Avelox Special Precautions



Bayer HealthCare Pharma


Full Prescribing Info
Special Precautions
In some instances, the hypersensitivity and allergic reactions already occurred after the 1st 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 1st administration. In these cases moxifloxacin has to be discontinued, medical treatment (eg, treatment for shock) is required.
Moxifloxacin has been shown to prolong the QT interval of the ECG in some patients. It should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalaemia and patients receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with the drug in these patient populations.
An additive effect of moxifloxacin and drugs that prolong the QT interval eg, cisapride, erythromycin, antipsychotics and tricyclic antidepressants cannot be excluded. Therefore, moxifloxacin should be used with caution when given concurrently with these drugs.
Moxifloxacin should be used with caution in patients with ongoing pro-arrhythmic conditions eg, clinically significant bradycardia, acute myocardial ischemia.
As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose 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 Torsade de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in clinical studies with >9000 patients, however certain predisposing conditions may increase the risk for ventricular arrhythmias.
Seizures may occur with quinolone therapy. Moxifloxacin should be used with caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold.
Due to limited clinical data, the use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child-Pugh C).
Antibiotic-associated colitis has been reported with the use of broad-spectrum antibiotics including moxifloxacin, therefore, it is important to consider this diagnosis in patients who develop serious diarrhoea in association with the use of moxifloxacin. In this clinical situation, adequate therapeutic measures should be initiated immediately.
Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. At the 1st sign of pain or inflammation, patients should discontinue treatment and rest the affected limbs.
Quinolones have been shown to cause photosensitivity reactions in patients. However, in specially designed preclinical and clinical studies, photosensitivity has not been observed with moxifloxacin. In addition, since first marketed, there has been no clinical evidence that moxifloxacin causes photosensitivity reactions. Nevertheless, patients should be advised to avoid extensive exposure to either ultraviolet irradiation or sunlight.
For patients with complicated pelvic inflammatory disease (eg, associated with a tubo-ovarian or pelvic abscess), for whom an IV treatment is considered necessary, treatment with moxifloxacin 400 mg tablets is not recommended.
Effect on the Ability to Drive or Operate Machinery: In clinical trials, a low incidence of CNS reactions was observed. However, patients should be cautioned to see how they react before driving or operating machinery.
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