Ospamox DT dispersible tablets 1000mg №6×2

Name Ospamox DT tabl. disp.1000mg in bl. in pack. No. 6×2 Active ingredient: amoxicillin; 1 tablet contains amoxicillin 1000 mg in the form of amoxicillin trihydrate; Excipients: magnesium stearate, aspartame (E 951), croscarmellose sodium, mannitol (E 421), talc, colloidal silicon dioxide, microcrystalline cellulose, maltodextrin, soluble starch, titanium dioxide (E 171), peach-apricot flavor powder, orange flavor powdery. Dosage form Tablets, dispersible. Basic physical and chemical properties: oblong biconvex tablets from white to yellowish-white in color with a slight fruity and characteristic odor for the active substance, with a notch on both sides of the tablet. Pharmacological group Antimicrobial agents for systemic use. Beta-lactam antibiotics. Broad spectrum penicillins. Amoxicillin. ATX code J01C A04. Pharmacological properties Pharmacological. Amoxicillin is a broad-spectrum bactericidal antibiotic from the group of semi-synthetic penicillins. Suppresses the synthesis of the bacterial cell wall. Amoxicillin is inactive to microorganisms that produce beta-lactamase. The level of resistance in susceptible organisms may vary by region. The following types of microorganisms are sensitive to the drug: gram-positive aerobes Enterococcus faecalis, Listeria monocytogenes, beta-hemolytic streptococci (groups A, B, C, G) – Streptococcus agalactiae, Streptococcus bovis, Streptococcus pyogenes; gram-negative aerobes Helicobacter pylori; anaerobes: Peptostreptococci; others: Borrelia. Intermittently susceptible (acquired resistance can be a problem): Enterococcus faecium, Streptococcus pneumoniae, Streptococcus viridans, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Proteus mirabilis, Salmonella spp., Prevotella, Clostridium spp., Fusobacterium spp. Resistant species such as: Staphylococcus aureus, Acinetobacter, Citrobacter, Enterobacter, Klebsiella, Legionella, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, Serratia, Bacteroides fragilis, Chlamydia, Mycoplasma, Rickettsia. Pharmacokinetics Absorption. The bioavailability of amoxicillin is dose-dependent and ranges from 75 to 90%. In doses from 250 mg to 1000 mg, bioavailability (AUC and C max ) is linearly proportional to dose. At higher doses, the degree of absorption decreases. Eating practically does not affect the absorption of the drug. After taking a single dose of 500 mg, the concentration of amoxicillin in the blood plasma is 6-11 mg / l. The maximum plasma concentration is reached after 1-2 hours. Distribution. Approximately 17% of amoxicillin binds to plasma proteins. Therapeutic concentrations are rapidly achieved in blood serum, lungs, bronchial secretions, middle ear fluid, bile and urine. The concentration of the drug in bile exceeds its concentration in the blood by 2-4 times. Amoxicillin does not penetrate well into the cerebrospinal fluid; however, with inflammation of the meninges (for example, with meningitis), the concentration in the cerebrospinal fluid is approximately 20% of the concentration in the blood plasma. Metabolism. Amoxicillin is partially metabolized, most of its metabolites are inactive. Conclusion. Amoxicillin is excreted mainly by the kidneys. Approximately 60-80% of the dose taken is eliminated after 6:00 unchanged. The half-life of the drug is 1-1.5 hours. In case of impaired renal function, the half-life of the drug increases and reaches 8.5 hours with anuria. The half-life of the drug does not change with impaired liver function. Amoxicillin is indicated for the treatment of such infections: acute bacterial sinusitis; acute otitis media; acute streptococcal tonsillitis and pharyngitis; exacerbation of chronic bronchitis; community-acquired pneumonia; acute cystitis; asymptomatic bacteriuria during pregnancy; acute pyelonephritis; typhoid and paratyphoid fever; articular eradication of Helicobacter pylori (as part of combination therapy); Lyme disease. The drug is used to treat and prevent endocarditis. Contraindications Hypersensitivity to amoxicillin, other penicillins or drug excipients. A history of severe hypersensitivity reactions (including anaphylaxis) to beta-lactam antibiotics (including cephalosporins, carbapenems or monobactams). Interaction with other drugs and other forms of interaction Probenecid, phenylbutazone, oxyphenbutazone, to a lesser extent – acetylsalicylic acid and sulfinpyrazone reduce the renal tubular secretion of amoxicillin, which can lead to an increase in its plasma level and prolongation of action. Simultaneous use with amoxicillin is not recommended. Allopurinol. Simultaneous use with amoxicillin may increase the likelihood of allergic skin reactions. Tetracycline. Tetracycline and other drugs that have a bacteriostatic effect (macrolides, chloramphenicol) can neutralize the bactericidal effect of amoxicillin. Simultaneous use of aminoglycosides is possible (synergistic effect). Oral anticoagulants. Oral anticoagulants and penicillin antibiotics are widely used in practice; however, there were no reports of interaction. However, isolated cases of an increase in the level of international normalized ratio (INR) have been described in patients who simultaneously took amoxicillin and acenocoumarol or warfarin. If such use is necessary, prothrombin time or INR should be carefully monitored. In addition, it may be necessary to adjust the dose of oral anticoagulants. Methotrexate. The use of amoxicillin with methotrexate leads to an increase in the toxic effect of the latter. Amoxicillin reduces the renal clearance of methotrexate, so you should check the level of its concentration in the blood serum. Digoxin. The absorption of digoxin increases, so a dose adjustment is necessary. Amoxicillin should be used with caution in conjunction with oral hormonal contraceptives, since plasma levels of estrogen and progesterone may temporarily decrease, which may reduce the effectiveness of hormonal contraceptives. Therefore, it is recommended to use additional non-hormonal contraceptives. Other types of interactions Forced diuresis leads to a decrease in the concentration of the drug in the blood plasma due to an increase in its elimination. The occurrence of diarrhea can lead to a decrease in the absorption of other drugs and adversely affect their effectiveness. Elevated levels of the drug in plasma and urine may affect the results of some laboratory tests. When applying chemical methods, false positive results are usually observed. When determining glucose in urine, it is recommended to use the enzymatic glucose oxidase method. The presence of amoxicillin may affect the results of the quantitative determination of estriol in pregnant women. At high concentrations, amoxicillin can reduce the level of glycemia in the blood serum. Amoxicillin may interfere with the determination of protein by the colorimetric method. Application features Hypersensitivity. Before starting treatment with amoxicillin, it is necessary to verify the presence / absence of a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibacterial drugs and allergens. Cross-hypersensitivity (10-15%) between penicillins and cephalosporins is possible. Serious and sometimes even fatal cases of hypersensitivity (anaphylactoid reactions) are observed in patients during penicillin therapy. Such reactions are more likely to occur in patients with a history of hypersensitivity to penicillins or hypersensitivity to various allergens. In the event of an allergic reaction, amoxicillin therapy should be discontinued and appropriate treatment instituted. Insensitive microorganisms. Since amoxicillin is not intended for the treatment of certain types of infections, the drug should be used only when a pathogen is identified or when there is reason to believe that this infectious agent is likely to be sensitive to the action of amoxicillin (see section “Pharmacological properties”). This is especially true for patients with urinary tract infections and severe infections of the ear, nose, and throat. Seizures. Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug or have a tendency to convulsions (for example, a history of epileptic seizures, treated epilepsy, meningitis) (see section “Adverse reactions”). Renal failure. In patients with renal insufficiency, the dose of amoxicillin should be adjusted according to the degree of renal insufficiency. Skin reactions. The appearance at the beginning of treatment of generalized erythema with fever associated with pustules may be a symptom of acute generalized exanthematous pustulosis. In this case, it is necessary to stop treatment and further use of amoxicillin is contraindicated. The use of amoxicillin should be avoided if infectious mononucleosis is suspected, since the occurrence of a measles-like rash in this case may be associated with hypersensitivity to penicillins. Amoxicillin is not recommended for the treatment of patients with viral infections, acute lymphocytic leukemia due to an increased risk of erythematous skin rashes. Jarisch-Herxheimer reaction. In the treatment of Lyme disease, a Jarisch-Herxheimer reaction may occur (see section “Adverse reactions”), which occurs due to the bactericidal action of amoxicillin on the causative agent of Lyme disease, the Borrelia burgdorferi spirochete. resistance. Prolonged use of the drug may cause excessive growth of microflora insensitive to the drug. As with other broad-spectrum penicillins, superinfections may occur. With the use of almost all antibacterial drugs, including amoxicillin, antibiotic-associated colitis from mild to life-threatening has been reported. If severe diarrhea occurs, characteristic of pseudomembranous colitis (in most cases caused by Clostridium difficile), it is recommended to stop using the drug and take appropriate measures. The use of antiperistaltic agents is contraindicated. You should also take the necessary measures in the event of hemorrhagic colitis or hypersensitivity reactions. Patients with severe disorders of the digestive tract, accompanied by diarrhea and vomiting, should not use the drug because of the risk of reduced absorption. Long term therapy. When treating for a long time, it is recommended to periodically evaluate the indicators of the function of body systems, including the urinary, hepatobiliary and hematopoietic systems. An increase in the activity of liver enzymes and cases of changes in blood parameters have been reported. Anticoagulants. Prolongation of PT has been very rarely reported in patients treated with amoxicillin. With the simultaneous appointment of the drug with anticoagulants, appropriate monitoring should be carried out and the dose of the latter adjusted, if necessary. Crystalluria. In patients with reduced diuresis, crystalluria was very rarely observed, mainly with parenteral therapy. When using high doses of the drug, it is necessary to consume a sufficient amount of fluid to prevent crystalluria associated with amoxicillin. The presence of a high concentration of the drug in the urine can cause precipitation in the urinary catheter, so it should be visually checked at regular intervals. In premature babies and in the neonatal period, kidney, liver and blood function should be monitored. When using the drug as part of combination therapy for eradication Helicobacter pylori, you should read the instructions for use of other drugs for combination therapy. Ospamox ZN should be used with extreme caution in patients with phenylketonuria, since the drug contains aspartame (E 951). Use during pregnancy or lactation. Amoxicillin crosses the placental barrier; its concentration in the blood plasma of the fetus is approximately 25-30% of the concentration in the blood plasma of a pregnant woman. Limited data on the use of amoxicillin during pregnancy indicate no adverse effects on the fetus / newborn. Animal studies have shown no teratogenic effects of amoxicillin. If it is necessary to prescribe amoxicillin during pregnancy, a careful assessment of the ratio of the potential risk to the fetus and the expected benefit to the woman should be carried out. Amoxicillin is excreted in small amounts into breast milk, so the risk of developing hypersensitivity in a child during breastfeeding cannot be ruled out. The use of the drug during this period is possible only when the expected benefit to the mother outweighs the potential risk to the child. Breastfeeding should be discontinued if the newborn develops gastrointestinal disorders (diarrhoea), candidiasis, or skin rashes. Fertility. Data on the effect of amoxicillin on fertility in humans are not available. Reproductive toxicity studies in animals have shown no effect on fertility. The ability to influence the reaction rate when driving vehicles or operating other mechanisms. A study of the effect on the ability to drive a car and other mechanisms has not been conducted. However, some adverse reactions (for example, allergic reactions, dizziness, convulsions) can affect the ability to drive a car or other mechanisms. Overdose Symptoms: digestive tract dysfunction – nausea, vomiting, diarrhea, which may result in a violation of water and electrolyte balance. Cases of crystalluria have occasionally been reported leading to renal failure. In patients with impaired renal function or those who received high doses of amoxicillin, convulsions may occur (see sections “Peculiarities of use” and “Adverse reactions”). Treatment: induce vomiting or gastric lavage, followed by activated charcoal and an osmotic laxative. Water and electrolyte balance should be maintained. Amoxicillin is removed from the blood by hemodialysis. The specific antidote is unknown. Adverse Reactions The most common side effects are diarrhea, nausea and rash. Criteria for assessing the incidence of adverse reactions: often (? 1/100, <1/10), infrequent (? 1/1000, <1/100), rare (? 1/10000, <1/1000), rare (see Infections and invasions: rarely - prolonged or repeated use of the drug can lead to the development of superinfection and overgrowth of insensitive microorganisms or yeasts that cause candidiasis of the skin and mucous membranes.On the part of the blood and lymphatic system: single - eosinophilia, hemolytic anemia; rare - leukopenia, severe neutropenia , agranulocytosis, thrombocytopenia, pancytopenia, myelosuppression, granulocytopenia, increased bleeding time and prothrombin index.These manifestations are reversible upon discontinuation of treatment.On the part of the immune system: rarely - severe allergic reactions, including angioedema (angioedema), anaphylaxis, serum sickness, allergic vasculitis, laryngeal edema, anaphylactic shock frequency unknown - Jarisch-Herxheimer reaction. CT: often - diarrhea, nausea, vomiting, flatulence, stomach pain, soft stools, itching in the anus, loss of appetite, enanthema (especially in the mouth), dry mouth, taste disturbance; single - discoloration of the surface of the teeth (especially in children when taking a suspension). Proper oral hygiene can prevent discoloration of the teeth, since most of this plaque is removed by brushing the teeth; rare - antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis), intestinal candidiasis, black staining of the tongue. These side effects are generally not severe and disappear either during treatment or immediately after completion of therapy. The occurrence of such phenomena can be avoided if amoxicillin is used during meals. From the nervous system: rarely - hyperkinesia, hyperactivity, dizziness, convulsions (in patients with epilepsy and meningitis, with impaired renal function, when using high doses of amoxicillin), aseptic meningitis From the digestive system: rarely - hepatitis, cholestatic jaundice, moderate and short-term increase in the level of liver enzymes (AST, ALT). From the side of the skin and subcutaneous tissue: often - skin rash, urticaria, itching rare - erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis, Lyell's syndrome. The sudden onset of urticaria indicates an allergic reaction to amoxicillin and requires immediate discontinuation of therapy. From the side of the kidneys and urinary system: single - acute interstitial nephritis, crystalluria. Others: single - fever. Shelf life 3 years. Storage conditions Store at a temperature not exceeding 30 ° C in the original packaging. Keep out of the reach of children. Prescription category Buy Ospamox DT dispersible tablets 1000mg No. 6x2 Price for Ospamox DT dispersible tablets 1000 mg No. 6x2