Composition
1 tablet contains:
Active ingredient:
levofloxacin 500 mg;
Auxiliary substances:
crospovidone;
methylhydroxypropylcellulose;
MCC;
sodium stearyl fumarate;
macrogol 8000;
talc;
titanium dioxide (E171);
iron oxide red (E172);
iron oxide yellow (E172).
Pharmacological action
Tavanic is a synthetic broad-spectrum antibacterial drug from the group of fluoroquinolones containing levofloxacin, the levorotatory isomer of ofloxacin, as the Active ingredient.
Levofloxacin blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and crosslinking of DNA breaks, inhibits DNA synthesis, and causes deep morphological changes in the cytoplasm, cell wall, and membranes of microbial cells.
Indications
- bronchitis, pneumonia
- otitis media, sinusitis, tonsillitis
- infections of the skin, soft tissues, urinary tract
- chronic prostatitis, gonorrhea.
Use during pregnancy and lactation
Tavanic is contraindicated in children under 14 years of age, as well as during pregnancy and lactation
Contraindications
Epilepsy, hypersensitivity to the drug Tavanic
Side effects
From the side of the heart: Â rarely-sinus tachycardia, palpitation sensation; unknown frequency (post-marketing data)Â – prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest (see “Overdose”, “Special instructions”).
Blood and lymphatic system disorders: Â infrequently-leukopenia (decrease in the number of white blood cells in the peripheral blood), eosinophilia (increase in the number of eosinophils in the peripheral blood); rarely-neutropenia (decrease in the number of neutrophils in the peripheral blood), thrombocytopenia (decrease in the number of platelets in the peripheral blood); unknown frequency (post-marketing data)Â – pancytopenia (a decrease in the number of all shaped elements in the peripheral blood), agranulocytosis (the absence or sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia.
Nervous system disorders:  often-headache, dizziness; infrequently-drowsiness, tremor, dysgeusia (perversion of taste); rarely-paresthesia, convulsions (see “Special instructions”); unknown frequency (post-marketing data) — peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see “Special instructions”), dyskinesia, extrapyramidal disorders, ageusia (loss of taste sensations), parosmia (smell sensation disorder, especially subjective smell sensation, objectively absent), including loss of smell, syncope, benign intracranial hypertension.
From the side of the visual organ:  very rarely-visual disturbances, such as blurring of the visible image; unknown frequency — transient loss of vision.
Hearing disorders and labyrinth disorders: Â infrequently-vertigo (feeling deflected or whirling, or one’s own body or surrounding objects); rarely-tinnitus; unknown frequency (post-marketing data)Â – hearing loss, hearing loss.
Respiratory, thoracic and mediastinal disorders:  infrequently — shortness of breath; unknown frequency (post-marketing data) – bronchospasm, allergic pneumonitis.
From the gastrointestinal tract:  often — diarrhea, vomiting, nausea; infrequently-abdominal pain, dyspepsia, flatulence, constipation; unknown frequency (post-marketing data) – hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see “Special instructions”), pancreatitis.
From the side of the kidneys and urinary tract: Â infrequently-increased serum creatinine; rarely-acute renal failure (for example, due to the development of interstitial nephritis).
Skin and subcutaneous tissue disorders: Â infrequently-rash, pruritus, urticaria, hyperhidrosis; unknown frequency (post-marketing data)Â – toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitization reactions (hypersensitivity to sunlight and UV radiation) (see “Special instructions”), leukocytoclastic vasculitis, stomatitis. Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.
Musculoskeletal and connective tissue disorders: Â infrequently-arthralgia, myalgia; rarely-tendon damage, including tendinitis (for example, Achilles tendon), muscle weakness, which can be particularly dangerous in patients with pseudoparalytic myasthenia gravis (see “Special instructions”); unknown frequency (post-marketing data): rhabdomyolysis, tendon rupture (for example, Achilles tendon). This side effect may occur within 48 hours after starting treatment and may be bilateral in nature( see also the section “Special instructions”), ligament rupture, muscle rupture, arthritis.
From the side of metabolism and nutrition:  infrequently — anorexia; rarely-hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: “wolfish” appetite, nervousness, perspiration, trembling); unknown frequency-hyperglycemia, hypoglycemic coma (see “Special instructions”).
Infectious and parasitic diseases: Â infrequently-fungal infections, development of resistance of pathogenic microorganisms.
From the side of blood vessels: Â rarely-a decrease in blood pressure.
Common disorders: Â infrequently-asthenia; rarely-pyrexia (fever); unknown frequency-pain (including pain in the back, chest and extremities).
From the immune system:  rarely-angioedema; unknown frequency (post-marketing data) — anaphylactic shock, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.
Liver and biliary tract disorders:  often — an increase in the activity of “liver” enzymes in the blood (for example, ALT, AST), an increase in the activity of alkaline phosphatase and GGT; infrequently-an increase in the concentration of bilirubin in the blood; unknown frequency (post-marketing data) – severe hepatic insufficiency, including cases of acute hepatic insufficiency, sometimes fatal, especially in patients with a severe underlying disease (for example, patients with sepsis) (see “Special instructions”), hepatitis, jaundice.
From the side of the psyche:  often — insomnia; infrequently-feelings of anxiety, anxiety, confusion; rarely-mental disorders (for example, hallucinations, paranoia), depression, agitation (agitation), sleep disorders, nightmares; unknown frequency (post-marketing data) – mental disorders with behavioral disorders involving self-harm, including suicidal thoughts and suicide attempts.
Other possible undesirable effects related to all fluoroquinolones:  very rarely — attacks of porphyria (a very rare metabolic disease) in patients who already suffer from this disease.
Interaction
Weaken the effect, reducing the absorption from the gastrointestinal tract and systemic concentration: sucralfate, magnesium-and aluminum-containing antacids, iron salts, zinc-containing multivitamins, didanosine, so it is necessary to observe the interval of at least 2 hours between taking these drugs and levofloxacin. When Tavanic is co-administered with theophylline, careful monitoring of theophylline levels and appropriate dose adjustment are necessary. Careful monitoring of MHO, prothrombin time, and other coagulation parameters, as well as monitoring for possible signs of bleeding, is necessary when Tavanic and warfarin are co-administered. NSAIDs may increase the risk of CNS stimulation and seizures.
How to take, course of use and 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.
Tablets should be taken orally, without chewing and with a sufficient amount of liquid (from 0.5 to 1 cup), before meals or at any time between meals.
 You should strictly follow the instructions for use, because otherwise Tavanic may cause an inadequate effect.
Overdose
Symptoms:  based on the data obtained in toxicological studies conducted in animals, the most important expected symptoms of an acute overdose of Tavanic® are symptoms from the central nervous system (impaired consciousness, including confusion, dizziness and convulsions).
CNS effects, including confusion, convulsions, hallucinations, and tremors, have been observed in post-marketing use of the drug in overdose.
It is possible to develop nausea and erosions of the gastrointestinal mucosa.
In clinical and pharmacological studies conducted with doses of levofloxacin exceeding therapeutic ones, prolongation of the QT interval was shown.
Treatment:  in case of overdose, careful monitoring of the patient is required, including ECG monitoring. Treatment is symptomatic. In case of acute overdose of Tavanic tablets gastric lavage and use of antacids to protect the gastric mucosa are indicated.
Levofloxacin is not eliminated by dialysis (hemodialysis, peritoneal dialysis, and permanent outpatient peritoneal dialysis). There is no specific antidote.
Special instructions
It is recommended to continue taking the drug Tavanic for at least 48-78 hours after normalization of body temperature or after reliable destruction of the pathogen. To avoid photosensitization, patients should not be exposed to strong solar or artificial ultraviolet radiation. Careful 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 discontinued immediately and appropriate treatment should be initiated, without using drugs that inhibit intestinal motility. If tendinitis is suspected, Tavanic should be discontinued immediately and appropriate treatment should be initiated. During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Tablets
Storage conditions
At a temperature not exceeding 25 °C
Shelf life
5 years
Active ingredient
Levofloxacin
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as directed by your doctor
Indications
Tuberculosis, Sinusitis, Bronchitis, Sinusitis, Prostatitis, Inflammation of the female genital organs, Pneumonia, Urinary tract infections, Infectious diseases, Skin Infections, Respiratory Tract infections
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Side effects of Tavanic, pills 500mg, 5pcs.
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