Flemoclav soljutab pills 875mg + 125mg №14

Dispersible tablets

Composition

1 pill dispersed contains: Amoxicillin 875 mg, clavulanic acid 125 mg.
Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavoring, saccharin, Magnesium stearate.

Packing

14 pcs.

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

Inside at the beginning of the meal (to prevent dyspeptic symptoms), without chewing, drinking a glass of water or dissolving the pill in half a glass of water (minimum 30 ml), thoroughly stirred before use.

The duration of treatment depends on the severity of the infection and should not, without special need, exceed 14 days.

Adults and children over 12 years old, as well as children under 12 years old weighing more than 40 kg, are prescribed the drug on 500 mg + 125 mg 3 times a day or 875 mg + 125 mg 2 times a day. A single dose is taken at regular intervals. For severe, recurrent and chronic infections, these doses can be doubled.

Children younger than 12 years old and weighing up to 40 kg should be prescribed Flemoclav Solutab with lower dosages: 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg.

For children aged 2 to 12 years (weighing about 13–37 kg), the daily dose is 20–30 mg / kg of amoxicillin and 5–7.5 mg / kg of clavulanic acid. Usually it is: for children 2–7 years old (body weight about 13–25 kg) - 125 mg + 31.25 mg 3 times a day; for children of 7–12 years old (body weight 25–37 kg) - 250 mg + 62.5 mg 3 times a day. In severe infections, these doses can be doubled (the maximum daily dose is 60 mg / kg of amoxicillin and 15 mg / kg of clavulanic acid).

In patients with renal insufficiency, the elimination of clavulanic acid and amoxicillin through the kidneys is delayed. Flemoclav Solutab at a dose of 875 mg + 125 mg can be used only with glomerular filtration rate> 30 ml / min. In this case, dose adjustment is not required.

Adverse reactions

Infections: infrequently (≥1 / 1000, <1/100) - bacterial or fungal superinfection (with long-term therapy or repeated courses of therapy).

On the part of the blood system and the blood-forming organs: rarely (≥1 / 10000, <1/1000) - thrombocytosis, hemolytic anemia; very rarely (<1/10000) - leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, an increase in PV and bleeding time. These adverse reactions are reversible and disappear after cessation of therapy.

Allergic reactions: often (≥1 / 100, <1/10) - skin rashes and itching; cortex-like exanthema appearing on the 5–11th day after the start of therapy. The appearance of urticaria immediately after the start of taking the drug with a high degree of probability is a manifestation of an allergic reaction and requires discontinuation of the drug; rarely (≥1 / 10000, <1/1000) - bullous or exfoliative dermatitis (exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactic shock; other allergic reactions - drug fever, eosinophilia, angioedema (angioedema), laryngeal edema, serum sickness, hemolytic anemia, allergic vasculitis, interstitial nephritis.

Nervous system: rarely (≥1 / 10000, <1/1000) - dizziness, headache, convulsions (in case of impaired renal function or overdose of the drug); very rarely (<1/10000) - hyperactivity, anxiety (anxiety), insomnia, impaired consciousness, aggressive behavior.

Cardiovascular: rarely (≥1 / 10000, <1/1000) - vasculitis.

Reactions from the alimentary system: often (≥1 / 100, <1/10) - abdominal pain, nausea (more often with an overdose), vomiting, flatulence, diarrhea (mostly reactions from the digestive system are transient and rarely pronounced; their intensity can be reduced, taking the drug at the beginning of the meal); pseudomembranous colitis (in the case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy) is in most cases caused by toxin-producing strainsClostridium difficile; rarely (≥ 1/10000, <1/1000) - intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel.

From the hepatobiliary system: often (≥ 1/100, <1/10) - a slight increase in liver enzyme activity; rarely (≥1 / 10000, <1/1000) - hepatitis and cholestatic jaundice. Symptoms of abnormal liver function occur during treatment or immediately after discontinuation of therapy, but in some cases they may appear several weeks after discontinuation of the drug; more common in men and patients over 60; in children - very rarely (<1/10000). The risk of adverse reactions increases with the use of the drug for more than 14 days. Liver dysfunction is usually reversible, sometimes severe and in very rare cases (<1/10000) and only in patients with severe concomitant diseases or while taking potentially hepatotoxic drugs can be fatal.

From the genitourinary system: infrequently (≥ 1/1000, <1/100) - itching, burning and vaginal discharge; rarely (> 1/10000, <1/1000) - interstitial nephritis.

Drug Interactions

Other antimicrobial drugs. When combined with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides, etc.) antagonism with amoxicillin / clavulanic acid was notedin vitro.

Disulfiram Amoxicillin / clavulanic acid should not be used simultaneously with disulfiram.

Drugs that inhibit the renal excretion of amoxicillin. The simultaneous intake of probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, Acetylsalicylic acid , Indomethacin and sulfinpyrazone promotes an increase in concentration and a longer stay of amoxicillin in blood plasma and bile. The excretion of clavulanic acid is not disturbed.

Antacids, Glucosamine , laxatives, drugs, aminoglycosides slow down and reduce absorption;vitamin C increases the absorption of amoxicillin.

Allopurinol. The use of Allopurinol and amoxicillin may increase the risk of skin rash.

Sulfasalazine. Aminopenicillins can reduce serum Sulfasalazine concentration.

Methotrexate. Amoxicillin reduces the renal clearance of Methotrexate , which can lead to an increase in the risk of its toxic action. When taken simultaneously with amoxicillin, it is necessary to monitor the concentration of methotrexate in the serum.

Digoxin. While taking amoxicillin / clavulanic acid, Digoxin absorption may increase.

Anticoagulants. When taken concomitantly with indirect anticoagulants, an increased risk of bleeding may occur.

Hormonal contraceptives. In rare cases, while taking amoxicillin, there was a decrease in the effectiveness of oral contraceptives, so patients should be advised to use non-hormonal methods of contraception.

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.