Tavanic Tablets

/ Sanofi

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.
Tavanic 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.
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.
Elderly population: No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function.
Paediatric population: Tavanic is contraindicated in children and growing adolescents.
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, zinc salts, magnesium- or aluminium-containing antacids, or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents), and sucralfate administration, since reduction of absorption can occur.

Mild to moderate infections including acute sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, complicated urinary tract infections including pyelonephritis, skin and soft tissue infections.

Hypersensitivity to any of the components, epilepsy, fluoroquinolone related tendon disorders, pregnancy, lactation, children or growing adolescents under 18 years old.

In the most severe cases of pneumococal pneumonia, Tavanic may not be the optimal therapy. Nosocomial infections due to P. aeruginosa may require combination therapy. Infusion time of at least 60 minutes should be observed. If pseudomembranous colitis is suspected, Tavanic tablets must be stopped immediately and patients should be treated with supportive measures. Tendinitis, patients with a history of epilepsy, patients with G-6-phosphate dehydrogenase deficiency. The dose should be adjusted in patients with renal impairment. Patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays.

Pruritus, rash, nausea, diarrhea, anorexia, vomiting, abdominal pain, dyspepsia, headache, dizziness/vertigo, drowsiness, insomnia, increased liver enzyme levels (e.g. ALT, AST), increase in bilirubin, increase in serum creatinine, pain, reddening of the infusion site and phlebitis, acute confusional states and depressive mood changes, extrapyramidal symptoms, attacks of porphyria in patients with porphyria.
See prescribing information for full details.

Quinolone antibacterial agents. iron salts, magnesium- or aluminum-containing antacids should be taken 2 hours before administration. Sucrafalt should be administered 2 hours after Tavanic. Theophylline, fenbufen or similar NSAIDs. Probenecid, cimetidine, cyclosporin, vitamin K antagonist.

Pregnancy: There is limited data on the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. However 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 pregnant women.
Breast -feeding: Tavanic 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 pregnant women.

According to toxicity studies in animals or clinical pharmacology studies performed with supratherapeutic doses, the most important signs to be expected following acute overdose of Tavanic 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.
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. Antacids may be used for protection of gastric mucosa. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in
removing levofloxacin from the body. No specific antidote exists.