Tavanik

  • Jun 03, 2018

tavanic analogues:

tavanic instruction:

Manufacturer:

"Aventis Pharma Deutschland GmbH" "Aventis Pharma" companies, Germany / France

Active substance Tavanica

  • Levofloxacin;
  • Excipients: methyl hydroxypropylcellulose, crospovidone, microcrystalline cellulose, sodium stearyl fumarate, macrogol 8000, talc, iron oxide red( E 172), iron oxide yellow( E 172), titanium dioxide( E 171).

Forms of release Tavanika

  • Tablets coated with 250 mg, 500 mg No. 3, No. 5, No. 10
  • Solution for infusion, 500 mg / 100 ml of 100 ml in bottles No. 1.

To whom Tavanik

is indicated In adults withinfections of mild or moderate severity Tablets Tavanic is prescribed for the treatment of the following infections caused by levofloxacin-sensitive microorganisms:

acute sinusitis, exacerbations of chronic bronchiti

s, pneumonia, complicated and uncomplicated urinary tract infections( including pyelonephritis), skin and soft tissue infectionsit septicemia / bacteremia, intra-abdominal infections.

How to use Tavanik

How to use and dose.

Tablets

Tavanik tablets are taken once or twice a day. The dose depends on the type and severity of the infection. The duration of treatment depends on the course of the disease and is no more than 14 days. It is recommended to continue treatment with Tavanik( solution for intravenous administration or tablets) for at least 48-72 hours after normalization of body temperature or confirmed by microbiological tests of the destruction of pathogens.

Tablets Tavanik should be swallowed without chewing, squeezed with enough liquid. For the convenience of dispensing, the tablet can be separated by a dash for separation. You can take them both with food, and at other times.

For dosing, the following recommendations should be adhered to in adult patients with normal renal function who have a creatinine clearance above 50 mL / minute:

Indications Daily dose Number of doses per day Duration of treatment
Acute sinusitis 500 mg 1 time 10-14 days
Exacerbation of chronic bronchitis 250 - 500 mg 1 time 7-10 days
Non-hospitalized pneumonia 500 - 1000 mg 1-2 times 7-14 days
Uncomplicated urinary infectionsExtensive tract 250 mg 1 time 3 days
Complicated urinary tract infections inclusive with pyelonephritis 250 mg 1 time 7-10 days
Skin and soft tissue infections 500 -1000 mg 1-2 times 7-14days
Septicemia / Bacteremia 500 -1000 mg 1-2 times 10-14 days
Intra-abdominal infections * 500 mg 1 time 7-14 days

* In combination with antibiotics with action on anaerobic pathogens

Dosage for patientswith impaired renal function in which cl. Rense creatinine less than 50 ml / minute:

Creatinine clearance Dosing regimen( depending on severity of infection)
50-20 mL / min first dose: 250 mg
is as follows: 125 mg / 24 hours
first dose: 500 mg
is the following: 250 mg / 24 hours
firstdose: 500 mg
the following: 250 mg / 12 hours
19-10 ml / min the first dose: 250 mg
the following: 125 mg / 48 hours
first dose: 500 mg
the following: 125 mg / 24 hours
the first dose: 500 mg of
are as follows: 125 mg / 12 hours of
& lt;10 ml / min,( as well as hemodialysis and HADAP 1) first dose: 250 mg the following: 125 mg / 48 hours first dose: 500 mg the following: 125 mg / 24 hours first dose: 500 mg the following: 125 mg/ 24 hours

1 - No additional doses are required after hemodialysis or chronic outpatient peritoneal dialysis( HAID).

Dosage for patients with impaired liver function. Correction of the dose is not needed, since levofloxacin is metabolized to a small extent in the liver.

Dosage for patients of advanced years. If the renal function is not impaired, there is no need for dose adjustment.

Solution for infusion

Tavanik for intravenous administration should be used immediately( within 3 hours) after perforation of the rubber plug. Protection from light during infusion is not needed.

With room lighting, the I / O solution can be stored for a maximum of 3 days without protection from light.

Given the biological equivalence of oral and parenteral forms, the same dosing is possible.

Dosage depends on the type and severity of the infection.

For adults with normal renal function in which creatinine clearance is greater than 50 mL / minute, the following doses of the drug are usually recommended:

Indications Daily dose of Number of administrations per day Duration of treatment
Non-hospital pneumonia 500 -1000 mg 1-2 times 7-14 days
Complications of the urinary tract inclusive with pyelonephritis 250 mg * 1 time 7-10 days
Prostatitis 500 mg ** 1 time 28 days
Skin and soft tissue infections 500 -1000 mg 1-2 times 7-14 days
Septicemia / bacteremia 500 -1000 mg 1-2 times 10-14 days
Intra-abdominal infections *** 500 mg 1 time 7-14days

* Consider the advisability of increasing the dose in cases of severe infection( this reference only applies to solutions for infusions).

** According to the patient's condition after a few days, the transition from the initial intravenous administration to oral administration with the same dosing is possible.

*** In combination with antibiotics with action on anaerobic pathogens.

Because levofloxacin is excreted primarily through the kidneys, the dose should be reduced for patients with impaired renal function.

Dosage for adult patients with impaired renal function who have a creatinine clearance less than 50 mL / min:

Creatinine clearance
Dosing regimen( depending on the severity of the infection)
50-20 mL / min first dose: 250 mg
is as follows: 125 mg / 24 hours
first dose: 500 mg
is the following: 250 mg / 24 hours
firstdose: 500 mg
the following: 250 mg / 12 hours
19-10 ml / min the first dose: 250 mg
the following: 125 mg / 48 hours
the first dose: 500 mg
the following: 125 mg / 24 hours
the first dose: 500 mg are as follows: 125 mg / 12 hours
& lt;10 ml / min( also for hemodialysis and HADAP 1) first dose: 250 mg
is as follows: 125 mg / 48 hours
first dose: 500 mg
is the following: 125 mg / 24 hours
first dose: 500 mg
following:: 125 mg / 24 hours

No additional doses are necessary after hemodialysis or chronic outpatient peritoneal dialysis( HAID).

Dosage for patients with impaired liver function. Correction of the dose is not needed, since levofloxacin is metabolized by a minor measure in the liver.

Dosage for patients of advanced years. If the renal function is not impaired, there is no need for dose adjustment.

Solution for iv administration Tavanik is administered slowly, intravenously, by dropwise infusion. The duration of administration of one Tavanik bottle( 100 ml of the solution for IV administration with 500 mg of levofloxacin) should be at least 60 minutes.

According to the patient's condition after a few days, it is possible to switch from intravenous administration to oral administration with the same dosage.

The duration of treatment depends on the course of the disease and is no more than 14 days.

As with other antibacterial agents, it is recommended to continue treatment with Tananik for at least 48-72 hours after the normalization of body temperature or the destruction of pathogens confirmed by microbiological tests.

Application features.

Because of the lack of research on humans and the possible damage to the articular cartilage in quinolones in the body that grows, Tavanic can not be administered to pregnant women and women who are breastfeeding. If pregnancy is established during treatment with Tavanik, tell the doctor about it.

Children and adolescents under the age of 18 can not use Tavanic because damage to articular cartilage is not excluded.

In elderly patients, frequent impairment of renal function should be considered.

Patients who drive vehicles, work with machines and mechanisms should take into account possible undesirable actions with regard to the nervous system( dizziness, swelling, drowsiness, confusion, visual and hearing disorders, movement disorders, including walking).

Side effects of Tavanic

The undesirable effects associated with the use of Tavanic are given below.

Skin reactions and general hypersensitivity reactions.

  • In some cases: itching and redness of the skin.
  • Rarely: general reactions of hypersensitivity( anaphylactic and anaphylactoid) with signs such as urticaria, bronchospasm and possibly heavy breathing, and very rarely - swelling of the skin and mucous membranes( eg, facial skin and pharyngeal mucosa).
  • Very rare: sudden drop in blood pressure and shock;prolongation of QT-interval, increased sensitivity to solar and ultraviolet rays.
  • Single cases: severe rashes on the skin and mucous membranes with the formation of blisters, such as Stevens-Johnson syndrome, toxic epidermal necrolysis( Lyell's syndrome) and exudative erythema multiforme. General reactions of hypersensitivity can sometimes be preceded by lighter reactions from the skin.

Such reactions may appear after the first dose and within a few minutes or hours after administration.

Gastrointestinal tract / metabolism.

  • Often: nausea, vomiting.
  • In some cases: lack of appetite, vomiting, abdominal pain, digestive disorders.
  • Rarely: bloody transfusion, which can sometimes be a sign of inflammation of the intestine, including pseudomembranous colitis.
  • Very rare: a decrease in the content of sugar in the blood( hypoglycemia), which has, perhaps, a special significance for diabetics. Signs of hypoglycemia can be: increased appetite, nervousness, sweating, trembling of the limbs.

Concerning other quinolones, it is known that they may be capable of causing porphyria attacks in patients with porphyria. This can also apply to Tavanik.

Action on the nervous system.

  • In single cases: headache, dizziness / swelling, drowsiness, sleep disorders.
  • Rarely: unpleasant sensations, eg, paresthesia in the hands, trembling, anxiety, anxiety, convulsive seizures and confusion.
  • Very rare: visual and hearing disorders, taste and smell disturbances, reduced sensation of touch, and psychotic reactions such as hallucinations and depressive mood changes. Disorders of the movement processes, also during walking.

Action on the heart and circulation.

  • Rarely: tachycardia, lowering blood pressure.
  • Very rare: collapse, similar to shock.

Action on muscles, tendons and bones.

  • Rarely: tendon damage, including inflammation, joint or muscle pain.
  • Very rare: tendon rupture( eg, rupture of the Achilles tendon).This side effect can occur within 48 hours from the start of treatment and hit the Achilles tendons of both legs. There may be a muscle weakness, which may be of particular importance for patients with severe myasthenia gravis.
  • Single cases: musculature injury( rhabdomyolysis).

Action on the liver and kidneys.

  • Often: elevated liver enzymes( eg, ALT, AST).
  • In some cases: increased serum bilirubin and serum creatinine levels.
  • Very rarely: hepatic reactions, such as liver inflammation. Impairment of kidney function, up to acute renal failure, for example, as a result of allergic reactions( interstitial nephritis).

Action on the blood.

  • In some cases: an increase in the number of certain blood cells( eosinophilia), a decrease in the number of leukocytes( leukopenia).
  • Rarely: a decrease in the number of certain leukocytes( neutropenia), a decrease in the number of platelets( thrombocytopenia), which can cause an increased tendency to bleed or bleed.
  • Very rarely: a significant reduction in the number of certain leukocytes( agranulocytosis), which can lead to severe symptoms of the disease( prolonged or recurrent fever, pharyngitis, severe pain).
  • Single cases: decrease in the number of erythrocytes as a result of their destruction( hemolytic anemia).Reduced number of all types of blood cells( pancytopenia).

Other side effects.

  • In some cases: general weakness( asthenia).
  • Very rarely: fever, allergic reactions from the lungs( allergic pneumonitis) or small blood vessels( vasculitis).The use of any antibacterial agents can lead to violations associated with their influence on the normal microflora of the human body. For this reason, a secondary infection may develop which will require additional treatment.

To whom is contraindicated Tavanik

Hypersensitivity to levofloxacin or other quinolones, epilepsy, patients with complaints of adverse reactions from the tendons after the previous use of quinolones, children and adolescents under the age of 18, pregnancy, lactation.

Interaction of Tavanic

The adsorption of levofloxacin is significantly reduced when taken concomitantly with an antacid that contains magnesium and aluminum, as well as with preparations that contain iron salts.

The recommended time between taking Tavanic and the named drugs should be at least two hours. Bioavailability of Tavanic tablets is significantly reduced when taken concomitantly with sucralfate. The interval between taking these drugs should be at least two hours. Although the clinical studies have not established the interaction between levofloxacin and theophylline, it is possible to significantly reduce the convulsive threshold with simultaneous use of quinolones with theophylline, nonsteroidal anti-inflammatory drugs and other agents that reduce the convulsive threshold.

The concentration of levofloxacin in the presence of fenbufen was approximately 13% higher than with levofloxacin alone. Probenecid and cimetidine statistically significantly affect the excretion of levofloxacin. The renal clearance of levofloxacin decreases in the presence of probenecid by 34%, and of cimetidine by 24%.Due to this, both drugs are able to block tubular excretion of levofloxacin. The half-life of cyclosporine is increased by 33% with simultaneous administration with levofloxacin.

When co-administered with vitamin K antagonists, for example-warfarin, coagulation tests( IF / international normalization ratio) and / or bleeding that can be pronounced are increased. Taking this into account, patients who receive concurrent antagonists of vitamin K should monitor coagulation rates.

It is not recommended to use levofloxacin concomitantly with alcohol.

Tavanic overdose

The most important predictable symptoms of an overdose of Tavanic drug concern the central nervous system( confusion, dizziness, impaired consciousness and convulsive attacks);

reactions from the gastrointestinal system, such as nausea and erosion of the mucous membranes. According to the results of the studies, when applying doses higher than therapeutic, an extension of the QT interval was observed. In cases of overdose, careful monitoring of the patient, including ECG, is necessary. Treatment is symptomatic. In cases of an obvious overdose, gastric lavage is prescribed. Antacids are used to protect the gastric mucosa.

Hemodialysis, including peritoneal dialysis or TAPD, is not effective for removing levofloxacin from the body. There are no specific antidotes.