Amoxicar capsules 250mg in blister packs №8×2

NameAmoxicar. Release formCapsules. MHNAmoxicillin. FTGAantibiotic; semisynthetic penicillin. Qualitative and quantitative composition One capsule of Amoxicar 250 mg contains: Active ingredients: amoxicillin 250 mg (in the form of trihydrate); Excipients: magnesium stearate, sodium starch glycolate. Capsule composition: gelatin, distilled water, methylparaben (E 218), propylparaben (E 216), brilliant blue (E 133), carmoisine (E 122), orange yellow (E 110), tartrazine (E 102), titanium dioxide (E 171). Brief description of the finished dosage form Capsules 250 mg Capsules (light yellow body, blue cap) with the Pharmakar logo. Pharmacodynamic properties Pharmacotherapeutic group: Antibacterial agents for systemic use. Beta-lactam antibiotics – penicillins. Amoxicillin. ATX CODE: J01CA04 The active ingredient of Amoxicar is amoxicillin, a broad-spectrum antibacterial agent. Amoxicillin inhibits transpeptidase, thereby disrupting the synthesis of peptidoglycan (a structural mucopeptide of the bacterial cell wall that ensures its strength) during the period of division and growth of microorganisms and causing lysis of microorganisms. Amoxicillin has a wide spectrum of antimicrobial activity: Aerobic gram-positive microorganisms Staphylococcus spp. (except strains producing β-latcamase), Streptococcus spp., including Streptococcus faecalis, Streptococcus pneumonia, Enterococcus faecalis. Aerobic gram-negative microorganisms Neisseria gonorrhoeae (except β-lactamase producing strains), Neisseria meningitidis, Escherichia coli (except β-lactamase producing strains), Proteus mirabilis (except β-lactamase producing strains), Haemophilus influenzae (except β-lactamase producing strains), -lactamase), Helicobacter pylori, some strains of Salmonella, Shigella, Klebsiella. Pharmacokinetic properties Amoxicillin is stable in the presence of hydrochloric acid, when taken orally, it is quickly and well (75-90%) absorbed, distributed in tissues and body fluids. When taking capsules in doses of 250 mg and 500 mg, the maximum concentration in the blood (3.5-5.0 μg / ml and 5.5-7.5 μg / ml, respectively) is reached after 1 to 2 hours. Plasma protein binding is about 20%. Easily passes histohematic barriers, except for the BBB (becomes permeable during inflammation), quickly penetrates into most tissues and body fluids; accumulates at therapeutic concentrations in peritoneal fluid, urine, skin blisters, pleural effusion, lung tissue, intestinal mucosa, female genital organs, middle ear fluid, gallbladder and bile. The half-life is 1-1.5 hours. Amoxicillin is partially metabolized in the liver, most of its metabolites do not have microbiological activity. Excreted by the kidneys: 20% – by glomerular filtration and 80% – by tubular excretion. 8 hours after taking the drug, 90% of the active substance is excreted in the urine (and unchanged – 60-70%). 10-20% of the accepted dose of amoxicillin is excreted in the bile. After oral administration, it is determined in serum for 8 hours. In case of impaired renal function, the half-life is extended to 4-12.6 hours. In premature infants, newborns and children under 6 months of age. amoxicillin is excreted from the body within 3-4 hours. In premature infants born at 26-33 weeks of gestational age, after intravenous administration of amoxicillin on the third day of life, the total clearance is 0.75 – 2 ml / min., which is similar to inulin clearance (GFR ) in the same group of patients. When taking amoxicillin orally, its absorption and bioavailability in young children may differ from those in adults. Therefore, due to the reduced clearance, an increased exposure of amoxicillin to this group of patients is expected, which can be reduced by reducing oral bioavailability. In violation of liver function, the half-life does not change. Indications for use Bacterial infections caused by susceptible microorganisms: infections of the respiratory tract and ENT organs caused by Streptococcus spp. (α- and β-hemolytic strains), Streptococcus pneumoniae, Staphylococcus spp., Haemophilus influenzae; infections of the genitourinary system caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis; acute uncomplicated gonorrhea in men and women caused by Neisseria gonorrhoeae; chlamydial infections in pregnant women; abdominal and gastrointestinal infections (typhoid fever, paratyphoid fever, gastroenteritis caused by other salmonella, treatment of chronic carriers of typhoid pathogens); skin and soft tissue infections caused by Streptococcus spp. (α- and β-hemolytic strains), Staphylococcus spp., Escherichia coli; the initial stage of Lyme disease (stage I, isolated erythema migrans); eradication of Helicobacter pylori (as part of combination therapy); prevention of bacterial endocarditis in patients at risk of developing bacteremia during medical manipulations, such as tooth extraction. Official local guidelines (eg national standards and protocols) for the appropriate use of antibacterial agents should be taken into account. Method of application and doses The dosage regimen of the drug is determined by the doctor individually, depending on the type and severity of the infection. Take orally, regardless of meals. If you forget to take Amoxicar, take the medicine as soon as possible before your next appointment is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, Amoxicar is used according to the recommended dosing regimen. Adults (including the elderly) and children (weighing 40 kg or more): Standard dose: 250 mg three times a day, increased to 500 mg three times a day for more severe infections. High-dose therapy (maximum recommended oral dose of 6 g per day, divided into doses): A dose of 3 g twice daily is recommended for the treatment of severe or recurrent purulent respiratory tract infection. Short course of therapy: acute uncomplicated gonorrhea: 3 g once a day. Dosage in renal impairment: The dose should be reduced in patients with severe renal insufficiency. In patients with creatinine clearance less than 30 ml / min, it is recommended to increase the interval between doses and reduce the total daily dose. With creatinine clearance> 30 ml / min, dose adjustment is not required. With a creatinine clearance of 10-30 ml / min: 250 mg or 500 mg (maximum dose of amoxicillin) 2 times a day (every 12 hours) depending on the severity of the infection. With creatinine clearance <10 ml / min: 250 mg or 500 mg (maximum dose of amoxicillin) every 24 hours, depending on the severity of the infection. Patients on hemodialysis should receive 500 mg or 250 mg every 24 hours, depending on the severity of the infection. During and at the end of dialysis, an additional dose is recommended. Children weighing <40 kg: The daily dose is 20-40-90 mg / kg / day, divided into 2 or 3 times (but not more than 3 g / day), depending on the indications, the severity of the disease and the susceptibility of the pathogen. Dosing three times a day increases the effectiveness of the treatment. Dosing twice a day is only recommended when the dose is at the upper end of the dose range. Dosage for impaired renal function in children weighing up to 40 kg: creatinine clearance> 30 ml / min: usual dose, interval between injections is normal; creatinine clearance 10-30 ml / min: the usual single dose, the interval between injections is 12 hours (which corresponds to 2/3 of the usual daily dose); creatinine clearance <10 ml / min: the usual single dose, the interval between injections is 24 hours (corresponding to 1/3 of the usual daily dose). Specific dosage recommendations: Tonsillitis: 50 mg/kg/day. Acute otitis media: Follow national/local dosing recommendations. Early stage Lyme disease (isolated erythema migrans): 50 mg/kg/day divided into 3 divided doses for at least 14-21 days. Typhoid fever: 100 mg/kg daily or 1-1.5 g every 6 hours for 14 days. Chlamydial infection: 500 mg 3 times a day for 7 days to treat chlamydial infection in pregnant women. Retesting (preferably cultured) is recommended 3 weeks after completion of treatment. Helicobacter eradication in peptic ulcer (duodenal and gastric): Amoxicillin is recommended at a dose of 750-1000 mg twice a day in combination with proton pump inhibitors and antimicrobials. More information can be found in local official guidelines for the eradication of H. pylori in gastric and duodenal ulcers. Prevention of endocarditis: Adults: 3-4 g 1 hour before minor surgery and 6 hours after, if necessary, a second dose. Children: 50 mg/kg body weight 1 hour before surgery. For more information and information about high-risk groups, please refer to local official guidelines for endocarditis prevention. Duration of treatment Treatment should be continued for at least another 2-3 days after symptoms disappear or until evidence of eradication of the pathogen is obtained. In the case of infections caused by beta-hemolytic streptococcus, the course of treatment should be at least 10 days. Children under 10 years of age are not allowed to take capsules. In pediatric practice, Amoxicar suspension is used. Contraindications History of hypersensitivity to beta-lactam antibiotics, infectious mononucleosis. Hypersensitivity to the auxiliary components of the drug. PrecautionsHypersensitivity reactions (anaphylactic reactions) The risk of developing anaphylactic reactions is higher in patients with a history of hypersensitivity reactions to penicillin antibiotics or who have hypersensitivity to multiple allergens. Before prescribing amoxicillin, information about the patient's possible previous allergic reactions to penicillins, cephalosporins, or other allergens should be carefully collected and evaluated. With the development of allergic reactions, you should immediately stop taking Amoxicar and take measures to stop the allergic reaction. Serious anaphylactic reactions are treated with adrenaline, intravenous glucocorticosteroids and, if necessary, breathing, including intubation. Pseudomembranous colitis When taking almost all antibacterial drugs, including amoxicillin, it is possible to develop pseudomembranous colitis, varying in severity from mild to life-threatening conditions. In this regard, in the case of the development of diarrhea while taking antibacterial drugs, the patient's condition should be assessed in terms of the possible risk of developing pseudomembranous colitis. Taking antibacterial drugs changes the state of the normal intestinal flora, which can contribute to the overgrowth of Clostridium. Studies have shown that a toxin produced by Clostridium difficile is the root cause of the development of antibiotic-associated colitis. When the diagnosis of pseudomembranous colitis is made, appropriate therapeutic measures are taken. With a mild form of the disease, in most cases it is enough to cancel the antibacterial drug. In moderate to severe superinfection, consideration should be given to fluids and electrolytes, amino acid nutrition, and antibiotics, which have been shown to be effective in Clostridium difficile colitis. General: when conducting antibiotic therapy, one should be aware of the possibility of developing superinfections of a fungal and bacterial nature. With the development of superinfections, amoxicillin should be canceled and appropriate pathogenetic therapy should be prescribed. Patients with mononucleosis have a high risk of developing an erythematous skin rash while taking amoxicillin, and therefore this antibiotic is contraindicated in patients with mononucleosis. Prophylactic use of amoxicillin in the absence of a proven or reasonable suspicion of bacterial infection is of dubious benefit to the patient and increases the risk of developing bacterial resistance to the antibiotic. Use in children: children under 10 years of age should not take the capsules. In pediatric practice, Amoxicar suspension is used. Use in elderly patients: Since renal dysfunction is more common in elderly patients and the risk of toxic reactions increases with impaired renal function, care should be taken when choosing a dose. Follow-up continuous monitoring of renal function is recommended. Some components of the Amoxicar capsule, such as dyes: orange yellow (E 110), carmoisine (E 122) - can cause allergic reactions in patients with hypersensitivity reactions to azo dyes; methylparaben (E 218) and propylparaben (E 216) - in patients with hypersensitivity reactions to para-hydroxybenzoic acid esters. As part of the drug Amoxicar, sodium starch glycolate is present as one of the auxiliary components. This must be taken into account in patients on a low sodium diet. In patients with reduced diuresis, crystalluria very rarely occurs, mainly with parenteral therapy. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. With the simultaneous use of amoxicillin and indirect anticoagulants, an increase in prothrombin time (an increase in INR) is rarely observed. If concomitant use is necessary, proper monitoring is required. To achieve the desired level of inhibition of blood clotting, dose adjustment of oral anticoagulants may be required. Interaction with other drugs Chloramphenicol, macrolides, sulfonamides, lincosamides and tetracyclines (bacteriostatic antibiotics) may interfere with the bactericidal action of amoxicillin. Estrogen-containing oral contraceptives: influence on the intestinal microflora can lead to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined contraceptive preparations. Methotrexate: Amoxicillin reduces the clearance and increases the toxicity of methotrexate. Indirect anticoagulants: it is possible to increase the effectiveness of indirect anticoagulants due to the suppression of intestinal microflora, a decrease in the synthesis of vitamin K and the prothrombin index. Antacids and enterosorbents (activated charcoal, white clay, etc.): it is possible to reduce the absorption of amoxicillin while taking it. The interval between doses should be at least 2 hours. NSAIDs, diuretics, allopurinol, probenicid and other drugs that suppress tubular secretion: when taken simultaneously with amoxicillin, an increase in the serum concentration of amoxicillin and an increase in the half-life are possible. Simultaneous use of allopurinol in the treatment of amoxicillin may increase the likelihood of allergic reactions from the skin. Cases of increased INR have been described in patients receiving maintenance therapy with acenocoumarol or warfarin against the background of the prescribed course of amoxicillin. If concomitant use is necessary, prothrombin time or INR should be carefully monitored at the start and after discontinuation of amoxicillin treatment. When taking amoxicillin, it is recommended to use enzymatic reactions with glucose oxidase in determining urine glucose. High concentrations of amoxicillin give a false positive reaction to urine glucose when using chemical methods. When using amoxicillin in pregnant women, a transient decrease in the concentration of total conjugated estriol, estriol-glucuronide, conjugated estrion and estradiol in plasma was observed. Use during pregnancy and lactation Conducted on rats and mice, studies of the effect of amoxicillin on reproduction at doses up to 10 times the recommended therapeutic doses did not reveal cases of impaired fertility or adverse effects of amoxicillin on the fetus. However, adequate controlled studies in pregnant women have not been conducted. Since animal studies do not always allow us to determine the consequences of taking the drug in humans, the use of amoxicillin in pregnant women is possible only if the expected benefit significantly outweighs the potential risk to the mother and fetus. Penicillins are excreted into breast milk. The use of amoxicillin during breastfeeding may contribute to the sensitization of the child. Care should be taken to prescribe amoxicillin during lactation only if the expected benefit outweighs the potential risk. Influence on the ability to drive vehicles and work with dangerous devices and mechanisms No negative effect of amoxicillin on the ability to drive vehicles and work with dangerous devices and mechanisms was found. Side effects As with other antibacterial drugs of the penicillin group, hypersensitivity reactions account for the majority of undesirable adverse reactions. Patients who have previously experienced hypersensitivity reactions to penicillin antibiotics, as well as allergies, bronchial asthma, hay fever or urticaria in history, should stop taking this group of antibiotics. When taking amoxicillin, the following adverse reactions were identified: hypersensitivity reactions: skin flushing, rhinitis, conjunctivitis, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular dermatitis, exanthematous rash, itching, urticaria, angioedema, reactions , resembling serum sickness; gastrointestinal tract: nausea, vomiting, diarrhea, taste change, stomatitis, glossitis, hemorrhagic/pseudomembranous colitis, dysbacteriosis; hepato-biliary tract: moderate increase in ACT and / or ALT, hepatitis, cholestatic jaundice; from the side of the kidneys: crystalluria, interstitial nephritis; hematopoietic system: anemia, including hemolytic, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, neutropenia and agranulocytosis; prolongation of bleeding time, increase in prothrombin time; Others: superinfections (especially in patients with chronic diseases or reduced body resistance), candidiasis of the oral cavity or vagina, changes in the tongue and color of the teeth. If the listed adverse reactions occur, as well as reactions not indicated in the instructions, the patient is advised to contact their doctor. OverdoseSymptoms: nausea, vomiting, diarrhea, disturbance of water and electrolyte balance as a result of nausea and vomiting. Several cases of interstitial nephritis with subsequent oliguria have been described. Cases of crystalluria have been reported following an overdose of amoxicillin, which in some cases led to renal failure. With prolonged use in high doses - neurotoxic reactions and thrombocytopenia (disappear after discontinuation of the drug). Treatment: gastric lavage, administration of activated charcoal, saline laxatives, correction of water and electrolyte balance, adequate fluid intake and maintenance of diuresis (to reduce the risk of crystalluria). An excess amount of amoxicillin can be removed from the circulating blood by hemodialysis. Carcinogenicity, mutagenicity, impaired reproductive function Long-term studies of amoxicillin in animals have not revealed a carcinogenic effect. Mutagenicity tests have not been performed on amoxicillin alone, but mutagenicity test results are available for a combination of amoxicillin and potassium clavulanate in a 4:1 ratio. Ames-test of bacterial mutation and conversion of yeast cell genes demonstrated the absence of a mutagenic effect of this combination. A certain increase in the frequency of mutations was detected in the test on mouse lymphoma cells, however, this trend manifested itself at doses that also reduced cell survival. This combination showed no mutagenic activity in the micronucleus test on mouse erythrocytes and in the dominant lethality test on mice. In studies evaluating the effect of amoxicillin on the reproductive function of mice in several generations, there were no violations of fertility and other adverse effects on reproductive function at doses up to 500 mg / kg (approximately 3 times the recommended therapeutic doses). Pharmaceutical incompatibilities Not known Shelf life 3 years Do not use after the expiry date stated on the package. Storage conditionsStore in a place protected from moisture at a temperature not exceeding +25°C. Keep out of the reach of children. Conditions of releaseAvailable by prescription. Buy Amoxicar 250mg capsules in blister packs No. 8x2 Price for Amoxicar 250mg capsules in blister packs in packs No. 8x2