Augmentin powder for suspension preparation 200 mg + 28.5 mg 5 ml bottle 70 ml
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Amoxicillin + Clavulanic Acid
Release form
Powder
Composition
5 ml of the prepared suspension contain: Active substance: amoxicillin (in the form of trihydrate) - 200 mg, clavulanic acid (in the form of potassium salt) - 28.5 mg. Excipients: xanthan gum - 12.5 mg, aspartame - 12.5 mg, succinic acid - 0.84 mg, colloidal silicon dioxide - 25 mg, hypromellose - 79.65 mg, orange flavoring 1 - 15 mg, orange flavoring 2 - 11.25 mg, raspberry flavor - 22.5 mg, Light syrup flavor - 23.75 mg, silicon dioxide - up to 552 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 degradation by β-lactamases, and therefore the spectrum of amoxicillin activity does not extend to microorganisms that produce this enzyme. Clavulanic acid, an β-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of β-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid β-lactamase, which most often causes resistance of bacteria, and less effective against chromosomal β-lactamase type 1, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the preparation Augmentin protects amoxicillin from destruction by β-lactamase enzymes, 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 a combination of amoxicillin with clavulanic acid: Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus spp. (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, Streptococcus pneumoniae1,2, Streptococcus Viridans2 group. Bacteria possessing natural resistance to the combination of amoxicillin with clavulanic acid: Gram-negative aerobes: mapp., Maf. Yersinia 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 types of bacteria do not produce β-lactamase. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid. When Augmentin is used, plasma concentrations of amoxicillin are similar to oral administration of amoxicillin in equivalent doses. Augmentin 125 mg / 31.25 mg per 5 ml suspension powder for oral administration Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies, when healthy volunteers aged 2-12 years on an empty stomach took 3 doses of 40 mg / 10 mg / kg of body weight / day of the drug Augmentin, powder for suspension for oral administration, 125 mg / 31.25 mg in 5 ml (156.25 mg). Augmentin 400 mg / 57 mg in 5 ml suspension powder for oral administration Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies, when healthy volunteers took one dose of Augmentin, powder for oral suspension, 400 mg / 57 mg in 5 ml (457 mg). Distribution: Therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (abdominal organs, fat, bone and muscle tissue, synovial and peritoneal fluids, skin, bile, purulent discharge). Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that plasma proteins are associated with 25% of the total amount of clavulanic acid and 18% of amoxicillin. In animal studies, the cumulation of the ingredients of the drug Augmentin was not found. Amoxicillin, like most penicillins, passes into breast milk.Trace amounts of clavulanic acid are also found in breast milk. Reproductive studies in animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier, and no signs of negative effects on the fetus have been identified. Metabolism: 10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid, is extensively metabolized to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys , through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide. Withdrawal: Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted by both renal and extrarenal mechanisms. Studies have shown that, on average, about 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted by the kidneys unchanged in the first 6 hours after taking 1 tablet of 250 mg / 125 mg or 1 tablet of 500 mg / 125 mg.
Indications
Bacterial infections caused by susceptible microorganisms: Infections of the upper respiratory tract and upper respiratory tract (eg, recurrent tonsillitis, sinusitis, otitis media), usually caused by streptococcus pneumoniae, haemophilus influenzae *, moraxella catarrhalis *, streptococcus pyrophococcus pneumoniae; : exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, usually caused by streptococcus pneumoniae, haemophilus influenzae *, and moraxella catarrhalis * (except 250 mg / 125 mg pills). Urogenital tract infections: cystitis, urethritis, pyelonephritis, infections of women, females, pyrethritis, pyelonephritis, pyrethritis, pneumonia, pneumonia, pneumonia, and moraxella catarrhalis *. Lovovye organs, usually caused by species of the enterobacteriaceae family (mainly escherichia coli *), staphylococcus saprophyticus, and species of the genus enterococcus. Monorea caused by neisseria gonorrhoeae * (except pills 250 mg / 125 mg). Infections of the skin and soft tissues, usually caused by staphylococcus aureus * streptococcus pyogenes and species of the bacteroides genus *. Infections of bones and joints: osteomyelitis, usually caused by staphylococcus aureus *, when long-term therapy is needed. current 500 mg / 125 mg or 875 mg / 125 mg). Other mixed infections (for example, septic abortion, postpartum sepsis, intra-abdominal sepsis) as part of staged therapy (for pills 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg.) * individual members of the indicated genus of microorganisms produce β-lactamase, which makes them insensitive to amoxicillin. Infections caused by amoxicillin-sensitive microorganisms can be treated with augmentin, since amoxicillin is one of its active ingredients.The drug augmentin is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing β-lactamase sensitive to amoxicillin combination with clavulanic acid. The sensitivity of bacteria to amoxicillin combination with clavulanic acid varies depending on region. . Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples and bacteriological sensitivity analysis should be carried out.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in history. Previous episodes of jaundice or impaired liver function when using amoxicillin with clavulanic acid in an history. bodies less than 40 kg (for pills 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg). Children up to 3 months (for powder to prepare a suspension for oral administration 200 mg / 28.5 mg and 400 mg / 57 mg). Renal impairment (QC ≤ 30 ml / min) (for pills 875 mg / 125 mg, for powder for the preparation of oral suspension 200 mg / 28.5 mg and 400 mg / 57 mg). Phenylketonuria (for powder for oral suspension). With caution: abnormal liver function.
Precautionary measures
With care: abnormal liver function.
Use during pregnancy and lactation
In reproductive studies in animals, 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 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 drug Augmentin can be used during breastfeeding. With the exception of the possibility of diarrhea or candidiasis of the mucous membranes of the oral cavity, 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 babies.In the event of adverse effects in breastfed babies, breastfeeding should be discontinued.
Dosage and administration
The dosage regimen is set individually depending on the age, body weight, renal function of the patient, as well as the severity of the infection. For optimal absorption and reduction of possible side effects from the digestive system, Augmentin is recommended to be taken at the beginning of a meal. The minimum course of antibiotic therapy is 5 days. Treatment should not last more than 14 days without a review of the clinical situation. If necessary, it is possible to conduct stepwise therapy (at the beginning of therapy, parenteral administration of the drug with the subsequent transition to oral administration). Adults and children over 12 years old or with a body weight of 40 kg or more 1 tablet of 250 mg / 125 mg 3 times / day (for mild to moderate infections), or 1 tablet of 500 mg / 125 mg 3 times / day, or 1 tablet of 875 mg / 125 mg 2 times / day, or 11 ml of suspension 400 mg / 57 mg / 5 ml 2 times / day (equivalent to 1 tablet of 875 mg / 125 mg). 2 pills of 250 mg / 125 mg are not equivalent to 1 tablet of 500 mg / 125 mg. Children from 3 months and up to 12 years old with a body weight less than 40 kg The drug is prescribed in the form of a suspension for taking Inside. The dose calculation is made depending on the age and body weight, indicated in mg / kg body weight / day (calculation of amoxicillin) or in ml of suspension. The frequency of receiving the suspension is 125 mg / 31.25 mg in 5 ml - 3 times / day every 8 hours. The frequency of receiving the suspension is 200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml - 2 times / day every 12 hours. doses of the drug Augmentin are used to treat infections of the skin and soft tissues, as well as recurrent tonsillitis. High doses of the drug Augmentin are used to treat diseases such as otitis media, sinusitis, lower respiratory infections and urinary tract infections, infections of bones and joints. There is not enough clinical data to recommend the use of Augmentin at a dose of more than 40 mg / kg / day in 3 doses (4: 1 suspension) in children under 2 years of age. Children from birth to 3 months Due to the immaturity of renal excretory function, the recommended dose of Augmentin (calculated on amoxicillin) is 30 mg / kg / day in 2 doses in the form of a 4: 1 suspension. The use of a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) in this population is not recommended. Children born prematurely There are no recommendations regarding the dosing regimen.
Side effects
Infectious and parasitic diseases are often candida of the skin and mucous membranes. For the blood and lymphatic system, there is rarely a reversible leukopenia (including neutropenia) and reversible thrombocytopenia. very rarely - reversible agranulocytosis and reversible hemolytic anemia, prolonged prothrombin time and bleeding time, anemia, eosinophilia, trombotsitoz.So the immune system is very rarely - angioneurotic edema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vaskulit.So 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. Of the gastrointestinal tract, adults very often - diarrhea, often - nausea, vomiting. children - often - diarrhea, nausea, vomiting. The entire population of nausea is most often observed when taking high doses of the drug. If, after starting the drug, undesirable reactions from the gastrointestinal tract are observed, they can be eliminated if you take the drug at the beginning of the meal. Infrequently - digestive disorders. very rarely, antibiotic-associated colitis induced by antibiotics (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue, gastritis, stomatitis. In children, when using the suspension, very rarely was a change in the color of the surface layer of the tooth enamel. Oral care helps prevent discoloration of tooth enamel, because it is enough to brush your teeth. On the side of the liver and biliary tract, it is not often - a moderate increase in the activity of ACT and / or ALT (seen in patients receiving beta-lactam antibiotics, but its clinical significance unknown). very rarely - hepatitis and cholestatic jaundice (these phenomena were observed during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. Adverse effects of the liver were observed mainly in men and elderly patients, and may be associated with long-term therapy. These adverse events are very rarely observed in children. The listed 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 the end of therapy.Adverse events are usually reversible. Adverse effects on the part of the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were persons with serious comorbidities or persons receiving potentially hepatotoxic drugs at the same time. On the side of the skin and subcutaneous tissues it is not often - a rash, itching, urticaria. rarely erythema multiforme. very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exantymatous pustules. In the case of allergic skin reactions, treatment with Augmentin must be stopped.
Overdose
Symptoms: symptoms may arise from the gastrointestinal tract and water-electrolyte imbalance. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure. Seizures may occur in patients with impaired renal function, as well as in those who receive high doses of the drug. Treatment: symptoms of the gastrointestinal tract - symptomatic therapy, focusing on the normalization of water and electrolyte balance. In case of overdose, amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis. The results of a prospective study, which was conducted with the participation of 51 children in the poison control center, showed that the administration of amoxicillin in a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.
Interaction with other drugs
Simultaneous use of the drug Augmentin and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Augmentin and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid. The simultaneous use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently there are no data in the literature about the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.Penicillins can slow down the elimination of methotrexate from the body by inhibiting its tubular secretion; therefore, the simultaneous use of Augmentin and methotrexate can increase the toxicity of methotrexate. Like other antibacterial drugs, Augmentin may affect the intestinal microflora, leading to a decrease in the absorption of estrogen from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives. The literature describes rare cases of an increase in MHO in patients with co-administration of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous appointment of the drug Augmentin with anticoagulants prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the drug Augmentin, you may need to adjust the dose of anticoagulants for oral administration.
special instructions
Before starting treatment with the drug Augmentin, a detailed history should be collected regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Described serious, and sometimes lethal, hypersensitivity reactions (anaphylactic reactions) to penicillins. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, it is necessary to discontinue treatment with Augmentin and initiate appropriate alternative therapy. For serious hypersensitivity reactions, epinephrine should be administered immediately. Oxygen therapy, intravenous administration of the GCS and airway management, including intubation, may also be required. The administration of the drug Augmentin in case of suspected infectious mononucleosis is not recommended, since amoxicillin can cause a core-like rash in patients with this disease, which makes it difficult to diagnose the disease. Long-term treatment with Augmentin sometimes leads to overproduction of insensitive microorganisms. In general, the drug Augmentin is well tolerated and has a low toxicity peculiar to all penicillins. During prolonged therapy with Augmentin, it is recommended to periodically evaluate the function of the kidneys, liver, and blood formation.In order to reduce the risk of side effects from the gastrointestinal tract should take the drug at the beginning of the meal. In patients who received the combination of amoxicillin with clavulanic acid, together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in MHO) was reported in rare cases. When co-administration of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid, control of the relevant indicators is necessary. To maintain the desired effect of oral anticoagulants, it may be necessary to adjust their dose. In patients with impaired renal function, the dose of Augmentin should be reduced according to the degree of impairment. In patients with reduced diuresis, in very rare cases, the development of crystalluria has been reported, mainly with parenteral use of the drug. During the introduction of high doses of amoxicillin, it is recommended to take a sufficient amount of liquid and maintain adequate diuresis to reduce the likelihood of the formation of amoxicillin crystals. Taking the drug Augmentin orally leads to a high content of amoxicillin in the urine, which can lead to false positive results in the determination of glucose in the urine (for example, Benedict test, Fehling test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. Oral care helps to prevent discoloration of teeth, because it is enough to brush your teeth. Tablets must be used within 30 days from the date of opening the package from laminated aluminum foil. Abuse and drug dependence: There was no drug dependence, addiction or euphoria reactions associated with the use of the drug Augmentin. Impact on the ability to drive vehicles and control mechanisms Because the drug can cause dizziness, it is necessary to warn patients about the precautions when driving or working with moving machinery.