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Amoxiclav powder for the preparation of suspension for oral administration 250 mg+62.5 mg/5 ml 25 g

Inside. The dosage regimen is set individually depending on the age, body weight, kidney function of the patient and the severity of the infection. The daily dose of suspensions is 125 mg + 31.25 mg/5 ml and 250 mg + 62.5 mg/5 ml (to facilitate correct dosing in each package of suspensions 125 mg + 31.25 mg/5 ml and 250 mg + 62.5 mg/5 ml, insert a dosing pipette graduated into 5 ml with a 0.1 ml division scale or a dosing spoon with a capacity of 5 ml, with ring marks in the cavity at 2.5 ml and 5 ml). Newborns and children up to 3 months: 30 mg/kg (amoxicillin) per day, divided into 2 doses (every 12 hours). Children over 3 months: From 20 mg/kg for mild and moderate infections to 40 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis (amoxicillin) per day, divided into 3 doses ( every 8 hours). The daily dose of the suspension is 400 mg + 57 mg/5 ml. The dose is calculated per kg of body weight depending on the severity of the infection. From 25 mg/kg for mild and moderate infections to 45 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses. To facilitate correct dosing, a dosage pipette is inserted into each package of the 400 mg + 57 mg/5 ml suspension, graduated simultaneously into 1, 2, 3, 4, 5 ml and into 4 equal parts. Exact daily doses are calculated based on the child's body weight, not his age. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg for children. The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children. In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin. Patients with CC more than 30 ml/min do not require any dose adjustment. Adults and children weighing more than 40 kg (the indicated dosage regimen is used for moderate and severe infections). For patients with creatinine clearance 10-30 ml/min, 500 mg/125 mg twice daily. For CC less than 10 ml/min, the recommended dose is 500 mg/125 mg once a day. For patients on hemodialysis, the recommended dose is 500 mg/125 mg every 24 hours plus 500 mg/125 mg during the dialysis session and another dose at the end of the dialysis session (as serum concentrations of amoxicillin and clavulanic acid are reduced). Children weighing less than 40 kg. For CC 10-30 ml/min, the recommended dose is 15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily). For CC less than 10 ml/min, the recommended dose is 15 mg/3.75 mg/kg once daily (maximum 500 mg/125 mg). For hemodialysis, the recommended dose is 15 mg/3.75 mg/kg once daily. Before hemodialysis 15 mg/3.75 mg/kg. To restore appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15 mg/3.75 mg/kg after hemodialysis. The course of treatment is 5? 14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without reviewing the clinical situation. Powder for preparing a suspension 125 mg + 31.25 mg/5 ml: shake the bottle vigorously, add 86 ml of water in two additions (to the mark), shaking well each time until the powder is completely dissolved. Powder for preparing a suspension 250 mg + 62.5 mg/5 ml: shake the bottle vigorously, add 85 ml of water in two additions (to the mark), shaking well each time until the powder is completely dissolved. Powder for preparing a suspension 400 mg + 57 mg/5 ml: shake the bottle vigorously, add water in two doses (to the mark) in the amount indicated on the label and given in the table, shaking well each time until the powder is completely dissolved. Shake vigorously before use! To prepare the suspension, it is recommended to dilute the powder with boiled water at room temperature. It is recommended to place the finished suspension in the refrigerator. It is not recommended to heat the suspension before use (it is necessary to bring the suspension to room temperature). After taking the drug, it is recommended to rinse the dosage pipette with boiled water.

Amoxiclav powder for the preparation of Forte suspension for oral administration (250 mg + 62.5 mg)/5 ml 100 ml No. 1

Name

Amoxiclav por d/prig.susp. forte d/internal approx. (250mg+62.5mg)/5ml in vial. 100ml per pack. No. 1

Description

White or yellowish-white crystalline powder.

Main active ingredient

Amoxicillin+clavulanic acid

Release form

Powder

Dosage

5 ml of suspension for internal use contains 250 mg of amoxicillin in the form of trihydrate and 62.5 mg of clavulanic acid in the form of potassium salt.

Pharmacological properties

Pharmacodynamics

Amoxicillin is a semisynthetic penicillin, a beta-lactam antibiotic that inhibits one or more enzymes (often called penicillin-binding proteins) in the biosynthesis of peptidoglycan, a structural component of the bacterial cell wall. Suppression of peptidoglycan synthesis leads to loss of cell wall strength, which usually causes cell death. Amoxicillin is destroyed by beta-lactamases produced by resistant bacteria, so it is inactive against microorganisms that produce these enzymes. Clavulanic acid is a beta-lactam structurally similar to penicillins. It inhibits some beta-lactamases and thereby prevents the inactivation of amoxicillin. Clavulanic acid alone does not have a clinically useful antibacterial effect. The time to maintain concentrations above the minimum inhibitory concentration (T>MIC) is recognized as the main determining factor in the effectiveness of amoxicillin. The two main mechanisms for the development of resistance to amoxicillin/clavulanic acid are: inactivation by bacterial beta-lactamases that are insensitive to the inhibitory effect of clavulanic acid, including beta-lactamases of classes B, C and D; and changes in penicillin-binding proteins, which cause a decrease in the affinity of the antibacterial drug for the target. Impermeability of bacteria or mechanisms of active drug transport from the bacterial cell can directly cause or contribute to resistance, especially in Gram-negative bacteria. Minimum inhibitory concentrations (MICs) for amoxicillin/clavulanic acid correspond to the limits of sensitivity established by the European Committee on Antibiotic Susceptibility Assessment (EUCAST) Microorganism Limits of sensitivity (µg/ml) Sensitivity Intermediate sensitivity Resistance Haemophilus influenzae1 ? 1 — > 1 Moraxella catarrhalis1 ? 1 — > 1 Staphylococcus aureus2 ? 2 — > 2 Coagulase-negative staphylococcus2 ? 0.25 > 0.25 Enterococcus1 ? 4 8 > 8 Streptococcus A, B, C, G5 ? 0.25 — > 0.25 Streptococcus pneumoniae3 ? 0.5 1-2 > 2 Enterobacteriaceae1.4 — — > 8 Gram-negative anaerobes1 ? 4 8 > 8 Gram-positive anaerobes1 ? 4 8 > 8 Non-species-specific limits1 ? 2 4-8 > 8 1 The obtained values correspond to the concentrations of amoxicillin. To assess sensitivity, a fixed concentration of clavulanic acid is used - 2 mg/l. 2 The obtained values correspond to the concentrations of oxacillin. 3 The limit values in the table are based on ampicillin susceptibility limits. 4 The resistance limit R > 8 mg/l guarantees antibiotic resistance of all isolated strains with resistance mechanisms. 5 The limit values in the table are based on the limits of sensitivity to benzylpenicillin. The prevalence of resistance of individual species is geographically and temporally dependent, and therefore it is advisable to obtain local information on antibiotic resistance before initiating therapy, especially in the case of severe infections. If local rates of antibiotic resistance call into question the effectiveness of the drug for at least some types of infections, assistance should be sought from appropriate expert specialists. Commonly susceptible species Gram-positive aerobes: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (methicillin-sensitive)?, Coagulase-negative staphylococci (methicillin-sensitive)?, Streptococcus agalactiae, Streptococcus pneumoniae1, Streptococcus pyogenes and other beta-hemolytic streptococci, group Streptococcus cus viridians . Gram-negative aerobes: Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae2, Moraxella catarrhalis, Pasteurella multocida. Anaerobes: Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp. Species with possible development of acquired resistance Gram-positive aerobes: Enterococcus faecium$ Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris. Species with natural resistance Gram-negative aerobes: Acinetobacter sp., Citrobacter freundii, Enterobacter sp., Legionella pneumophila, Morganela morganii, Providencia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia. Other microorganisms: Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumonia. $ Natural intermediate sensitivity in the absence of an acquired resistance mechanism. ? All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid. 1 Infections caused by Streptococcus pneumonia, which are fully sensitive to penicillin, can be treated with this dosage form of the drug. Infections caused by microorganisms with any degree of resistance to penicillin should not be treated with this dosage form of the drug. 2 In some EU countries, strains with reduced susceptibility have been identified, occurring at frequencies above 10%.

Pharmacokinetics

Amoxicillin and clavulanic acid are completely soluble in water at physiological pH levels. Both components are quickly and well absorbed after oral administration. Their absorption is improved if the drug is taken immediately before meals. When taken orally, the bioavailability of amoxicillin and clavulanic acid reaches approximately 70%. The plasma concentration profiles of both components are similar, and the time to peak concentration (Tmax) for each substance is approximately one hour. In a group of healthy volunteers, when taking the combination drug at a dose of 875 mg/125 mg in tablet form twice a day on an empty stomach, maximum serum concentrations were 11.64 ± 2.78 μg/ml for amoxicillin and 2.18 ± 0.99 μg/ml for clavulanic acid. Time to maximum concentration was 1.5 hours (range 1.0–2.5) for amoxicillin and 1.25 hours (range 1.0–2.0) for clavulanic acid. The AUC(0-24) values were 53.52 ± 12.31 μg/hour/ml for amoxicillin and 10.16 ± 3.04 μg/hour/ml for clavulanic acid. The half-life (T?) was 1.19 ± 0.21 hours for amoxicillin and 0.96 ± 0.12 hours for clavulanic acid. Serum concentrations of amoxicillin and clavulanic acid achieved by oral administration are similar to those obtained by oral administration of equivalent doses of amoxicillin or clavulanic acid alone. Approximately 25% of the total content of clavulanic acid and 18% of the total content of amoxicillin in plasma is in a protein-bound state. The apparent volume of distribution is about 0.3 - 0.4 l/kg for amoxicillin and about 0.2 l/kg for clavulanic acid. After intravenous administration, amoxicillin and clavulanic acid are found in the gallbladder, abdominal wall tissue, skin, adipose tissue, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin penetrates into the cerebrospinal fluid to a weak extent. In animal studies, there was no evidence of significant retention of drug components in tissues. Amoxicillin passes into breast milk. Trace amounts of clavulanic acid are also detected in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier. Amoxicillin is partially excreted in the urine in the form of inactive penicillic acid in quantities equivalent to no more than 10-25% of the original dose. Clavulanic acid is extensively metabolized, excreted in urine and feces, and also in the form of carbon dioxide in exhaled air. Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated from the body through both renal and extrarenal mechanisms. The amoxicillin/clavulanic acid combination in healthy individuals has an average half-life of approximately one hour and an average total clearance of approximately 25 L/h. Approximately 60-70% of amoxicillin and approximately 40-65% of clavulanic acid are excreted unchanged in the urine in the first 6 hours after a single dose of amoxicillin/clavulanic acid tablets at a dose of 250 mg/125 mg or 500 mg/125 mg. Urinary excretion over a 24-hour period is 50-85% for amoxicillin and 27-60% for clavulanic acid. The maximum amount of clavulanic acid is excreted in the first two hours after taking the drug. Concomitant use of probenecid causes a delay in the elimination of amoxicillin, however, does not affect the renal excretion of clavulanic acid. Age The half-life of amoxicillin is similar in children aged 3 months to 2 years, older children and adults. In very young children (including premature newborns) in the first week of life, the drug should not be used more than twice a day due to the immaturity of the renal excretion pathway. Because the likelihood of decreased renal function is increased in older adults, dose selection should be done with caution and monitoring of renal function may be required. Gender The pharmacokinetics of amoxicillin or clavulanic acid does not depend on the gender of the patient. Impaired renal function The total plasma clearance of amoxicillin/clavulanic acid decreases in proportion to the decrease in renal function. The decrease in clearance is more pronounced for amoxicillin than for clavulanic acid, since the proportion of amoxicillin excreted by the kidneys is higher. In renal failure, doses are adjusted to avoid excessive accumulation of amoxicillin while maintaining adequate levels of clavulanic acid. Liver failure Patients with liver failure are treated with caution and regular monitoring of liver function is required.

Indications for use

Amoxiclav is indicated for the treatment of the following infections in adults and children: • acute bacterial sinusitis; • acute otitis media; • acute bronchitis, exacerbation of chronic bronchitis; • community-acquired pneumonia; • cystitis; • pyelonephritis; • infections of the skin and soft tissues, in particular inflammation of the subcutaneous tissue, wounds from animal bites, severe tooth abscess with widespread phlegmon; • infections of bones and joints, in particular osteomyelitis. Official guidelines on the appropriate use of antibacterial drugs should be considered.

Directions for use and doses

Doses reflect the content of amoxicillin/clavulanic acid, unless the dose is indicated to indicate the content of an individual component. When choosing a dose for the treatment of specific infections, the following factors must be taken into account: • suspected pathogens and their possible susceptibility to antibacterial drugs; • severity and location of infection; • age, weight and kidney function as follows. The use of other dosage forms of Amoxiclav (for example, with higher doses of amoxicillin and/or with a different amoxicillin/clavulanic acid dose ratio) is considered as needed. When taking Amoxiclav in accordance with the recommendations below, the total daily dose for adults and children weighing ? 40 kg would be 1500 mg amoxicillin/375 mg clavulanic acid; Overweight children

Use during pregnancy and lactation

Animal studies have shown no direct or indirect harmful effects on pregnancy, embryo/fetal development, childbirth or neonatal development. Limited data on the use of the drug during pregnancy do not indicate an increased risk of congenital anomalies. In women with premature premature rupture of membranes, prophylactic treatment with amoxicillin/clavulanic acid was potentially associated with an increased risk of necrotizing enterocolitis in newborns. The use of the drug should be avoided during pregnancy unless the doctor considers treatment necessary. Both active ingredients are excreted into breast milk (there are no data on the effect of clavulanic acid on breastfed children). Breastfed babies may develop diarrhea and fungal infections of the mucous membranes, which may require stopping breastfeeding. Possible sensitization should be taken into account. Taking the drug during breastfeeding is possible only after an assessment of the benefits and risks by the attending physician.

Precautionary measures

Before starting therapy with the drug, it is necessary to carefully collect anamnesis for hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam drugs. Serious and sometimes fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been observed with penicillin therapy. They are most likely to develop in patients with a history of hypersensitivity reactions to penicillins and in individuals prone to developing allergic reactions. If an allergic reaction develops, Amoxiclav therapy should be discontinued and other appropriate antibacterial drugs should be prescribed. In cases of proven susceptibility of infectious agents to amoxicillin, a switch from Amoxiclav to amoxicillin should be considered in accordance with official guidelines. This dosage form of the drug is not suitable for use if there is a high risk that the suspected pathogens have reduced sensitivity or resistance to beta-lactam drugs due to non-beta-lactamases sensitive to inhibition by clavulanic acid. The drug should not be used to treat infections caused by penicillin-resistant strains of S. pneumoniae. Patients with impaired renal function or those receiving high-dose therapy may develop seizures. You should not take Amoxiclav if you suspect infectious mononucleosis, since after using amoxicillin against the background of this disease, the appearance of a measles-like rash was observed. Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of developing allergic skin reactions. Long-term use of the drug can sometimes lead to excessive proliferation of resistant microorganisms. The development of generalized erythema with fever and pustule formation at the beginning of therapy is a potential symptom of acute generalized exanthematous pustulosis. Such a reaction requires discontinuation of Amoxiclav therapy and is a contraindication to the subsequent use of amoxicillin. Treatment of patients with liver failure must be carried out with caution. Hepatic adverse events were observed predominantly in men and elderly patients and are potentially associated with long-term treatment. These adverse events have been observed in very rare cases in children. In all patient groups, signs and symptoms usually develop during or shortly after treatment, but in some cases they do not appear until several weeks after stopping therapy. Usually they are reversible. Severe liver side effects may develop, extremely rarely with death. They have almost always been observed in patients with serious underlying medical conditions or in those taking medications that can damage the liver. Cases of antibiotic-associated colitis, observed during therapy with almost all antibacterial drugs, can range in severity from mild to life-threatening. It is important to consider this diagnosis in patients with diarrhea during or after completion of any course of antibiotic therapy. If antibiotic-associated colitis develops, you should immediately stop Amoxiclav therapy, consult a doctor and begin appropriate treatment. In this situation, the use of drugs that inhibit peristalsis is contraindicated. During long-term therapy, periodic assessment of the functions of various organ systems, including the kidneys, liver and hematopoietic organs, is recommended. In rare cases, while taking the drug, an increase in prothrombin time was observed. When taking anticoagulants concomitantly, appropriate monitoring must be carried out. Dosage adjustments of oral anticoagulants may be necessary to achieve the desired level of anticoagulation. In patients with renal failure, dose adjustment is required according to the level of insufficiency. In patients with reduced diuresis, crystalluria was observed in rare cases, mainly during parenteral therapy. During high-dose amoxicillin therapy, adequate fluid intake and diuresis control are recommended to reduce the likelihood of amoxicillin-associated crystalluria. In patients with a catheter installed in the bladder, it is necessary to regularly monitor its patency. If it is necessary to assess urine glucose levels during treatment with amoxicillin, it is necessary to use enzymatic methods with glucose oxidase, since non-enzymatic methods sometimes give false-positive results. The presence of clavulanic acid in Amoxiclav may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may cause false-positive Coombs test results. Cases of positive enzyme immunoassay (ELISA) results for Aspergillus have been observed in patients receiving the drug who were subsequently determined to be free of Aspergillus infections. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses have been observed in the Aspergillus ELISA test. Positive test results in patients taking Amoxiclav should be interpreted with caution and confirmed by other diagnostic methods.

Interaction with other drugs

Oral anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used together, and there have been no reports of drug interactions. However, the literature describes cases of increased international normalized ratio (INR) in patients receiving maintenance therapy with acenocoumarol or warfarin during a prescribed course of amoxicillin. If concomitant use is necessary, the prothrombin time or INR should be carefully monitored during treatment initiation and discontinuation of amoxicillin. Dose adjustment of oral anticoagulants may be required. Methotrexate Penicillins may decrease the excretion rate of methotrexate, which may result in increased toxicity. Probenecid Concomitant use of probenecid is not recommended. It reduces the secretion of amoxicillin in the renal tubules. Concomitant use of probenecid with Amoxiclav may lead to increased levels of amoxicillin (but not clavulanic acid) in the blood and their longer maintenance. Mycophenolate mofetil In patients taking mycophenolate mofetil, after starting oral amoxicillin and clavulanic acid, there was an approximately 50% decrease in the concentration of the active metabolite mycophenolic acid (MPA) before taking the next dose of mycophenolate mofetil. Such a change in concentration before taking the next dose cannot indicate a change in the overall exposure of MPA. Therefore, in the absence of clinical signs of graft dysfunction, there is usually no need to change the dose of mycophenolate mofetil. However, careful medical supervision is necessary during such combination therapy and for some time after the end of antibiotic therapy.

Contraindications

Hypersensitivity to the active or excipients of the drug, as well as to any penicillins. History of severe immediate hypersensitivity reactions (eg, anaphylaxis) to other beta-lactam drugs (eg, cephalosporins, carbapenems or monobactams). History of jaundice or other liver damage associated with amoxicillin/clavulanic acid use.

Compound

Amoxiclav (250mg+62.5mg)/5ml 5 ml of suspension for internal use contains 250 mg of amoxicillin in the form of trihydrate and 62.5 mg of clavulanic acid in the form of potassium salt. Excipients: anhydrous crushed citric acid, crushed anhydrous sodium citrate, microcrystalline cellulose and dried sodium carboxymethylcellulose, xanthan gum, anhydrous colloidal silicon dioxide, silicon dioxide, wild cherry flavoring, sodium benzoate, dried sodium saccharin, mannitol.

Overdose

Gastrointestinal symptoms and water and electrolyte imbalance may develop. Cases of amoxicillin-associated crystalluria, sometimes leading to renal failure, have been observed. Patients with impaired renal function or those receiving high-dose therapy may experience seizures. Amoxicillin precipitates in urinary catheters, mainly after intravenous administration of large doses. It is necessary to regularly monitor the patency of catheters. For gastrointestinal symptoms, symptomatic treatment can be carried out along with restoration of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the body by hemodialysis.

Side effect

The most common adverse reactions are diarrhea, nausea and vomiting. The following categories were used to classify the incidence of adverse effects: very common (? 1/10), common (? 1/100 to

Storage conditions

Keep out of the reach of children. Store in a dry place at a temperature not exceeding 25°C. Store the prepared suspension in a tightly closed bottle at a temperature of 2-8 °C for no more than 7 days.