Levofloxacin-Teva, pills 500 mg 14 pcs.

Composition

Active ingredient:

levofloxacin (levofloxacin hemigadrate) 500.00 (512.46) mg;

Auxiliary substances:

silicon dioxide colloidal 12,00 mg

of hyprolose of 28.00 mg,

carboximetilkrahmal sodium,

a type of 55.00 mg,

talc 55,20 mg,

croscarmellose sodium 20,60 mg,

magnesium stearate of 6.74 mg,

sheath Opadry 15 26688 brown (hypromellose 2910 3 CP 4,760 mg, hypromellose 2910 6 MS 4,760 mg, titanium dioxide E 171 3,044 mg, macrogol-400 1,120 mg, Polysorbate-800,140 mg, dye iron oxide yellow E 172 0,120 mg, dye iron oxide red E 172 0.043 mg, dye iron oxide black E 172 0,013 mg).

Pharmacological action

Broad-spectrum antimicrobial agent, fluoroquinolone.

It acts bactericidal. It 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.

Active against Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus agalactiae, Viridans group streptococci, Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Klebsiella oxytoca, Legionella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Pseudomonas fluorescens, Chlamydia pneumoniae, Mycoplasma pneumoniae, Acinetobacter anitratus, Acinetobacter baumannii, Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter diversus, Citrobacter freundii, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providcncia stuartii, Serratia marcescens, Clostridium perfringens.

Pharmacokinetics

When taken orally, it is absorbed from the gastrointestinal tract quickly and almost completely. Food intake has little effect on the rate and completeness of absorption. Bioavailability is 99%. Cmax is reached after 1-2 hours and when taking 250 mg and 500 mg is 2.8 and 5.2 mcg / ml, respectively.

Binding to plasma proteins is 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, organs of the genitourinary system, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and / or deacetylated. Renal clearance is 70% of the total clearance.

T1 / 2 – 6-8 hours. It is excreted mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites.

In unchanged form,70% is excreted in the urine within 24 hours and 87% in 48 hours; 4% of the oral dose is detected in the feces within 72 hours. After an intravenous infusion of 500 mg for 60 minutes, the Cmax is 6.2 mcg / ml. With intravenous single and multiple administration, the apparent Vd after administration of the same dose is 89-112 l, Cmax – 6.2 mcg/ml, T1/2 – 6.4 h.

Indications

• bronchitis, pneumonia
• otitis media, sinusitis, tonsillitis
• infections of the skin, soft tissues, urinary tract
• chronic prostatitis, gonorrhea.

Contraindications

Epilepsy, hypersensitivity to Levofloxacin-Teva

Interaction

Absorption of levofloxacin is significantly reduced when used concomitantly with sucralfate, magnesium-or aluminum-containing antacids, as well as with iron salts (the interval between taking levofloxacin and these drugs should be at least 2 hours). No interactions were found with calcium carbonate.

Quinolones can enhance the ability of drugs (including theophylline) to lower the threshold of convulsive readiness. When co-administered with fenbufen, higher concentrations of levofloxacin (by 13%) were observed than with monotherapy.

Levofloxacin elimination is slowed by cimetidine (by 24%) and probenecid (by 34%).

Levofloxacin causes a slight increase in T1 / 2 cyclosporine.

Concomitant use with glucocorticosteroids (corticosteroids) increases the risk of tendon rupture. Concomitant administration of levofloxacin with oral anticoagulants increases the time of coagulation and / or bleeding.

Levofloxacin, when used concomitantly with Class IA and III antiarrhythmic drugs, tricyclic antidepressants, and macrolides, may cause prolongation of the QT interval.

How to take, course of administration and dosage

Levofloxacin-Teva is taken orally 1-2 times a day. The dose and duration of treatment are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. Tablets should be taken without chewing and washed down with a sufficient amount of liquid (from ½ to 1 cup). When selecting doses, tablets can be broken along the dividing groove into equal parts. The drug can be taken before meals or at any time between meals.

Treatment with Levofloxacin-Teva is recommended to continue for at least 48-72 hours after normalization of body temperature or after significant eradication of the pathogen.

Acute bacterial sinusitis: take 1 tablet (500 mg) once a day for 10-14 days.

Acute bronchitis and exacerbation of chronic bronchitis: 1/2-1 tablet (250-500 mg) once a day for 7-10 days.

Community-acquired pneumonia: take 1 tablet (500 mg) 1-2 times a day for 7-14 days.

Complicated infectious diseases of the kidneys and urinary tract, including pyelonephritis: take ½ tablet (250 mg) once a day for 7-10 days.

Chronic bacterial prostatitis: take 1 tablet (500 mg) once a day for 28 days.

Skin and soft tissue infections: take 1 tablet (500 mg) 1-2 times a day for 7-14 days. Patients with impaired liver function do not need to adjust the dosage regimen.

Patients with impaired renal function (creatinine clearance less than 50 ml/min) need to adjust the dosage regimen depending on the value of creatinine clearance.

Overdose

Symptoms: nausea, erosive lesions of the gastrointestinal mucosa, dizziness, blurred consciousness and seizures of the type of epileptic seizures.

Treatment: conduct symptomatic therapy, ECG monitoring. There is no specific antidote. Hemodialysis is not effective.

Special instructions

When using levofloxacin, cases of tendinitis have been observed, which mainly affects the Achilles tendon and can lead to its rupture. In elderly patients, as well as with concomitant use of corticosteroids, the likelihood of developing tendinitis and tendon rupture with levofloxacin increases. If tendinitis is suspected, levofloxacin should be discontinued immediately and appropriate treatment should be initiated, ensuring a state of rest in the affected area.

If pseudomembranous colitis is suspected (especially severe and/or bloody diarrhea), levofloxacin should be discontinued immediately and appropriate treatment should be initiated.

During treatment with levofloxacin, seizures may occur in patients with previous brain damage (including those with a stroke or severe brain injury).

When using quinolones in patients with glucose-6-phosphate dehydrogenase deficiency, hemolysis of red blood cells is possible.

If it is necessary to use levofloxacin in patients with diabetes mellitus, it is necessary to monitor the concentration of glucose in the blood. Sometimes, after taking the first dose of levofloxacin, severe, potentially dangerous hypersensitivity reactions (angioedema, anaphylactic shock) may develop.

Although photosensitization is very rare when levofloxacin is used, patients should avoid exposure to the sun or UV radiation to prevent its development.

With simultaneous use of levofloxacin and indirect anticoagulants, it is necessary to monitor the state of the blood coagulation system.

When taking fluoroquinolones, including levofloxacin, it is possible to develop psychotic reactions, which very rarely with progression can lead to suicidal thoughts and potentially dangerous behavior. With the development of such phenomena, the drug should be discontinued.

When using levofloxacin in patients who have predisposing factors to prolongation of the QT interval, it is necessary to conduct an electrocardiogram study before and during treatment with levofloxacin.

When taking fluoroquinolones, cases of sensory or sensorimotor peripheral neuropathy have been observed. Levofloxacin should be discontinued immediately to prevent the development of irreversible effects when symptoms of peripheral neuropathy develop.

 When taking levofloxacin, patients may have false positive test results for the presence of opiates in the urine. More specific methods should be used to confirm a positive test result.

There are reports of rare cases of liver failure during treatment with levofloxacin, primarily in patients with severe diseases such as sepsis. Levofloxacin should be discontinued if symptoms of impaired liver function occur, such as decreased appetite, jaundice, dark urine, pruritus, or sensitivity of the abdominal wall on palpation.

When prescribing the drug to elderly patients, it should be borne in mind that patients in this group often have impaired renal function.

Form of production

Film-coated tablets

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

of the tablet

Purpose

Adults as prescribed by a doctor

Indications

Boils, Skin infections, Bronchitis, Pneumonia, Urinary tract infections, Sinusitis, Otitis media, Sinusitis, Inflammation of the female genital organs, Respiratory tract infections

Weight

Weight: 43 gr.