TAVANIC ® Levofloxacin

TAVANIC ® is a drug based on Levofloxacin hemihydrate

THERAPEUTIC GROUP: Antimicrobials - antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications TAVANIC ® Levofloxacin

TAVANIC ® is indicated in the treatment of infections caused by microorganisms sensitive to Quinolones and in particular to Levofloxacin.

The latter proved to be particularly effective against pathogens responsible for respiratory, skin and soft tissue pathologies.

Mechanism of action TAVANIC ® Levofloxacin

TAVANIC ® owes its particular clinical efficacy to the presence of the active ingredient Levofloxacin, an antibiotic belonging to the third-generation Fluoroquinolones category, therefore also effective towards streptococci, enterococci, and atypical intracellular bacteria.

Its activity, essentially linked to the ability to stop bacterial proliferation, inhibiting enzymes such as DNA gyrase and DNA topoisomerases, is sometimes compromised by the onset of resistance mechanisms that make the bacteria immune to the pharmacological action of the antibiotic.

These mechanisms, represented by variation of the biological target, expression of efflux pumps and inactivating enzymes, prevent the drug from reaching therapeutically effective concentrations in the bacterial cytosol, thus preventing the antibiotic from carrying out its therapeutic action.

These conditions are opposed to the excellent pharmacokinetic properties that allow Levofloxacin, taken orally, to be absorbed systemically and immediately distributed among the various tissues, being able to exert a post-antibiotic effect for different hours.

The elimination of the unchanged active principle through the urine extends the antiseptic action also to the urinary tract, even though it does not represent a specific therapeutic indication.

Studies carried out and clinical efficacy

ADVERSE REACTIONS TO LEVOFLOXACINE

Case report which demonstrates the very rare occurrence of an adverse reaction to Levofloxacin most probably determined by a hypersensitivity to the active ingredient, which is not diagnosed in time.

This form of bullous pemphigoid is fortunately regressed once the therapy has been suspended.

THE EFFICACY OF LEVOFLOXACINE IN THE TREATMENT OF URINARY AND RESPIRATORY INFECTIONS

Clinical trial conducted on over 250 patients demonstrating that levofloxacin, like analogues of more recent formulation, can be effective and well tolerated in the treatment of respiratory and urinary tract infections.

DIABETIC PATIENTS AND HEPATOTOSSICITY BY LEVOFLOXACINE

Important review that evaluating the different data present in the literature, identifies diabetic patients subjected to insulin treatment, as a class more susceptible to the side effects of Levofloxacin and in particular to hepatotoxicity.

Method of use and dosage

TAVANIC ®

Levofloxacin 250 - 500 mg coated tablets.

Levofloxacin dosage should be defined by the competent doctor based on the patient's physiopathological conditions, the severity of the clinical picture and the therapeutic goals.

Generally the dosages should be between 250 mg and 1000 mg of Levofloxacin a day, which can be taken in two doses, taking care to prolong the therapy at least 48 hours after the symptoms disappear.

Warnings TAVANIC ® Levofloxacin

Although the use of TAVANIC ® is generally safe and well tolerated, the proscription physician and the patient should pay close attention to the administration of Levofloxacin, in order to avoid unpleasant side effects.

For this reason it would be appropriate for patients suffering from kidney disease, patients suffering from glucose 6 phosphate dehydrogenase enzyme deficiency, patients suffering from epilepsy and patients in the growth phase, to take great care with the use of TAVANIC ® in order to respectively reduce the risk of increased persistence of the circulating drug, haemolytic crises, convulsive crises and highly debilitating tendon pathologies.

It is also useful to remember how Fluoroquinolones can induce:

photosensitivity, thus increasing the risk of erythema and skin rash when exposed to ultraviolet radiation;
diarrhea and gastro-enteric diseases with overlapping Clostridium difficile infections following prolonged therapies.

PREGNANCY AND BREASTFEEDING

The absence of studies able to clarify the safety profile of Levofloxacin for the exposed fetus and its ability to concentrate in breast milk in therapeutic doses, extend the aforementioned contraindications to the use of TAVANIC ® also to pregnancy and the subsequent period breastfeeding.

Interactions

Patients on TAVANIC ® therapy should pay particular attention to the simultaneous intake of:

Foods, supplements and drugs containing divalent metals, given the ability to form chelating complexes, responsible for reducing the therapeutic efficacy of the antibiotic;
Tiazanidine, methotrexate, theophylline, xanthine and phenytoin due to the altered tubular secretion induced by Fluoroquinolone and the consequent strengthening of biological and collateral effects;
Oral anticoagulants, due to the increased anticoagulant activity induced by the antibiotic.

Contraindications TAVANIC ® Levofloxacin

TAVANIC ® is contraindicated in patients who are hypersensitive to the active substance or to one of its excipients, in patients who are developing, to patients with severe kidney disease or seizures.

Undesirable effects - Side effects

Different clinical trials and common clinical practice demonstrate the onset of nausea, diarrhea, vomiting, abdominal pain and in severe cases pseudomembranous colitis, hypertransaminasemia and impaired renal function, headache, irritability, convulsions and epileptogenic risk, and only rarely, tendinitis and arthralgias, especially during growth phases in patients receiving fluoroquinolones.

Fortunately, the symptoms regress spontaneously once the therapy is suspended.