LEVOFLOXACIN HEMIHYDRATE PDFLEVOFLOXACIN HEMIHYDRATE PDF

Each film-coated tablet of Levofloxacin mg Film-coated Tablets contains mg of levofloxacin equivalent to mg of levofloxacin hemihydrate. Name: Levofloxacin hemihydrate; Drug Entry: Levofloxacin. A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling. Find patient medical information for Levofloxacin Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.

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Each film-coated tablet of Levofloxacin mg Film-coated Tablets contains mg of levofloxacin equivalent to Excipient with known effect: Each mg film-coated tablet contains 7. Approximately 16mm long and 8mm wide. For the above-mentioned infections Levofloxacin mg Film-coated Tablets should be used only when hemihyvrate is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.

Levofloxacin mg Film-coated Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Levofloxacin mg Film-coated Tablets – Summary of Product Characteristics (SmPC) – (eMC)

The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen.

Levofloxacin mg Film-coated Tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin; given the bioequivalence of the parenteral and oral forms, the same dosage can be used. 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. No adjustment of dose is required in the elderly, other than that imposed by consideration of renal function see section 4.

Levofloxacin mg Film-coated Tablets is contraindicated in children and growing adolescents see section 4. Levofloxacin mg Film-coated Tablets tablets should be swallowed without crushing and with sufficient amount of liquid.

They may be divided at the score line to adapt the dose. The tablets may be taken during meals or between meals. Levofloxacin mg Film-coated Tablets tablets should be taken at least two hours before or after iron salts, zinc salts, magnesium- or aluminium-containing antacids, or didanosine only didanosine formulations with aluminium or magnesium containing buffering agentsand sucralfate administration, since reduction of absorption can occur see section 4.

Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate. Levofloxacin may be used in the treatment of Acute Bacterial Sinusitis and Acute Exacerbation of Chronic Bronchitis when these infections have been adequately diagnosed. Resistance to fluoroquinolones of E.

Prescribers are advised to take into account the local prevalence of resistance in E. Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. 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.

The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, in patients receiving daily doses of mg and in patients using corticosteroids. The daily dose should be adjusted in elderly patients based on creatinine clearance see section 4. Close monitoring of these patients is therefore necessary if they are prescribed levofloxacin.

All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with levofloxacin must be halted immediately, and appropriate treatment e. CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis see section 4. It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin.

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If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay. Anti-peristaltic medicinal products are contraindicated in this clinical situation. Jemihydrate may lower the seizure threshold and may trigger seizures.

Levofloxacin is contraindicated in patients with a history of epilepsy see section 4. In case of convulsive seizures see section 4.

Patients with latent or actual defects in glucosephosphate dehydrogenase activity may be prone to hemihydraye reactions when treated with quinolone antibacterial agents. Therefore, if levofloxacin has to hemihyrrate used in these patients, potential occurrence of haemolysis should be monitored. Since levofloxacin is excreted mainly by the kidneys, the dose of levofloxacin should be adjusted in patients with renal impairment see section 4.

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions e. Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.

Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with levofloxacin see section levofloxacim. 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. Cases of hypoglycaemic coma have been reported.

Levofloxacin 500mg Film-coated Tablets

In diabetic patients, careful monitoring of blood levofllxacin is recommended see section 4. Photosensitisation has been reported with levofloxacin see section 4. It is recommended that levkfloxacin should not expose themselves unnecessarily to strong sunlight or to artificial UV rays e. Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin.

In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin see section 4. In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease. QT interval 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:.

Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations. 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 should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition. Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Levofloxacin is not recommended in patients with a known history of myasthenia gravis. If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately see sections 4.

The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken. In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method. Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.

Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids, or didanosine only didanosine formulations with aluminium or magnesium containing buffering agents are administered concomitantly with levofloxacin tablets. Concurrent administration of fluoroquinolones with multi-vitamins containing zinc appears to reduce their oral absorption. It is recommended that hemhiydrate containing divalent or levofloxacih cautions such as iron salts, zinc-salts or magnesium- or aluminium-containing antacids, or didanosine only didanosine formulations with aluminium or magnesium containing buffering agents should not be taken 2 hours before or leovfloxacin Levofloxacin mg Film-coated Tablets administration see section 4.

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Calcium salts have a minimal effect on the oral absorption of levofloxacin. The bioavailability of Levofloxacin mg Film-coated Tablets is significantly reduced when administered together with sucralfate.

If the patient is to receive both sucralfate and levofloxacin, it is best to administer sucralfate 2 hours after the Levofloxacin mg Film-coated Tablets administration see section 4. No pharmacokinetic interactions of levofloxacin were found with theophylline in a clinical study. However a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, non-steroidal anti-inflammatory drugs, levofloxxacin other agents which lower the seizure threshold.

Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin.

Levofloxacin – Wikipedia

This is because both drugs are capable of blocking the renal tubular secretion of levofloxacin. However, at the tested doses in the study, the statistically significant kinetic differences are unlikely to be of clinical relevance. Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially gemihydrate renally impaired patients. Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with the following drugs: Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists see section 4.

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval e. In a pharmacokinetic interaction study, levofloxacin did not hemihydrat the pharmacokinetics of theophylline which is a probe substrate for CYP1A2indicating that levofloxacin is not a CYP1A2 inhibitor.

There is no clinically relevant interaction with food.

Levofloxacin mg Film-coated Tablets may therefore be administered regardless of food intake. There are limited amount of data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity see section 5.

However in the absence of human data and due to levfoloxacin experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women see sections 4.

Levofloxacin mg Film-coated Tablets is contraindicated in breast-feeding women. There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk. In the absence of human data and due to that experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in breast-feeding women see sections 4.

Some undesirable effects e. The information given below is based on data from clinical studies in more than patients and on extensive post marketing experience. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Fungal infection including Candida infection. Blood and lymphatic system disorders. Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt see section 4. Visual disturbances such as blurred vision see section 4. Ventricular arrhythmia and torsade de pointes hmeihydrate predominantly in patients with risk factors of QT prolongation hejihydrate, electrocardiogram QT prolonged see sections 4. Respiratory, thoracic and mediastinal disorders.