Tavanic, 500 mg 5 pcs

How to take, the dosage

Tavanic tablets 250 mg or 500 mg are taken orally once or twice a day. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. It is necessary to adhere strictly to the instructions for use, because otherwise Tavanic may cause inadequate effect. Patients with normal or moderately reduced renal function (creatinine clearance > 50 ml/min.

• Sinusitis (inflammation of the sinuses): 2 tablets of Tavanic 250 mg or 1 tablet of Tavanic 500 mg once daily (500 mg of levofloxacin respectively) – 10-14 days
• acute exacerbation of chronic bronchitis: 1 tablet of Tavanic 250 mg once daily (respectively 250 mg of levofloxacin) or 2 tablets of Tavanic 250 mg or 1 tablet of Tavanic 500 mg once daily (respectively 500 mg of levofloxacin) – 7-10 days;
• inpatient pneumonia: 2 tablets of Tavanic 250 mg or 1 tablet of Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg of levofloxacin) – 7-14 days;
• uncomplicated urinary tract infections: 1 tablet Tavanic 250 mg once daily (respectively 250 mg levofloxacin) -3 days;
• prostatitis: 2 tablets Tavanic 250 mg or 1 tablet Tavanic 500 mg – once daily (respectively 500 mg levofloxacin) 28 days.
• complicated urinary tract infections, including pyelonephritis: 1 tablet of Tavanic 250 mg once daily (respectively 250 mg of levofloxacin) for 7-10 days;
• infections of skin and soft tissue: 1 tablet Tavanic 250 mg once daily (respectively 250 mg levofloxacin) or 2 tablets Tavanic 250 mg or 1 tablet Tavanic 500 mg 1-2 times daily (respectively 500-1000 mg levofloxacin) 7-14 days;
• senticemia/bacteremia: 2 tablets of Tavanic 250 mg or 1 tablet of Tavanic 500 mg 1-2 times daily (respectively 500-1000 mg of levofloxacin) for 10-14 days;
• intra-abdominal infection: 2 tablets of Tavanic 250 mg or 1 tablet of Tavanic 500 mg once daily (500 mg of levofloxacin, respectively) for 7-14 days (in combination with antibacterials acting on anaerobic flora);
• comprehensive treatment of drug-resistant forms of tuberculosis: 1-2 tablets Tavanic 500 mg 1-2 times a day (respectively 500-1000 mg of levofloxacin) for up to 3 months;

Levofloxacin is excreted mainly through the kidneys, so when treating patients with impaired renal function, a lower dose of the drug is required. Relevant information on this matter is contained in the following table.

Interaction

There are reports of a marked decrease in seizure threshold when using quinolones concomitantly with substances that can in turn lower the cerebral seizure threshold. This also applies to the simultaneous use of quinolones and theophylline, phenbufen or similar non-steroidal anti-inflammatory drugs (agents for treatment of rheumatic diseases).

The effect of Tavanic is weakened by concomitant use of sucralfate (gastric mucosal protection agent). The same happens when using simultaneously magnesium- or aluminum-containing antacids (drugs for heartburn and gastralgia), as well as iron salts (drugs for anemia). Tavanic should be taken at least 2 hours before or 2 hours after taking these drugs. No interaction has been shown with calcium carbonate. Administration of glucocorticosteroids increases the risk of tendon rupture.

With simultaneous use of vitamin K antagonists it is necessary to monitor the blood clotting system.

Levofloxacin excretion (renal clearance) is slightly delayed under the influence of cimetidine and probenicid. It should be noted that this interaction has almost no clinical significance. Nevertheless, when concomitant use of drugs such as probenicidin and cimetidine that block a particular excretion pathway (tubule secretion), treatment with levofloxacin should be performed with caution. This applies primarily to patients with limited renal function.

Levofloxacin slightly increases the half-life of cyclosporine.

Taking glucocorticosteroids increases the risk of tendon rupture.

Special Instructions

Tavanic should not be used in children and adolescents because of the possibility of joint cartilage damage.

When treating elderly patients it should be borne in mind that patients in this group often have impaired renal function (see section “Dosage and administration”)

In very severe pneumococcal pneumonia, Tavanic may not provide optimal therapeutic effect. Hospital infections caused by certain pathogens (P. aeruginosa) may require combined treatment.

During treatment with Tavanic, seizures may develop in patients with prior brain damage due to, for example, stroke or severe trauma. Seizure readiness may also increase with concomitant use of phenbufen, similar non-steroidal anti-inflammatory drugs or theophylline (see “Interaction”).

Although photosensitization is rare during levofloxacin administration, in order to avoid photosensitization patients should not be exposed to strong sunlight or artificial ultraviolet radiation without a specific need (such as sun exposure in high altitude areas or solarium).

If pseudomembranous colitis is suspected, Tavanic should be stopped immediately and appropriate treatment started. Do not use intestinal motility depressant drugs in such cases.

Tendinitis rarely observed with the use of Tavanic (primarily inflammation of Achilles tendon) can lead to tendon rupture. Older patients are more prone to tendinitis. Treatment with corticosteroids (“cortisone drugs”) likely increases the risk of tendon rupture. If tendinitis is suspected, treatment with Tavanic should be stopped immediately and appropriate treatment of the affected tendon should be initiated, e.g. resting state (see “Contraindications” and “Side Effects”).

Patients with glucose-6-phosphate dehydrogenase deficiency (inherited metabolic disorder) may respond to fluoroquinolones by destruction of red blood cells (hemolysis). Therefore, treatment of such patients with levofloxacin should be performed with great caution.

Such side effects of the drug Tavanic as dizziness or stupor, somnolence and visual disturbances (see also section “Side effects”) may impair the ability to react and concentrate. This may represent a certain risk in situations in which these abilities are particularly important (e.g., when driving a car, operating machines and mechanisms, working in unsteady positions). This is especially true if the drug interacts with alcohol.

Contraindications

• hypersensitivity to levofloxacin or other quinolones;
• Epilepsy;
• tendon lesions in previous treatment with quinolones;
• childhood and adolescence (under 18 years);
• pregnancy;
• lactation period.

The drug should be used with caution in elderly patients because of high possibility of concomitant reduction of renal function (deficiency of glucose-6-phosphate dehydrogenase).

Side effects

Heart: rare – sinus tachycardia, palpitations; unknown frequency (post-marketing data) – prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia type “pirouette”, which may lead to cardiac arrest (see “Overdose”, “Cautions”).

Blood and lymphatic system disorders: infrequent – leukopenia (decreased number of leukocytes in peripheral blood), eosinophilia (increased number of eosinophils in peripheral blood); rare – neutropenia (decreased number of neutrophils in peripheral blood), thrombocytopenia (decreased number of platelets in peripheral blood); unknown frequency (post-marketing data) – pancytopenia (decrease of all formular elements in peripheral blood), agranulocytosis (absence or dramatic decrease of granulocytes in peripheral blood), hemolytic anemia.

Nervous system: frequently – headache, dizziness; infrequently – somnolence, tremor, dysgeusia (perversion of taste); rarely – paresthesia, seizures (see “Particular indications”); unknown frequency (post-marketing data) – peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see “Special indications”). “Special Indications”), dyskinesia, extrapyramidal disorders, agueusia (loss of taste sensation), parosmia (disorder of smell sensation, especially subjective sense of smell objectively absent), including loss of smell, syncope, benign intracranial hypertension.

Visual organ disorders: very rare – visual disturbances such as blurred vision; unknown frequency – transient loss of vision.

Hearing organ and labyrinth disorders: infrequent – vertigo (feeling of deviation or spinning or own body or surrounding objects); rare – ringing in the ears; unknown frequency (postmarketing data) – hearing loss, hearing loss.

Respiratory system, thoracic and mediastinal organs: infrequent – dyspnea; unknown frequency (postmarketing data) – bronchospasm, allergic pneumonitis.

Gastrointestinal disorders: common – diarrhea, vomiting, nausea; infrequent – abdominal pain, dyspepsia, flatulence, constipation; unknown frequency (postmarketing data) – hemorrhagic diarrhea which in very rare cases may be a sign of enterocolitis, including pseudomembranous colitis (see “Special Indications”), pancreatitis.

Renal and urinary tract disorders: infrequent – increase of serum creatinine concentration; rare – acute renal failure (e.g., due to development of interstitial nephritis).

Skin and subcutaneous tissue: infrequent – rash, pruritus, urticaria, hyperhidrosis; unknown frequency (post-marketing data) – toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme exudative, photosensitization reactions (hypersensitivity to the sun and UV radiation) (see “Indications”). “Special indications”), leukocytoclastic vasculitis, stomatitis. Skin and mucous membrane reactions may sometimes develop even after the first dose of the drug.

Skeletal-muscular system and connective tissue disorders: infrequent – arthralgia, myalgia; rare – tendon disorders including tendinitis (e.g. Achilles tendon), muscle weakness which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (see “Special information”). (see “Special Indications”); unknown frequency (post-marketing data): rhabdomyolysis, tendon rupture (e.g. Achilles tendon). This side effect may occur within 48 hours after the start of treatment and may be bilateral (see also section “Special Precautions”), ligament tears, muscle tears, arthritis.

Metabolism and nutrition: infrequent – anorexia; rare – hypoglycemia, especially in patients with diabetes (possible signs of hypoglycemia: “wolf” appetite, nervousness, sweating, trembling); unknown frequency – hyperglycemia, hypoglycemic coma (see “Special Instructions”).

Infectious and parasitic diseases: infrequent – fungal infections, development of resistance of pathogens.

Vascular disorders: rarely – decreased BP.

General disorders: infrequent – asthenia; rare – pyrexia (increase in body temperature); unknown frequency – pain (including pain in the back, chest and extremities).

The immune system: rare – angioedema; unknown frequency (post-marketing data) – anaphylactic shock, anaphylactoid shock.

Anaphylactic and anaphylactoid reactions may sometimes develop even after the first dose of the drug.

Liver and biliary tract disorders: frequent – increased activity of “liver” enzymes in blood (e.g., ALT, AST), increased activity of alkaline phosphate and GGT; infrequent – increased concentration of bilirubin in blood; unknown frequency (postmarketing data) – severe liver failure, including cases of acute liver failure, sometimes with fatal outcome, especially in patients with severe underlying disease (e.g., in patients with sepsis) (see “Special Indications), hepatitis, jaundice.

Psychiatric disorders: frequent – insomnia; infrequent – anxiety, anxiety, confusion; rare – mental disorders (e.g. hallucinations, paranoia), depression, agitation (agitation), sleep disorders, nightmares; unknown frequency (post-marketing data) – mental disorders with behavior disorders with self-harm, including suicidal thoughts and suicide attempts.

Other possible adverse effects relevant to all fluoroquinolones: very rare – attacks of porphyria (a very rare metabolic disease) in patients already suffering from this disease.

Overdose

Symptoms: Based on data from animal toxicology studies, the most important expected symptoms of acute overdose of Tavanic® are CNS symptoms (disturbances of consciousness including confusion, dizziness and seizures).

In post-marketing use of the drug, CNS effects including confusion, seizures, hallucinations and tremors have been observed in overdose.

Possible nausea and gastrointestinal mucosal erosions.

In clinical and pharmacological studies conducted with doses of levofloxacin greater than therapeutic, prolongation of the QT interval has been shown.

Treatment: in case of overdose, close monitoring of the patient is required, including ECG monitoring. Treatment is symptomatic. In case of acute overdose of Tavanic® tablets gastric lavage and administration of antacids for protection of gastric mucosa are indicated.

Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis and continuous ambulatory peritoneal dialysis). There is no specific antidote.

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Similarities

Signicef, Tavanic, Oftavix, Flexid, Levolet R, Levofloxacin-Teva, Glevo, Haileflox, Leflobakt, L-Optik Rompharm, Levofloxacin, Korfecin