Glevo - instructions for use, dose, side effects, contraindications

Excipients: Microcrystalline cellulose, starch, povidone (povidone K-30), crospovidone, magnesium stearate, microcrystalline cellulose (avicel pH 101);

Film sheath: Hypromellose, macrogol (polyethylene glycol 6000), dibutyl phthalate, talc, titanium dioxide, iron oxide red dye.

For a dosage of 500 mg:

Active substance: Levofloxacin hemihydrate, in terms of levofloxacin - 500 mg

Excipients: Microcrystalline cellulose, povidone (povidone K-30), crospovidone, magnesium stearate, microcrystalline cellulose (avicel pH 10; 1);

Film sheath: Gipromellose, macrogol (polyethylene glycol 6000), dibutyl phthalate, talc, titanium dioxide, iron dye oxide red, iron oxide dye yellow.

Description:

250 mg tablets: brick-red round biconvex tablets covered with a film sheath, with a fault line on one side and smooth on the other.

Tablets 500 mg: light orange with a pink shade of color biconvex tablets in the form of "oblong", film-coated, with a fault line on one side. Insignificant surface roughness of the tablets is allowed.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Glevo (levofloxacin) is a broad-spectrum antimicrobial bactericide from the group of fluoroquinolones. It blocks 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.

To the drug are sensitive:

Aerobic Gram-positive organisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative Methicillin-sensitive (methicillin-moderately sensitive), Staphylococcus aureus methicillin-sensitive, Staphylococcus epidermidis methicillin-sensitive, Staphylococcus spp (CNS), Streptococci group C and G, Streptococcus agalactiae, Streptococcus. pneumoniae penicillin-sensitive / -residually sensitive / -resistant, Streptococcus pyogenes, Viridans streptococci Penicillin-moderately sensitive / -resistant.

Aerobic Gram-negative microorganisms: Acinetobacter baumannii, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Enterobacter spp., Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampicillin-sensitive / -resistant, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Klebsiella pneumoniae, Klebsiella spp., Moraxella catarrhalis β+/β-, Morganella morganii, Neisseria gonorrhoeae not producing penicillinase / producing penicillinase, Neisseria meningitidis, Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida, Pasteurella spp., Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas spp., Salmonella spp., Serratia marcescens, Serratia 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, Legionella spp., Micobacterium leprae, Micobacterium tuberculosis, Micobacterium spp., Mycoplasma hominis, Mycoplasma pneumoniae, Ricketsia spp., Ureaplasma urealyticum.

Pharmacokinetics:

When ingested quickly and almost completely absorbed (eating little influence on speed and completeness of absorption). Bioavailability is 99%. Time to reach the maximum concentration in the blood (Tcmah) - 1-2 hours; at reception of 250 and 500 mg the maximum concentration in a blood (Withmax) is 2.8 and 5.2 μg / ml, respectively. 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. The half-life (T1 / 2) is 6-8 hours.It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Less than 5 % Levofloxacin is excreted in the form of metabolites. In unchanged form, daughters deduce 70% within 24 hours and 87% in 48 hours; in the intestine for 72 hours 4 % taken inward dose.

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;

- septicemia / bacteremia associated with the above indications;

- infection of the abdominal cavity;

- for the complex treatment of drug-resistant forms of tuberculosis.

Contraindications:

Hypersensitivity to levofloxacin and other fluoroquinolones, epilepsy, tendon damage with previously treated quinolones, pregnancy, lactation, children and adolescence (up to 18 years).

Carefully:

Elderly age (high probability of concomitant decrease in kidney function), deficiency of glucose-6-phosphate dehydrogenase.

Dosing and Administration:

The drug is taken orally once or twice a day.Tablets can not be chewed and washed down with a sufficient amount of liquid (0.5 to 1 cup), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the suspected pathogen susceptibility.

Patients with normal or moderately reduced renal function (creatinine clearance> 50 mL / min) are recommended the following dosing regimen:

Sinusitis: 500 mg once a day - 10-14 days.

Exacerbation of chronic bronchitis: 250 mg or 500 mg once a day - 7-10 days.

Community-acquired pneumonia: 500 mg 1-2 times a day - 7-14 days.

Uncomplicated urinary tract infections: 250 mg once a day - 3 days.

Prostatitis: 500 mg - once a day - 28 days.

Complicated urinary tract infections, including pyelonephritis: 250 mg once a day - 7-10 days.

Infections of the skin and soft tissues: 250-500 mg 1-2 times a day - 7-14 days. Intra-abdominal infection: 500 mg once a day - 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

Dosing regimen for patients with impaired renal function:

Creatinine clearance	250 mg / 24 h	500 mg / 24 h	500 mg / 12 h
	first dose:	first dose:	first dose:
	250 mg	500 mg	500 mg
50-20 ml / min	then:	then:	then:
	125 mg / 24 h	250 mg / 24 h	250 mg / 12 h each
19-10 ml / min	then:	then:	then:
	125 mg / 48 h	125 mg / 24 h	125 mg / 12 h
<10 ml / min (including	then:	then:	then:
hemodialysis and CAPD)	125 mg / 48 h	125 mg / 24 h	125 mg / 24 h

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

If the liver function is not required, a special dose selection is required, since levofloxacin is metabolized in the liver only to a very small extent.

For elderly patients, there is no need to change the dosage regimen, except for cases of low creatinine clearance.

As with the use of other antibiotics, treatment with the Glevo drug, film-coated tablets, 250 mg and 500 mg is recommended to continue at least 48-78 hours after normalization of body temperature or after a reliable eradication of the pathogen.

If you missed taking the drug, you should take a pill as soon as possible until the time of the next appointment is near. Then continue taking the drug according to the scheme.

Side effects:

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

Data from clinical studies of levofloxacin

Heart Disease

Rare: sinus tachycardia

Unknown frequency: elongation interval QT.

Violations of the blood and lymphatic system

Infrequent: leukopenia (decrease in the number of leukocytes in peripheral blood), eosinophilia (an increase in the number of eosinophils in peripheral blood).

Rare: neutropenia (decrease of neutrophils in peripheral blood), thrombocytopenia (decrease the number of platelets in the peripheral blood).

Unknown frequency: pancytopenia (decrease in the number of all form elements in peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in peripheral blood), hemolytic anemia.

Disturbances from the nervous system

Frequent: headache, dizziness.

Infrequent: drowsiness, tremor, dysgeusia (perversion of taste).

Rare: paresthesia, convulsions.

Unknown frequency: peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, loss of taste, parosmia (disorder of a sense of smell, especially subjective sense of smell, objectively absent), including loss of smell.

Disturbance of the organs of vision

Very rare: visual impairment, such as the vagueness of the visible image.

Hearing disorders and labyrinthine disorders

Infrequent: vertigo (feeling deflection or twisting or own body or surrounding objects).

Rare: ringing in the ears.

Unknown frequency: decrease hearing.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequent: shortness of breath.

Unknown frequency: bronchospasm, allergic pneumonitis.

Disorders from the gastrointestinal tract

Frequent: diarrhea, vomiting, nausea.

Infrequent: abdominal pain, indigestion.

Unknown frequency: hemorrhagic diarrhea, which in very rare cases may be a sign of enterocolitis, including pseudomembranous colitis.

Disorders from the kidneys and urinary tract

Infrequent: increased serum creatinine concentration.

Rare: acute renal insufficiency (for example, due to development interstitial nephritis).

Disturbances from the skin and subcutaneous tissues

Infrequent: rash, itching, hives.

Unknown frequency: toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (hypersensitivity to solar and ultraviolet radiation), leukocytoclastic vasculitis. Reactions from the skin and mucous membranes can sometimes develop even after taking

Disturbances from the musculoskeletal system and connective tissue

Infrequent: arthralgia, myalgia.

Rare: lesions of tendons, including tendonitis (for example, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia gravis (myasthenia gravis).

Unknown frequency: rhabdomyolysis, tendon rupture (eg Achilles tendon). This side effect can be observed within 48 hours after the start of treatment and can be bilateral.

Disorders from the metabolism and nutrition

Infrequent: anorexia.

Rare: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: "wolfish" appetite, nervousness, perspiration, trembling).

Infectious and parasitic diseases

Infrequent: fungal infections, development of resistance of pathogenic microorganisms.

Vascular disorders

Rare: decreased blood pressure pressure.

General disorders

Infrequent: asthenia.

Rare: pyrexia (increased body temperature).

Immune system disorders

Rare: angioedema.

Unknown frequency: 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

Frequent: increased activity "hepatic" enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (ASAT)).

Infrequent: increased concentration of bilirubin in the blood.

Unknown frequency: severe liver failure, including cases of development of acute hepatic insufficiency, especially in patients with severe underlying disease (eg, sepsis); hepatitis.

Disorders of the psyche

Frequent: insomnia.

Infrequent: a sense of anxiety, confusion of consciousness.

Rare: mental disorders (for example, with hallucinations), depression, agitation (agitation), sleep disturbance, nightmares.

Unknown frequency: mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts.

Other possible undesirable effects related to all fluoroquinolones

Very rare: attacks of porphyria (a very rare metabolic disease) in patients already suffering from this disease.

Overdose:

Symptoms: nausea, erosive lesions of the mucous membranes of the gastrointestinal tract, lengthening of the interval Q-T, confusion, dizziness, convulsions.

Treatment: symptomatic, dialysis is not effective.

Interaction:

Increases T1 / 2 cyclosporine.

The effect of the drug reduces drugs that depress intestinal motility, sucralfate, aluminum / magnesium-containing antacid drugs and iron salts (a break between intake of at least 2 hours is necessary).

Non-steroidal anti-inflammatory drugs (NSAIDs), theophylline increase convulsive readiness, glucocorticosteroids increase the risk of rupture of tendons.

Cimetidine and drugs that block tubular secretion, slow down excretion. Hypoglycemic drugs: strict control over the level of glucose in the blood is necessary, since there is a possibility of hyper- and hypoglycemia with simultaneous use with levofloxacin.

Special instructions:

Although levofloxacin and more soluble than other quinolones, patients should adequate hydration of the body.

During treatment, sun and artificial UV irradiation should be avoided to avoid damage to the skin (photosensitivity).

When there are signs of tendonitis, pseudomembranous colitis levofloxacin immediately cancel and prescribe appropriate therapy.

It should be borne in mind that in patients with a history of brain damage (stroke, severe trauma), convulsions may develop, with insufficiency of glucose-6-phosphate dehydrogenase - the risk of hemolysis increases.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets, 250 mg and 500 mg.

Packaging:

For 5 tablets in a contour mesh box made of PVC-aluminum foil.

1, 2 or 5 contour squares are placed in a cardboard box together with the instruction for use.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 of the year. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002342/08

Date of registration:02.04.2008 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

GLENMARK PHARMACEUTICALS, Ltd. India

Representation: & nbspGLENMARK PHARMACEUTICALS LTD. GLENMARK PHARMACEUTICALS LTD. India

Information update date: & nbsp26.04.2017

Illustrated instructions

Instructions

Glevo (Glevo)