Levonat Special Precautions

In the presence of very severe pneumonia, caused by pneumococcus, the drug product levofloxacin (Levonat) may not provide optimal therapeutic effect.
Hospital acquired diseases, caused by P. aeruginosa, may require combined therapy.
Duration of administration: Recommended duration of administration is at least 60 minutes for 500 mg of solution for infusion levofloxacin (Levonat). Concerning ofloxacin, it is known that during infusion, tachycardia and transient increase in blood pressure can occur. Rarely, sudden decrease in blood pressure and circulatory collapse can be observed. If during levofloxacin administration (l-isomer ofloxacin), expressed decrease of blood pressure is observed, administration should be immediately stopped.
Tendinitis and tendons ruptures: Cases of tendinitis can occur rarely. Mostly this concerns Achilles tendon and can cause tendon rupture. Risk of tendinitis and tendon rupture increases in elderly patients and in patients taking corticosteroids. Thus, careful monitoring of these patients is required if they are prescribed levofloxacin (Levonat). Patients should consult a doctor, if they observe tendinitis symptoms. If tendinitis is suspected, treatment with levofloxacin (Levonat) should be immediately discontinued and appropriate treatment should be initiated (e.g., provide tendon immobilization).
Diseases, caused by Clostridium difficile: Diarrhea, especially in severe cases, persistent and/or hemorrhagic diarrhea, during or after treatment with levofloxacin (Levonat), could be a symptom of disease caused by Clostridium difficile, the most severe form of which is pseudomembraneous colitis. If pseudomembraneous colitis is suspected, levofloxacin (Levonat) infusion should be discontinued, and patients should be immediately treated with supportive agents ± specific therapy (e.g., oral administration of vancomycin). Inhibitors of intestinal motility are contraindicated in this clinical situation.
Patients disposed to seizures: Levofloxacin (Levonat) solution for infusion is contraindicated to patients with history of epilepsy. As in cases with other quinolones, it should be used with extreme caution in patients disposed to seizures, such as patients with central nervous system disturbances in history, at concomitant therapy with fenbufen and similar non-steroidal anti-inflammatory medicinal products or medicines that increase seizure activity (lower seizure threshold), such as theophylline (see Interactions). If seizures occur, treatment with levofloxacin should be discontinued.
Patients with glucose-6-phosphatedehydrogenase deficiency: Patients with latent or present defects of glucose-6-phosphatedehydrogenase activity could be disposed to hemolytic reactions at therapy with antibacterial agents of quinolone group, therefore they should use levofloxacin with caution.
Patients with renal insufficiency: As levofloxacin is excreted mainly by kidneys, dose adjustment is required for patients with impaired renal function (renal insufficiency) (see Dosage & Administration).
Hypersensitivity reactions: Sometimes levofloxacin could cause serious potentially fatal reactions of hypersensitivity (e.g., angioedema to anaphylactic shock) after initial dose administration (see Adverse Reactions).
In this case, patients should immediately discontinue the treatment and consult a doctor.
Hypoglycemia: As well as in case with all quinolones, cases of hypoglycemia were reported, especially in patients suffered from diabetes mellitus receiving concomitant therapy with oral hypoglycemic agents (e.g., glibenclamide) or insulin. Careful monitoring of blood glucose levels in patients suffering from diabetes mellitus is recommended (see Adverse Reactions).
Prophylaxis of photosensitivity: Though photosensitivity rarely occurs at administration of levofloxacin, patients are recommended not to be exposed to sunlight or artificial UV radiation in order to avoid it (e.g., lamps of synthetic ultraviolet radiation, solarium).
Patients who obtained vitamin K antagonists: Due to possible increase of coagulation tests parameters (PT/International Normalized Ratio) and/or bleeding in patients taking levofloxacin (Levonat) in combination with vitamin K antagonist (e.g., warfarin), coagulation tests should be monitored if these medicinal products are used concomitantly (see Interactions).
Psychotic reactions: Psychotic reactions were reported in patients who take quinolones, including levofloxacin. Rarely they developed to suicidal ideation and self-destructive behaviour, sometimes after administration of single dose of levofloxacin (see Adverse Reactions). If these reactions occur, administration of levofloxacin should be cancelled and appropriate measures should be taken. Levofloxacin should be used with caution in patients with psychotic disorders or patients with mental disorders in history.
QT interval prolongation: Fluoroquinolones, including levofloxacin, should be used with caution in patients with known risk factors for QT prolongation, such as, e.g.: congenital syndrome of QT prolongation; concomitant use of medicinal products known for ability to prolong QТ interval (e.g., Class ІА or III antiarrhythmic agents, tricyclic antidepressants, macrolides); uncorrected electrolyte imbalance (e.g., hypokalemia, hypomagnesemia); elderly patients; heart disease (e.g. heart failure, myocardial infarction, bradycardia) (see Elderly patients under Dosage & Administration, Interactions, Adverse Reactions, and Overdosage).
Peripheral neuropathy: Sensory or sensomotor peripheral neuropathy with potential for rapid development was reported in patients who obtained fluoroquinolones, including levofloxacin. Administration of levofloxacin should be discontinued in order to prevent occurrence of irreversible state if neuropathy symptoms are observed in patient.
Opiates: Determination of urine opiates may provide false-positive result in patients who obtained levofloxacin.
It might be necessary to confirm positive results for opiates by means of specific methods.
Hepatobiliary disorders: Cases of necrotic hepatitis to life-threatening hepatic failure were reported at administration of levofloxacin, mainly in patients with severe basic diseases, e.g. sepsis (see Adverse Reactions).
Patients should be recommended to discontinue therapy and contact their doctor, if liver disease manifestations and symptoms as anorexia, jaundice, black urine, itching or abdominal pains occur.
Effects on ability to drive and operate machines: Patients who drive and operate vehicles and machines should consider possible side effect on nervous system (dizziness, numbness, drowsiness, confused consciousness, vision disorders and acoustic disturbance, coordination disturbance, also during walking).
Use in Children: Application of medicinal product levofloxacin (Levonat) is contraindicated to children and adolescence (under the age of 18), as damage of articular cartilage is possible.