Flexid, 500 mg 14 pcs.

Levofloxacin is a broad-spectrum antimicrobial bactericidal drug, it blocks DNA-gyrease and topoisomerase IV, inhibits DNA synthesis.

It is active against aerobic gram-positive microorganisms:Enterococcus faecalis, Staphylococcus aureus (strains sensitive to methicillin), Staphylococcus haemolyticus (strains sensitive to methicillin), Staphylococcus saprophyticus, Streptococcus group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes; aerobic gram-negative microorganisms: Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens; anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus spp.other microorganisms: Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae.

Aerobic gram-positive microorganisms are intermediately sensitive to the drug: Staphylococcus haemolyticus (methicillin-resistant strains); aerobic gram-negative microorganisms: Burkholderia cepacia; anaerobic microorganisms: Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgatus, Clostridium difficile.

Staphylococcus aureus (methicillin-resistant strains) are insensitive to levofloxacin.

Indications

Infections caused by strains of microorganisms sensitive to the drug:
— infections of the ENT organs (acute sinusitis);
— infections of the lower respiratory tract (acute bronchitis, chronic bronchitis, community-acquired pneumonia);
– uncomplicated urinary tract and kidney infections;
– complicated urinary tract and kidney infections (including pyelonephritis);
– prostatitis;
– infections of the skin and soft tissues.

Pharmacological effect

Levofloxacin is a broad-spectrum antimicrobial bactericidal drug that blocks DNA gyrase and topoisomerase IV, and inhibits DNA synthesis.

Active against aerobic gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus (strains sensitive to methicillin), Staphylococcus haemolyticus (strains sensitive to methicillin), Staphylococcus saprophyticus, Streptococcus groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes; aerobic gram-negative microorganisms: Acinetobacter baumannii, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Morganella morganii, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens; anaerobic microorganisms: Bacteroides fragilis, Clostridium perfringens, Peptostreptococcus spp.; other microorganisms: Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Mycoplasma pneumoniae.

Aerobic gram-positive microorganisms are intermediately sensitive to the drug: Staphylococcus haemolyticus (methicillin-resistant strains); aerobic gram-negative microorganisms: Burkholderia cepacia; anaerobic microorganisms: Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgatus, Clostridium difficile.

Staphylococcus aureus (methicillin-resistant strains) is insensitive to levofloxacin.

Active ingredient

Levofloxacin

Composition

1 table contains:

Active ingredients:

levofloxacin (in the form of hemihydrate) 500 mg;

Excipients:

lactose monohydrate,

povidone,

sodium carboxymethyl starch,

talc,

silicon dioxide colloidal anhydrous,

croscarmellose sodium,

glyceryl dibehenate;

Shell composition:

hypromellose, hyprolose, macrogol 6000, iron oxide yellow, iron oxide red, titanium dioxide, talc

Contraindications

— epilepsy;
– tendon lesions that occurred during previous treatment with fluoroquinolones;
– age up to 18 years;
— pregnancy;
– period of lactation (breastfeeding);
– hypersensitivity to levofloxacin or other quinolones, and/or to other components of Flexid.
Please be careful:
– when prescribing levofloxacin in combination with drugs that affect tubular secretion, such as probenecid and cimetidine, especially in the treatment of patients with impaired renal function;
– in the treatment of patients with a predisposition to epileptic seizures, during treatment with fenbufen and similar non-steroidal anti-inflammatory drugs (NSAIDs) or drugs that lower the threshold for epileptic seizures, such as theophylline;
– in patients with latent or obvious disturbances in the activity of glucose-6-phosphate dehydrogenase due to the risk of developing hemolytic reactions.

Side Effects

The following side effects were classified as follows: very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (On the part of the digestive system: common – nausea, diarrhea (including blood), increased activity of liver enzymes (ALT, AST); common – decreased appetite, vomiting, pain in abdomen, dyspepsia, hyperbilirubinemia; rare – enterocolitis, pseudomembranous colitis; very rare – hypoglycemia, hepatitis.

From the nervous system: uncommon – headache, dizziness, sleep disturbance; rare – paresthesia, tremor, anxiety, agitation, confusion, convulsions; very rare – hallucinations, extrapyramidal disorders and other coordination disorders.

From the senses: very rare – disturbances of vision, hearing, smell, taste and tactile sensitivity.

From the cardiovascular system: rare – tachycardia, hypotension; very rare – vascular collapse.

From the musculoskeletal system: rare – arthralgia, myalgia, tendinitis; very rare – tendon rupture (for example, Achilles tendon), muscle weakness (of particular importance for patients with myasthenia gravis); in some cases – rhabdomyolysis.

From the urinary system: uncommon – hypercreatininemia; very rare – interstitial nephritis, deterioration of kidney function up to acute renal failure.

From the blood system and hematopoietic organs: uncommon – eosinophilia, leukopenia; rare – neutropenia, thrombocytopenia; very rare – agranulocytosis; in some cases – hemolytic anemia, pancytopenia.

Allergic reactions: uncommon – itching, skin rash; rare – urticaria, bronchospasm, shortness of breath; very rare – angioedema, hypotension, anaphylactic shock, allergic pneumonitis, photosensitivity; in some cases – Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme.

Other: uncommon – asthenia; very rare – fever, vasculitis.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Manufacturer

Lek d.d., Slovenia