Augmentin EC Powder for Suspension 23.13 g
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Active ingredients
Amoxicillin + Clavulanic Acid
Composition
Powder for suspension for oral administration is almost white, with a characteristic smell of strawberries. when diluted with water, a suspension of almost white color is formed. 5 ml of prepared suspension.1 of amoxicillin trihydrate2 697.65 mg, which corresponds to the content of amoxicillin 600.00 mg of potassium clavulanate3 52.31 mg, which corresponds to the content of clavulanic acid 42.90 mg Auxiliary substances: xanthan gum - 3.00 mg, aspartame - 12.5 mg, colloidal silica - 35.00 mg, carmellose sodium - 30.00 mg, strawberry flavor - 26.00 mg, silicon dioxide4 - up to 1009.96 mg.
Pharmacological effect
Amoxicillin is a semi-synthetic broad-spectrum antibiotic that has activity against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction of.-Lactamases, and therefore the spectrum of amoxicillin activity does not extend to microorganisms that produce these enzymes. Clavulanic acid is an inhibitor of &. 946.-Lactamase, structurally related to penicillins, has the ability to inactivate a wide range of &. 946.-Lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid & # 946.-Lactamase, which most often causes resistance of bacteria, and less effective against chromosomal & # 946.-Lactamase type 1, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the Augmentin preparation. The EU protects amoxicillin from destruction by the enzymes - &. 946.-Lactamases, which allows you to extend the antibacterial spectrum of amoxicillin. Below is the in vitro combination of amoxicillin with clavulanic acid. Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, npp (other beta-hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), Staphylococcus spp. (coagulase-negative, methicillin-sensitive). Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae. Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum. Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp.Gram-negative anaerobes: Bacteroides fragilis, Bacteroides spp., Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp. Bacteria that are likely to acquire resistance to the combination of amoxicillin with clavulanic acid Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae1, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp. Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium. Bacteria with natural resistance to the combination of amoxicillin with clavulanic acid. enterocolitica. Other: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, Mycoplasma spp. 1 - for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid was demonstrated in clinical studies. 2 - strains of these species of bacteria do not produce. # -46. Lactamase. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.
Indications
Treatment of infections caused by susceptible microorganisms in children: - ENT organs infections: recurrent or persistent acute otitis media caused by Streptococcus pneumoniae (BMD & # 8804. 4 mcg / ml), Haemophilus influenzae * and Moraxella catarrhalis *. - Tonsillopharyngitis and sinusitis, usually caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis * and Streptococcus pyogenes. - lower respiratory tract infections: lobar pneumonia and bronchopneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis *. - infections of the skin and soft tissue, usually caused by Staphylococcus aureus * and Streptococcus pyogenes. * Some strains of these types of bacteria produce & .946.-lactamase, which makes them insensitive to amoxicillin monotherapy. Infections caused by microorganisms susceptible to amoxicillin can be treated with Augmentin. EU, since amoxicillin is one of its active ingredients. Drug Augmentin. The EU is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing & # 946.-Lactamase, sensitive to the combination of amoxicillin with clavulanic acid. The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples and bacteriological sensitivity analysis should be carried out.
Use during pregnancy and lactation
Pregnancy In animals' reproductive function studies, oral and parenteral administration of the drug Augmentin. did not cause teratogenic effects.In a single study in women with premature rupture of the membranes, it was found that preventive drug therapy may be associated with an increased risk of necrotizing enterocolitis in the newborn. Like all drugs, Augmentin. The EU is not recommended for use during pregnancy, except in cases where the expected benefit to the mother outweighs the potential risk to the fetus. The period of breastfeeding Drug Augmentin. EU can be applied during breastfeeding. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the oral mucous membranes associated with the penetration into the breast milk of trace amounts of the active ingredients of this drug, no other adverse effects were observed in breastfed children. In the event of adverse effects in breastfed babies, breastfeeding should be discontinued.
Side effects
The adverse reactions listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100, <1/10), infrequently (& # 8805 .1 / 1000, <1/100), rarely (& # 8805 .1 / 10 000, <1/1000), very rarely (<1/10 000). Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation. Infectious and parasitic diseases: often - candidiasis of the skin and mucous membranes. On the part of the blood and lymphatic system: rarely - reversible leukopenia (including neutropenia) and reversible thrombocytopenia. very rarely - reversible agranulocytosis and reversible hemolytic anemia, prolongation of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis. On the part of the immune system: very rarely - angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis. On the part of the nervous system: infrequently - dizziness, headache. very rarely - reversible hyperactivity, convulsions (convulsions can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug), insomnia, agitation, anxiety, behavior change.On the part of the gastrointestinal tract: often - diarrhea, nausea, vomiting (nausea is more often observed when taking high doses orally. If violations of the gastrointestinal tract are confirmed, they can be eliminated if you take the drug at the beginning of a meal). infrequently - digestive disorders. very rarely - antibiotic-associated colitis, induced by antibiotics (including pseudomembranous colitis and hemorrhagic colitis (see section "Special Instructions"), black "hairy" tongue. Children rarely noticed a change in color of the surface layer of the tooth enamel. Oral care helps prevent discoloration of tooth enamel, since it is enough to brush teeth. For the liver and biliary tract: infrequently - a moderate increase in the activity of ACT and / or ALT (observed in patients receiving therapy beta-lactam antibiotics, however, its clinical significance is unknown. very rarely - hepatitis and cholestatic jaundice (these reactions were observed during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rarely seen in children. These signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after completion of therapy. Undesirable reactions, as a rule, are reversible. Unwanted reactions from the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were persons with severe comorbidities or persons receiving potentially potentially hepatotoxic drugs at the same time. On the part of the skin and subcutaneous tissues: rarely - rash, itching, urticaria. rarely erythema multiforme. very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exantmatous pustus. In case of skin allergic reactions, treatment with Augmentin. The EU needs to stop. On the part of the kidneys and urinary tract: very rarely - interstitial nephritis, crystalluria, hematuria.
special instructions
The adverse reactions listed below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (& # 8805 .1 / 10), often (& # 8805 .1 / 100, <1/10), infrequently (& # 8805 .1 / 1000, <1/100), rarely (& # 8805 .1 / 10 000, <1/1000), very rarely (<1/10 000). Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation. Infectious and parasitic diseases: often - candidiasis of the skin and mucous membranes. On the part of the blood and lymphatic system: rarely - reversible leukopenia (including neutropenia) and reversible thrombocytopenia. very rarely - reversible agranulocytosis and reversible hemolytic anemia, prolongation of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis. On the part of the immune system: very rarely - angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis. On the part of the nervous system: infrequently - dizziness, headache. very rarely - reversible hyperactivity, convulsions (convulsions can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug), insomnia, agitation, anxiety, behavior change. On the part of the gastrointestinal tract: often - diarrhea, nausea, vomiting (nausea is more often observed when taking high doses orally. If violations of the gastrointestinal tract are confirmed, they can be eliminated if you take the drug at the beginning of a meal). infrequently - digestive disorders. very rarely - antibiotic-associated colitis, induced by antibiotics (including pseudomembranous colitis and hemorrhagic colitis (see section "Special Instructions"), black "hairy" tongue. Children rarely noticed a change in color of the surface layer of the tooth enamel. Oral care helps prevent discoloration of tooth enamel, since it is enough to brush teeth. For the liver and biliary tract: infrequently - a moderate increase in the activity of ACT and / or ALT (observed in patients receiving therapy beta-lactam antibiotics, however, its clinical significance is unknown. very rarely - hepatitis and cholestatic jaundice (these reactions were observed in the treatment with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. and elderly patients and may be associated with long-term therapy.These adverse reactions are very rarely observed in children. These signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after completion of therapy. Undesirable reactions, as a rule, are reversible. Unwanted reactions from the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were persons with severe comorbidities or persons receiving potentially potentially hepatotoxic drugs at the same time. On the part of the skin and subcutaneous tissues: rarely - rash, itching, urticaria. rarely erythema multiforme. very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exantmatous pustus. In case of skin allergic reactions, treatment with Augmentin. The EU needs to stop. On the part of the kidneys and urinary tract: very rarely - interstitial nephritis, crystalluria, hematuria.