Rofloks-Scan - instructions for use, doses, side effects, contraindications

One tablet, film-coated, contains:
Active substance: levofloxacin hemihydrate 256.23 mg / 512.45 mg / 768.68 mg in terms of levofloxacin 250.0 mg / 500.0 mg / 750.0 mg
Excipients (core): corn starch 33.03 mg / 66.05 mg / 99.07 mg; cellulose microcrystalline 20.00 mg / 40.00 mg / 60.00 mg; sodium carboxymethyl starch 7.50 mg / 15.00 mg / 22.50 mg; crospovidone 7.50 mg / 15.00 mg / 22.50 mg; Silica colloidal dioxide 7.50 mg / 15.00 mg / 22.50 mg; talc 5.00 mg / 10.00 mg / 15.00 mg; magnesium stearate 3.25 mg / 6.50 mg / 9.75 mg.

Auxiliary substances (shell): Opaprai II pink (85F540146): 8.50 mg / 17.00 mg / 25.50 mg (polyvinyl alcohol (partially hydrolyzed) 3,400 mg / 6,800 mg / 10,200 mg; titanium dioxide 2,091 mg / 4,182 mg / 6.273 mg; macrogol 4000 1.717 mg / 3.434 mg / 5.151 mg, talc 1.258 mg / 2.516 mg / 3.774 mg, iron oxide red 0.034 mg / 0.068 mg / 0.102 mg).

Description:

D250-mg ozation
Round biconvex tablets covered with a film coating of light red-orange color, with a risk on one side. On the cross section, the core of the tablet is yellow.

Dosage 500 mg
Capsule biconvex tablets, covered with a film coating of light red-orange color, with a risk on one side. On the cross section, the core of the tablet is yellow.

Dosage of 750 mg
Capsule biconvex tablets, covered with a film coating of light red-orange color, with a risk on one side. On the cross section, the core of the tablet is yellow.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone.

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Roflox-Scan is a synthetic broad-spectrum antibacterial agent from the group of fluoroquinolones, containing as an active substance levofloxacin - the left-handed isomer of ofloxacin.

Levofloxacin blocks the DNA-gyrase and topoisomerase IV, disrupts supercoiling and cross-linking DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall, and membranes of microbial cells. Levofloxacin active against most strains of microorganisms, as in conditions in vitro, and in vivo.

In vitro

Sensitive microorganisms (IPC ≤ 2 mg / l; inhibition zone ≥17 mm)

- Aerobic Gram-positive microorganisms: Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus faecalis, Enterococcus spp., Listeriamonocytogenes, Staphylococcus coagulase-negative methi-S (I), Staphylococcus aureus methi-S (methicillin-susceptible), Staphylococcus epidermidis methi-S (methicillin-sensitive), Staphylococcus spp. CNS (coagulase-negative), Streptococci spp. C and G, Streptococcus agalactiae, Streptococcus pneumonia peni I / S / R, (penicillin-moderately sensitive / -sensitive / -resistant), Streptococcus pyogenes, Viridans streptococci peni-S / R (penicillin-sensitive / -resistant).

- Aerobic Gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter spp., Escherichia coli, Gardneirella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S / R (ampicillin-sensitive / -resistant), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumonia, Klebsiella spp., Moraxella catarrhalis ß + / ß- (and producing no-producing beta-lactamase), Morganella morganii, Neisseria gonorrhoeae non PPNG / PPNG (and producing no penicillinase), Neisseria meningitidis, Pasteurelia canis , Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa (hospital infections caused by Pseudo monas aeruginosa may require combined treatment), Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia spp.

- Anaerobic microorganisms: Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus, Propionibacterium spp., Veillonella spp.

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

Moderately sensitive microorganisms (IPC = 4 mg / L, inhibition zone 16-14 mm)

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

- Aerobic Gram-negative microorganisms: Campylobacter jejuni/coli

- Anaerobic microorganisms: Prevotella spp., Porphyromonas spp.

Resistant to levofoloxacin microorganisms (IPC ≥ 8 mg / l; inhibition zone ≤ 13 mm):

- Aerobic Gram-positive microorganisms: Staphylococcus aureus methi-R (methicillin-resistant), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant).

- Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans.

- Anaerobic microorganisms: Bacteroides thetaiotaomicron.

- Other microorganisms: Mycobacterium avium.

Resistance

Resistance to levofloxacin develops as a result of a phased process of mutations of genes encoding both topoisomerases of type II: DNA-gyrase and topoisomerase IV. Other mechanisms of resistance, such as the mechanism of influence on the penetration barriers of a microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and the mechanism of efflux (active removal of the antimicrobial from the microbial cell), can also reduce the sensitivity of microorganisms to levofloxacin.

Due to the peculiarities of the mechanism of action of levofloxacin, there is usually no cross-resistance between levofloxacin and other antimicrobial agents.

Clinical efficacy (effectiveness in clinical trials in the treatment of infections caused by the microorganisms listed below)

Aerobic Gram-positive microorganisms: Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.

- Aerobic Gram-negative microorganisms: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.

- Other: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Pharmacokinetics:

Absorption

Levofloxacin is quickly and almost completely absorbed after ingestion, eating has little effect on its absorption. Absolute bioavailability with oral administration is 99-100%. After a single dose of 500 mg of levofloxacin, the maximum concentration in the blood plasma (C_max) is achieved within 1-2 hours and is 5.2±1.2 μg / ml. The pharmacokinetics of levofloxacin is linear in the dosage range of about 50 to 1000 mg. The equilibrium state of the concentration of levofloxacin in plasma with the administration of 500 mg of levofloxacin 1 or 2 times a day is reached within 48 hours.

On the 10th day of taking 500 mg of levofloxacin once a day C_max levofloxacin was 5.7 ± 1.4 μg / ml, and the minimum concentration of levofloxacin (concentrations before taking the next dose) in blood plasma (C_m_in) was 0.5 ± 0.2 μg / ml.

On the 10th day of ingestion 500 mg of levofloxacin 2 times a day C_max levofloxacin was 7.8 ± 1.1 μg / ml, and C_mi_n - 3.0 ± 0.9 μg / ml.

Distribution

The connection with serum proteins is 30-40%. After a single and repeated administration of 500 mg of levofloxacin, the volume of distribution of levofloxacin is, on the average, 100 liters, which indicates a good penetration of levofloxacin into the organs and tissues of the human body.

Penetration into the bronchial mucosa, epithelial lining fluid, alveolar macrophages

After a single oral intake of 500 mg of levofloxacin, the maximum concentrations of levofloxacin in the bronchial mucosa and epithelial lining fluid were achieved within 1 hour or 4 hours and were 8.3 μg / g and 10.8 μg / ml, respectively, with coefficients penetration into bronchial mucosa and epithelial lining fluid, as compared with the concentration in the blood plasma components of 1.1-1.8 and 0.8-3, respectively.

After 5 days of oral administration of 500 mg of levofloxacin, the average concentrations of levofloxacin 4 hours after the last administration of the drug in the epithelial lining fluid were 9.94 μg / ml and in alveolar macrophages 97.9 μg / ml.

Penetration into lung tissue

Maximum concentrations in the lung tissue after oral administration of 500 mg levofloxacin was approximately 11.3 μg / g and was achieved 4-6 hours after taking the drug with penetration factors of 2-5, compared with the concentration in the blood plasma.

Penetration into the alveolar fluid

After 3 days of taking 500 mg of levofloxacin 1 or 2 times a day, the maximum concentrations of levofloxacin in the alveolar fluid were achieved 2-4 hours after the administration of the drug and were 4.0 and 6.7 mg / ml, respectively, with a penetration coefficient of 1, in comparison with the concentrations in the blood plasma.

Penetration into bone tissue

Levofloxacin well penetrates into cortical and spongy bone tissue, as in proximal, and in the distal parts of the femur with a coefficient of penetration (bone tissue / blood plasma) 0.1-3. The maximum concentration of levofloxacin in the spongy bone of the proximal femur after taking 500 g of the oral preparation was approximately 15.1 μg / g (2 hours after the drug was administered.)

Penetration into the cerebrospinal fluid

Levofloxacin poorly penetrates into the cerebrospinal fluid.

Penetration into prostate tissue

After oral administration of 500 mg of levofloxacin 1 time per day for 3 days, the average concentration of levofloxacin in the prostate tissue was 8.7 μg / g, the average ratio of the concentrations of the prostate gland / blood plasma was 1.84.

Concentrations in the urine

Average concentrations in the urine 8-12 hours after oral doses of 150, 300 and 600 mg levofloxacin were 44 μg / ml, 91 μg / ml and 162 μg / ml, respectively.

Metabolism

Levofloxacin is metabolized to a small extent (5% of the dose taken). Its metabolites are demethyllevofloxacin and N-oxide levofloxacin, which are excreted by the kidneys. Levofloxacin is stereochemically stable and undergoes chiral transformations.

Excretion

After oral administration levofloxacin relatively slowly excreted from the blood plasma (half-life (T1 / 2) - 6-8 hours). Excretion, mainly through the kidneys (more than 85% of the dose). The total clearance of levofloxacin after a single dose of 500 mg was 175 ± 29.2 ml / min.

There are no significant differences in the pharmacokinetics of levofloxacin with its intravenous administration and ingestion, which confirms that oral and intravenous administration are interchangeable.

Pharmacokinetics in selected patient groups

The pharmacokinetics of levofloxacin in men and women do not differ.

Pharmacokinetics in elderly patients does not differ from that in young patients, except for differences in pharmacokinetics associated with differences in creatinine clearance (CC).

With renal failure, the pharmacokinetics of levofloxacin varies. decrease kidney function by excretion through the kidneys and kidney clearance (ClR) decrease, and T1 / 2 increases.

Pharmacokinetics in renal failure after a single oral intake of 500 mg of levofloxacin.

CK (ml / min)	<20	20-49	50-80
ClR (ml / min)	13	26	57
T1 / 2 (h)	35	27	9

Indications:

Bacterial infections sensitive to levofloxacin in adults:

acute sinusitis;
exacerbation of chronic bronchitis;
community acquired pneumonia;
uncomplicated urinary tract infections;
complicated urinary tract infections (including pyelonephritis);
chronic bacterial prostatitis;
infections of the skin and soft tissues;
for the complex treatment of drug-resistant forms of tuberculosis;
prevention and treatment of anthrax during airborne infection;
hospital pneumonia (for a dosage of 750 mg).

When using the drug Roflox-Scan should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country (see section "Special instructions").

Contraindications:

hypersensitivity to levofloxacin or other quinolones, as well as to any of the excipients of the drug Roflox-Scan;
epilepsy;
pseudo-paralytic myasthenia gravis (myasthenia gravis) (see the sections " action "," Special instructions ");
lesions of tendons with the administration of fluoroquinolones in the anamnesis;
children and adolescents under 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to the cartilaginous growth points can not be completely excluded);
pregnancy (the risk of destruction of the cartilage growth points in the fetus can not be completely ruled out);
the period of breastfeeding (the risk of cartilage points of bone growth in a child).

Carefully:

- Patients who are predisposed to developing seizures [in patients with previous central nervous system (CNS) lesions, in patients receiving concomitant drugs, lowering the threshold of seizure readiness of the brain, such as fenbufen, theophylline] (see.section "Interaction with other drugs").

- Patients with a latent or manifested deficiency

glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions in the treatment of quinolones).

- In patients with impaired renal function (mandatory monitoring of kidney function, as well as correction of dosing regimens, see section "Method of administration and dose").

- In patients with known risk factors for prolonging the QT interval: in elderly patients; in female patients; in patients with uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); with the syndrome of congenital elongation of the IТ interval; with diseases of the heart (heart failure, myocardial infarction, bradycardia); with simultaneous reception

drugs that can prolong the QT interval (antiarrhythmics grade IA and III, tricyclic antidepressants, macrolides, neuroleptics) (see sections "Overdose", "Interaction with other drugs", "Special instructions ").

- In patients with diabetes mellitus receiving oral hypoglycemic agents, for example, glibenclamide or insulin preparations (the risk of developing hypoglycemia increases).

- In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar undesirable reactions with levofloxacin).

- In patients with psychoses or in patients with a history of mental illness (see section "Special instructions").

Pregnancy and lactation:

The drug Roflox-Scan is contraindicated for use in pregnant women and women during breastfeeding.

Dosing and Administration:

Tablets Roflox-Scan 250 mg, 500 mg or 750 mg are taken orally once or twice a day. Tablets should be swallowed without chewing and drinking with a sufficient amount of liquid (0.5 to 1 cup). If necessary, tablets can be broken at risk. The drug can be taken before meals or at any time between meals, as eating does not affect the absorption of the drug (see section "Pharmacokinetics").

The drug should be taken at least 2 hours before or 2 hours after taking medications containing magnesium and / or aluminum, iron, zinc, or sucralfate (see.section "Interaction with other drugs").

Given that the bioavailability of levofloxacin in the administration of the drug Roflox-Scan in tablets is 99-100%, in the case of transfer of the patient from intravenous infusion, the preparation of Roflox-Scan for the taking of tablets should continue treatment at the same dose that was used for intravenous infusion (see section "Pharmacokinetics").

Missing one or more doses of the drug

If the medication is accidentally missed, it is necessary, as soon as possible, to take the next dose and continue to take the drug Roflox-Scan according to the recommended dosage regimen.

Doses and duration of treatment

The dosage regimen is determined by the nature and severity of the infection, as well as by the suspected pathogen susceptibility. Duration of treatment varies depending on the course of the disease.

The recommended dosing regimen and duration of treatment in patients with normal renal function (CK> 50 mL / min)

Indication	Daily dose, mg	Multiplicity of reception per day	Duration of treatment, days
Acute Sinusitis	500	1	10-14
Acute Sinusitis	750	1	5
Exacerbation of chronic bronchitis	500	1	7-10
Hospital pneumonia	750	1	7-14
Community-acquired pneumonia	500-1000	1-2	7-14
Community-acquired pneumonia	750 *	1	5
Uncomplicated infection urinary tract	250	1	3
Complicated urinary tract infections	500	1	7-14
Complicated urinary tract infections	750 **	1	5
Pyelonephritis	500	1	7-10
Pyelonephritis	750 **	1	5
Chronic bacterial prostatitis	500	1	28
Infections of the skin and soft tissues	500-1000	1-2	7-14
Complicated infections of skin and soft tissues	750	1	10-14
Complex treatment of drug-resistant forms of tuberculosis	500-1000	1-2	up to 3 months
Prevention and treatment of anthrax in case of airborne infection	500	1	8 weeks

* Community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-moderately sensitive / -sensitive / -resistant), Haemophilus influenza, Haemophilus-parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae.

** Complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and acute pyelonephritis caused by Escherichia coli, including cases of concomitant bacteremia.

Dosing regimen in patients with impaired renal function (QC ≤ 50 ml / min)

Levofloxacin is excreted mainly by the kidneys, therefore, in the treatment of patients with impaired renal function, a dose reduction is required (see table below).

QC	Dosing regimen of tablets Roflox-Scan
QC	Recommended dose with KK> 50 ml / min: 250 mg / 24 h	Recommended dose with KK> 50 ml / min: 500 mg / 24 h	Recommended dose with KK> 50 ml / min: 500 mg / 12 h	Recommended dose with KK> 50 ml / min: for "750 mg / 24 h ,;"
50-20 ml / min	first dose: 250 mg then 125 mg / 24 h	first dose: 500 mg then 250 mg / 24 h	first dose: 500 mg then 250 mg / 12 h	for 750 mg / 48 h ~ 9
19-10 ml / min	first dose: 250 mg then 125 mg / 48 h	first dose: 500 mg then 125 mg / 24 h	first dose: 500 mg then 125 mg / 12 h	the first dose: 750 mg / 48 h then 250 mg / 24 h
<10 ml / min (including hemodialysis and CAPD¹)	first dose: 250 mg then 125 mg / 48 h	first dose: 500 mg then 125 mg / 24 h	first dose: 500 mg then 125 mg / 24 h	the first dose: ^ 750 mg / 48 h 'K> .. then 250 mg / 24 h

¹= after hemodialysis or permanent ambulatory peritoneal dialysis (CAPD) no additional doses are required.

Dosing regimen in patients with impaired hepatic function

If the liver function is not corrected, correction of the dosing regimen is not required, since levofloxacin only slightly metabolized in the liver.

Dosage regimen in elderly patients

For elderly patients, there is no need to change the dosage regimen, for except for cases of a decrease in SC to 50 ml / min and below.

Side effects:

The following side effects are presented in accordance with the following gradations of their frequency: very often (≥1 / 10), often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000,<1/1000); very rarely (<1/10000) (including individual messages); the frequency is unknown (it is not possible to determine the frequency of occurrence according to the available data).

Heart Disease
Rarely: sinus tachycardia, palpitation.
The frequency is unknown: prolongation of QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular pirouette tachycardia, which can lead to cardiac arrest (see sections "Overdose", "Special instructions").

Violations of the blood and lymphatic system
Infrequently: leukopenia (decrease in the number of leukocytes in peripheral blood), eosinophilia (an increase in the number of eosinophils in peripheral blood).
Rarely: neutropenia (a decrease in the number of neutrophils in peripheral blood), thrombocytopenia (a decrease in the number of platelets in the peripheral blood).
The frequency is unknown: pancytopenia (decrease in the number of all formed elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the amount of 10 granulocytes in the peripheral blood), hemolytic anemia.

Disturbances from the nervous system
Often: headache, dizziness.
Infrequently: drowsiness, tremor, dysgeusia (distortion of taste).
Rarely: paresthesia, convulsions (see section "Special instructions").
The frequency is unknown: peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see section "Special instructions"), dyskinesia, extrapyramidaldisorders, agevzia (loss of taste sensations), parosmia (sensation disorder odor, especially a subjective sense of smell, objectively absent), including loss of smell, fainting, benign intracranial hypertension.

Disturbances on the part of the organ of sight
Rarely: visual impairment, such as blurred vision.
The frequency is unknown: transient loss of vision, uveitis.

Hearing disorders and labyrinthine disorders Infrequently: Vertigo (feeling of deflection or twisting or own body or surrounding objects).
Rarely: ringing in the ears.
The frequency is unknown: hearing loss, hearing loss.

Disturbances from the respiratory system, chest and mediastinal organs
Infrequent: shortness of breath.
The frequency is unknown: bronchospasm, allergic pneumonitis.

Disorders from the gastrointestinal tract
Often: diarrhea, vomiting, nausea.
Infrequently: abdominal pain, indigestion, flatulence, constipation.
The frequency is unknown: hemorrhagic diarrhea, which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"), pancreatitis.

Disorders from the kidneys and urinary tract
Infrequent: increased serum creatinine concentration.
Rarely: acute renal failure (eg, due to the development of interstitial nephritis).

Disturbances from the skin and subcutaneous tissues
Infrequent: rash, itching, hives, hyperhidrosis.
The frequency is unknown: toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (hypersensitivity to sun and ultraviolet radiation) (see "Special instructions"), leukocytoclastic vasculitis, stomatitis.
Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.

Disturbances from musculoskeletal system and connective tissue
Infrequent: arthralgia, myalgia
Rarely: tendon damage, including tendonitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia gravis (see section "Special instructions").
The frequency is unknown: rhabdomyolysis, tendon rupture (eg Achilles tendon This side effect can occur within 48 hours after the start of treatment and can be bilateral (see also section "Special instructions")), ligament rupture, muscle rupture, arthritis.

Disorders from the metabolism and nutrition
Infrequently: anorexia.
Rarely: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling).
The frequency is unknown: hyperglycemia, hypoglycemic coma (see section "Special instructions").

Infectious and parasitic diseases
Infrequently: fungal infections, development of resistance of pathogenic microorganisms.

Vascular disorders
Rarely: lowering blood pressure.

General disorders
Infrequently: asthenia.
Rarely: pyrexia (fever).
Frequency unknown: pain (including pain in the back, chest and extremities).

Immune system disorders
Rarely: angioedema.
The frequency is unknown: anaphylactic shock, anaphylactoid shock.
Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.

Disturbances from the liver and bile ducts
Often: increased activity of "hepatic" enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (ACT)), increased activity of alkaline phosphatase (AP) and gamma glutamyl transferase (GGT).
Infrequent: increased bilirubin concentration in the blood.
The frequency is unknown: severe hepatic insufficiency, including cases of development of acute hepatic insufficiency, sometimes with fatal outcome, especially in patients with severe underlying disease (for example, in patients with sepsis) (see section "Special instructions"); hepatitis, jaundice.

Disorders of the psyche
Often: insomnia.
Uncommon: a feeling of anxiety, anxiety, confusion.
Rarely: mental disorders (eg, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares.
The frequency is unknown: mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts.

Other possible undesirable effects related to all fluoroquinolones
Very rarely: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.

Overdose:

Overdose Symptoms: disorders of consciousness, including confusion, gcramping, convulsions, hallucinations, tremor, nausea, erosive lesions of the mucous membrane of the gastrointestinal tract, lengthening of the interval QT.

Treatment of overdose

In case of an overdose, careful monitoring of the patient, including monitoring the electrocardiogram, is required. Treatment is symptomatic. In the case of an acute overdose of the Roflox-Scan tablets, gastric lavage and administration of antacids are indicated to protect the gastric mucosa. Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis and continuous ambulatory peritoneal dialysis). There is no specific antidote.

Interaction:

Interactions requiring caution
With preparations containing magnesium, aluminum, iron and zinc, didanosine
Preparations containing divalent or trivalent cations,such as zinc or iron salts (drugs for the treatment of anemia), magnesium and / or Aluminum-containing preparations (such as antacids), didanosine (medicinal only forms containing aluminum or magnesium as a buffer), it is recommended to take at least 2 hours before or 2 hours after taking the Roflox-Scan tablets.
Calcium salts have a minimal effect on the absorption of levofloxacin with its ingestion.

With sucralfatom
The effect of the drug Roflox-Scan is significantly weakened by the simultaneous use of sucralfate (a means to protect the gastric mucosa).
Patients receiving levofloxacin and sucralfate, it is recommended to take sucralfate 2 hours after taking levofloxacin.

With theophylline, fenbufen or similar drugs from the group non-steroidal anti-inflammatory drugs that reduce the threshold of convulsive brain readiness

The pharmacokinetic interaction of levofloxacin with theophylline has not been revealed. However, with simultaneous use of quinolones and theophylline, non-steroidal anti-inflammatory drugs and other drugs,reducing the threshold of convulsive readiness of the brain, possibly a marked decrease in the threshold convulsive readiness of the brain.
The concentration of levofloxacin with simultaneous administration of fenbufen is only increased by 13%.

With indirect anticoagulants (antagonists of vitamin K)
In patients treated with levofloxacin in combination with indirect anticoagulants (eg, warfarin), there was an increase in prothrombin time / international normalized ratio and / or bleeding, including severe and severe. Therefore, with simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood clotting parameters is necessary.

With probenicide and cimetidine
With the simultaneous use of drugs that disrupt renal tubular secretion, such as probenicide and cimetidine, and levofloxacin, caution should be used especially in patients with renal insufficiency. Removal (renal clearance) of levofloxacin is slowed by cimetidine by 24% and probenicid by 34%. It is unlikely that this can be of clinical significance in normal kidney function.

With cyclosporine
Levofloxacin increased T1 / 2 cyclosporine by 33%. Since this increase is clinically insignificant, correction of the dose of cyclosporine when it is used simultaneously with levofloxacin is not required.

With glucocorticosteroids
Simultaneous reception of glucocorticosteroids increases the risk of rupture of tendons.

With drugs that extend the QT interval.
Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving QT prolonging drugs (for example, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics).

Other
Conducted clinical and pharmacological studies to study possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine, and warfarin have shown that the pharmacokinetics of levofloxacin when used concomitantly with these drugs does not change sufficiently to make it clinically important.

Special instructions:

Hospital infections caused by Pseudomonas aeruginosa (Pseudomonas aeruginosa), may require combined treatment.

The prevalence of acquired resistance of the sown strains of microorganisms can vary depending on the geographic region and over time. In this regard, information about drug resistance in a particular country is required. For the treatment of severe infections or in the ineffectiveness of treatment, a microbiological diagnosis should be made, isolating the pathogen and determining its sensitivity to levofloxacin.

Methicillin-resistant Staphylococcus aureus
There is a high likelihood that Methicillin-Resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. therefore levofloxacin It is not recommended for treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, in the case ofif laboratory tests did not confirm the sensitivity of this microorganism to levofloxacin.

Patients who are predisposed to develop seizures
Like other quinolones, levofloxacin should be used with great care in patients with a predisposition to convulsions.Such patients include patients with previous lesions of the central nervous system, such as stroke, severe craniocerebral trauma; patients simultaneously receiving drugs that reduce the threshold of convulsive brain readiness, such as fenbufen and other nonsteroidal anti-inflammatory drugs like it or other drugs that lower the threshold of convulsive readiness, such as theophylline (see section "Interaction with other drugs").

Pseudomembranous colitis
Developed during or after levofloxacin treatment, diarrhea, especially severe, persistent and / or with blood, may be a symptom of pseudomembranous colic; of the called Clostridium difficile. In case of suspected development of pseudomembrane colitis, treatment with levofloxacin should be stopped immediately and immediately begin specific antibiotic therapy (vancomycin, teicoplanin or metronidazole inside). Drugs that inhibit the intestinal peristalsis are contraindicated.

Tendonitis
Rarely observed tendonitis in the use of quinolones, including levofloxacin, can lead to the rupture of tendons, including the Achilles tendon.This side effect can develop within 48 hours after initiation of treatment and can be bilateral. Older patients are more prone to tendonitis. Risk of rupture of tendons may increase with simultaneous administration of glucocorticosteroids. If suspicion of tendonitis should immediately stop the treatment with Roflox-Scan and begin appropriate treatment of the affected tendon, for example, providing him with sufficient immobilization (see the sections "Contraindications" and "Side effect").

Hypersensitivity reactions
Levofloxacin can cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even with the use of initial doses (see the "Side effect" section). Patients should immediately stop taking the drug and consult a doctor.

Severe bullous reactions
When taking levofloxacin, there were cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section "Side effect"). In case of any reactions from the skin or mucous membranes, the patient should immediately turn todoctor and do not continue treatment until his consultation.

Disturbances from the liver and bile ducts

There have been reports of hepatic necrosis, including fatal liver failure with the use of levofloxacin, mainly in patients with severe underlying diseases, for example, with sepsis (see section "Side effect"). Patients should be warned about the need for discontinuation of treatment and urgent medical attention in case of signs and symptoms of liver damage such as anorexia, jaundice, darkening of urine, pruritus and abdominal pain.

Patients with renal insufficiency
As levofloxacin excreted, mainly through the kidneys, in patientswith impaired renal function, mandatory monitoring of kidney function is required, as well as correction of the dosing regimen (see section "Method of administration and dose"). In the treatment of elderly patients, it should be borne in mind that patients of this group often have impaired renal function (see section "Method of administration and dose").

Prevention of the development of photosensitization reactions
Although photosensitization with levofloxacin is very rare,to prevent its development, patients are not recommended during treatment and subjected to extreme sunlight or artificial ultraviolet irradiation (for example, to visit the solarium) without much need for 48 hours after the end of treatment with levofloxacin.

Superinfection
As with the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased reproduction of insensitive microorganisms (bacteria and fungi), which can cause changes in microflora, which is normally present in humans. As a result, superinfection may develop. Therefore, during the treatment, it is mandatory to reevaluate the patient's condition, and, if developed during the treatment of superinfection, appropriate measures should be taken.

The elongation of the QT interval
Very rare cases of prolongation of the QT interval in patients taking fluoroquinolones have been reported, including levofloxacin.
When using fluoroquinolones, including levofloxacincaution should be exercised in patients with known risk factors for prolonging the QT interval: in patients with uncorrected electrolyte disorders (hypokalemia,hypomagnesemia); with the syndrome of congenital elongation of the QT interval; with diseases of the heart (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval, such as antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, neuroleptics.
Elderly patients and female patients may be more sensitive to drugs that extend the QT interval. Therefore, care should be taken to use fluoroquinolones, including levofloxacin (see the sections "With caution", "Method of administration and dose", "Side effect", "Overdose" and "Interaction with other medicinal products").

Patients with deficiency of glucose-6-phosphate dehydrogenase
Patients with a latent or manifested deficiency of glucose-6-phosphate dehydrogenase have a predisposition to hemolytic reactions in the treatment with quinolones, which should be taken into account when treating levofloxacin.

Hypo-and hyperlikemia (dysglycemia)
As with the use of other quinolones, when levofloxacin was used, cases of hyperglycemia and hypoglycemia were observed,usually in patients with caspic diabetes, receiving concurrent treatment with oral hypoglycemic drugs (eg, glibenclamide) or insulin preparations. There have been reports of cases of hypoglycemic coma. Patients with diabetes are required to monitor the concentration of glucose in the blood (see section "Side effect").

Peripheral Neuropathy
In patients taking fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy was noted, the onset of which can be rapid. If the patient has symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the possible risk of irreversible changes.

Exacerbation of pseudo-paralytic myasthenia gravis (myasthenia gravis)
Fluoroquinolones, including levofloxacin, are characterized by neuromuscular blocking of activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the postmarketing period observed adverse reactions, including pulmonary insufficiency, requiring artificial ventilation, and fatal outcome, which were associated with the use of fluoroquinolones in patients with pseudo-paralytic myasthenia gravis.The use of levofloxacin in a patient with an established diagnosis of pseudo-paralytic myasthenia gravis is not recommended (see the "Side effect" section).

Application in the airborne route of infection with anthrax
The use of levofloxacin in humans according to this indication is based on data on sensitivity to it Bacillus anthracis, obtained in studies in vitro and in experimental studies conducted on animals, as well as on limited data on the use of levofloxacin in humans. The attending physicians should refer to national and / or international documents that reflect the common point of view on the treatment of anthrax.

Psychotic reactions
When using quinolones, including levofloxacin, reported on the development of psychotic reactions, which in very rare cases progressed to the development of suicidal thoughts and behavioral disorders with self-harm (sometimes after taking a single dose of levofloxacin (see the section "Side effect")). With the development of such reactions, treatment with levofloxacin should be discontinued and appropriate therapy prescribed.Caution should be used to prescribe the drug to patients with psychoses or patients who have a history of mental illness.

Visual disturbances
With the development of any visual impairment, an immediate consultation of the ophthalmologist is required (see the "Side effect" section).

Impact on laboratory tests

In patients receiving levofloxacin, the definition of opiates in urine can lead to false positive results, which should be confirmed by more specific methods.
Levofloxacin can inhibit growth Mycobacterium tuberculosis and lead in the future to false-negative results of a bacteriological diagnosis of tuberculosis.

Effect on the ability to drive transp. cf. and fur:

Such side effects of Roflox-Scan as dizziness or vertigo, drowsiness and visual disturbances (see section "Side effect") may reduce psychomotor reactions and the ability to concentrate. This may represent there is a certain risk in situations where these abilities are of particular importance (for example, when driving, servicing machines and mechanisms, performing work in an unstable position).

Form release / dosage:Tablets, film-coated, 250 mg, 500 mg, 750 mg.

Packaging:

$Signature:: h \).$ For 5 or 10 tablets per blister of PVC / Al.
1 blister together with instructions for use in a pack of cardboard.

Storage conditions:2 of the year.

Do not use after the expiry date printed on the package.

Shelf life:

Store in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Terms of leave from pharmacies:On prescription

Registration number:LP-003526

Date of registration:24.03.2016 / 19.05.2016

Expiration Date:24.03.2021

The owner of the registration certificate:Rowecq LimitedRowecq Limited United Kingdom

Manufacturer: & nbsp

SCAN BIOTECH, Ltd. India

Representation: & nbspROUTEC LIMITEDROUTEC LIMITEDUnited Kingdom

Information update date: & nbsp24.08.16

Illustrated instructions

Instructions

Rofloks-Scan (Roflox-Scan)