Lefloxin Warnings

(Based on Notification of the Ministry of Public Health): 1. Do not use the drug in patients with a history of hypersensitivity to the drug or any other quinolones.
2. Pregnant women and breastfeeding women should avoid the use of this drug.
3. If the symptoms of rash, malaise, myalgia, arthralgia and tendonitis had occurred after the administration of the drug, the patient should discontinue this drug and consult the physician immediately.
4. The drug may cause hepatic and renal toxicities.
5. Do not use this drug or used with caution in patients with central nervous system (CNS) disorder that may predispose to seizure dosing dependent.
6. This drug may cause prolongation of QT interval, so this drug should be used with caution in patient who has risks of prolongation of QT interval including geriatric, cardiac disease especially arrhythmia, hypertension, and hypokalemia.
7. Avoid using this drug with other drugs that cause prolongation of QT interval including antiarrhythmic class IA (quinidine, procainamide), class III (amiodarone), cisapride, erythromycin, antipsychotics, and tricyclic antidepressants.
8. This drug may cause phototoxicity reaction including Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, and Erythema Multiforme.
9. This drug should be used with caution in diabetic patient because this drug may cause dysglycemia.
10. Concomitant use of this drug and warfarin may increase the activities of warfarin.
Warning: 1. Levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving Levofloxacin. Levofloxacin should be maintained to prevent the formation of highly concentrated urine.
2. Serious colitis with bloody stool, such as pseudomembranous colitis: If such symptoms as abdominal pain and frequent diarrhea are noted, treatment with Levofloxacin should be discontinued immediately and appropriate therapeutic measures taken.
3. Rhabdomyolysis characterized by myalgia, weakness, elevated CK (CPK) and increased myoglobin in plasma and urine, etc., and accompany with acute exacerbation of renal function.
4. Tendon disorder such as Achilles tendonitis or tendon rupture: If symptoms such as pain and edema in the peritendinous region are observed, treatment with Levofloxacin should be discontinued immediately and appropriate therapeutic measures taken. The risk of tendonitis and tendon rupture is increased in those over age 60, in those on concomitant corticosteroid therapy and transplant recipients.
5. Levofloxacin may inhibit the growth of Mycobacterium tuberculosis, and therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.
6. Some undesirable effects may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situation where these abilities are of special importance (e.g. driving a car or operating machinery).
7. Hepatitis fulminant, hepatic function disorder or jaundice (initial syndromes: nausea, vomiting, anorexia, malaise, pruritus, etc.).
8. Pancytopenia, agranulocytosis (initial symptoms: pyrexia, pharynx pain, malaise, etc.), hemolytic anemia with hemoglobinuria or thrombocytopenia.
9. Interstitial pneumonia or eosinophilic pneumonia accompanied with pyrexia, cough, dyspnea, abnormal chest X-ray, or eosinophilia, etc.
10. Psychiatric symptoms such as confusion, delirium, depression.
11. Hypersensitivity vasculitis: If symptoms such as pyrexia, abdominal pain, arthralgia, purpura or maculopapules, and skin biopsy evidence of leukocytoclastic vasculitis are observed, treatment with Levofloxacin should be discontinued immediately and appropriate therapeutic measures taken.
12. Patients received Levofloxacin dose of 750 mg may develop some adverse reaction such as dizziness, headache, nausea or vomiting more than Levofloxacin dose of 500 mg.