Flemoclav soljutab pills 125mg + 31.25mg №20

Dosage form

Pills

Composition

1 pill dispersed contains: Amoxicillin 125 mg, clavulanic acid 31.25 mg.
Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavoring, saccharin, Magnesium stearate.

Packing

In the blister 4 tablets. In packing 5 blisters.

Mechanism of action

Flemoclav Solutab - broad-spectrum antibiotic; combined drug amoxicillin and clavulanic acid - an inhibitor of β-lactamase. Active against gram-positive and gram-negative microorganisms (including strains producing β-lactamase).
Amoxicillin acts bactericidal, inhibits the synthesis of the bacterial wall. Clavulanic acid inhibits β-lactamase II, III, IV, and V types according to the classification of Richmond-Sykes. Inactive against type-β-lactamase produced by: Enterobacter spp, Pseudomonas aeruginosa, Serratia spp, Acinetobacter spp.
Clavulanic acid has a high tropism for penicillinases, thereby forming a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamase and expands its spectrum of action.

Indications and usage

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- Infections of the upper respiratory tract and ENT organs: 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.

Contraindications

- Liver dysfunction (including jaundice) while taking amoxicillin / clavulanic acid in history.
- Infectious mononucleosis or lymphocytic leukemia (danger of exanthema).
- Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug.
- Hypersensitivity to other beta-lactam antibiotics, such as penicillins and cephalosporins.
Precautions should be prescribed the drug in the following cases:
- Severe liver failure.
- Chronic renal failure.
- Diseases of the digestive tract (including colitis associated with the use of penicillins in history).

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 the secretion of clavulanic acid in breast milk. There were no adverse effects on the child during breastfeeding while taking Flemoclav Solutab.

Dosage and administration

To prevent the appearance of side effects from the digestive system, the drug is recommended to be taken at the beginning of a meal. The pill is swallowed whole with a glass of water, or dissolved in half a glass of water (at least 30 ml), stirring well before use. The duration of treatment depends on the severity of the infection and, if necessary, should not exceed 14 days. Adults and children weighing more than 40 kg are prescribed the drug 500/125 mg 3 times / day. For severe, chronic, recurrent infections, this dose can be doubled. For children weighing up to 40 kg, the daily dose is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. In severe infections, these doses can be doubled (the maximum daily dose is 60 mg of amoxicillin and 15 mg of clavulanic acid per kg of body weight).
With impaired renal function, the elimination of clavulanic acid and amoxicillin by the kidneys slows down. Depending on the severity of renal insufficiency, the dose of Flemoclav Solutab (based on amoxicillin) should not exceed the dose given (creatinine clearance / adults / children): 10-30 ml / min / 500 mg 2 times / day / 15 mg / kg 2 times / day; less than 10 ml / min / 500 mg / day / 15 mg / kg / day; hemodialysis / 500 mg / day and 500 mg during and after dialysis / 15 mg / kg / day and 15 mg / kg during and after dialysis.

Adverse reactions

Allergic reactions: urticaria, erythematous rashes; rarely, 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. Allergic reactions depend on the dose of the drug and the patient's condition.
Gastrointestinal: nausea, vomiting, diarrhea, abdominal pain, abnormal liver function, increased liver transaminase activity; 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. The risk of such changes increases when taking the drug for more than 14 days. 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. Most reactions from the digestive system are transient and insignificant, but sometimes are pronounced.
Hemic and lymphatic: rarely - leukopenia, thrombocytopenia, hemolytic anemia.
Other: development of superinfection (including candidiasis), rash; rarely - a reversible increase in prothrombin time, interstitial nephritis, vasculitis.

Special notes

If Anaphylactic reactions develop, the drug should be immediately discontinued and appropriate therapy should be given: urgent treatment of anaphylactic shock may require urgent administration of epinephrine (adrenaline), GCS and the elimination of respiratory failure.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), 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. 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 a course of treatment, it is necessary to control the functions of the blood-forming organs, the liver and the 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 Solutyab bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, Vancomycin, rifampicin) exhibit synergism; 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 being used with Flemoclav Solutyub, increase amoxicillin concentration (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 disturbances of water and electrolyte balance.
Treatment: Activated carbon is prescribed, it is necessary to maintain water and electrolyte balance, symptomatic therapy is carried out. When convulsions prescribed diazepam. In renal failure, hemodialysis is severe.

The drug should be stored at a temperature not higher than 25 ° C.

3 years.