Levofloxacin-Vertex pills 250mg, 5pcs

Composition

Yellow film-coated tablets, round, biconvex, light yellow at the break; tablet weight 330 mg

.1 tab. levofloxacin (in the form of hemihydrate) 250 mg

Auxiliary substances:

sodium croscarmellose (primellose) 7 mg,

magnesium stearate 3.2 mg,

polyvinylpyrrolidone medium molecular weight 14 mg,

microcrystalline cellulose 21.6 mg,

colloidal silicon dioxide (aerosil) 5 mg,

talc 6.4 mg,

pregelatinized starch (Starch-1500) 12.8 mg.

Shell composition:  

Opadry II (partially hydrolyzed polyvinyl alcohol) 4 mg, macrogol (polyethylene glycol 3350) 2.02 mg,1.48 mg talc, titanium dioxide 1.459 mg, aluminum lacquer based on quinoline yellow (E 104) 0.84 mg, dye iron oxide (II) (E 172) 0.198 mg, aluminum lacquer based on Indigo Carmine (E 132) 0.003 mg

Pharmacological action

Antimicrobial agent, fluoroquinolone

Indications

Infectious-inflammatory diseases caused by sensitive to levofloxacin microorganisms, including:

— acute bacterial sinusitis

— infection of the lower respiratory tract (including exacerbation of chronic bronchitis, community-acquired pneumonia);

— infections of the urinary tract and kidneys (including acute pyelonephritis);

chronic bacterial prostatitis;

infections of skin and soft tissues (festering atheroma, abscess, furunkulez);

— intra-abdominal infections in combination with drugs acting on the anaerobic microflora;

Contraindications

Hypersensitivity to levofloxacin and other fluoroquinolones, epilepsy, tendon damage during previous treatment with quinolones, pregnancy, breastfeeding, children and adolescents (up to 18 years).

With caution

Advanced age (high probability of concomitant decline in renal function), glucose-6-phosphate dehydrogenase deficiency.

Side effects

From the digestive system:  nausea, vomiting, diarrhea (including blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis; increased activity of “liver” transaminases, hyperbilirubinemia, hepatitis, dysbiosis.

From the cardiovascular system:  reduced blood pressure, vascular collapse, tachycardia, prolongation of the Q-T interval, atrial fibrillation.

From the side of metabolism:  hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia.

Nervous system disorders:  headache, dizziness, weakness, drowsiness, insomnia, tremor, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, seizures.

From the side of the senses:  disorders of vision, hearing, smell, taste and tactile sensitivity.

From the musculoskeletal system:  arthralgia, muscle weakness, myalgia, tendon rupture, tendinitis, rhabdomyolysis.

From the urinary system:  hypercreatininemia, interstitial nephritis, acute renal failure.

From the side of hematopoietic organs:  eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

Allergic reactions:  pruritus and hyperemia of the skin, edema of the skin and mucous membranes, urticaria, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, suffocation, anaphylactic shock, allergic pneumonitis, vasculitis.

Other services:  photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

Interaction

Increases T1 / 2 of cyclosporine.

The effect of the drug is reduced by drugs that inhibit intestinal motility, sucralfate, aluminum-and magnesium-containing antacids and iron salts (a break between use of at least 2 hours is necessary).

Nonsteroidal anti-inflammatory drugs, theophylline increase the risk of seizures, and glucocorticosteroids increase the risk of tendon rupture.

Cimetidine and drugs that block tubular secretion slow down excretion.

Hypoglycemic drugs:  strict monitoring of blood glucose concentration is necessary, as there is a possibility of hyper-and hypoglycemia when they are used simultaneously with levofloxacin.

Levofloxacin enhances the anticoagulant efficacy of warfarin.

How to take, course of use and dosage

The drug is taken orally once or twice a day. Tablets should not be chewed and washed down with a sufficient amount of liquid (from 0.5 to 1 cup), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

In patients with normal or moderately reduced renal function (creatinine clearance > 50 ml / min), the following dosage regimen is recommended:

Acute bacterial sinusitis:  500 mg 1 time a day – 10-14 days.

Exacerbation of chronic bronchitis:  250 mg or 500 mg once a day for 7-10 days.

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

Uncomplicated urinary tract infections:  250 mg once a day for 3 days.

Chronic bacterial prostatitis:  500 mg-1 time a day for 28 days.

Complicated urinary tract infections, including pyelonephritis:  250 mg once a day for 7-10 days.

Skin and soft tissue infections:  250-500 mg 1-2 times a day for 7-14 days.

Intraabdominal infection:  500 mg 1 time a day – 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

For tuberculosis (as part of complex therapy) – 500 mg 1-2 times a day, the course of treatment is up to 3 months.

Dose adjustment of levofloxacin in adult patients with impaired renal function (creatinine clearance less than 50 ml / min)

Dose for normal renal function every 24 hours creatinine clearance from 20 to 49 ml/min creatinine clearance from 10 to 19 ml/min creatinine clearance less than 10 ml/min, including with hemodialysis or chronic outpatient peritoneal dialesis 1000 mg Initial dose 500 mg every 12 hours, then 250 mg every 12 hours Initial dose 500 mg every 12 hours, then 125 mg every 12 hours Initial dose 500 mg every 12 hours, then 125 mg every 24 hours 500 mg every 12 hours, then 125 mg every 24 hours Initial dose 500 mg, then 250 mg every 24 h Initial dose 500 mg, then 250 mg every 48 h Initial dose 500 mg, then 250 mg every 48 h 250 mg Dose adjustment is not required 250 mg every 48 h. For uncomplicated urinary tract infections, no dose adjustment is required. There is no information about dose adjustment

No additional doses are required after hemodialysis or permanent outpatient peritoneal dialysis (PAPD).

When liver function is impaired, no special dose selection is required, since levofloxacin is metabolized in the liver only to an extremely small extent. Elderly patients do not need to change the dosage regimen, except in cases of low creatinine clearance

As with other antimicrobial agents, treatment with levofloxacin is recommended to continue for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.

If you miss taking the drug, you should take the pill as soon as possible, before the time of the next appointment approaches. Then continue to take the drug according to the scheme.

Overdose

Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, prolongation of the Q-T interval, confusion, dizziness, convulsions.

Treatment: gastric lavage, symptomatic therapy, dialysis is not effective.

Special instructions

Levofloxacin is taken at least 2 hours before or 2 hours after taking aluminum-or magnesium-containing antacids, or sucralfate, or other drugs containing calcium, iron, or zinc salts.

During treatment, it is necessary to avoid sun and artificial UV radiation in order to avoid damage to the skin (photosensitization).

If signs of tendinitis, pseudomembranous colitis, or allergic reactions occur, levofloxacin is immediately discontinued.

It should be borne in mind that patients with a history of brain damage (stroke, severe injury) may develop seizures, and if glucose-6-phosphate dehydrogenase is insufficient, the risk of hemolysis increases.

In patients with diabetes mellitus, blood glucose levels should be carefully monitored during treatment with levofloxacin.

When levofloxacin and warfarin are co-administered, monitoring of prothrombin time, international normalized ratio, or other anticoagulation tests is indicated, as well as monitoring for signs of bleeding. During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets