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Hypersensitivity: In some instances, the hypersensitivity and allergic reactions already occurred after the first administration and the doctor should be informed immediately.
Anaphylactic reactions in very rare instances can progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with Moxifloxacin (Avelox) has to be discontinued, medical treatment (e.g. treatment for shock) is required.
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with Moxifloxacin (Avelox) (see "Adverse Reactions"). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Cardiac disorders: Moxifloxacin (Avelox) has been shown to prolong the QT interval of the electrocardiogram in some patients. 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. As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose and the infusion rate (400 mg within 60 minutes) should not be exceeded. However, in patients suffering from pneumonia no correlation between plasma concentrations of moxifloxacin and QTc prolongation was observed. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Moxifloxacin (Avelox) treatment in clinical studies with more than 9000 patients, however certain predisposing conditions may increase the risk for ventricular arrhythmias.
Therefore, treatment with Moxifloxacin (Avelox) should be avoided due to the lack of clinical experience with the drug in these patient populations: in patients with known prolongation of the QT interval; in patients with uncorrected hypokalemia; in patients receiving class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents.
Moxifloxacin (Avelox) should be used with caution as an additive effect of moxifloxacin on the QT interval cannot be excluded for the following conditions: in patients treated concomitantly with drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics and tricyclic antidepressants; in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia; in patients with liver cirrhosis as preexisting QT prolongation in these patients cannot be excluded; in women and elderly patients who, both, may be more susceptible to QTc-prolonging drugs.
Hepatobiliary system: Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with Moxifloxacin (Avelox) (see "Adverse Reactions"). Patients should be advised to contact their doctor immediately prior to continuing treatment if symptoms related to liver failure occur.
Seizures: Seizures may occur with fluoroquinolone therapy. It should be used with caution in patients with known or suspected CNS disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke), which may predispose to seizures or lower the seizure threshold.
Gastrointestinal system: Antibiotic associated colitis has been reported with the use of broad-spectrum antibiotics including Moxifloxacin (Avelox); therefore it is important to consider this diagnosis in patients who develop serious diarrhoea in association with the use of Moxifloxacin (Avelox). In this clinical situation adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
Myasthenia gravis: Moxifloxacin (Avelox) should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Tendinitis and tendon rupture: Tendinitis and tendon rupture (predominantly Achilles tendon), sometimes bilateral, may occur with fluoroquinolone therapy including moxifloxacin, even within the first 48 hours of treatment. Cases occurring up to several months after completion of therapy have been reported. The risk of tendinopathy may be increased, in elderly patients, during strenuous physical activity, in patients treated concomitantly with corticosteroids, in patients with renal impairment including renal failure and patients with solid organ transplants. At the first sign of tendinitis (e.g. painful swelling, inflammation) the affected extremity should be kept at rest, any inappropriate physical exercise should be avoided, a physician should be consulted and the antibiotic treatment should be discontinued.
Complicated 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 (Avelox) 400 mg film-coated tablets is not recommended.
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 (see "Pharmacology: Pharmacodynamics under Actions").
Interaction with tests: Moxifloxacin in vitro activity may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking Moxifloxacin (Avelox).
Peripheral neuropathy: Cases of sensory or sensorimotor polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, or weakness have been reported in patients receiving fluoroquinolones including Moxifloxacin (Avelox). Patients under treatment with Moxifloxacin (Avelox) should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see "Adverse Reactions").
Psychiatric reactions: Psychiatric reactions may occur even after the first administration of fluoroquinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-injurious behavior such as suicide attempts (see "Adverse Reactions"). In the event that the patient develops these reactions, Moxifloxacin (Avelox) should be discontinued and appropriate measures instituted. Caution is recommended if Moxifloxacin (Avelox) is to be used in psychotic patients or in patients with a history of psychiatric disease.
Genital tract infections: Because of the widespread and rising prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae infections, monotherapy with moxifloxacin should be avoided in patients with pelvic inflammatory disease, unless fluoroquinolone-resistant N. gonorrhoeae can be excluded. If fluoroquinolone-resistant N. gonorrhoeae can not be excluded, the addition of an appropriate antibiotic which is regularly active against N. gonorrhoeae (e.g., a cephalosporin) to empirical moxifloxacin therapy, should be considered.
Dysglycemia: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with Moxifloxacin (Avelox). In Moxifloxacin (Avelox)-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 (see "Adverse Reactions").
Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Information about excipients: In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional sodium load of the solution for infusion should be taken into account.
Effects on ability to drive or use machines: Fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions and vision disorders (see "Adverse Reactions").
