Tavanic, 250 mg 10 pcs

Tavanic is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing levofloxacin, the left-handed isomer ofofloxacin, as an active substance.

Levofloxacin blocks DNA-enzyme (topoisomerase II) and topoisomerase IV, disrupts superspiralization and cross-linking of DNA breaks, inhibits DNA synthesis and causes deep morphological changes in cytoplasm, cell wall and membranes of microbial cells.

Indications

Active ingredient

Composition

1 tablet contains:

Active substance:

levofloxacin 250 mg;

Associates:

crospovidone;

methylhydroxypropylcellulose;

MCC;

sodium stearyl fumarate;

MacroGol 8000;

T talc;

Titanium dioxide (E171);

Red iron oxide (E172);

Yellow iron oxide (E172).

How to take, the dosage

The drug is taken orally at 250-500 mg 1-2 times a day. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

The tablets are taken orally, without chewing and with plenty of fluid (0.5 to 1 cup), before meals or at any time between meals.

Strict adherence to the instructions for use is necessary because otherwise Tavanic may cause inadequate effects.

Interaction

Weaken the effect by reducing gastrointestinal absorption and systemic concentration: sucralfate, magnesium- and aluminum-containing antacids, iron salts, zinc-containing multivitamins, didanosine, therefore it is necessary to observe an interval of at least 2 hours between the administration of these drugs and levofloxacin.

If Tavanic and theophylline are used simultaneously it is necessary to monitor closely theophylline level and adjust the dose accordingly.

Close monitoring of MHO, prothrombin time and other coagulation parameters, monitoring of possible bleeding signs in concurrent use of Tavanic and warfarin is necessary.

NSAIDs may increase the risk of CNS stimulation and seizures.

Special Instructions

It is recommended to continue taking Tavanic at least 48-78 hours after body temperature normalization or after reliable elimination of the pathogen.

Patients should not be exposed to strong sunlight or artificial ultraviolet radiation to avoid photosensitization.

Close monitoring of blood glucose levels is recommended in diabetic patients receiving oral hypoglycemic agents or insulin.

If pseudomembranous colitis is suspected, the drug should be immediately withdrawn and appropriate treatment should be initiated without the use of drugs that inhibit intestinal motility.

If tendinitis is suspected, the drug Tavanic should be immediately withdrawn and appropriate treatment initiated.

During the treatment it is necessary to refrain from driving motor transport and engaging in potentially dangerous activities that require high concentration and quick psychomotor reactions.

Contraindications

Epilepsy, hypersensitivity to Tavanic

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 blurring of the visible image; 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 Indications”).

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 (post-marketing data) – severe liver failure, including cases of acute liver failure, sometimes with fatal outcome, especially in patients with severe underlying disease (e.g., 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.

Pregnancy use

Tavanic is contraindicated in children under 14 years of age, as well as during pregnancy and lactation

Similarities