Levolet p pills 250mg №10

Active ingredient and dosage form

Levolet film-coated tablets:
1 tab. contains Levofloxacin hemihydrate 256.233 and 512.466 mg (equivalent to levofloxacin 250 and 500 mg, respectively);
Excipients: MCC (Avicel PH 101); corn starch; colloidal silicon dioxide; crospovidone; hypromellose (15 cps); MCC (Avicel PH 102); Magnesium stearate;
shell: Opadry dye white OY 58900 (hypromellose 5 cP, titanium dioxide, macrogol 400);
in the package 10 pcs.;

solution for infusion:
5 mg / ml contains 512 mg of levofloxacin hemihydrate (equivalent to 500 mg of levofloxacin);
Excipients: dextrose; hydrochloric acid; sodium hydroxide; water for injections;
in the PE bottle 100 ml.

Mechanism of action

Levolet has a broad spectrum bactericidal, antimicrobial effect.

Indications and usage

Common to both dosage forms
Infectious and inflammatory diseases of mild and moderate severity caused by pathogens that are sensitive to the drug:
community-acquired pneumonia;
drug-resistant forms of tuberculosis (as part of complex therapy);
complicated infections of the kidneys and urinary tract, including pyelonephritis;
uncomplicated urinary tract infections;
prostatitis, incl. bacterial;
septicemia / bacteremia associated with the above indications;
intra-abdominal infection.
For film-pills (optional)
infections of LOR-organs (acute sinusitis);
lower respiratory tract infection (exacerbation of chronic bronchitis);
infections of the skin and soft tissues.

Contraindications

hypersensitivity to levofloxacin or other quinolones;
hypersensitivity to the auxiliary components of Levolet;
epilepsy;
tendon lesions associated with a history of quinolone;
children and adolescents up to 18 years;
pregnancy;
lactation period (breastfeeding).
Carefully:
advanced age (high probability of concomitant decline in renal function);
deficiency of glucose-6-phosphate dehydrogenase.

Adverse reactions

The frequency of side effects is classified depending on the frequency of occurrence: often (1–10%), sometimes (less than 0.1–1%), rarely (0.01–0.1%), very rarely (less than 0.01% ), including individual messages.
On the part of the blood system and the blood-forming organs: sometimes - eosinophilia, leukopenia; rarely - neutropenia, thrombocytopenia; very rarely - pronounced agranulocytosis; in some cases - hemolytic anemia, pancytopenia.
From the digestive system: often - nausea, diarrhea, increased activity of ALT, ACT, dysbiosis; sometimes - loss of appetite, vomiting, abdominal pain, digestive disorders, hyperbilirubinemia; rarely, diarrhea mixed with blood (in very rare cases it may be a sign of inflammation of the intestine or pseudomembranous colitis); very rarely - hepatitis.
Cardiovascular: rarely - tachycardia, lowering blood pressure; very rarely - vascular collapse; in some cases - prolongation of the QT interval.
From the central and peripheral nervous system: sometimes - headache, dizziness, stiffness of movement, drowsiness, sleep disturbance; rarely - paresthesias in the hands, tremors, anxiety, states of fear, seizures, convulsions, confusion; very rarely - psychotic reactions such as hallucinations and depressions, movement disorders.
From the senses: very rarely - impaired vision and hearing, smell, taste and tactile sensitivity.
Metabolism: very rarely - hypoglycemia (manifested by a sharp increase in appetite, nervousness, sweat, tremors); in some cases - the aggravation of the existing porphyria.
On the part of the urinary system: rarely - hypercreatininemia; very rarely - deterioration of renal function up to acute renal failure (for example, due to allergic reactions - interstitial nephritis).
Musculoskeletal system: rarely - lesions of tendons (including tendonitis), joint and muscle pain; very rarely - tendon ruptures (including Achilles, which can be bilateral and occur within 48 hours after the start of treatment), muscle weakness (is of particular importance for patients with myasthenia); in some cases - rhabdomyolysis.
Allergic reactions: sometimes - itching and redness of the skin; rarely - anaphylactic and anaphylactoid reactions (manifested by symptoms such as urticaria, bronchospasm and possible severe choking, and in rare cases - swelling of the face, larynx); very rarely - a sharp decrease in blood pressure, anaphylactic shock; in some cases - Stevens-Johnson syndrome,toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme, allergic pneumonitis, vasculitis.
Dermatological reactions: very rarely - photosensitivity.
Other: sometimes - asthenia; very rarely - persistent fever, development of superinfection.
Local reactions (for solution for infusions additionally): often - pain, redness, phlebitis.

Dosage and administration

Levolet is applied inside, in / in.
Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.
For film-coated tablets
Inside, to food or in a break between meals, without chewing, drinking plenty of liquid.
Sinusitis: 500 mg 1 time per day. The course of treatment is 10-14 days.
Exacerbation of chronic bronchitis: 250–500 mg 1 time per day. The course of treatment is 10-14 days.
Infections of the skin and soft tissues: 250 mg 1–2 times per day or 500 mg 1 time per day. The course of treatment is 7-14 days.
For both dosage forms
Community-acquired pneumonia: 500 mg 1-2 times a day. The course of treatment is 7-14 days.
Uncomplicated urinary tract infections: 250 mg 1 time per day. The course of treatment is 3 days.
Complicated urinary tract infections (including pyelonephritis): 250 mg 1 time per day. The course of treatment is 7–10 days.
Prostatitis, incl. bacterial (solution for infusion): 500 mg 1 time per day. The course of treatment is 28 days.
Septicemia / bacteremia: 500 mg 1-2 times a day. The course of treatment is 10-14 days.
Intraabdominal infection: 500 mg 1 time per day. The course of treatment is 7–14 days, in combination with antibacterial drugs acting on the anaerobic flora.
In the complex therapy of drug-resistant forms of tuberculosis: 500 mg 1–2 times a day (500–1000 mg of levofloxacin per day), depending on the severity of the disease and the treatment regimen used. The course of treatment is up to 3 months.

Storage conditions

Store in a cool and dark place, protected from light and moisture, at a temperature not higher than 25 ° C.