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General characteristics. Structure:

Active agents: amoxicillin (in the form of trihydrate) 125 mg; clavulanic acid (in the form of potassium clavulanate) 31.25 mg

Excipients: lactulose - 200 mg, aspartame - 5.5 mg, silicon dioxide colloid (aerosil) - 16.885 mg, gum xanthane - 10 mg, кросповидон (коллидон CL-M) - 28.1 mg, citric acid anhydrous - 2.165 mg, citrate sodium a dihydrate - 8.335 mg, Natrium benzoicum - 2.085 mg, talc - 25 mg, fragrance orange - 4 mg, Mannitolum (mannitol) - to 1:25 g.

 
Active agents: amoxicillin (in the form of trihydrate) 250 mg; clavulanic acid (in the form of potassium clavulanate) 62.5 mg

Excipients: lactulose - 400 mg, aspartame - 5.5 mg, silicon dioxide colloid (aerosil) - 16.885 mg, gum xanthane - 10 mg, кросповидон (коллидон CL-M) - 28.1 mg, citric acid anhydrous - 2.165 mg, citrate sodium a dihydrate - 8.335 mg, Natrium benzoicum - 2.085 mg, talc - 25 mg, fragrance orange - 4 mg, Mannitolum (mannitol) - to 1:25 g.

Pharmacological properties:

The combined drug of amoxicillin and clavulanic acid - inhibitor beta лактамаз. Amoxicillin – a semi-synthetic antibiotic of a wide range; works bakteritsidno, oppressing synthesis of protein of a cell wall of sensitive bacteria at growth stage. Klavulanovy acid has high affinity to bacterial beta lactamelements and forms with them a stable complex. Thus, amoxicillin biodegradation by beta lactamelements is prevented, and bactericidal activity of an antibiotic remains. Klavulanovy acid inhibits beta lactamelements of the II-V types on classification of Richmond Sykes and is not active concerning the beta laktamaz of the I type produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
The combined drug of amoxicillin and clavulanic acid by results of tests of in vitro and clinical trials is active concerning the following microorganisms:
Gram-positive aerobic microorganisms:
Staphylococcus aureus (the strains which are producing and not producing beta lactamelements);
Gram-negative aerobic microorganisms:
Enterobacter spp. (in spite of the fact that the majority of strains of Enterobacter in vitro are steady, efficiency of drug at treatment of the infectious diseases of an urinary system caused by this activator is clinically proved);
Escherichia coli (the strains which are producing and not producing beta lactamelements);
Haemophilus influenzae (the strains which are producing and not producing beta lactamelements);
Klebsiella spp. (all known strains produce beta lactamelements);
Moraxella catarrhalis (the strains which are producing and not producing beta lactamelements).
On результатм the researches in vitro sensitivity to a combination of amoxicillin and clavulanic acid of the following microorganisms is shown:
Gram-positive aerobic microorganisms:
Enterococcus faecalis **;
Staphylococcus epidermidis (the strains which are producing and not producing beta lactamelements);
Staphylococcus saprophyticus (the strains which are producing and not producing beta lactamelements);
Streptococcus pneumoniae ** (beta лактамаз does not produce);
Streptococcus pyogenes ** (beta лактамаз does not produce);
Streptococcus spp. the viridans groups ** (beta лактамаз does not produce).
Gram-negative aerobic microorganisms:
Eikenella corrodens (the strains which are producing and not producing beta lactamelements);
Neisseria gonorrhoeae ** (the strains which are producing and not producing beta lactamelements);
Proteus mirabilis ** (the strains which are producing and not producing beta lactamelements).
Anaerobic microorganisms:
Bacteroidesspp., including Bacteroides fragilis (the strains which are producing and not producing beta lactamelements);
Fusobacterium spp. (the strains which are producing and not producing beta lactamelements);
Peptostreptococcus spp. (beta лактамаз does not produce).
NOTE: ** - (efficiency of amoxicillin at treatment of a number of the infections caused by these activators is clinically proved).
The lactulose which is a part Ekoklava as a bifidogenny factor is synthetic disaccharide which molecule consists of the remains of a galactose and fructose. Lactulose in a stomach and upper parts of intestines is not soaked up and not hydrolyzed. The lactulose which is released from tablets Ekoklava as substrate is fermented by normal microflora of a large intestine, stimulating growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in a large intestine organic acids - milk, acetic and ant, suppressing growth of pathogenic microorganisms and reducing thereof products of nitrogen-containing toxic substances are formed.
Thus, lactulose in structure Ekoklava reduces the damaging action of an antibiotic on the normal intestinal microflora and risks of side effects connected with disbioza.

Pharmacokinetics. Absorption. After intake both components of drug are quickly soaked up from digestive tract. Absorption of active ingredients of drug is optimum in case of its reception at the beginning of food.
After intake in a dose of 125 mg +31.25 mg:
- Cmax of amoxicillin – 1.96 mkg/ml, clavulanic acid – 0.77 mkg/ml;
- Tmax of amoxicillin is 1.5 h, clavulanic acid – 1.0 h;
- AUC amoxicillin – 9.19 mg • h/l, clavulanic acid – 2.69 mg • h/l.
At use of drug of concentration of amoxicillin in blood serum are similar to those at oral administration of equivalent doses of one amoxicillin.

Distribution. Both components of drug are characterized by the good volume of distribution – therapeutic concentration of amoxicillin and clavulanic acid are created in various bodies and fabrics, intersticial liquid: lungs, middle ear, abdominal organs, bodies of a small pelvis (prostate gland, uterus, ovaries), skin; fatty, bone and muscular fabrics; pleural, synovial and peritoneal liquids; to plasma, bile, purulent separated, a phlegm, a bronchial secret.
Amoxicillin and clavulanic acid possess moderate extent of linkng with proteins of plasma, respectively, for 18% and 25%.
Both components of drug get through a placental barrier, however data on a negative impact on a fruit are not published.
Amoxicillin and clavulanic acid in low concentration are found in breast milk.

Metabolism, removal. About 60-70% of amoxicillin are removed by kidneys: by canalicular secretion and glomerular filtering in an invariable look, about 10-25% in the form of inactive penitsilloyevy acid. Clavulanic acid is actively metabolized in a liver and removed by glomerular filtering (40-65%), partially in the form of metabolites. A smaller part is removed by intestines. At a renal failure the clearance of amoxicillin with clavulanic acid decreases therefore dose adjustment is required.
The lactulose which is a part Ekoklava does not exert impact on the key pharmacokinetic parameters characterizing bioavailability of amoxicillin and clavulanic acid.

Indications to use:

The infectious and inflammatory diseases caused by activators, sensitive to drug:
— lower respiratory tract infections (bronchitis, pneumonia);
— infections of ENT organs (sinusitis, tonsillitis, average otitis);
— infections of urinogenital system and bodies of a small pelvis (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingo-oophoritis, endometritis, bacterial vaginitis, septic abortion, venereal ulcer, gonorrhea);
— infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis, abscess, phlegmon, a wound fever);
— infections of bones and joints (osteomyelitis).

Route of administration and doses:

Inside. The mode of dosing is set individually depending on the body weight of the patient, weight of a current and localization of infectious process, and also sensitivity of the activator.
The minimum course of antibacterial therapy - of 5 days. It is longer not necessary to continue treatment 14 days without review of a clinical situation. Duration of treatment of acute uncomplicated average otitis makes 5-7 days, children up to 2 years have 7-10 days.
The single dose is established depending on age and the body weight (calculation for amoxicillin):
Children up to 3 months - 30 mg/kg/days in 2 receptions;
Children of 3 months are also more senior:
— low doses (for treatment of infections of skin and soft tissues, and also an adenoid disease) – 20 mg/kg/days in 3 receptions;
— high doses (for treatment of average otitis, sinusitis, lower respiratory tract infections, infections of urinary tract) – 40 mg/kg/days in 3 receptions.
Children with a body weight of 40 kg and more should appoint doses as the adult.
Suspension can be applied at adults at swallowing difficulty.
The recommended dosing mode for adults: 20 ml of suspension in a dosage of 125 mg +31.25 mg / сут.5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml of 2-3 times/days.
The maximum daily dose of amoxicillin for adults and children is more senior than 12 years - 6 g, for children up to 12 years - 45 mg/kg of body weight.
The maximum daily dose of clavulanic acid for adults and children is more senior than 12 years - 600 mg, for children up to 12 years - 10 mg/kg.

Patients with a renal failure:
Correction of doses is based on the maximum recommended dose of amoxicillin and value of clearance of creatinine.

Children
The clearance of creatinine more than 30 ml/min. dose adjustment is not required;
Clearance of creatinine of 10-30 ml/min. – 15 mg / 3.75 mg/kg 2vnutr. The mode of dosing is set individually depending on the body weight of the patient, weight of a current and localization of infectious process, and also sensitivity of the activator.
The minimum course of antibacterial therapy - of 5 days. It is longer not necessary to continue treatment 14 days without review of a clinical situation. Duration of treatment of acute uncomplicated average otitis makes 5-7 days, children up to 2 years have 7-10 days.
The single dose is established depending on age and the body weight (calculation for amoxicillin):
Children up to 3 months - 30 mg/kg/days in 2 receptions;
Children of 3 months are also more senior:
— low doses (for treatment of infections of skin and soft tissues, and also an adenoid disease) – 20 mg/kg/days in 3 receptions;
— high doses (for treatment of average otitis, sinusitis, lower respiratory tract infections, infections of urinary tract) – 40 mg/kg/days in 3 receptions.
Children with a body weight of 40 kg and more should appoint doses as the adult.
Suspension can be applied at adults at swallowing difficulty.
The recommended dosing mode for adults: 20 ml of suspension in a dosage of 125 mg +31.25 mg / сут.5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml of 2-3 times/days.
The maximum daily dose of amoxicillin for adults and children is more senior than 12 years - 6 g, for children up to 12 years - 45 mg/kg of body weight.
The maximum daily dose of clavulanic acid for adults and children is more senior than 12 years - 600 mg, for children up to 12 years - 10 mg/kg.

Patients with a renal failure:
Correction of doses is based on the maximum recommended dose of amoxicillin and value of clearance of creatinine.

Children
The clearance of creatinine more than 30 ml/min. dose adjustment is not required;
Clearance of creatinine of 10-30 ml/min. – 15 mg / 3.75 mg/kg 2, the maximum dose of 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 2 times/days;
Clearance of creatinine less than 10 ml/min. – 15 mg / 3.75 mg/kg of 1 time/days, the maximum daily dose of 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml);

Adults
The clearance of creatinine more than 30 ml/min. dose adjustment is not required;
Clearance of creatinine of 10-30 ml/min. – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 2;
Clearance of creatinine less than 10 ml/min. – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 1 time/days;

The patients who are on a hemodialysis:
Correction of doses is based on the maximum recommended amoxicillin dose
Children – 15 mg / 3.75 mg/kg of 1 times/days.
Before a session of a hemodialysis it is necessary to accept one additional dose of 15 mg / 3.75 mg/kg. For recovery of concentration of active components of drug in blood the second additional dose of 15 mg / 3.75 mg/kg should be accepted after the hemodialysis session.

Adult – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) once each 24 hours.
In addition 1 dose during the session of dialysis and one more dose at the end of dialysis session (for compensation of decrease in serumal concentration of amoxicillin and clavulanic acid)

Way of preparation of suspension:
Suspension prepares just before use.
Powder in a bottle is previously stirred up, then, adding a small amount of the boiled and cooled to room temperature water, mix, receiving homogeneous suspension, then add water to a tag on a bottle. For exact dosing of suspension it is necessary to use a dosing bilateral spoon which needs to be rinsed well water after each use. After cultivation it is necessary to store suspension no more than 7 days in the refrigerator, but not to freeze., the maximum dose of 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 2 times/days;
Clearance of creatinine less than 10 ml/min. – 15 mg / 3.75 mg/kg of 1 time/days, the maximum daily dose of 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml);

Adults
The clearance of creatinine more than 30 ml/min. dose adjustment is not required;
Clearance of creatinine of 10-30 ml/min. – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 2;
Clearance of creatinine less than 10 ml/min. – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) 1 time/days;

The patients who are on a hemodialysis:
Correction of doses is based on the maximum recommended amoxicillin dose
Children – 15 mg / 3.75 mg/kg of 1 times/days.
Before a session of a hemodialysis it is necessary to accept one additional dose of 15 mg / 3.75 mg/kg. For recovery of concentration of active components of drug in blood the second additional dose of 15 mg / 3.75 mg/kg should be accepted after the hemodialysis session.

Adult – 500 mg +125 mg (20 ml of suspension in a dosage of 125 mg +31.25 mg / 5 ml or 10 ml of suspension in a dosage of 250 mg +62.5 mg / 5 ml) once each 24 hours.
In addition 1 dose during the session of dialysis and one more dose at the end of dialysis session (for compensation of decrease in serumal concentration of amoxicillin and clavulanic acid)

Way of preparation of suspension:
Suspension prepares just before use.
Powder in a bottle is previously stirred up, then, adding a small amount of the boiled and cooled to room temperature water, mix, receiving homogeneous suspension, then add water to a tag on a bottle. For exact dosing of suspension it is necessary to use a dosing bilateral spoon which needs to be rinsed well water after each use. After cultivation it is necessary to store suspension no more than 7 days in the refrigerator, but not to freeze.

Features of use:

Expressiveness of gastrointestinal symptoms decreases at administration of drug at the beginning of food.

At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys.

Development of superinfection due to selection of resistant forms of the activator is possible.

False positive results when determining content of glucose in urine can be revealed. In this case it is recommended to apply a glyukozooksidazny method of definition of concentration of glucose in urine.

At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.

In case of suspicion on an infectious mononucleosis drug should not be used as with this disease amoxicillin can cause korepodobny skin rash in patients that complicates diagnosis of a disease.

Considering probability of development of side effects from the central nervous system, it is necessary to be careful at control of vehicles and work with moving mechanisms.

Side effects:

Drug is well transferred. Side effects arise seldom, happen preferential slight and have tranzitorny character.
From the alimentary system: nausea, vomiting, diarrhea, gastritis, stomatitis, a glossitis, cholestatic jaundice, hepatitis, a liver failure (is more often at elderly, men, at long therapy), colitis (including pseudomembranous), black "hairy" language, darkening of an adamantine substance of tooth, increase in activity of "hepatic" transaminases, increase in content of bilirubin and activity of an alkaline phosphatase.
From bodies of a hemopoiesis: reversible increase in a prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolitic anemia.
From the central nervous system: dizziness, headache, hyperactivity, alarm, change of behavior, spasm.
Allergic reactions: urticaria, erythematic rashes, multiformny exudative erythema, acute anaphylaxis, Quincke's disease, exfoliative dermatitis, malignant exudative erythema (Stephens-Johnson's syndrome), allergic vasculitis, syndrome similar to a serum disease, acute generalized exanthematous пустулез.
From kidneys and urinary tract: intersticial nephrite, crystalluria, hamaturia.
Others: candidiasis, development of superinfection.

Interaction with other medicines:

It is not recommended to use the combined drug of amoxicillin and clavulanic acid along with probenetsidy. Probenetsid reduces canalicular secretion of amoxicillin therefore their combined use can lead to increase and a persistention of concentration of amoxicillin in serum, at the same time serumal concentration of clavulanic acid does not change.

Diuretics, Allopyrinolum, phenylbutazone, the non-steroidal anti-inflammatory drugs and other medicines blocking canalicular secretion increase concentration of amoxicillin (clavulanic acid is removed generally by glomerular filtering).

Antacids, glycosamine, purgatives slow down and reduce amoxicillin absorption; ascorbic acid - raises.

Allopyrinolum increases risk of developing of skin rash.

As well as efficiency of oral contraceptives can reduce other antibiotics of a broad spectrum of activity, the combined drug of amoxicillin and clavulanic acid, and patients need to be informed on it.

In literature exceptional cases of increase in the international normalized relation (INR) at patients at combined use of an atsenokumarol or warfarin and amoxicillin are described. In need of simultaneous primeneniyakombinirovanny drug of amoxicillin and clavulanic acid with indirect anticoagulants the prothrombin time or MNO have to monitorirovatsya carefully at appointment or drug withdrawal.

Contraindications:

— hypersensitivity (including to cephalosporins and another beta лактамным to antibiotics);
— infectious mononucleosis;
— episodes of jaundice or an abnormal liver function as a result of use of amoxicillin/clavulanic acid in the anamnesis;
— a fenilketonuriya (contains aspartame).

With care:
Heavy liver failure, digestive tract diseases (including the colitis in the anamnesis connected using penicillin), a chronic renal failure.

Drug EKOKLAV® use suspension for intake at pregnancy and feeding by a breast
It is recommended to appoint the combined drug of amoxicillin and clavulanic acid at pregnancy only in cases when the expected advantage of its reception for mother exceeds potential risk for a fruit.
Drug can be used during breastfeeding. Except for the risk of a sensitization connected with penetration into breast milk of trace amounts of active ingredients of this drug, any other adverse effects at the babies who are on breastfeeding it was not revealed.

Use at abnormal liver functions
It is contraindicated in the presence of episodes of jaundice or an abnormal liver function as a result of use of amoxicillin/clavulanic acid in the anamnesis.
With care to appoint at a heavy liver failure.

Use at renal failures
With care to appoint at a chronic renal failure.

Use for children
Use is possible according to the dosing mode.

Overdose:

Symptoms: dysfunction of digestive tract and water and electrolytic balance.
Treatment: symptomatic. The hemodialysis is effective.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C.
Ready suspension is stored at a temperature from 2 °C to 8 °C in densely closed bottle.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Powder for пригот. сусп. for intake of 125 mg +31.25 mg / 5 ml: фл. 25 g about the doser. spoon 

Powder for пригот. сусп. for intake of 250 mg +62.5 mg / 5 ml: фл. 25 g about the doser. spoon.