Levofloxacin solution for infusion 5mg/ml 100ml vial, 1pc

Composition

Active ingredient-levofloxacin hemihydrate ( in terms of levofloxacin) – 5 g.

Auxiliary substances:

sodium chloride-900 mg,

lactic acid-25 mg,

d/i water-up to 100 ml

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.

Indications

Treatment of mild, moderate and severe infections caused by levofloxacin-sensitive strains of microorganisms: acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarhalis

Recommendations for use

The drug Levofloxacin is administered intravenously slowly at 250-750 mg every 24 hours (a dose of 250-500 mg is administered for 60 minutes,750 mg – for 90 minutes). A subsequent transition to oral use at the same dose is possible. The duration of treatment depends on the indications for use, as well as the sensitivity of the suspected pathogen. The recommended dosage regimen should be strictly followed. The use of the drug is recommended to continue for 2-3 days after normalization of body temperature. Self-interruption or early termination of treatment with the drug is unacceptable. For pneumonia, iv 500 mg 1-2 times / day. within 7-14 days. For uncomplicated urinary tract infections-IV 250 mg 1 time / day, for 3 days. For severe urinary tract and kidney infections, the dose for intravenous use and the duration of treatment may be increased. For infections of the skin and soft tissues, iv-500 mg 2 times a day. within 7-14 days. For severe pneumonia caused by pneumococcus and hospital infection caused by the causative agent Pseudomonas aeruginosa, the use of the drug may not be effective enough and combined treatment may be required. Patients with impaired renal function need to adjust the dosage regimen depending on the value of creatinine clearance to prescribe the drug according to the following scheme: With a creatinine clearance of 50-20 ml / min, the usual dose is administered on the first day (recommended for patients with normal creatinine clearance), starting from the second day-the dose of the drug is halved. With a creatinine clearance of 19-10 ml / min, the usual dose is administered on the first day (recommended for patients with normal creatinine clearance), starting from the second day – the dose of the drug is reduced four times. If the creatinine clearance is less than 10 ml / min (including hemodialysis and long-term outpatient peritoneal dialysis), the usual dose (recommended for patients with normal creatinine clearance) is administered on the first day. At prescribed doses of no more than 500 mg / day, starting from the second day, the dose of the drug is reduced four times. Patients who are prescribed a dose of 500 to 1000 mg / day, starting from the second day, the dose of the drug is reduced eight times.

Contraindications

Hypersensitivity to levofloxacin or other quinolones; epilepsy; a history of tendon damage associated with taking quinolones; children and adolescents under 18 years of age.

Side effects

Allergic reactions: sometimes-itching and redness of the skin; rarely-anaphylactic and anaphylactoid reactions (manifested by symptoms such as urticaria, facial edema, very rarely – a sudden drop in blood pressure and shock; in some cases – Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and exudative erythema multiforme. Local reactions: with intravenous use, pain and inflammation at the injection site, back and chest pain, increased sweating;From the nervous system: sometimes – headache, dizziness, fatigue, impaired taste sensitivity; rarely – paresthesia in the hands, trembling, anxiety, states of fear, seizures and confusion; very rarely – visual and hearing disorders, impaired taste sensitivity and smell, decreased tactile sensitivity, impaired concentration, psychotic reactions such as hallucinations and depression, impaired coordination (including walking)From the digestive system: often-nausea, diarrhea, sometimes-loss of appetite, vomiting, abdominal pain, digestive disorders; rarely-dry mouth, gastrointestinal bleeding, increased serum bilirubin;); very rarely – diarrhea with blood (in very rare cases, this may be a sign of intestinal inflammation or pseudomembranous colitis, liver function disorders (hepatitis, cholelithiasis). Hematopoietic disorders: sometimes – eosinophilia, leukopenia; rarely-neutropenia, thrombocytopenia (increased tendency to hemorrhage or bleeding); very rarely-severe agranulocytosis (accompanied by persistent or recurrent fever, inflammation of the tonsils and persistent deterioration of health); in some cases-hemolytic anemia, pancytopenia. From the cardiovascular system: rarely-tachycardia, hypotension and hypertension; very rarely – increased QT interval on the cardiogram, vascular collapse, flutter – ventricular fibrillation;From the musculoskeletal system: rarely-tendon damage (including tendinitis), joint and muscle pain; very rarely-Achilles tendon rupture (may be bilateral and manifest within 48 hours after the start of treatment), muscle weakness (of particular importance for patients with myasthenia gravis); in some cases – rhabdomyolysis. From the genitourinary system: sometimes-vaginitis, very rarely-deterioration of kidney function up to acute renal failure (for example, due to allergic reactions-interstitial nephritis). Other sometimes-asthenia; very rarely-hypoglycemia, fever, allergic pneumonitis, vasculitis. Laboratory parameters: sometimes-an increase in ALT, AST activity, an increase in serum creatinine; rarely-an increase in LDH, an increase or decrease in glucose.

Interaction

When combined with fenbufen and similar NSAIDs, theophylline, the drug can increase the threshold of convulsive readiness. Sucrafalt, iron salts and magnesium-or aluminum-containing antacids significantly reduce the effect of levofloxacin (the interval between drug use should be at least 2 hours). When used concomitantly with warfarin, prothrombin time and the risk of bleeding increases (careful monitoring of INR, prothrombin time and other coagulation parameters is necessary, as well as monitoring for possible signs of bleeding). Levofloxacin elimination is slightly slowed by cimetidine and probenecid. Levofloxacin causes a slight increase in T1 / 2 of cyclosporine from the blood plasma. Glucocorticoids increase the risk of tendon rupture (especially in the elderly). Alcohol can increase the side effects of the central nervous system (dizziness, numbness, drowsiness)In diabetic patients receiving oral hypoglycemic agents or insulin, hypo – and hyperglycemic conditions may occur while taking levofloxacin (careful monitoring of blood glucose levels is recommended).

Special instructions

The infusion solution of the drug is compatible with the following infusion solutions: saline solution,5% glucose solution,2.5% Ringer’s solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). The infusion solution of the drug should not be mixed with heparin or solutions with an alkaline reaction (for example, with a solution of sodium bicarbonate). Influence on the ability to drive a car and potentially dangerous mechanisms: during the treatment period, it is necessary to stop driving a car and potentially dangerous mechanisms due to the possible appearance of dizziness, drowsiness, stiffness and visual disturbances, which can lead to impaired reactivity and reduced concentration.

Form of production

Solution for infusions

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Purpose

Adults as prescribed by a doctor, Children over 1 year old, Children as prescribed by a doctor

Indications

From pneumonia, From tuberculosis, Bronchitis, From urinary tract infections, From respiratory tract infections, From infectious diseases, From boils, From skin infections, From sinusitis, From sinusitis