirmation of susceptibility.
It has been shown that moxifloxacin has an effect of QT interval prolongation as like other quinolones or macrolides. Females generally have longer QTc interval than males, so females response more sensibly to the drugs to prolong QTc interval. Elderly patients also response more sensibly to the drugs to have effects on the QT interval. The magnitude of QT prolongation may be increased with an increased plasma concentration of moxifloxacin. Therefore, the recommended dose should not be exceeded and the duration of infusion should not be less than the recommended 60 minutes for the administration of 400 mg. QT prolongation may lead to an increased risk for ventricular arrhythmias, including Torsades de pointes. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 8,000 patients (oral and parenteral administration), but QTc prolongation may lead to an increased risk for ventricular arrhythmias.
Cases of bullous skin reactions like mucocutaneous ocular syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) have been reported with moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Hypersensitivity and allergic reactions have been sometimes reported after first administration and in these cases patients should be advised to contact their doctor immediately. Anaphylactoid reactions can progress to a life-threatening shock after the first administration very rarely. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
The risk of developing quinolone-associated tendinitis and tendon rupture is further increased in elderly patients, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Cases occurring up to several months after completion of therapy have been reported.
Moxifloxacin should be discontinued and patients should be advised to put their affected limb(s) at rest if the patient experiences pain or inflammation.
Antibiotic-associated colitis has been reported in association with the use of broad spectrum antibacterial agents, including moxifloxacin. Therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of moxifloxacin. In this case, adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
Quinolones have been shown to cause photosensitivity reactions in patients. However, no photosensitivity reactions have been reported in the preclinical and clinical studies which have been designed to confirm the photosensitivity of moxifloxacin. And any post-approval evidences have not been reported that moxifloxacin causes photosensitivity reactions. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
In patients whose sodium intake is to be considered medically (congestive cardiac failure, renal impairment, nephritic syndrome etc), the infused amount of sodium chloride should be considered.
This drug contains 34 mmol sodium per 250 mL.
Cases of sensory or sensorimotor axonal polyneuropathy resulting in paraesthesias, dysaesthesias, hypoesthesias or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, numbness, or weakness develop.
Psychiatric reactions may occur even after the first administration of fluoroquinolones including moxifloxacin. In very rare cases depression or psychotic reactions have culminated in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts. In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started.
In vitro activity of moxifloxacin may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false negative results in samples taken from patients currently receiving moxifloxacin.
Quinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions and transient loss of vision.
Others: Like other quinolones, main organs involving toxicity of this drug are hematopoietic system (decrease of myelomonocytes in dogs and monkeys), CNS (convulsion in monkeys) and liver (increase of liver enzyme and necrosis of mono cell in rats, dogs and monkeys). Generally, such changes have been observed with overdose or long term use.
Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs. Studies in rats (oral and I.V) and monkeys (oral) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin. Vertebral and rib malformations were observed in rabbits that had been treated with an I.V dose of 20 mg/kg. There was an increase in the incidence of a miscarriage in monkeys and rabbits at human therapeutic concentrations. In rates, decreased fetal weights, an increased prenatal loss, a slightly increased duration of pregnancy and an increased spontaneous activity of some male and female offspring was observed at doses that are 63 times the maximum recommended human dose based upon plasma concentrations (mg/kg).
Animal studies to determine the carcinogenic potential of moxifloxacin have not been performed.
As the results of genotoxicity tests, negative response was obtained with moxifloxacin in in vivo micronucleus test using rodent hematopoietic cells, however positive responses were obtained in in vitro reverse mutagenic test using bacterial strains and in in vitro chromosome aberration assay using cultured mammalian cells regardless of metabolic activation.
Use in the Elderly: In clinical studies, the adverse reactions and its rate reported in the elderly patients are similar to those in non-elderly people. However, it should be carefully administered considering the condition of patient because physiological function of the elderly people is generally decreased. Especially in the elderly patients less than 40 kg body weight, it is easy to occur adverse reactions by the high plasma/tissue concentrations; therefore caution should be taken as using the low doses (200 mg). And the elderly people may be more susceptible to drug-associated QT interval prolongation.
