Floxsafe/Floxsafe IV Contraindications

Floxsafe: Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in Description.
Pregnancy and lactation.
Patients below 18 years of age.
Patients with a history of tendon disease/disorder related to quinolone treatment.
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: Congenital or documented acquired QT prolongation.
Electrolyte disturbances, particularly in uncorrected hypokalaemia.
Clinically relevant bradycardia.
Clinically relevant heart failure with reduced left-ventricular ejection fraction.
Previous history of symptomatic arrhythmias.
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval.
Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase >5 fold ULN.
Floxsafe IV: Patients with a history of hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Pediatric patients and adolescents less than 18 years of age (Safety and effectiveness in pediatric patients and adolescents have not been established.)
Pregnant, women of child bearing potential, and lactating women.
Patients with severe hepatic insufficiency (the clinical data are limited).
Patient with high aminotransferase level (more than 5 times of normal value).
Patients with a history of tendon disorder related to quinolones treatment.
QT interval prolongation patient.
Electrolyte imbalance patient (especially patients with untreated hypokalemia).
Patients with bradycardia, and with a history of symptomatic arrhythmias.
Clinically relevant heart failure with reduced left-ventricular ejection fraction.
Patients receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents, antipsychotics, tricyclic antidepressants, certain antimicrobial antimicrobial agents (saquinavir, sparfloxacin, erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), cisapride, vincamine I.V, bepridil and diphemanil (concomitant use with moxifloxacin may increase the effect on QT interval prolongation).