Tavanic, 500 mg 5 pcs

Pharmacotherapeutic group: antimicrobial agent, fluoroquinolone.

The ATX classification code is J01MA12.

Pharmacological action

Pharmacodynamics

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

Levofloxacin blocks DNA gyrase (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.

Levofloxacin is active against most strains of microorganisms under both in vitro and in vivo conditions.

In vitro:

Sensitive microorganisms (MAC ≤2 mg/mL)

Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I) [methicillin-sensitive (methicillin-moderately sensitive)] , Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp (CNS), Staphylococcus spp (CNS), Streptococci groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R (penicillin-sensitive/ moderately sensitive/resistant), Streptococcus pyogenes, Viridans streptococci peni-S/Rbr>
Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R (ampicillin-sensitive/resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis β+/β-, Morganella morganii, Neisseria gonorrhoeae pop PPNG/PPNG, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp, Pseudomonas aeruginosa, Pseudomonas spp, Salmonella spp, Serratia marcescens, Serratia spp.

Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp, Clostridium perfringens, Fusobacterium spp, Peptostreptococcus, Propionibacterum spp, Veilonella spp.

Other microorganisms: Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp, Mycobacterium spp, Mycobacterium leprae, Micobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp, Ureaplasma urealyticum.

Levofloxacin is moderately active (MPC >4 mg/L):

Aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant), Staphylococcus haemolyticus methi-R

Aerobic gram negative microorganisms: Burkholderia cepacia, Campilobacter jejuni/coli

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovaius, Prevotella spp, Porphyromonas spp.

Levofoloxacin resistant (MPC >8 mg/L):

Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R, Staphylococcus coagulase-negative methi-R

Aerobic gram negative microorganisms: Alcaligenes xylosoxidans

Other microorganisms: Mycobacterium avium.

Pharmacokinetics

Levofloxacin is quickly and almost completely absorbed after oral administration. Food intake has little effect on the speed and completeness of absorption. The bioavailability of 500 mg of levofloxacin after oral administration is almost 100%. After a single dose of 500 mg of levofloxacin the maximum concentration is 5.2-6.9 mcg/ml, the maximum time is 1.3 h, the elimination half-life is 6-8 h.

The binding to plasma proteins is 30-40%. It penetrates into organs and tissues: lungs, mucous membrane of bronchi, sputum, urogenital organs, bone tissue, cerebrospinal fluid, prostate, polymorphonuclear leukocytes, alveolar macrophages.

In the liver a small part is oxidized and/or deacetylated. It is excreted from the body mainly by the kidneys by glomerular filtration and tubular secretion. After oral administration, approximately 87% of the administered dose is excreted unchanged in the urine within 48 hours. Less than 4% is detected in the feces over a period of 72 hours.

Indications

Active ingredient

Composition

1 tablet contains:

The active ingredient:

levofloxacin 500 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

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.

Interaction

Special Instructions

Contraindications

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.

Similarities