ORACEFTIN 500 MG 10 FILM TABLET

Peripheral neuropathy Peripheral sensory neuropathy and peripheral sensory motor neuropathy have been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset see section 4. Levofloxacin has been shown to penetrate into bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin blister fluid , prostatic tissue and urine. No special requirements Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Levofloxacin is not recommended in patients with a known history of myasthenia gravis. Other undesirable effects which have been associated with fluoroquinolone administration include:. Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption. Psychotic reactions Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.

As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Levofloxacin is not recommended in patients with a known history of myasthenia gravis. Daily dose regimen according to severity. Achilles tendon see sections 4. Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption. As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent e.

Effect tabket other medicinal products on levofloxacin Iron salts, zinc-salts, magnesium- or aluminium-containing antacids, didanosine Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids, or didanosine only didanosine formulations with aluminium 01 magnesium containing buffering agents are administered concomitantly with tableet tablets. According to toxicity studies in animals or clinical pharmacology studies performed with supra-therapeutic doses, the most important signs to be expected following acute overdose of levofloxacin tablets are central nervous system symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures, increases in QT interval as well as gastro-intestinal reactions such as nausea and mucosal erosions.

The pharmacokinetics of levofloxacin are affected by renal impairment. These findings were more marked taboet young animals. Quinolones may lower the seizure threshold and may trigger seizures. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease. Due to the mechanism of action, there is generally no cross-resistance between levofloxacin and other classes of antibacterial agents.

Non-species related breakpoints 4. Non-clinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential and toxicity to reproduction and development. Fertility Levofloxacin caused no impairment of fertility or reproductive performance in rats.

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In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Levofloxacin can cause serious, potentially fatal hypersensitivity reactions e. Continue typing to refine. This site uses cookies. If superinfection occurs during therapy, appropriate measures should be taken.

There are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects, except those associated with differences in creatinine clearance. Each mg film-coated tablet contains 7. Levofloxacin mg Film-coated Tablets is contraindicated in children and growing filn see section 4. Jaundice and severe liver injury, including cases with fatal acute liver failure, primarily in patients with severe underlying diseases see section 4.

Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored. Levofloxacin mg Film-coated Tablets is contraindicated in breast-feeding women.

Visual disturbances such as blurred vision see section 4. Photosensitisation has been reported with levofloxacin see section 4. Sucralfate The bioavailability of Levofloxacin gm Film-coated Tablets is significantly reduced when administered together with sucralfate. Hyperglycaemia Hypoglycaemic coma praceftin section 4. Rhabdomyolysis Tendon rupture e. No adjustment of dose is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.

Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. Pain including pain in back, chest, and extremities. Convulsion see sections m. QT oracftin prolongation Caution should be taken when using fluoroquinolones, including levofloxacin in patients with known risk factors for prolongation of the QT interval such as, for example: QT interval prolongation Other relevant information In a pharmacokinetic interaction study, levofloxacin did not affect the pharmacokinetics odaceftin theophylline which is a probe substrate for CYP1A2indicating that levofloxacin is not a CYP1A2 inhibitor.

Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renally impaired patients. Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis.

Until there is evidence regarding clinical response for confirmed isolates with MIC above the current resistant breakpoint they should be reported resistant. Levofloxacin has been shown to penetrate into bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, skin blister fluidprostatic tissue and urine. Epidemiologic studies report an increased risk of aortic aneurysm tablft dissection after intake of fluoroquinolones, particularly in the older population.

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Separate analysis for male and female subjects showed small to marginal gender differences in levofloxacin pharmacokinetics. In diabetic patients, careful monitoring of blood glucose is recommended see section 4.

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Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations. Superinfection The use of levofloxacin, especially if prolonged, may result in overgrowth of oracsftin organisms. Angioedema Hypersensitivity see section 4. Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S – enantiomer of the racemic active substance ofloxacin.

Transient vision loss see section 4. This medicinal product does not require any special storage conditions.

Ventricular arrhythmia and torsade de pointes reported predominantly in patients with risk factors of QT prolongationelectrocardiogram QT prolonged see sections 4. Approximately 16mm long and 8mm wide.

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Absorption Orally administered levofloxacin is rapidly tablst almost completely absorbed with peak plasma concentrations being obtained within h. Not known cannot be estimated from available data. Ventricular tachycardia, which may result in cardiac arrest Ventricular arrhythmia oraceftun torsade de pointes reported predominantly in patients with risk factors of QT prolongationelectrocardiogram QT prolonged see sections 4.

Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with levofloxacin and have been reported up to several months after discontinuation of treatment.

Levofloxacin 500mg Film-coated Tablets

In vivo tests micronucleus, sister chromatid exchange, unscheduled DNA synthesis, dominant lethal tests did not show any genotoxic potential. Levofloxacin mg Film-coated Tablets is indicated in adults for the treatment of the following infections see sections 4. Levofloxacin is metabolised to a very small extent, the metabolites being desmethyl-levofloxacin and levofloxacin N-oxide.

Blood and lymphatic system disorders. General disorders and administration site conditions. Calcium salts have a minimal effect on the oral absorption of levofloxacin.