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Drug Details

TAVANIC 500mg tablets

• Drug Class Description
  quinolone antibacterials, fluoroquinolones
• Generic Name
  levofloxacin hemihydrate
• Presentation
  Film-coated tablet. Score line pale yellowish-white to reddish-white film-coated tablets
• Description
  Each film-coated tablet of Tavanic contains 500 mg of levofloxacin as active substance corresponding to 512.46 mg of levofloxacin hemihydrate.
• Indications
  

  In adults with infections of mild or moderate severity, Tavanic tablets are indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms:

  • Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)

  • Acute bacterial exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local guidelines on the treatment of respiratory tract infections)

  • Community-acquired pneumonia

  • Uncomplicated urinary tract infections

  • Complicated urinary tract infections including pyelonephritis

  • Chronic bacterial prostatitis.

  • Skin and soft tissue infections. Before prescribing Tavanic, consideration should be given to national and/or local guidance on the appropriate use of fluoroquinolones.

• Adult Dosage
  

  Tavanic tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen.

  Duration of treatment

  The duration of treatment varies according to the course of the disease (see table below). As with antibiotic therapy in general, administration of Tavanic tablets should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

  Method of administration

  Tavanic tablets should be swallowed without crushing and with sufficient amount of liquid. They may be divided at the score line to adapt the dosage. The tablets may be taken during meals or between meals. Tavanic tablets should be taken at least two hours before or after iron salts, antacids and sucralfate administration since reduction of absorption can occur.

  Posology

  The following dose recommendations can be given for Tavanic:

  Dosage in patients with normal renal function (creatinine clearance > 50 ml/min)

  Indication	Daily dose regimen(according to severity)	Duration of treatment
  Acute sinusitis	500 mg once daily	10 - 14 days
  Acute exacerbations of chronic bronchitis	250 to 500 mg once daily	7 - 10 days<
  Community-acquired pneumonia	500 mg once or twice daily	7 - 14 days
  Uncomplicated urinary tract infections	250 mg once daily	3 days
  Complicated urinary tract infections including pyelonephritis	250 mg once daily<	7 - 10 days
  Chronic bacterial prostatitis.	500 mg once daily	28 days
  	250 mg once daily or 500 mg once or twice daily	7 - 14 days

  Special populations

  Impaired renal function (creatinine clearance 50ml/min)

  	Dose regimen
  	250 mg/24 h	500 mg/24 h	500 mg/12 h
  Creatinine clearance	first dose: 250 mg	first dose: 500 mg	first dose: 500 mg
  50-20 ml/min	then: 125 mg/24 h	then: 250 mg/24 h	then: 250 mg/12 h
  19-10 ml/min	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/12 h
  < 10 ml/min (including haemodialysis and CAPD) 1	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/24 h

  ¹ No additional doses are required after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

  Impaired liver function

  No adjustment of dosage is required since levofloxacin is not metabolised to any relevant extent by the liver and is mainly excreted by the kidneys.

• Child Dosage
  

  Tavanic is contraindicated in children and growing adolescents

• Elderly Dosage
  

  No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function. (See section 4.4 QT interval prolongation).

• Contra Indications
  

  Tavanic tablets must not be used:

  • in patients hypersensitive to levofloxacin or other quinolones or 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 Tavanic may not be the optimal therapy.

  Nosocomial infections due to P. aeruginosa may require combination therapy.

  Tendinitis and tendon rupture

  Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendinitis and tendon rupture is increased in the elderly and in patients using corticosteroids. Close monitoring of these patients is therefore necessary if they are prescribed Tavanic. All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with Tavanic must be halted immediately, and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon.

  Clostridium difficile-associated disease

  Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with Tavanic tablets, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudomembranous colitis. If pseudomembranous colitis is suspected, Tavanic tablets must be stopped immediately and patients should be treated with supportive measures ± specific therapy without delay (e.g. oral vancomycin). Products inhibiting the peristalsis are contraindicated in this clinical situation.

  Patients predisposed to seizures

  Tavanic tablets are contraindicated in patients with a history of epilepsy and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures, such as patients with pre-existing central nervous system lesions, concomitant treatment with fenbufen and similar non-steroidal anti-inflammatory drugs or with drugs which lower the cerebral seizure threshold, such as theophylline. In case of convulsive seizures, treatment with levofloxacin should be discontinued.

  Patients with G-6- phosphate dehydrogenase deficiency

  Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution.

  Patients with renal impairment

  Since levofloxacin is excreted mainly by the kidneys, the dose of Tavanic should be adjusted in patients with renal impairment. Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema up to anaphylactic shock), occasionally following the initial dose. Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.

  Hypoglycemia

  As with all quinolones, hypoglycemia has been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glibenclamide) or with insulin. In these diabetic patients, careful monitoring of blood glucose is recommended.

  Prevention of photosensitisation

  Although photosensitisation is very rare with levofloxacin, it is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium), in order to prevent photosensitisation.

  Patients treated with Vitamin K antagonists

  Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with Tavanic in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these drugs are given concomittantly.

  Psychotic reactions

  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. 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:

  - congenital long QT syndrome

  - concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides).

  - uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)

  - elderly

  - cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

  Peripheral neuropathy

  Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.

  Opiates

  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.

  Hepatobiliary disorders

  Cases of hepatic necrosis up to life threatening hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis. 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.

• Interactions
  

  Effect of other medicinal products on Tavanic

  Iron salts, magnesium- or aluminium-containing antacids

  Levofloxacin absorption is significantly reduced when iron salts, or magnesium- or aluminium-containing antacids are administered concomitantly with Tavanic tablets. It is recommended that preparations containing divalent or trivalent cations such as iron salts, or magnesium- or aluminium-containing antacids should not be taken 2 hours before or after Tavanic tablet administration. No interaction was found with calcium carbonate.

  Sucralfate

  The bioavailability of Tavanic tablets is significantly reduced when administered together with sucralfate. If the patient is to receive both sucralfate and Tavanic, it is best to administer sucralfate 2 hours after the Tavanic tablet administration.

  Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs

  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, or other agents which lower the seizure threshold.

  Levofloxacin concentrations were about 13% higher in the presence of fenbufen than when administered alone.

  Probenecid and cimetidine

  Probenecid and cimetidine had a statistically significant effect on the elimination of levofloxacin. The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%). 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 in renally impaired patients.

  Other relevant information

  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: calcium carbonate, digoxin, glibenclamide, ranitidine.

  Effect of Tavanic on other medicinal products

  Ciclosporin

  The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.

  Vitamin K antagonists

  Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin). Coagulation tests, therefore, should be monitored in patients treated with vitamin K antagonists.

  Drugs known to prolong QT interval

  Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides).

  Other forms of interactions

  Meals

  There is no clinically relevant interaction with food. Tavanic tablets may therefore be administered regardless of food intake.

• Adverse Drug Reactions
  

  The information given below is based on data from clinical studies in more than 5000 patients and on extensive post marketing experience.

  The adverse reactions are described according to the MedDRA system organ class below.

  Frequencies are defined using the following convention: very common (1/10), common (1/100, <1/10), uncommon (1/1000, 1/100), rare (1/10000, 1/1000), very rare (1/10000), not known (cannot be estimated from the available data).

  Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  Infections and infestations

  Uncommon : Fungal infection (and proliferation of other resistant microorganisms)

  Blood and lymphatic system disorders

  Uncommon : Leukopenia, eosinophilia

  Rare : Thrombocytopenia, neutropenia

  Very rare : Agranulocytosis

  Not Known : Pancytopenia, haemolytic anaemia

  Immune system disorders

  Very rare : Anaphylactic shock

  Anaphylactic and anaphylactoid reactions may sometimes occur even after the first dose

  Not known : Hypersensitivity

  Metabolism and nutrition disorders

  Uncommon : Anorexia

  Very rare : Hypoglycemia, particularly in diabetic patients

  Psychiatric disorders

  Uncommon : Insomnia, nervousness

  Rare : Psychotic disorder, Depression, confusional state, agitation, anxiety

  Very rare : Psychotic reactions with self-endangering behaviour including suicidal ideation or acts, hallucination

  Nervous system disorders

  Uncommon : Dizziness, headache, somnolence

  Rare : Convulsion, tremor, paraesthesia,

  Very rare : sensory or sensorimotor peripheral neuropathy, dysgeusia including ageusia, parosmia including anosmia

  Eye disorders

  Very rare : Visual disturbance

  Ear and Labyrinth disorders

  Uncommon : Vertigo

  Very rare : Hearing impaired

  Not known : Tinnitus

  Cardiac disorders

  Rare : Tachycardia

  Not Known : Electrocardiogram QT prolonged

  Vascular disorders

  Rare : Hypotension

  Respiratory, thoracic and mediastinal disorders

  Rare : Bronchospasm, dyspnoea

  Very rare : Pneumonitis allergic

  Gastrointestinal disorders

  Common : Diarrhoea, nausea

  Uncommon : Vomiting, abdominal pain, dyspepsia, flatulence, constipation

  Rare : Diarrhoea –haemorrhagic which in very rare cases may be indicative of enterocolitis, including pseudomembranous colitis

  Hepatobiliary disorders

  Common : Hepatic enzyme increased (ALT/AST, alkaline phosphatase, GGT)

  Uncommon : Blood bilirubin increased

  Very rare : Hepatitis

  Not known: Jaundice and severe liver injury, including cases with acute liver failure, have been reported with levofloxacin, primarily in patients with severe underlying diseases.

  Skin and subcutaneous tissue disorders

  Uncommon : Rash, pruritus

  Rare : Urticaria

  Very rare : Angioneurotic oedema, photosensitivity reaction

  Not Known : Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, hyperhidrosis

  Mucocutaneous reactions may sometimes occur even after the first dose

  Musculoskeletal and Connective tissue disorders

  Rare : Tendon disorder including tendinitis (e.g. Achilles tendon), arthralgia, myalgia

  Very rare : Tendon rupture. This undesirable effect may occur within 48 hours of starting treatment and may be bilateral, muscular weakness which may be of special importance in patients with myasthenia gravis

  Not Known : Rhabdomyolysis

  Renal and urinary disorders

  Uncommon : Blood creatinine increased

  Very rare : Renal failure acute (e.g. due to nephritis interstitial)

  General disorders and administration site conditions

  Uncommon : Asthenia

  Very rare : Pyrexia

  Not known : Pain (including pain in back, chest, and extremities)

  Other undesirable effects which have been associated with fluoroquinolone administration include:

  • extrapyramidal symptoms and other disorders of muscular coordination,

  • hypersensitivity vasculitis,

  • attacks of porphyria in patients with porphyria.