AMOXI powder for suspension for oral administration 250mg/5ml 33.3g №1

Name:
Amoxicillin susp. 250mg5ml 33.3g
Description:
White or almost white powder with a fruity odor. When added to the contents of the vial of carbon dioxide-free water (freshly boiled and cooled), a pink suspension with white inclusions with a characteristic strawberry odor is obtained. Stratification of the suspension is allowed, which is eliminated by shaking. The main active ingredient Amoxicillin Suspension form Dosage 250 mg 5 ml Special instructions and precautions Hypersensitivity reactions Before starting treatment with amoxicillin, it is imperative to find out if the patient had previously had hypersensitivity reactions, the occurrence of which was associated with taking any antibiotic from the group of penicillins, cephalosporins or other beta-lactam (see . sections “Contraindications” and “Side effects”). There are reports of the development of serious hypersensitivity reactions, sometimes fatal, (including anaphylactoid and severe skin adverse reactions) in patients treated with penicillin. These reactions are more common in people with a history of hypersensitivity to penicillin and atopy. If an allergic reaction develops, amoxicillin should be discontinued and an appropriate alternative treatment instituted. Non-susceptible organisms Amoxicillin should be used to treat infections only if one of the following conditions is met: the pathogen has been identified and found to be susceptible to amoxicillin; the suspected causative agent is very likely to be sensitive to amoxicillin (see section “Pharmacological properties”). This information is especially important to take into account when deciding whether to prescribe amoxicillin to patients with a urinary tract infection or a severe infection of the ear, nose, or pharynx. Convulsions Convulsions may occur in patients: with impaired renal function; taking amoxicillin in high doses; with the presence of predisposing factors (for example, a history of seizures, treated epilepsy or meningeal disorders) (see section “Side effects”). Impaired renal function In patients with impaired renal function, the dose should be selected in accordance with the severity of the pathology (see section “Method of application and doses”). Skin reactions Generalized erythema with fever and pustules that occurs at the beginning of treatment with amoxicillin may be a symptom of acute generalized exanthematous pustulosis (see section “Side effect”). If such a reaction occurs, you should immediately stop taking amoxicillin; in the future, the appointment of amoxicillin is contraindicated in any case. Amoxicillin should be avoided if infectious mononucleosis is suspected. Taking amoxicillin with infectious mononucleosis can lead to a measles-like rash. There are reports of the development of serious hypersensitivity reactions, sometimes fatal, (including anaphylactoid and severe skin adverse reactions) in patients treated with penicillin. The Jarisch-Herxheimer reaction The Jarisch-Herxheimer reaction has been noted with the use of amoxicillin for the treatment of Lyme disease (see section “Side Effects”). Its appearance is a direct consequence of the bactericidal activity of amoxicillin against the bacterium that is the causative agent of Lyme disease (spirochete Borrelia burgdorferi). Patients should be warned that this reaction is common, usually self-limiting, and is considered a natural consequence of antibiotic therapy for Lyme disease. Overgrowth of non-susceptible organisms Long-term use of amoxicillin can sometimes lead to overgrowth of non-susceptible organisms. When taking almost all antibacterial drugs, cases of antibiotic-associated colitis have been reported. Its severity can vary from mild to life-threatening (see section “Side effect”). If a patient develops diarrhea during or after treatment with any antibiotic, this diagnosis should always be assumed. If antibiotic-associated colitis is suspected or confirmed, amoxicillin should be stopped immediately and appropriate treatment instituted. In this situation, antiperistaltic drugs are contraindicated. Long-term treatment With long-term treatment with amoxicillin, it is recommended to regularly monitor the function of organ systems, including kidney function, liver function, hematopoiesis function. When taking amoxicillin, there have been cases of increased activity of liver enzymes and changes in the cellular composition of the blood (see section “Side Effects”). Anticoagulants Prolongation of prothrombin time has been reported in rare cases in patients treated with amoxicillin. Appropriate monitoring should be carried out if the patient is taking amoxicillin with anticoagulants. It may be necessary to adjust the dose of oral anticoagulant in order to maintain the level of anticoagulation at the desired level (see sections “Interaction with other medicinal products and other forms of interaction” and “Side effect”). Crystalluria In patients with reduced urine output (diuresis), crystalluria has been observed in very rare cases, mainly with the introduction of an antibiotic parenterally. When prescribing amoxicillin in high doses, it is recommended to ensure the introduction of an adequate amount of fluid and maintain a sufficient level of urine output in order to reduce the likelihood of crystalluria associated with taking amoxicillin. In patients with urinary catheters, it is necessary to regularly check the patency of the urinary tract (see sections “Side Effects” and “Overdose”). Interference with laboratory tests Elevated serum and urinary concentrations of amoxicillin may interfere with the results of certain laboratory tests. Due to high concentrations of amoxicillin in the urine, false positive results are often observed when using chemical diagnostic methods. In the course of treatment with amoxicillin, if it is necessary to determine the concentration of glucose in the urine, it is recommended to use enzymatic glucose oxidase methods. In the presence of amoxicillin, the results of determining the concentration of estriol in pregnant women may be distorted. Auxiliary components AMOXI contains white crystalline sugar. If you know that you have an intolerance to some sugars (for example, due to rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency), consult your doctor before taking the medicine. Patients with diabetes should take into account the fact that each 5 ml of suspension contains 1.43 g of sugar (for a dosage of 125 mg/5 ml) or 1.31 g of sugar (for a dosage of 250 mg/5 ml). Due to the sugar content, the drug with prolonged use (2 weeks or more) can have a negative effect on tooth enamel. AMOXY contains aspartame, which is a source of phenylalanine. Patients with phenylketonuria should use this drug with caution and take into account the fact that each 5 ml of suspension contains aspartame in an amount of 12.5 mg (for both dosages: 125 mg / 5 ml and 250 mg / 5 ml). There are no available data from preclinical and clinical studies that have allowed aspartame to be used in products containing it in children under 12 weeks of age. AMOXY contains the dye Carmoisine, which can cause allergic reactions. AMOXY contains sodium benzoate, which may be slightly irritating to the eyes, skin and mucous membranes. Sodium benzoate may increase the risk and severity of jaundice (yellowing of the skin and eyes) in newborns (under 4 weeks of age). Each 5 ml suspension contains sodium benzoate in an amount of 25 mg (for both dosages: 125 mg / 5 ml and 250 mg / 5 ml). Pharmacological properties Amoxicillin is a broad-spectrum semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins) involved in the biosynthesis of peptidoglycan in bacteria. Peptidoglycan is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the strength of the cell wall, which usually results in cell lysis and death. Thus, amoxicillin has a bactericidal effect. Amoxicillin can be broken down by beta-lactamases, enzymes produced by antibiotic-resistant bacteria. Therefore, the spectrum of action of amoxicillin (when used in monotherapy) does not include microorganisms that are capable of producing these enzymes. The main mechanisms that provide bacterial resistance to amoxicillin are: inactivation by bacterial beta-lactamases; a change in the structure of penicillin-binding proteins, which reduces the affinity of the antibiotic for the target. Bacterial impermeability or efflux mechanisms may cause or promote bacterial resistance, especially in Gram-negative bacteria. The prevalence of resistance may vary by geographic location and over time for certain species. It is desirable to focus on local information on resistance, especially when treating severe infections. If necessary, qualified advice should be sought if the local prevalence of resistance is such that the effectiveness of the drug in the treatment of specific types of infections is doubtful. In vitro sensitivity of microorganisms to amoxicillin Usually sensitive microorganisms are gram-positive aerobes: Enterococcus faecalis, beta-hemolytic streptococci (groups A, B, C and G), Listeria monocytogenes. Microorganisms, the acquired resistance of which may be a problem in the treatment of infection: gram-negative aerobes: Escherichia coli, Haemophilus influenzae, Helicobacter pylori, Proteus mirabilis, Salmonella typhi, Salmonella paratyphi, Pasteurella multocida; gram-positive aerobes: coagulase-negative staphylococci, Staphylococcus aureus1, Streptococcus pneumoniae, a group of green streptococci; gram-positive anaerobes: Clostridium spp.; gram-negative anaerobes: Fusobacterium spp.; other microorganisms: Borrelia burgdorferi. Organisms with natural resistance2: Gram-positive aerobes: Enterococcus faecium2; gram-negative aerobes: Acinetobacter spp., Enterobacter spp., Klebsiella spp., Pseudomonas spp.; gram-negative anaerobes: Bacteroides spp. (many strains of Bacteroides fragilis are resistant); other microorganisms: Chlamydia spp., Mycoplasma spp., Legionella spp. 1Almost all Staphylococcus aureus are resistant to amoxicillin due to penicillinase production. In addition, all methicillin-resistant strains are resistant to amoxicillin. 2Natural intermediate susceptibility in the absence of acquired resistance mechanisms. Amoxicillin is rapidly and well absorbed after oral administration. Simultaneous food intake does not affect the absorption of amoxicillin. Hemodialysis can be used to remove amoxicillin from the circulation. After intravenous administration, amoxicillin is found in the gallbladder, abdominal tissues, skin, adipose tissue, muscles, synovial and peritoneal fluids, bile and pus. Amoxicillin does not penetrate well into the cerebrospinal fluid. In animal studies, no significant retention of amoxicillin derivatives in body tissues was found. Amoxicillin, like most penicillins, can be found in breast milk (see Fertility, Pregnancy and Lactation). Amoxicillin crosses the placental barrier (see the Fertility, Pregnancy and Lactation section). The main route of elimination of amoxicillin is through the kidneys. In every child in the first week of life (including premature newborns), the interval between injections should be at least 12 hours (use no more than 2 times a day) due to the immaturity of the renal excretion pathway. Since the elderly may experience a decrease in renal function, in this category of patients it is necessary to carefully select the dose and periodically monitor renal function. Indications for use AMOXY can be used in children and adults to treat the following infections: acute bacterial sinusitis; acute otitis media; acute streptococcal tonsillitis and pharyngitis; exacerbation of chronic bronchitis; community-acquired pneumonia; acute cystitis; asymptomatic bacteriuria in pregnant women; acute pyelonephritis; typhoid and paratyphoid; peridental abscess with spreading cellulitis; prosthetic joint infections; eradication of Helicobacter pylori; Lyme disease. AMOXI can also be used to prevent endocarditis. When deciding whether to prescribe AMOXI, one should rely on the general principles of antibiotic therapy and on the information provided in official guidelines for the appropriate use of antibacterial drugs. Dosage and Administration Always use this medicine exactly as directed by your healthcare professional. If you have any questions or doubts, ask your doctor or pharmacist for advice. Method of application AMOXI is intended for oral administration. Eating does not affect the absorption of amoxicillin. Therefore, the drug can be taken regardless of the meal. Treatment can be started with parenteral (intravenous) amoxicillin (at the doses recommended for this route of administration) and continued with AMOXI oral suspension. AMOXY is available in powder form. Before using the drug, it is necessary to prepare a suspension. To do this, first shake the powder in the vial, then add boiled, cooled to room temperature, drinking water to the “60 ml” mark (for a vial containing 20.0 g of powder) or to the “100 ml” mark (for a vial containing 33 .3 g of powder) and shake vigorously. After the resulting foam settles, add an additional volume of suspension with water to 60 ml (for a vial containing 20.0 g of powder) or up to 100 ml (for a vial containing 33.3 g of powder), shake thoroughly. After completing these steps, the suspension is ready for use. Before each use, the contents of the vial should be shaken vigorously and left to stand until the resulting foam settles. Doses When prescribing a specific dose of amoxicillin for the treatment of a specific infection, one should take into account: the type of suspected pathogen and the characteristic profile of sensitivity / resistance to antibacterial agents for this pathogen (see section “Special Instructions and Precautions”); severity and localization of the infectious process; age, body weight, kidney function status of the patient. The duration of the course of treatment should be determined based on the type of infection, the individual patient’s response to the drug. In general, the duration of the course should be as short as possible. Some infections require long-term therapy with amoxicillin (see the “Special instructions and precautions” section of the relative prolonged treatment). Each 5 ml suspension contains 125 mg (for a dosage of 125 mg/5 ml) or 250 mg (for a dosage of 250 mg/5 ml) of amoxicillin. Children weighing <40 kg For more accurate and convenient dosing, as well as due to possible difficulties in swallowing a tablet, in children (especially young children), it is advisable to use amoxicillin in the form of a suspension or in other dosage forms. In children under 6 months of age, amoxicillin suspension is recommended. In every child in the first week of life (including premature newborns), the interval between injections should be at least 12 hours (use no more than 2 times a day) due to the immaturity of the renal excretion pathway. Elderly patients Correction of the dosing regimen is not required. However, in the elderly, there may be a decrease in renal function, therefore, for this category of patients, it is necessary to carefully select the dose and periodically monitor renal function. The maximum daily dose of amoxicillin is 500 mg. Patients with impaired liver function In the presence of this pathology, the dosage regimen should be selected with caution and regular monitoring of the state of liver function during treatment should be carried out (see sections "Special Instructions and Precautions" and "Side Effects"). If you forget to take another dose of the medicine, it must be taken as soon as possible. The next scheduled dose should be taken at least 4 hours after the missed dose. Do not take a double dose to make up for a missed dose! If you have taken an overdose of the drug, seek advice from your doctor or a doctor at the nearest medical facility (for example, a polyclinic or a hospital emergency department); If possible, please take the medicine package and the package leaflet with you. Symptoms that may develop after taking an overdose are listed in the "Overdose" section. You should not interrupt the course of treatment prescribed by your doctor, even if you feel better. If after completing the prescribed course of treatment, the state of health has not improved, you should consult your doctor. Use during pregnancy and lactation Pregnancy Animal studies have not revealed direct or indirect negative effects that are manifestations of reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin should only be used in pregnant women if the expected benefit outweighs the potential risks. Breast-feeding Amoxicillin is excreted in small amounts into breast milk, which creates a possible risk of sensitization. Consequently, in children who are breastfed, diarrhea and fungal infections of the mucous membranes may occur; therefore, before starting amoxicillin, breastfeeding should be suspended. Amoxicillin is allowed to be used during breastfeeding only after a thorough assessment of the benefit / risk ratio by a doctor. Fertility There are no data on the effect of amoxicillin on human fertility. Animal reproduction studies have shown no effect on fertility. Contraindications Known individual hypersensitivity to amoxicillin and / or to any of the auxiliary components of the drug. Known increased individual sensitivity to any antibiotic from the penicillin series. A history of severe immediate-type hypersensitivity reaction (eg, anaphylaxis) associated with another beta-lactam drug (eg, cephalosporins, carbapenems, or monobactams). The composition of the suspension contains 125 mg or 250 mg of amoxicillin trihydrate in terms of amoxicillin as an active ingredient. Excipients: xanthan gum, anhydrous colloidal silicon dioxide, calcium stearate, sodium benzoate, sodium citrate, aspartame (E 951), carmoisine dye (E 122), Vanillin PX 1496 flavor, Strawberry PX 1377 flavor, white crystalline sugar. OverdoseSymptoms In case of an overdose of amoxicillin, obvious disorders of the gastrointestinal tract (nausea, vomiting, diarrhea), obvious disturbances in water and electrolyte balance can be observed. Crystalluria has been reported with the use of amoxicillin, in some cases leading to renal failure. In patients with impaired renal function or in those patients who take amoxicillin in high doses, convulsions may occur (see sections "Special Instructions and Precautions" and "Side Effects"). Treatment In violation of the function of the gastrointestinal tract, symptomatic treatment is indicated. Particular attention should be paid to the normalization of water and electrolyte balance. Amoxicillin can be removed from the vascular bed by hemodialysis. Interaction with other drugs Probenecid Concomitant use of probenecid is not recommended. Probenecid reduces tubular secretion of amoxicillin in the kidneys. Simultaneous administration of probenecid can lead to an increase in the concentration of amoxicillin and a prolongation of its half-life from blood plasma. Allopurinol The combined use of amoxicillin and allopurinol may increase the likelihood of allergic skin reactions. Tetracyclines Tetracyclines and other bacteriostatic agents may interfere with the bactericidal effects of amoxicillin. Oral anticoagulants Oral anticoagulants and antibiotics from the penicillin group are widely used in clinical practice, with no evidence of interaction between drugs. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients undergoing course treatment with amoxicillin while taking acenocoumarol or warfarin. If the combined use of oral anticoagulants and amoxicillin is considered necessary, careful monitoring of the value of prothrombin time or INR should be carried out when increasing the dose of amoxicillin after stopping treatment with amoxicillin. Moreover, dose adjustment of oral anticoagulants may be required (see sections "Special instructions and precautions" and "Side effects"). Methotrexate Penicillins can reduce the excretion of methotrexate, which will increase the likelihood of manifestation of the toxic properties of the latter. Side effect The drug AMOXI can cause the development of unwanted reactions, but not everyone develops them. The frequency of occurrence of adverse reactions is indicated as: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (< 1/10000); unknown (frequency cannot be estimated from the available data). Storage conditions Store in a place protected from light and moisture at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy AMOXI powder for oral suspension 250mg/5ml 33.3g №1 Price for AMOXI powder for oral suspension 250mg/5ml 33.3g №1 for oral administration 250mg/5ml 33.3g №1