Flemoclav soljutab pills 250mg + 62.5mg №20

Dispersible tablets

Composition

1 tab. contains Amoxicillin trihydrate 500 mg, potassium clavulanate 125 mg.

Packing

20 pcs.

Mechanism of action

Antibiotic penicillin group of a broad spectrum of action; contains semi-synthetic penicillin amoxicillin and b-lactamase inhibitor clavulanic acid.
Amoxicillin acts bactericidal, inhibits cell wall synthesis. Clavulanic acid inhibits the majority of clinically significant b-lactamase (types II, III, IV and V - according to the classification of Richmond-Sykes). Inactive against b-lactamase type I produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid forms a stable inactivated complex with these enzymes, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamase and expands its spectrum of action.
Flemoclav Solutab is active in respect of both amoxicillin-sensitive strains and strains producing b-lactamase.
Flemoclav Solutabactive against aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Staphylococcus aureus (including strains producing b-lactamases), Staphylococcus epidermidis (including strains producing b-lactamases), Enterococcus faecalis, Corynephroschropes occhestricheschethropes ochertchenthemes, inchemeshartherzeffeschartcheffeschartsercus b.anaerobic gram-positive bacteria: Clostridium spp., Peptostreptococcus spp., Peptococcus spp.;aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including strains of the above bacteria, produce b-lactamase), Neisseria meningitidis, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarralis, Pasteurela multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori;anaerobic gram-negative bacteria: Bacteroides spp., Including Bacteroides fragilis (including b-lactamase producing strains).

Indications and usage

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and upper respiratory tract (including otitis media, sinusitis, tonsillitis, pharyngitis);
- infections of the lower respiratory tract (chronic bronchitis and its exacerbation, community-acquired pneumonia);
- infections of the skin and soft tissues;
- infections of the kidneys and urinary tract;
- genital infections.

Contraindications

- abnormal liver function (including jaundice) while taking amoxicillin / clavulanic acid in history;
- infectious mononucleosis or lymphocytic leukemia (danger of exanthema);
- children's age up to 2 years (for this dosage form);
- hypersensitivity to other beta-lactam antibiotics, such as penicillins and cephalosporins;
- hypersensitivity to amoxicillin, clavulanic acid and other components of the drug.
with caution It should be prescribed for severe liver failure, chronic renal failure, gastrointestinal diseases (includinghistory of colitis associated with the use of penicillins).

Pregnancy and Breastfeeding

When using Flemoclav Solutab during pregnancy, there was no negative effect on the fetus or newborn. Use of the drug in the II and III trimester of pregnancy is considered safe. In the first trimester of pregnancy, Flemoclav Solutab should be used with caution.
Amoxicillin is excreted in breast milk. There is no data on removal of clavulanic acid with breast milk. There were no adverse effects on the child during breastfeeding while taking Flemoclav Solyubt.

Dosage and administration

Adults and children over 12 years old (weighing more than 40 kg) are prescribed 1 pill each. 500/125 mg 3 times / day. Atsevere, chronic, recurrent infections this dose can be doubled.
For children aged 2 to 12 years (with a body weight of 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 dose is 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). Atsevere 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 re-medical examination, becauseThe risk of side effects increases when taking the drug for more than 14 days.

Adverse reactions

Allergic reactions: often - urticaria, erythematous rashes; rarely, exudative erythema multiforme; in rare cases - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock, angioedema. In some cases, the so-called "fifth day rash" (coregid rash) appears.
Gastrointestinal: often - nausea, vomiting, diarrhea, abdominal pain, abnormal liver function, increased activity of hepatic transaminases; rarely - hepatitis, cholestatic jaundice; in rare cases - pseudomembranous colitis. An increase in transaminase activity (ACT and ALT), bilirubin and alkaline phosphatase is usually observed in males and in elderly patients, especially those over 65 years of age. These phenomena are very rarely observed in children. The above changes usually appear during treatment or immediately after. Sometimes it may appear a few weeks after discontinuation of the drug. In general, reactions from the digestive system are transient and insignificant, but sometimes they are pronounced.
Hemic and lymphatic: rarely - leukopenia, thrombocytopenia, hemolytic anemia.
Other: candidiasis, development of superinfection, rash; rarely - a reversible increase in prothrombin time, interstitial nephritis, vasculitis.

Special notes

In the case of Anaphylactic reactions in response to taking Flemoclav Solutab, the drug should be stopped immediately and appropriate therapy (administration of epinephrine / adrenaline /, GCS, elimination of respiratory failure) should be carried out.
When taking Flemoclav Solutab there is the possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.
Perhaps the development of superinfection (in particular - candidiasis) due to the growth of microflora insensitive to the drug, especially in patients with chronic diseases and / or impaired function of the immune system. In the event of a superinfection, taking the drug is canceled and / or modified in appropriate way antibiotic therapy.
In case of abnormal liver function, the drug should be prescribed with caution and under constant medical supervision. Do not use the drug for more than 14 days without assessing liver function.
An increase in prothrombin time may be observed while taking the drug. Therefore, Flemoclav Solutab should be prescribed with caution to patients receiving anticoagulant therapy (it is necessary to monitor blood clotting rates).
Amoxicillin should not be administered with disulfiram.
During the period of application of Flemoclav Solyubab, non-enzymatic methods for determining glucose in the urine, as well as the test for urobilinogen, can give false positive results.
In the course of treatment, it is necessary to monitor the state of the function of the blood-forming organs, liver and kidneys.

Drug Interactions

With simultaneous use with Flemoklavom Solutab antacids, Glucosamine, laxative drugs, aminoglycosides slow down and reduce the absorption of the active components of the drug; Ascorbic acid - increases.
With simultaneous use with Flemoclav Solutab bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, Vancomycin, rifampicin) exhibit synergism of interaction; bacteriostatic drugs (macrolides, chloramphenicol, linkosamides, tetracyclines, sulfonamides) - antagonism.
With the simultaneous use of Flemoclav Solutab increases the effectiveness of indirect anticoagulants by suppressing the intestinal microflora, reducing the synthesis of vitamin K and prothrombin index.
Flemoclav Solutab with simultaneous use reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which PABK is formed, ethinyl estradiol (risk of developing acyclic bleeding).
Diuretics, Allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, while used with Flemoclav Solutab increase the concentration of amoxicillin (clavulanic acid is derived mainly by glomerular filtration).
The simultaneous use of Flemoclav Solutab with allopurinol increases the risk of skin rash.
The simultaneous use of amoxicillin and Digoxin can lead to an increase in the concentration of digoxin in the blood plasma.

Symptoms: nausea, vomiting, diarrhea with possible disturbance of water and electrolyte balance.
Treatment: activated charcoal is prescribed, it is necessary to maintain water and electrolyte balance, symptomatic therapy is carried out, diazepam is prescribed for convulsions, hemodialysis is used for severe renal insufficiency.

The drug should be stored out of the reach of children at a temperature up to 25 ° C.