Universal reference book for medicines
Product name: HAYLEFLOX (HILEFLOX)

Active substance: levofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: HIGLANCE LABORATORIES Pvt.
Ltd. (India)
Composition, form of production and packaging
The tablets covered with a film membrane
from light orange to orange color, round, biconcave;
on the fracture - the core of the white with a yellow tinge to yellow.
1 tab.

levofloxacin (in the form of hemihydrate) 250 mg

Excipients: corn starch, microcrystalline cellulose, povidone K30, methyl parahydroxybenzoate, propyl parahydroxybenzoate, talc purified, magnesium stearate, sodium carboxymethyl starch.

Composition of the film coat: hypromellose, purified talc, macrogol 6000, titanium dioxide, dye sunset yellow.

3 pcs.
- blisters (1) - packs of cardboard.
3 pcs.
- blisters (10) - packs of cardboard.
5 pieces.
- blisters (1) - packs of cardboard.
5 pieces.
- blisters (2) - packs of cardboard.
5 pieces.
- blisters (10) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
100 pieces.
- polymer bags (1) - plastic cans.
500 pcs.
- polymer bags (1) - plastic cans.
1000 pcs.
- polymer bags (1) - plastic cans.
The tablets covered with a film cover from light orange to orange color, oval, biconcave, with risk on one side;
on the fracture - the core of the white with a yellow tinge to yellow.
1 tab.

levofloxacin (in the form of hemihydrate) 500 mg

Excipients: corn starch, microcrystalline cellulose, povidone K30, methyl parahydroxybenzoate, propyl parahydroxybenzoate, talc purified, magnesium stearate, sodium carboxymethyl starch.

Composition of the film coat: hypromellose, purified talc, macrogol 6000, titanium dioxide, dye sunset yellow.

5 pieces.
- blisters (1) - packs of cardboard.
5 pieces.
- blisters (10) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
100 pieces.
- polymer bags (1) - plastic cans.
500 pcs.
- polymer bags (1) - plastic cans.
1000 pcs.
- polymer bags (1) - plastic cans.
The tablets covered with a film cover from light orange to orange color, oval, biconcave, with risk on one side;
on the fracture - the core of the white with a yellow tinge to yellow.
1 tab.

levofloxacin (in the form of hemihydrate) 750 mg

Excipients: corn starch, microcrystalline cellulose, povidone K30, methyl parahydroxybenzoate, propyl parahydroxybenzoate, talc purified, magnesium stearate, sodium carboxymethyl starch.

Composition of the film coat: hypromellose, purified talc, macrogol 6000, titanium dioxide, dye sunset yellow.

5 pieces.
- blisters (1) - packs of cardboard.
5 pieces.
- blisters (10) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
100 pieces.
- polymer bags (1) - plastic cans.
500 pcs.
- polymer bags (1) - plastic cans.
1000 pcs.
- polymer bags (1) - plastic cans.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Levofloxacin is a synthetic fluoroquinolone with a broad spectrum of action.
Inhibits DNA-gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes of sensitive microorganisms.
Levofloxacin is active against 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 methicillin-sensitive strains of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus spp. (including strains of Staphylococcus groups C and G, Streptococcus agalactiae, Streptococcus pyogenes , penicillin-sensitive / moderately sensitive / resistant strains of Streptococcus pneumoniae, penicillin-sensitive strains of Streptococcus group of viridans), aerobic gram-negative microorganisms: Acinetobacter spp. (including Acinetobacter baumanii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (Including Enterobac ter aerogenes, Enterobacter agglomerans, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus spp. (including Haemophilus ducreyi, Haemophilus parainfluenzae, ampicillin-sensitive / resistant strains of Haemophilus influenzae), Helicobacter pylori, Klebsiella spp. (in tons Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis (producing and non-β-lactamase strains), Morganella morganii, Neisseria spp. (including Neisseria meningitidis, producing and not producing penicillinase strains of Neisseria gonorroeae), Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus spp. (including Proteus mirabilis, Proteus vulgaris), Providencia spp. (including 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., Propionibacterum spp., Veilonella spp .; other microorganisms: Bartonella spp., Chlamydia spp. (including Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis), Legionella pneumophila, Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis), Mycoplasma spp. (including Mycoplasma hominis, Mycoplasma pneumoniae), Rickettsia spp., Ureaplasma urealyticum.
The drug is resistant to aerobic Gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus spp.
(coagulase-negative methicillin-resistant strains, including methicillin-resistant Staphylococcus aureus strains); and eroded gram-negative microorganisms: Alcaligenes xylosoxidans; other microorganisms:Mycobacterium avium.
PHARMACOKINETICS

Suction

After oral administration, levofloxacin is rapidly and almost completely absorbed from the digestive tract.
Food intake has little effect on the speed and completeness of absorption. Bioavailability is 99%. C max in plasma is achieved after 1-2 hours and for levofloxacin in doses of 250 mg, 500 and 750 mg is 2.8 μg / ml, 5.2 μg / ml and 8 μg / ml, respectively.
Distribution

After taking a single or multiple dose, the amount of absorbed drug is directly proportional to the dose taken.
C ss in plasma is achieved after 48 hours. The average Vd of levofloxacin varies from 74 to 112 liters. Binding to plasma proteins is 30-40%. It penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, alveolar macrophages (concentration in the lung tissues is 2-5 times higher than the concentration in the plasma), organs of the genitourinary system, polymorphonuclear leukocytes.
Metabolism

Levofloxacin undergoes a limited metabolism in the liver (oxidation and / or deacetylation).

Excretion

It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion.
T 1/2 levofloxacin 6-8 hours. Less than 5% of the dose received is excreted as desmethyl- and N-oxide metabolites. In unchanged form, 70% of the dose taken internally is excreted by the kidneys within 24 hours and 87% in 48 hours. 4% of the ingested dose is excreted by the intestine within 72 hours.
INDICATIONS

Infectious-inflammatory diseases of mild and moderate severity caused by microorganisms sensitive to the preparation:

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

acute bacterial sinusitis;

- Urinary tract and kidney infections (including acute pyelonephritis);

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

- chronic bacterial prostatitis;

- intra-abdominal infection (in combination with antibacterial drugs acting on anaerobic microflora);

- tuberculosis (as part of complex therapy of drug-resistant forms).

DOSING MODE

Inside, before meals or at a break between meals, without chewing, squeezed enough water.

Adult patients with normal renal function (CK> 50 ml / min) should be administered in accordance with the charts presented in the table:

Infection Dose (mg) Frequency of administration per day Duration of treatment (days)

Hospital pneumonia 750 1 7-14

Community-acquired pneumonia 500 1-2 7-14

750 1 5 *

Acute bacterial exacerbation of chronic bronchitis 500 1 7

Acute bacterial sinusitis 500 1 10-14

750 1 5

Uncomplicated urinary tract infections 250 1 3

Complicated urinary tract infections, incl.
acute pyelonephritis 250 1 10 **
750 1 5 ***

Uncomplicated infections of the skin and subcutaneous tissue 500 1 7-10

Complicated infections of the skin and subcutaneous tissue 750 1 7-14

Chronic bacterial prostatitis 500 1 28

Intra-abdominal infection (in combination with antibacterial drugs acting on anaerobic microflora) 500 1 7-14

Tuberculosis (as part of complex therapy of drug-resistant forms) 500 1-2 Up to 3 months

* This regimen is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae.

** This regimen is indicated for the treatment of urinary tract infections caused by Enterococcus faecalis, Enterococcus cloacae, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and acute pyelonephritis caused by Escherichia coli.

*** This regimen is indicated for the treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and acute pyelonephritis caused by Escherichia coli, including cases with concomitant bacteremia.

Adjusting the dose of levofloxacin in adult patients with impaired renal function (CK <50 mL / min).

The dose for normal kidney function every 24 hours KK 20-49 ml / min KK 10-19 ml / min KK <10 ml / min, incl.
with hemodialysis or chronic outpatient peritoneal dialysis
750 mg 750 mg every 48 h Initial dose 750 mg, then 500 mg every 48 h Initial dose 750 mg, then 500 mg every 48 h

500 mg Initial dose 500 mg, then 250 mg every 24 hours Initial dose 500 mg, then 250 mg every 48 hours Initial dose 500 mg, then 250 mg every 48 hours

250 mg No dose adjustment is required 250 mg every 48 hours. In case of uncomplicated urinary tract infections, dose adjustment is not required Information on dose adjustment is not available

If there is a violation of the liver function, dose adjustment is not required, because
the volume of metabolism of levofloxacin in the liver is limited.
SIDE EFFECT

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

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

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

On the part of the digestive system: nausea, vomiting, diarrhea (including with blood), digestive disorders, decreased appetite, abdominal pain, pseudomembranous colitis;
increased activity of hepatic transaminases, hyperbilirubinemia, hepatitis, dysbacteriosis.
On the part of metabolism: hypoglycemia (increased appetite, increased sweating, trembling, nervousness).

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

From the side of 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: skin itching and hyperemia, swelling 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: photosensitization, asthenia, exacerbation of porphyria, persistent fever, development of superinfection.

CONTRAINDICATIONS

- epilepsy;

- the defeat of tendons, associated with the administration of quinolones in the anamnesis;

- children and adolescence under 18;

- Pregnancy;

- lactation period;

- hypersensitivity to levofoxacin, other fluoroquinolones or other components of the drug in the history.

With caution should prescribe the drug to elderly patients (high probability of concomitant decline in kidney function), with a deficiency of glucose-6-phosphate dehydrogenase.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Adjusting the dose of levofloxacin in adult patients with impaired renal function (CK <50 mL / min).

The dose for normal kidney function every 24 hours KK 20-49 ml / min KK 10-19 ml / min KK <10 ml / min, incl.
with hemodialysis or chronic outpatient peritoneal dialysis
750 mg 750 mg every 48 h Initial dose 750 mg, then 500 mg every 48 h Initial dose 750 mg, then 500 mg every 48 h

500 mg Initial dose 500 mg, then 250 mg every 24 hours Initial dose 500 mg, then 250 mg every 48 hours Initial dose 500 mg, then 250 mg every 48 hours

250 mg No dose adjustment is required 250 mg every 48 hours. In case of uncomplicated urinary tract infections, dose adjustment is not required Information on dose adjustment is not available

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

If there is a violation of the liver function, dose adjustment is not required, because
the volume of metabolism of levofloxacin in the liver is limited.
APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients (high probability of concomitant decrease in kidney function).

SPECIAL INSTRUCTIONS

After normalization of body temperature, it is recommended to continue treatment for at least 48-72 hours.

Levofloxacin is taken at least 2 hours before or 2 hours after the administration of magnesium / aluminum antacids, or sucralfate, or other drugs containing calcium, iron or zinc.

Due to possible photosensitization during the treatment period and within 5 days after the end of levofloxacin treatment, sunlight and artificial ultraviolet irradiation should be avoided.
With the development of phototoxicity, drug treatment should be discontinued.
When there are signs of tendonitis and pseudomembranous colitis, levofloxacin is immediately withdrawn.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma) may develop seizures.

With insufficiency of glucose-6-phosphate dehydrogenase, the risk of hemolytic reactions is possible.

Patients with diabetes mellitus during treatment with levofloxacin should carefully monitor blood glucose levels.

With the simultaneous use of levofloxacin and warfarin, monitoring of prothrombin time, INR or other coagulation indicators, as well as monitoring of bleeding symptoms, is indicated.

Data on the use of the preparation Haileflex (750 mg) in the operation of radical or sparing sinusotomy in patients with chronic odontogenic perforated maxillary sinusitis testifies to the high clinical efficacy.
Microbiological control of the drug application showed that 750 mg once a day for 10 days suppresses a number of aggressive bacteria capable of causing infectious complications. The results obtained make it possible to recommend the preparation Haileflex (750 mg) in order to prevent inflammatory complications of the operation of sparing sinusotomy with plastic oroanthral communication.
Impact on the ability to drive vehicles and manage mechanisms

On the background of taking levofloxacin, the patient's ability to concentrate and speed of psychomotor reactions may be impaired.
In this regard, care must be taken when driving vehicles and engaging in other potentially hazardous activities.
OVERDOSE

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

Treatment: gastric lavage, if necessary - symptomatic therapy.
There is no specific antidote, dialysis is ineffective.
DRUG INTERACTION

Levofloxacin increases T 1/2 cyclosporin.

The effect of levofloxacin reduces drugs that depress intestinal motility, sucralfate, aluminum-or magnesium-containing antacid drugs and iron preparations.

NSAIDs and theophylline, when used concomitantly with levofloxacin, increase the risk of seizures in predisposed patients, and SCS increases the risk of rupture of tendons.

With the simultaneous administration of levofloxacin with hypoglycemic drugs, changes in blood glucose levels, including hyperglycemia and hypoglycemia, are possible.

Levofloxacin increases the effect of warfarin.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light, at a temperature of 8 ° to 25 ° C.
Shelf life - 3 years.
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