Flemoxin SoluTab pills soluble 500 mg 20 pcs
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Active ingredients
Amoxicillin
Release form
Uncoated Tablets
Composition
1 tablet contains: amoxicillin trihydrate 291.4 mg, which corresponds to the content of amoxicillin 250 mg. Excipients: lemon flavor - 2.8 mg, tangerine flavor - 2.3 mg, vanillin - 0.26 mg, crospovidone - 12.6 mg, magnesium stearate - 1.5 mg, saccharin - 3.3 mg, dispersible cellulose - 8.7 mg, microcrystalline cellulose - 12.6 mg.
Pharmacological effect
Broad-spectrum antibiotic; combined drug amoxicillin and clavulanic acid - an inhibitor of β-lactamase. Amoxicillin acts bactericidal, inhibits peptidoglycan synthesis of the bacterial cell wall. Active against gram-positive and gram-negative microorganisms (including strains that produce many plasmid and some chromosomal β-lactamase). Clavulanic acid, which is part of the preparation, inhibits β-lactamase II, III, IV, and V types, is not active 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. Flemoclav Solutab is active against aerobic gram-positive bacteria: Streptococcus spp., Staphylococcus spp. (except methicillin-resistant strains), Enterococcus spp., Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp. (except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp .; Aerobic Gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus spp., Yersinia enterocolitica, Salmonella spp., Shigella spp., Idian Drug Design, Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitashycrefi, jesus, hystomat, jesus, jesus, jesus,, Neemseria, Neemseria, Neemseria, Neemseria, Neemseria, Neemselah, Ibrahim, Drug Development Pasteurella multocida, Vibrio cholerae, Helicobacter pylori; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis, Fusobacterium spp.
Pharmacokinetics
Amoxicillin: Absorption: After oral administration, it is rapidly absorbed from the gastrointestinal tract. Amoxicillin absorption by oral administration is 90-94%. Absolute bioavailability reaches 94%. Simultaneous food intake does not affect absorption. Cmax in plasma is achieved within 1-2 hours after administration. After taking a single dose of 500 mg / 125 mg (amoxicillin / clavulanic acid), the average concentration of amoxicillin (after 8 h) is 0.3 mg / l. After a single dose of 875 mg / 125 mg (amoxicillin / clavulanic acid), Cmax of amoxicillin in the blood plasma is 12 μg / ml.Distribution: After a single dose of 875 mg / 125 mg (amoxicillin / clavulanic acid), AUC of amoxicillin is 33 μg × h / l. Binding to serum proteins is approximately 17-20%. Amoxicillin penetrates the placental barrier and in small quantities excreted in breast milk. Metabolism: A small part of amoxicillin is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (penicillic and penamaldovic acids are the main ones). Withdrawal: Approximately 60-80% of amoxicillin is eliminated through the kidneys during the first 6 hours after taking the drug. T1 / 2 is 0.9-1.2 hours. Pharmacokinetics in special clinical situations: In case of impaired renal function (CC within 10-30 ml / min) T1 / 2 is 6 hours, and in the case of anuria it varies between 10 and 15 hours. It is derived during hemodialysis. Clavulanic acid: Absorption: After ingestion is rapidly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Simultaneous food intake does not affect absorption. Cmax in plasma is reached approximately 1-2 hours after administration. After taking a single dose of 500 mg / 125 mg (amoxicillin / clavulanic acid), the average concentration of clavulanic acid reaches 0.08 mg / l (after 8 hours). After a single dose of 875 mg / 125 mg (amoxicillin / clavulanic acid), Cmax of clavulanic acid in the blood plasma is 3 μg / ml. Distribution: After a single dose of 875 mg / 125 mg (amoxicillin / clavulanic acid), the AUC of clavulanic acid is 6 μg × h / l. Binding to serum proteins is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on the allocation of breast milk. Metabolism: Clavulanic acid is extensively metabolized by hydrolysis and subsequent decarboxylation. Withdrawal: Approximately 30-50% of clavulanic acid is eliminated through the kidneys during the first 6 hours after taking the drug. T1 / 2 is approximately 1 hour. The total clearance for amoxicillin and clavulanic acid is 25 l / h. Pharmacokinetics in special clinical situations: In case of impaired renal function (CC from 20 to 70 ml / min), T1 / 2 is 2.6 hours, and in anuria it ranges from 3-4 hours. It is eliminated during hemodialysis.
Indications
Infectious and inflammatory diseases caused by susceptible microorganisms: Respiratory infections. Infections of the genitourinary system. Infections of the organs of gastrointestinal infections
Contraindications
Hypersensitivity to the drug components. Increased sensitivity to other beta-lactam antibiotics, incl. For other penicillins, cephalosporins, and carbapenems. The drug should be used with caution in case of polyvalent hypersensitivity to xenobiotics, infectious mononucleosis, lymphocytic leukemia, and gastrointestinal diseases in history (especially for colitis associated with the use of antibiotics), renal failure, during pregnancy and during lactation. allergic reactions (including history).
Precautionary measures
From the hematopoietic system: rarely - thrombocytosis, hemolytic anemia; very rarely - leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia. These adverse reactions are reversible and disappear after cessation of therapy. On the part of the coagulation system: very rarely - an increase in prothrombin time and bleeding time. These adverse reactions are reversible and disappear after cessation of therapy. On the part of the nervous system: rarely - dizziness, headache, convulsions (in the case of renal dysfunction or overdose of the drug); very rarely - hyperactivity, anxiety, anxiety, insomnia, impaired consciousness, aggressive behavior. Since the cardiovascular system: rarely - vasculitis. On the part of the digestive system: often - abdominal pain, nausea (more often with overdose), vomiting, flatulence, diarrhea (mostly, reactions from the digestive system are transient and rarely pronounced; their intensity can be reduced by taking the drug at the beginning of the reception food); pseudomembranous colitis (in the case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy), in most cases caused by Clostridium difficile; rarely - intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel. On the part of the liver: often - a slight increase in the activity of liver enzymes; rarely, 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; children are very rarely observed (less than 1/10 000).The risk of adverse reactions increases with the use of the drug for more than 14 days. Liver dysfunction is usually reversible, but sometimes it is severe and in very rare cases (less than 1/10 000) (only in patients with severe concomitant diseases or while taking potentially hepatotoxic drugs) can be fatal. From the genitourinary system: infrequently - itching, burning and vaginal discharge; rarely interstitial nephritis.
Use during pregnancy and lactation
When using Flemoclav Solutab during pregnancy, there was no negative effect on the fetus or newborn. The use of the drug in the II and III trimesters of pregnancy is possible after a medical risk / benefit assessment. In the first trimester of pregnancy, the use of Flemoclav Solutab should be avoided (only for dispersible pills 875 mg / 125 mg). Dispersible pills 125 mg / 31.25 mg, 250 mg / 62.5 mg, 500 mg / 125 mg in the first trimester of pregnancy should be administered with caution. Amoxicillin and clavulanic acid penetrate the hemato-placental barrier and are excreted in breast milk. Perhaps the use of the drug during breastfeeding. If the child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.
Dosage and administration
The drug is taken inside. The drug is prescribed before, during or after a meal. The tablet can be swallowed whole, divided into parts or chewed, washed down with a glass of water, and can also be diluted in water to form a syrup (in 20 ml) or a suspension (in 100 ml), with a pleasant fruity taste. Dosing regimen set individually, taking into account the severity of the disease, the sensitivity of the pathogen to the drug, the patient's age. In case of infectious and inflammatory diseases of mild and moderate severity, the use of the drug is recommended according to the following scheme: adults and children over 10 years old are prescribed 500-750 mg 2 times / day or 375-500 mg 3 times / day; children aged 3 to 10 years, appoint 375 mg 2 times / day or 250 mg 3 times / day; children aged 1 to 3 years should be prescribed 250 mg 2 times / day or 125 mg 3 times / day. The daily dose of the drug for children (including children up to 1 year) is 30-60 mg / kg / day, divided into 2-3 doses. In the treatment of severe infections, as well as in hard-to-reach foci of infection (for example, acute otitis media), a triple dose is recommended.In chronic diseases, recurrent infections, and severe infections, adults are prescribed 0.75–1 g 3 times / day; children - 60 mg / kg / day, divided into 3 doses. In acute uncomplicated gonorrhea, 3 g of the drug is prescribed in 1 administration in combination with 1 g of probenecid. Patients with impaired renal function with CK≤10 ml / min reduce the dose of the drug by 15-50%. In case of mild to moderate infections, the drug is taken for 5-7 days. However, for infections caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days. The drug should be continued for 48 hours after the disappearance of the symptoms of the disease.
Side effects
On the part of the digestive system rarely - a change in taste, nausea, vomiting, diarrhea, dysbiosis, stomatitis, glossitis. in some cases, a moderate increase in the activity of hepatic transaminases, cholestatic jaundice, acute cytolysis agranulocytosis, hemolytic anemia. In the nervous system, agitation, anxiety, insomnia, ataxia, confusion , behavioral changes, depression, peripheral neuropathy, headache, dizziness, epileptic seizures. Allergic reactions skin reactions, mainly in the form of a specific maculo-papular rash, urticaria, skin hyperemia, erythematous rashes, rhinitis, conjunctivitis, multiformal exudates, erythematosus, erythematous rashes, rhinitis, conjunctivitis, multiformal exudates, erythematous rashes, rhinitis, conjunctivitis, multiforme, rheumatic Stevens-Johnson), fever, arthralgia, eosinophilia, exfoliative dermatitis, reactions similar to serum sickness, toxic epidermal necrolysis, allergic vasculitis, acute generalized exanthematous pustullez. in some cases - anaphylactic shock, angioedema. Other difficulty breathing, vaginal candidiasis, superinfection (especially in patients with chronic diseases or low body resistance).
Overdose
Symptoms: nausea, vomiting, diarrhea with possible disturbances of water and electrolyte balance.Treatment: prescribe activated carbon and osmodiuretiki, it is necessary to maintain water and electrolyte balance, spend symptomatic therapy. When convulsions prescribed diazepam. In renal failure, hemodialysis is severe.
Interaction with other drugs
With simultaneous use with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin / clavulanic acid was observed in vitro. Amoxicillin / clavulanic acid should not be administered concurrently with disulfiram. Simultaneous administration of drugs that inhibit the renal excretion of amoxicillin (probenecid, phenylbutazone, oxyphenbutazone, and, to a lesser extent, acetylsalicylic acid, indomethacin, and sulfinpyrazone), contributes to an increase in the concentration and prolonged presence of amoxicillin in blood plasma and bile. The excretion of clavulanic acid is not disturbed. With simultaneous use with Flemoklavom Solutab antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce the absorption of amoxicillin, ascorbic acid increases the absorption of amoxicillin. The simultaneous use of Flemoclav Solutab with allopurinol may increase the risk of skin rash. Aminopenicillins can reduce serum sulfasalazine concentration. 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. The simultaneous use of amoxicillin / clavulanic acid and digoxin can lead to increased absorption of digoxin. With the simultaneous use of Flemoclav Solutab and indirect anticoagulants may increase the risk of bleeding. In rare cases, while taking amoxicillin, there was a decrease in the effectiveness of oral contraceptives, so the patient should be advised to use non-hormonal methods of contraception.
special instructions
When taking Flemoclav Solutab there is the possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.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. Superinfection is possible (for example, 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 appropriately altering antibiotic therapy. For patients with severe gastrointestinal disorders, accompanied by vomiting and / or diarrhea, the appointment of Flemoclav Solutab is impractical until the above symptoms are eliminated, since possible violation of the absorption of the drug from the gastrointestinal tract. The emergence of severe and persistent diarrhea may be associated with the development of pseudomembranous colitis, in this case, the drug is canceled and prescribed the necessary treatment. If hemorrhagic colitis develops, immediate withdrawal of the drug and corrective therapy are also necessary. The use of drugs that weaken intestinal peristalsis in these cases is contraindicated. In case of abnormal liver function, the drug should be prescribed with caution and under constant medical supervision. Do not use the drug for more than 14 days without assessing liver function. In a single study, prophylactic amoxicillin / clavulanate in women with premature rupture of the membranes increased the risk of necrotizing enterocolitis in the newborn. 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). Due to the high concentration of amoxicillin in the urine, it can settle on the walls of the urinary catheter, so these patients need periodic replacement of catheters. Forced diuresis accelerates the elimination of amoxicillin and reduces its concentration in plasma. 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. In the event of convulsions during therapy, the drug is canceled. It should be noted that in 1 dispersible tablet 875 mg / 125 mg contains 25 mg of potassium.