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  • Levofloxacin Teva
    / Abic


    Active Ingredient
    Levofloxacin 5 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    10 X 50 ml

    not in the basket chart

    Solution for Infusion

    10 X100 ml

    not in the basket chart 49810 12498

    Related information


    Dosage

    Patients with normal renal function (creatinine clearance > 50 ml/min): Community-acquired pneumonia- 500 mg once or twice daily. Complicated urinary tract infections including pyelonephritis- 250 mg¹ once daily. Skin and soft tissue infections – 250 mg¹ once daily.
    (1) Consideration should be given to increasing the dose in cases of severe infection.
    Special populations
    Patients with renal impairment:
    (creatinine clearance < 50 ml/min) dosage should be modified.
    Elderly: No adjustment of dosage is required, other than that imposed by consideration of renal function.
    Hepatic impairment: no dosage adjustment is needed.
    Renal impairment: In patients with creatinine clearance 50 ml/min dosage should be modified.
    See prescribing information for full details.


    Indications

    In adults for whom intravenous therapy is considered to be appropriate, Levofloxacin Teva Solution for Infusion is indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms: Community – acquired pneumonia. Complicated urinary tract infections  including pyelonephritis. Skin and soft tissue infections.


    Contra-Indications

    Levofloxacin Solution for Infusion must not be used: In patients hypersensitive to levofloxacin, other quinolones or to any of the excipients. In patients with epilepsy. In patients with history of tendon disorders related to fluoroquinolone administration. In children or growing adolescents. During pregnancy. In breast-feeding women.


    Special Precautions

    In the most severe cases of pneumococcal pneumonia levofloxacin may not be the optimal therapy. Nosocomial infections due to P. aeruginosa may require combination therapy. Tendinitis and tendon rupture, Clostridium difficile-associated disease, Patients predisposed to seizures, Patients with G6PD  dehydrogenase deficiency, Patients with renal impairment, Dysglycaemia, Prevention of photosensitization, Patients treated with vitamin K antagonists, Psychotic reactions, QT interval prolongation, Peripheral neuropathy, Hepatobiliary disorders, Exacerbation of myasthenia gravis, superinfection.
    See prescribing information for full details.


    Side Effects

    Infusion site reaction (pain, reddening), Fungal infection including Candida infection, Pathogen resistance, Leukopenia, Eosinophilia, Insomnia, Anxiety, Confusional state, Nervousness, Headache, Dizziness, Somnolence, Tremor, Dysgeusia, Diarrhoea, Vomiting, Nausea, Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT).
    See prescribing information for full details.


    Drug interactions

    Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs, probenecid and cimetidine, other relevant information, ciclosporin, other drugs which prolong QT interval.
    See prescribing information for full details.


    Pregnancy and Lactation

    The drug is contraindicated during pregnancy and lactation.


    Overdose

    According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdosage of Levofloxacin are central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and convulsive seizures, increases in QT interval.
    CNS effects including, confusional state, convulsion, hallucination and tremor have been observed in post marketing experience.
    In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.


    Important notes

    Compatibility: Levofloxacin Solution for Infusion should not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate). Levofloxacin Teva Solution for Infusion is compatible with the following solutions for infusion: 0.9% sodium chloride solution. 5% dextrose injection. 2.5% dextrose in Ringer solution. Combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). Chemical and physical compatibility of Levofloxacin Solution for Infusion with the above solutions have been demonstrated for 3 hours.
    Effects on ability to drive and use machines: Some undesirable effects (e.g. dizziness/vertigo, drowsiness, visual disturbances) may impair the patient’s ability to concentrate and react, and therefore may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).


    Manufacturer
    Teva Hungary
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