Universal reference book for medicines
Product name: IVACYN (IVACYN)

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: CLARIS LIFESCIENCES (India)
Composition, form of production and packaging
Solution for infusion
1 ml

levofloxacin 5 mg

100 ml - polyethylene bottles (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Fluoroquinolone, a broad-spectrum antimicrobial bactericide.
It blocks DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and bacterial membranes.
Levofloxacin is active in vivo and in vitro against the following microorganisms:

Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus spp.
(including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus spp. (leukotoxin-containing and coagulase-negative methicillin-sensitive / moderately sensitive strains), including Staphylococcus aureus (methicillin susceptible strains), Staphylococcus epidermidis (methicillin-sensitive strains); Streptococcus spp. Groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae (penicillin susceptible / moderately sensitive / resistant strains), Streptococcus pyogenes, Streptococcus spp. groups of viridans (penicillin-sensitive / resistant strains).
Aerobic Gram-negative microorganisms: Acinetobacter spp.
(including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (Ampicillin susceptible / resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (producing and non-producing beta-lactamase strains), Morganella morganii, Neisseria gonorrhoeae (producing and non-producing penicillinase strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella canis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (incl. Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Serratia marcescens), Salmonella spp.
Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterium spp., Veilonella spp.

Other microorganisms : Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycobacterium spp.(including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma hominis, Mycoplasma pneumoniae, Rickettsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (minimum inhibitory concentration more than 4 mg / l):

Aerobic Gram-positive microorganisms: Corvnebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis (methicillin-resistant strains), Staphylococcus haemolyticus (methicillin-resistant strains).

Aerobic Gram-negative microorganisms: Burkholderia cepacia, Campylobacter jejuni, Campilobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovatus, Prevotella spp., Porphyromonas spp.

Stable microorganisms (minimum inhibitory concentration more than 8 mg / l):

Aerobic Gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus (methicillin-resistant strains), other Staphylococcus spp.
(coagulase-negative methicillin-resistant strains).
Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

PHARMACOKINETICS

After IV infusion, 500 mg for 60 min C max is about 6 μg / ml.
With iv in a single and repeated administration, the apparent V d after administration of the same dose is 89-112 liters.
The connection with 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.

Kidney clearance is 70% of the total clearance.
T 1/2 - 6-8 hours. Excreted mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5% of levofloxacin is excreted as metabolites. In unchanged form, 70% are excreted by the kidneys within 24 hours and 87% in 48 hours.
INDICATIONS

Infectious-inflammatory diseases caused by susceptible to levofloxacin microorganisms:

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

acute acute maxillary sinusitis;

uncomplicated urinary tract infections;

- Complicated urinary tract infections (including acute pyelonephritis);

- skin and soft tissue infections (festering atheromas, abscess, boils);

- septicemia / bacteremia;

- chronic bacterial prostatitis;

- intra-abdominal infection;

- complex therapy of drug-resistant forms of tuberculosis.

DOSING MODE

Solution for infusion is injected / drip.
The duration of IV infusion of 500 mg of levofloxacin (100 ml of infusion solution) should be at least 60 minutes. Doses are determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.
Patients with normal renal function (creatinine clearance> 50 ml / min) are recommended the following dosing regimen:

Exacerbation of chronic bronchitis: 250-500 mg of levofloxacin 1 time per day for 7-10 days;

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

Acute maxillary sinusitis: 500 mg of levofloxacin 1 time per day for 10-14 days;

Uncomplicated urinary tract infections: 250 mg levofloxacin 1 time per day for 3 days;

Complicated urinary tract infections (including acute pyelonephritis): 250 mg of levofloxacin 1 time per day for 7-10 days;

Infections of the skin and soft tissues: 500 mg of levofloxacin 2 times a day for 7-14 days;

Septicemia / bacteremia: 500 mg of levofloxacin 1-2 times a day for 10-14 days;

Chronic bacterial prostatitis: 500 mg of levofloxacin 1 time per day for 28 days;

Intra-abdominal infection: 500 mg levofloxacin 1 time per day for 7-14 days (in combination with antibacterial drugs acting on anaerobic flora);

Complex therapy of drug-resistant forms of tuberculosis: 500 mg of levofloxacin 1-2 times a day for up to 3 months.

Patients with impaired renal function (creatinine clearance <50 mL / min) are recommended the following dosing regimen:

Creatinine clearance ml / min Dose for intravenous administration

250 mg / 24 h 500 mg / 12h 500 mg / 24 h

Initial dose 250 mg Initial dose 500 mg Initial dose 500 mg

50-20 Further 125 mg / 24 hours Further 250 mg / 24 hours Further 250 mg / 12 h

19-10 Further 125 mg / 48 h Further 125 mg / 24 h Further 125 mg / 12 h

<10 (including hemodialysis and permanent ambulatory peritoneal dialysis) Further 125 mg / 48 h Further 125 mg / 24 h Further 125 mg / 24 h

After hemodialysis or permanent ambulatory peritoneal dialysis (CAPD), no additional doses are required.

If there is a violation of the liver, dosage adjustment is not required, since levofloxacin is metabolized to a small extent in the liver.

Depending on the patient's condition after a few days of treatment, you can go from / in the drip to receive the same dose of the drug in a form intended for oral administration.

SIDE EFFECT

On the part of the digestive system: nausea, vomiting, diarrhea (including with blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis, increased activity of "liver" transaminases, hyperbilirubinemia, hepatitis, dysbiosis.

From the cardiovascular system: lowering blood pressure, vascular collapse, tachycardia, lengthening of the QT interval, atrial fibrillation.

On the part of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness), hyperglycemia.

From the side of the nervous system: headache, dizziness, weakness, drowsiness, insomnia, anxiety, paresthesia, fear, hallucinations, confusion, depression, movement disorders, convulsions.

From the senses: visual, hearing, smell, taste and tactile sensitivity.

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

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

On the part of the organs of hematopoiesis: eosinophilia, hemolytic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, pancytopenia, hemorrhages.

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

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

Local reactions: pain, redness at the injection site, phlebitis.

CONTRAINDICATIONS

Hypersensitivity to levofloxacin, any other component of the drug or other drugs from the group of fluoroquinolones, epilepsy, tendon lesions with previously treated quinolones, pregnancy, lactation, children and adolescence (up to 18 years).

With caution: in the elderly due to the high likelihood of concomitant decline in kidney function, with a deficiency of glucose-6-phosphate dehydrogenase.

PREGNANCY AND LACTATION

Contraindicated: pregnancy, lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function (creatinine clearance <50 mL / min) are recommended dose adjustment.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If there is a violation of the liver, dosage adjustment is not required, since levofloxacin is metabolized to a small extent in the liver.

APPLICATION FOR CHILDREN

Contraindicated: children and adolescence (up to 18 years).

APPLICATION IN ELDERLY PATIENTS

With caution: in the elderly due to the high likelihood of concomitant decline in kidney function.

SPECIAL INSTRUCTIONS

After normalization of body temperature, it is recommended to continue treatment for at least 48-72 hours. During treatment, sun and artificial UV irradiation should be avoided to avoid damage to the skin (photosensitivity).

When there are signs of tendinitis, pseudomembranous colitis, allergic reactions, levofloxacin is immediately canceled.

It should be borne in mind that the development of seizures is possible in patients with a history of brain damage (stroke, severe trauma), and the risk of hemolysis is a deficiency in glucose-6-phosphate dehydrogenase.

Influence on ability to operate mechanisms and the car.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE

Symptoms: manifested primarily from the central nervous system (confusion, dizziness, impaired consciousness and seizures as epileptic seizures).
In addition, gastrointestinal disorders (eg, nausea) and erosive lesions of the mucous membranes of the gastrointestinal tract, prolongation of the QT interval can be noted.
Treatment: symptomatic.
Dialysis is ineffective. The specific antidote is not known.
DRUG INTERACTION

Levofloxacin increases T 1/2 cyclosporin.

Non-steroidal anti-inflammatory drugs, theophylline increase the risk of seizures.

The use of glucocorticosteroids increases the risk of rupture of tendons.

Cimetidine and drugs that block tubular secretion, slow the withdrawal of levofloxacin.

Solution for infusion is compatible with 0.9% sodium chloride solution, 5% dextrose solution, 2.5% Ringer's solution with dextrose, combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Do not mix with heparin and solutions that have an alkaline reaction (for example, with sodium bicarbonate solution).

In patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, against the background of the use of levofloxacin hypo- and hyperglycemic conditions are possible, therefore it is recommended to control the concentration of glucose in the blood.
Levofloxacin increases the anticoagulant activity of warfarin.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

In dry, dark place at a temperature of no higher than 25 ° C.
Do not freeze. Keep out of the reach of children.
Shelf life.
2 years. Do not use after the expiration date.
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