Flemoklav Solutab dispersible tablets 500 + 125mg, No. 20

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• diseases of the upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);

• lower respiratory tract (including exacerbation of chronic bronchitis, COPD, community-acquired pneumonia);

• infections of the skin and soft tissues;

• urinary system (including cystitis, pyelonephritis).

For adults and children over 12 years old (weighing more than 40 kg), the drug is prescribed 1 tab. 500/125 mg 3 times / day. For severe, chronic, recurrent infections, this dose can be doubled.

For children aged 2 to 12 years (weighing approximately 13-37 kg), the daily dose is 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. On average, this is a dose of 125 / 31.25 mg 3 times / day for children aged 2 to 7 years (body weight about 13-25 kg) and 250 / 62.5 mg 3 times / day for children aged 7 to 12 years ( body weight about 25-37 kg). For severe infections, this dose can be doubled. The maximum daily dose is 60 mg of amoxicillin and 15 mg of clavulanic acid per kg of body weight.

The duration of treatment depends on the severity of the infection and is 5-14 days. Treatment should not be continued for more than 14 days without a second medical examination. the risk of side effects increases when the drug is taken for more than 14 days.

Dispersible tablets of oblong shape, from white to yellow color with brown dotted spots, without risks and bearing the marking '424' and the company logo.

1 tab.

amoxicillin trihydrate 582.8 mg,

which corresponds to the content of amoxicillin base 500 mg

potassium clavulanate 148.9 mg,

which corresponds to the content of clavulanic acid 125 mg

Excipients: microcrystalline cellulose - 327.3 mg, crospovidone - 100 mg, vanillin - 1 mg, apricot flavor - 9 mg, saccharin - 9 mg, magnesium stearate - 5 mg.

• Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;

• hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins);

• a history of jaundice or liver dysfunction while taking amoxicillin + clavulanic acid;

• Infectious mononucleosis;

• lymphocytic leukemia.

Carefully:

• severe liver failure;

• diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins);

• chronic renal failure.

pharmachologic effect

Combined preparation of amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Acts bactericidal, inhibits the synthesis of the bacterial wall.

Active against aerobic gram-positive bacteria (including strains producing beta-lactamase): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp .; as well as aerobic gram-negative bacteria (including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis,Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroides spp., including Bacteroides fragilis.

Clavulanic acid inhibits types II, III, IV and V beta-lactamases, is inactive against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Pharmacokinetics

After oral administration, both components are rapidly absorbed in the gastrointestinal tract. Concomitant food intake does not affect absorption. TCmax - 45 min. After oral administration at a dose of 250/125 mg every 8 hours Cmax of amoxicillin - 2.18-4.5 ?g / ml, clavulanic acid - 0.8-2.2 ?g / ml, at a dose of 500/125 mg every 12 hours Cmax of amoxicillin - 5.09-7.91 ?g / ml , clavulanic acid - 1.19-2.41 ?g / ml, at a dose of 500/125 mg every 8 hours Cmax of amoxicillin - 4.94-9.46 ?g / ml, clavulanic acid - 1.57-3.23 ?g / ml, at a dose of 875/125 mg Cmax of amoxicillin - 8.82 -14.38 ?g / ml, clavulanic acid - 1.21-3.19 ?g / ml.

After intravenous administration in doses of 1000/200 mg and 500/100 mg, Cmax of amoxicillin is 105.4 and 32.2 ?g / ml, respectively, and clavulanic acid is 28.5 and 10.5 ?g / ml.

The time to reach the maximum inhibitory concentration of 1 ?g / ml for amoxicillin is similar when used after 12 hours and 8 hours in both adults and children.

Plasma protein binding: amoxicillin - 17-20%, clavulanic acid - 22-30%.

Both components are metabolized in the liver: amoxicillin - by 10% of the administered dose, clavulanic acid - by 50%.

T1 / 2 after taking a dose of 375 and 625 mg - 1 and 1.3 hours for amoxicillin, 1.2 and 0.8 hours for clavulanic acid, respectively. T1 / 2 after i.v. administration at a dose of 1200 and 600 mg - 0.9 and 1.07 h - for amoxicillin, 0.9 and 1.12 h - for clavulanic acid, respectively. It is excreted mainly by the kidneys (glomerular filtration and tubular secretion): 50-78 and 25-40% of the administered dose of amoxicillin and clavulanic acid are excreted, respectively, unchanged during the first 6 hours after administration.

Side effect

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of hepatic transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with prolonged therapy), pseudomembranous and hemorrhagic colitis ( can also develop after therapy), enterocolitis, black 'hairy' tongue, darkening of tooth enamel.

From the side of hematopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

From the nervous system: dizziness, headache, hyperactivity, anxiety, change in behavior, seizures.

Local reactions: in some cases - phlebitis at the intravenous injection site.

Allergic reactions: urticaria, erythematous rash, rarely - exudative erythema multiforme, anaphylactic shock, angioedema, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), serous allergic vasculitis, pustular syndrome, similar to acute ...

Others: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

Application during pregnancy and lactation

Use with caution during pregnancy and lactation (breastfeeding).

Application for violations of liver function

Contraindicated in cases of jaundice or liver dysfunction as a result of amoxicillin / clavulanic acid use in history.

Precautions: severe hepatic impairment

Application for impaired renal function

In chronic renal failure, the dose and frequency of administration are adjusted depending on the CC: if CC is more than 30 ml / min, dose adjustment is not required; with CC 10-30 ml / min: inside - 250-500 mg / day every 12 hours; i / v - 1 g, then 500 mg i / v; with CC less than 10 ml / min - 1 g, then 500 mg / day intravenously or 250-500 mg / day orally in one dose. For children, doses should be reduced in the same way. With CC less than 30 ml / min, the use of 875 mg / 125 mg tablets is contraindicated.

Patients on hemodialysis - 250 mg or 500 mg orally at one time or 500 mg IV, an additional 1 dose during dialysis and 1 more dose at the end of the dialysis session.

Application in children

Children under 12 years old - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg / kg / day in 2 divided doses; 3 months and older - for infections of mild severity - 25 mg / kg / day in 2 doses or 20 mg / kg / day in 3 doses, for severe infections - 45 mg / kg / day in 2 doses or 40 mg / kg / days in 3 doses.
The maximum daily dose of amoxicillin for children under 12 years of age is 45 mg / kg of body weight.

The maximum daily dose of clavulanic acid for children under 12 years of age is 10 mg / kg of body weight.

special instructions

During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals.

The development of superinfection is possible due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.

May give false positive results for glucose in urine. In this case, it is recommended to use the glucose-oxidative method for determining the concentration of glucose in the urine.

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Drug interactions

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid enhances absorption.

Bacteriostatic antibiotics (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor the indicators of blood clotting.

Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which PABA is formed, ethinyl estradiol - the risk of bleeding 'breakthrough'.

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of skin rashes.