Flemoclav Solutab, dispersible pills 250mg+62.5mg, 20pcs

Composition

1 tab. contains amoxicillin trihydrate 250 mg,

potassium clavulanate 62.5 mg

Pharmacological action

Broad-spectrum penicillin group antibiotic; contains semi-synthetic penicillin amoxicillin and b-lactamase inhibitor clavulanic acid.

Amoxicillin acts bactericidal, inhibits the synthesis of the cell wall. Clavulanic acid inhibits most clinically significant b-lactamases (types II, III, IV and V – according to the Richmond-Sykes classification). Inactive against type I b-lactamases 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 b-lactamases and expands the spectrum of its action.

Flemoclav Solutab is active against both amoxicillin-sensitive strains and b-lactamase-producing strains. Flemoclav Solutab is active against aerobic gram-positive bacteria:  Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Staphylococcus aureus (including b-lactamase-producing strains), Staphylococcus epidermidis (including b-lactamase-producing strains), Enterococcus faecalis, Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes; 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 b-lactamase producing strains of the above bacteria), 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

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

Use during pregnancy and lactation

When using Flemoclav Solutab during pregnancy, its negative effect on the fetus or newborn was not noted.

The use of the drug in the second and third 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 are no data on the elimination of clavulanic acid in breast milk.

There were no negative effects on the child during breastfeeding while taking Flemoclav Solutab.

Contraindications

of liver dysfunction (including jaundice) while taking amoxicillin/clavulanic acid in history; infectious mononucleosis or lymphocytic leukemia (risk of appearance 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, the drug should be prescribed for severe hepatic insufficiency, chronic renal failure, gastrointestinal diseases (including colitis associated with the use of penicillins, in the anamnesis).

Side effects

Allergic reactions:  often – urticaria, erythematous rashes; rarely-erythema multiforme; in isolated cases-exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock, angioedema. In some cases, the so-called “rash of the fifth day” (korevidnaya exanthema) appears.

From the digestive system:  often – nausea, vomiting, diarrhea, abdominal pain, impaired liver function, increased activity of hepatic transaminases; rarely-hepatitis, cholestatic jaundice; in isolated cases-pseudomembranous colitis. Increased activity of transaminases (ACT and ALT), bilirubin and alkaline phosphatase is usually observed in males and in elderly patients, especially over 65 years of age. These phenomena are very rare in children.

The above changes usually appear during treatment or immediately after. Sometimes they may appear several weeks after discontinuation of the drug. In general, reactions from the digestive system are transient and insignificant, but sometimes they are pronounced.

From the hematopoietic system:  rarely-leukopenia, thrombocytopenia, hemolytic anemia. Other services:  candidiasis, development of superinfection, exanthema; rarely-reversible increase in prothrombin time, interstitial nephritis, vasculitis.

Interaction

When used concomitantly with Flemoclav Solutab, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of the active components of the drug; ascorbic acid increases.

When used concomitantly with Flemoclav Solutab, bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) show synergistic interactions; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonism.

When used concomitantly, Flemoclav Solutab increases the effectiveness of indirect anticoagulants by suppressing intestinal microflora, reducing the synthesis of vitamin K and the prothrombin index.

Flemoclav Solutab, when used concomitantly, reduces the effectiveness of oral contraceptives, drugs that produce PABA and ethinyl estradiol in the process of metabolism (the risk of acyclic bleeding).

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, when used simultaneously with Flemoclav Solutab, increase the concentration of amoxicillin (clavulanic acid is mainly excreted by glomerular filtration). Simultaneous use of Flemoclav Solutab with allopurinol increases the risk of skin rash.

Concomitant use of amoxicillin and digoxin may lead to an increase in the concentration of digoxin in blood plasma.

How to take, course of use and dosage

Adults and children over 12 years of age (with a body weight of more than 40 kg) the drug is prescribed for 1 tab. 500/125 mg 3 times a day. For severe, 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 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 7-12 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, as the risk of side effects increases if the drug is taken for more than 14 days.

Overdose

Symptoms:  nausea, vomiting, diarrhea with possible violations of water and electrolyte balance.

Treatment:  activated charcoal is prescribed, water and electrolyte balance must be maintained, symptomatic therapy is performed, diazepam is prescribed for convulsions, and hemodialysis is performed for severe renal failure.

Special instructions

If anaphylactic reactions develop in response to taking Flemoclav Solutab, the drug should be stopped immediately and appropriate therapy should be carried out (use of epinephrine /epinephrine/, corticosteroids, elimination of respiratory failure).

When taking Flemoclav Solutab, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

It is possible to develop superinfection (in particular, candidiasis) due to the growth of microflora that is insensitive to the drug, especially in patients with chronic diseases and / or impaired immune system function. In case of superinfection, the drug is discontinued and / or the antibacterial therapy is changed accordingly.

If liver function is impaired, the drug should be administered with caution and under constant medical supervision. Do not use the drug for more than 14 days without evaluating liver function.

Against the background of taking the drug, an increase in prothrombin time may occur. Therefore, Flemoclav Solutab should be administered with caution in patients receiving anticoagulant therapy (blood clotting parameters should be monitored). Amoxicillin should not be given with disulfiram.

During the period of application of Flemoclav Solutab, non-enzymatic methods for determining glucose in urine, as well as the urobilinogen test, can give false positive results.

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

Form of production

Dispersible tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Skin Infections, Otitis Media, Pharyngitis, Sore Throat, Sinusitis, Cholecystitis, Bronchitis, Tonsillitis, Pneumonia, Urinary Tract Infections, Periodontitis