Composition of Amoxiclav
- Amoxiclav 250 mg/125 mg tablets contain the active ingredients amoxicillin (trihydrate form) and clavulanic acid (potassium salt form). The tablets also contain auxiliary components: MCC sodium croscarmellose.
- Amoxiclav 2X 625 mg and 1000 mg tablets contain the active ingredients amoxicillin and clavulanic acid, as well as additional components: anhydrous colloidal silicon dioxide, flavorings, aspartame , yellow iron oxide, talc, hydrogenated castor oil, silicated MCC.
- Amoxiclav Quiktab 500 mg and 875 mg tablets contain the active ingredients amoxicillin and clavulanic acid, as well as additional components: anhydrous colloidal silicon dioxide, flavorings, aspartame, yellow iron oxide, talc, hydrogenated castor oil, silicated MCC.
- The powder from which the Amoxiclav suspension is prepared also contains amoxicillin and clavulanic acid, and also contains sodium citrate, MCC, sodium benzoate, mannitol, and sodium saccharin as inactive components.
- The powder for preparing Amoxiclav IV infusion contains amoxicillin and clavulanic acid.
Release form
The drug is produced in the form of tablets:
- Amoxiclav 250 mg/125 mg – film-coated tablets, package contains 15 pieces.
- Amoxiclav 2X (500 mg/125 mg; 875 mg/125 mg) - coated tablets; the package may contain 10 or 14 pieces.
- Amoxiclav Quiktab (500 mg/125 mg; 875 mg/125 mg) is available in the form of dispersed tablets, 10 such tablets per package.
The product is also produced in the form of a powder from which a suspension is made; the bottle contains powder for preparing 100 ml of the product.
A powder is also produced, from which a solution is made, which is administered intravenously. The bottle contains 600 mg of the product (amoxicillin 500 mg, clavulanic acid 100 mg), 1.2 g bottles are also available (amoxicillin 1000 mg, clavulanic acid 200 mg), the package contains 5 bottles.
Amoksiklav®
Inside.
Daily dosages of suspensions are 125 mg+31.25 mg/5 ml and 250 mg+62.5 mg/5 ml
(to facilitate correct dosing, each package of suspensions 125 mg + 31.25 mg/5 ml and 250 mg + 62.5 mg/5 ml includes a dosing spoon with a capacity of 5 ml or a graduated dosage pipette).
Newborns and children up to 3 months
prescribed 30 mg/kg (amoxicillin)/day, divided into 2 doses (every 12 hours);
children over 3 months
- from 20 mg (for amoxicillin)/kg/day for
mild and moderate
infections to 40 mg/kg (for amoxicillin)/day for
severe infections and respiratory tract infections
, divided into 3 doses (every 8 h).
Recommended doses of suspensions depending on the child’s body weight and the severity of the infection.
| Body weight (kg) | Age (approx.) | Mild/moderate infections | Severe infections | ||
| 125 mg+31.25 mg/5 ml | 250 mg+62.5 mg/5 ml | 125 mg+31.25 mg/5 ml | 250 mg+62.5 mg/5 ml | ||
| 5-10 | 3-12 months | 3 × 2.5 ml (1/2 l.) | 3 × 1.25 ml (1/4 l.) | 3 × 3.75 ml (3/4 l.) | 3 × 2 ml (1/4-1/2 l.) |
| 10-12 | 1-2 years | 3 × 3.75 ml (3/4 l.) | 3 × 2 ml (1/4-1/2 l.) | 3 × 6.25 ml (11/4 l.) | 3 × 3 ml (1/2-3/4 l.) |
| 12-15 | 2-4 years | 3 × 5 ml (1 l.) | 3 × 2.5 ml (1/2 l). | 3 × 7.5 ml (11/2 l.) | 3 × 3.75 ml (3/4 l.) |
| 15-20 | 4-6 years | 3 × 6.25 ml (11/4 l.) | 3 × 3 ml (1/2-3/4 l.) | 3 × 9.5 ml (13/4-2 l.) | 3 × 5 ml (1 l.) |
| 20-30 | 6-10 years | 3 × 8.75 ml (13/4 l.) | 3 × 4.5 ml (3/4-1 l.) | — | 3 × 7 ml (11/4-11/2 l.) |
| 30-40 | 10-12 years | — | 3 × 6.5 ml (11/4 l.) | — | 3 × 9.5 ml (13/4-2 l.) |
| ≥ 40 | ≥ 12 years | Amoxiclav® is prescribed in tablets | |||
Daily doses of suspension 400 mg + 57 mg/5 ml
are calculated per 1 kg of body weight depending on the severity of the infection and amount to 25-45 mg/kg body weight/day (in terms of amoxicillin), 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.
Recommended doses of the suspension depending on the child’s body weight and the severity of the infection.
| Body weight (kg) | Age (approx.) | Severe infections | Moderate infections |
| 5-10 | 3-12 months | 2 × 2.5 ml (1/2 pipette) | 2 × 1.25 ml (1/4 pipette) |
| 10-15 | 1-2 years | 2 × 3.75 ml (3/4 pipettes) | 2 × 2.5 ml (1/2 pipette) |
| 15-20 | 2-4 years | 2 × 5 ml (1 pipette) | 2 × 3.75 ml (3/4 pipettes) |
| 20-30 | 4-6 years | 2 × 7.5 ml (11/2 pipettes) | 2 × 5 ml (1 pipette) |
| 30-40 | 6-10 years | 2 × 10 ml (2 pipettes) | 2 × 6.5 ml (11/4 pipettes) |
Exact daily doses are calculated based on the child's body weight, not his age.
The maximum daily dose of amoxicillin is for adults
6 g, for
children
- 45 mg/kg body weight.
The maximum daily dose of clavulanic acid (in the form of potassium salt) is for adults
600 mg, for
children
- 10 mg/kg body weight.
In patients with severe renal failure (creatinine clearance less than 10 ml/min)
the dose should be adequately reduced or the interval between two doses should be increased (for anuria up to 48 hours or more).
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 repeated medical examination.
Rules for preparing the suspension
Powder for preparing a suspension 125 mg + 31.25 mg/5 ml: shake the bottle vigorously, add 86 ml of water (to the mark) in two doses, shaking well each time until the powder is completely dissolved.
Powder for preparing a suspension of 250 mg + 62.5 mg/5 ml: shake the bottle vigorously, add 85 ml of water (to the mark) in two doses, 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 the amount indicated on the label and given in the table (up to the mark) in two doses, shaking well each time until the powder is completely dissolved.
| Bottle size | Required amount of water |
| 35 ml | 29.5 ml |
| 50 ml | 42 ml |
| 70 ml | 59 ml |
| 140 ml | 118 ml |
The bottle should be shaken vigorously before use.
pharmachologic effect
The abstract provides information that the antibiotic Amoxiclav (INN Amoksiklav) is a broad-spectrum agent. Group of antibiotics: broad-spectrum penicillins. The medicine contains amoxicillin (semi-synthetic penicillin) and clavulanic acid (β-lactamase inhibitor). The presence of clavulanic acid in the composition of the drug ensures the resistance of amoxicillin to the action of β-lactamases produced by microorganisms.
The structure of clavulanic acid is similar to beta-lactam antibiotics, this substance also has an antibacterial effect. Amoxiclav is active against strains that demonstrate sensitivity to Amoxicillin. These are a number of gram-positive bacteria, aerobic gram-negative bacteria, gram-positive and gram-negative anaerobes.
Pharmacokinetics and pharmacodynamics
As the Vidal drug reference book informs, after oral administration, both substances are actively absorbed from the gastrointestinal tract; the absorption of the components is not affected by food intake, so it does not matter how you take it - before or after meals. The highest concentration in the blood is observed one hour after the drug was taken. Both active ingredients of the drug are distributed in fluids and tissues. Amoxicillin also enters the liver, synovial fluid, prostate, tonsils, gall bladder, muscle tissue, saliva, and bronchial secretions.
If the membranes of the brain are not inflamed, both active substances do not penetrate through the BBB. At the same time, the active components penetrate the placental barrier and traces of them are detected in breast milk. They bind to blood proteins to a small extent.
In the body, amoxicillin undergoes partial metabolism , clavulanic acid is intensively metabolized. It is excreted from the body through the kidneys; small particles of active substances are excreted by the intestines and lungs. The half-life of amoxicillin and clavulanic acid is 1-1.5 hours.
Buy Amoxiclav powder for the preparation of oral suspension 250mg+62.5mg/5ml 100ml in pharmacies
Amoxiclav Buy Amoxiclav in pharmacies DOSAGE FORMS powder for the preparation of an oral suspension 250mg+62.5 mg/5ml powder for the preparation of an oral suspension 250mg+62.5mg/5ml 20dz
MANUFACTURERS Lek dd. (Slovenia)
GROUP Combined antimicrobial agents
COMPOSITION Active substance: amoxicillin + clavulanic acid.
INTERNATIONAL NON-PROPENTED NAME Amoxicillin + Clavulanic acid
SYNONYMS Amoxiclav Quiktab, Arlet, Augmentin, Augmentin EU, Augmentin SR, Clamosar, Medoclav, Panclave, Ranclave, Rapiclav, Sinulox, Sinulox RTU, Flemoclav Solutab, Ecoclave
PHARMACOLOGICAL ACTION Broad spectrum antibacterial. Blocks the synthesis of peptidoglycan of the membrane of microbial cells (amoxicillin), inhibits beta-lactamases (clavulanic acid). Clavulanic acid forms a stable inactivated complex with these enzymes and protects amoxicillin from the loss of antibacterial activity caused by the production of beta-lactamases by the main pathogens and opportunistic microorganisms. Active against gram-positive aerobes: Streptococcus pneumoniae, S.pyogenes, S.viridans, S.bovis, Staphylococcus aureus (except methicillin-resistant strains), S.epidermidis (except methicillin-resistant strains), Listeria spp., Enterococcus spp. Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, E.coli, Gardnerella vaginalis, H.influenzae, H.ducreyi, Klebsiella spp., Moraxella catarrhalis, N.gonorrhoeae, N.meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii. Rapidly absorbed after oral administration (food intake does not affect absorption). The maximum concentration is reached 1 hour after administration. The maximum plasma concentration after a bolus injection of 1.2 g is 105.4 mg/l (for amoxicillin) and 28.5 mg/l (for clavulanic acid). It has a large volume of distribution - high concentrations are found in body fluids and tissues (lungs, pleural, peritoneal, synovial fluid, tonsils, bronchial secretions, prostate gland, peritoneal abscess, muscle tissue, adipose tissue, paranasal sinus secretions, middle ear, etc. .). Peak concentrations in body fluids are observed 1 hour after peak plasma concentrations are reached. Does not pass through the BBB when the meninges are not inflamed, passes through the placental barrier and penetrates into breast milk in trace concentrations. Weakly binds to plasma proteins. Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism. Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration; clavulanic acid - by glomerular filtration, partly in the form of metabolites. Small amounts are excreted by the intestines and lungs. The half-life is 1-1.5 hours, with severe renal failure it increases to 7.5 (for amoxicillin) and 4.5 hours (for clavulanic acid). It is removed during hemodialysis, and slightly - during peritoneal dialysis.
INDICATIONS FOR USE Infectious diseases of the upper (acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsilopharyngitis) and lower respiratory tract (acute and chronic bronchitis, pneumonia, pleural empyema); urinary tract infections (including cystitis, urethritis, pyelonephritis), gynecological infections (including salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis); biliary tract (cholecystitis, cholangitis), bone and connective tissue (including chronic osteomyelitis), skin and soft tissue (phlegmon, wound infection), odontogenic infections (periodontitis); sexually transmitted infections (gonorrhea, chancroid).
CONTRAINDICATIONS Hypersensitivity; history of allergic reactions to antibiotics of the penicillin and cephalosporin group; cholestatic jaundice, hepatitis caused by taking penicillin antibiotics (in history); liver failure; infectious mononucleosis, lymphocytic leukemia. Use during pregnancy and breastfeeding: Possible if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment.
SIDE EFFECTS In most cases, side effects are weak and transient, most often affecting the gastrointestinal tract: loss of appetite, nausea, vomiting, diarrhea. Possible development of superinfection, stomatitis, vaginitis; in rare cases - pseudomembranous colitis with severe diarrhea. Allergic reactions may occur: itching, skin rashes; in sensitive patients, immediate hypersensitivity reactions may develop (angioedema, bronchospasm, rarely - anaphylactic shock). It is extremely rare that a transient increase in the level of transaminases in the blood plasma can be observed. There are isolated reports of cholestatic jaundice, hepatitis, and liver dysfunction.
INTERACTION When used simultaneously with methotrexate, the toxicity of methotrexate increases, with allopurinol - the incidence of exanthema, and with anticoagulants - the prothrombin time is prolonged. Reduces the effectiveness of oral contraceptives. Concomitant use with disulfiram should be avoided. The effectiveness of Amoxiclav is weakened by combination with bacteriostatic antibiotics (macrolides, tetracyclines); combination with rifampicin is antagonistic. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Pharmaceutically incompatible with solutions containing blood, proteins, lipids, glucose, dextran, bicarbonate. Do not mix in a syringe or infusion bottle with other drugs. Incompatible with aminoglycosides.
OVERDOSE Symptoms: in most cases nausea, diarrhea, vomiting, possible agitation, insomnia, dizziness, and in some cases seizures. There are no reports of deaths or life-threatening side effects. Treatment: symptomatic, in case of recent use (less than 4 hours), remove the drug from the gastrointestinal tract (gastric lavage, taking activated charcoal to reduce absorption), hemodialysis is effective.
SPECIAL INSTRUCTIONS Prescribe with caution to patients prone to allergic reactions to cephalosporins and other beta-lactam antibiotics (risk of cross-sensitivity), with severe impairment of liver and kidney function (dosage regimen adjustment is necessary). High concentrations give a false positive reaction for glucose in urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucose oxidase).
STORAGE CONDITIONS List B. At room temperature.
Indications for use of Amoxiclav
Amoxiclav is prescribed for infectious and inflammatory diseases that develop due to the influence of microorganisms sensitive to this medicine. The following indications for the use of this drug are determined:
- infections of the ENT organs, as well as infectious diseases of the upper respiratory tract ( otitis media , retropharyngeal abscess, sinusitis , pharyngitis , tonsillitis );
- urinary tract infections ( cystitis , prostatitis , etc.);
- infectious diseases of the lower respiratory tract (pneumonia, acute and chronic bronchitis
- gynecological diseases of an infectious nature;
- connective and bone tissue infections;
- infectious diseases of soft tissues, skin (including consequences of bites);
- biliary tract infections (cholangitis, cholecystitis );
- odontogenic infections.
What else Amoxiclav helps with, you should ask a specialist during an individual consultation.
Buy Amoxiclav powder for the preparation of suspension orally 125 mg + 31.25 mg/5 ml 100 ml in pharmacies
Amoxiclav Buy Amoxiclav in pharmacies DOSAGE FORMS powder for the preparation of a suspension for oral administration 125mg+31 25mg/5ml powder for the preparation of an oral suspension 125mg+31 25mg/5ml 20dz
MANUFACTURERS Lek dd. (Slovenia)
GROUP Combined antimicrobial agents
COMPOSITION Active substance: amoxicillin + clavulanic acid.
INTERNATIONAL NON-PROPENTED NAME Amoxicillin + Clavulanic acid
SYNONYMS Amoxiclav Quiktab, Arlet, Augmentin, Augmentin EU, Augmentin SR, Clamosar, Medoclav, Panclave, Ranclave, Rapiclav, Sinulox, Sinulox RTU, Flemoclav Solutab, Ecoclave
PHARMACOLOGICAL ACTION Broad spectrum antibacterial. Blocks the synthesis of peptidoglycan of the membrane of microbial cells (amoxicillin), inhibits beta-lactamases (clavulanic acid). Clavulanic acid forms a stable inactivated complex with these enzymes and protects amoxicillin from the loss of antibacterial activity caused by the production of beta-lactamases by the main pathogens and opportunistic microorganisms. Active against gram-positive aerobes: Streptococcus pneumoniae, S.pyogenes, S.viridans, S.bovis, Staphylococcus aureus (except methicillin-resistant strains), S.epidermidis (except methicillin-resistant strains), Listeria spp., Enterococcus spp. Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, E.coli, Gardnerella vaginalis, H.influenzae, H.ducreyi, Klebsiella spp., Moraxella catarrhalis, N.gonorrhoeae, N.meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii. Rapidly absorbed after oral administration (food intake does not affect absorption). The maximum concentration is reached 1 hour after administration. The maximum plasma concentration after a bolus injection of 1.2 g is 105.4 mg/l (for amoxicillin) and 28.5 mg/l (for clavulanic acid). It has a large volume of distribution - high concentrations are found in body fluids and tissues (lungs, pleural, peritoneal, synovial fluid, tonsils, bronchial secretions, prostate gland, peritoneal abscess, muscle tissue, adipose tissue, paranasal sinus secretions, middle ear, etc. .). Peak concentrations in body fluids are observed 1 hour after peak plasma concentrations are reached. Does not pass through the BBB when the meninges are not inflamed, passes through the placental barrier and penetrates into breast milk in trace concentrations. Weakly binds to plasma proteins. Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism. Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration; clavulanic acid - by glomerular filtration, partly in the form of metabolites. Small amounts are excreted by the intestines and lungs. The half-life is 1-1.5 hours, with severe renal failure it increases to 7.5 (for amoxicillin) and 4.5 hours (for clavulanic acid). It is removed during hemodialysis, and slightly - during peritoneal dialysis.
INDICATIONS FOR USE Infectious diseases of the upper (acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsilopharyngitis) and lower respiratory tract (acute and chronic bronchitis, pneumonia, pleural empyema); urinary tract infections (including cystitis, urethritis, pyelonephritis), gynecological infections (including salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis); biliary tract (cholecystitis, cholangitis), bone and connective tissue (including chronic osteomyelitis), skin and soft tissue (phlegmon, wound infection), odontogenic infections (periodontitis); sexually transmitted infections (gonorrhea, chancroid).
CONTRAINDICATIONS Hypersensitivity; history of allergic reactions to antibiotics of the penicillin and cephalosporin group; cholestatic jaundice, hepatitis caused by taking penicillin antibiotics (in history); liver failure; infectious mononucleosis, lymphocytic leukemia. Use during pregnancy and breastfeeding: Possible if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment.
SIDE EFFECTS In most cases, side effects are weak and transient, most often affecting the gastrointestinal tract: loss of appetite, nausea, vomiting, diarrhea. Possible development of superinfection, stomatitis, vaginitis; in rare cases - pseudomembranous colitis with severe diarrhea. Allergic reactions may occur: itching, skin rashes; in sensitive patients, immediate hypersensitivity reactions may develop (angioedema, bronchospasm, rarely - anaphylactic shock). It is extremely rare that a transient increase in the level of transaminases in the blood plasma can be observed. There are isolated reports of cholestatic jaundice, hepatitis, and liver dysfunction.
INTERACTION When used simultaneously with methotrexate, the toxicity of methotrexate increases, with allopurinol - the incidence of exanthema, and with anticoagulants - the prothrombin time is prolonged. Reduces the effectiveness of oral contraceptives. Concomitant use with disulfiram should be avoided. The effectiveness of Amoxiclav is weakened by combination with bacteriostatic antibiotics (macrolides, tetracyclines); combination with rifampicin is antagonistic. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Pharmaceutically incompatible with solutions containing blood, proteins, lipids, glucose, dextran, bicarbonate. Do not mix in a syringe or infusion bottle with other drugs. Incompatible with aminoglycosides.
OVERDOSE Symptoms: in most cases nausea, diarrhea, vomiting, possible agitation, insomnia, dizziness, and in some cases seizures. There are no reports of deaths or life-threatening side effects. Treatment: symptomatic, in case of recent use (less than 4 hours), remove the drug from the gastrointestinal tract (gastric lavage, taking activated charcoal to reduce absorption), hemodialysis is effective.
SPECIAL INSTRUCTIONS Prescribe with caution to patients prone to allergic reactions to cephalosporins and other beta-lactam antibiotics (risk of cross-sensitivity), with severe impairment of liver and kidney function (dosage regimen adjustment is necessary). High concentrations give a false positive reaction for glucose in urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucose oxidase).
STORAGE CONDITIONS List B. At room temperature.
Contraindications
When determining why tablets and other forms of the drug help, you should also take into account existing contraindications:
- Infectious mononucleosis;
- previous liver disease or cholestatic jaundice when taking clavulanic acid or Amoxicillin;
- lymphocytic leukemia;
- high sensitivity to antibiotic drugs from the group of cephalosporins, penicillins, as well as other beta-lactam antibiotics;
- high sensitivity to the active components of the drug.
It is prescribed with caution to people suffering from liver failure and people with severe kidney disease.
Instructions for use AMOXIKLAV® (AMOKSIKLAV) for injection
Before prescribing the drug, a detailed history should be obtained regarding previous hypersensitivity reactions to penicillins, cephalosporins or other β-lactam antibiotics.
Serious (in some cases fatal) hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, it is necessary to stop treatment with Amoxiclav and begin alternative therapy. For severe hypersensitivity reactions, the patient should be given epinephrine (adrenaline) immediately. Oxygen therapy, intravenous administration of corticosteroids, and airway management, including intubation, may also be required.
Amoxiclav® should not be prescribed if infectious mononucleosis is suspected, since amoxicillin can cause a skin rash in patients with this disease, which makes diagnosing the disease difficult.
It is not recommended to prescribe Amoxiclav® if there is a high risk that the suspected pathogens have reduced susceptibility or are resistant to beta-lactam antibiotics (for example, penicillin-resistant Streptococcus pneumoniae). Seizures may occur in patients with impaired renal function or in patients receiving high doses.
Special caution is required if it is necessary to use the drug Amoxiclav® in patients with severe allergic diseases, bronchial asthma, with diarrhea and/or vomiting.
Amoxiclav® should be prescribed with caution to patients with impaired liver function. Drug-induced liver failure has been reported predominantly in men and elderly patients and may be associated with long-term therapy. Liver dysfunction has been very rarely reported in children. In all groups of patients, symptoms usually begin during or shortly after treatment, but in some cases become apparent only several weeks after treatment has stopped. Symptoms are usually reversible. Liver failure can be severe and, in extremely rare cases, fatal. It is almost always observed in patients with a serious underlying disease or who are concomitantly taking medications that can have undesirable effects on the liver.
During long-term therapy with Amoxiclav, it is recommended to periodically evaluate renal, liver and hematopoietic function. In patients receiving amoxicillin, an increase in prothrombin time is occasionally observed, therefore, with the simultaneous use of Amoxiclav and anticoagulants, it is necessary to regularly monitor the relevant indicators. With this combination, dose adjustment of oral anticoagulants may be required to achieve the desired level of coagulation.
Long-term treatment with Amoxiclav sometimes leads to excessive growth of insensitive microflora.
The appearance of febrile generalized erythema associated with a pustule at the beginning of treatment may be a symptom of acute generalized exanthemal pustulosis. This reaction requires discontinuation of treatment with Amoxiclav and is a contraindication for any subsequent prescriptions of amoxicillin.
In general, amoxicillin is well tolerated and has the low toxicity characteristic of all penicillins.
Antibiotic-induced colitis occurs with almost all antibacterial drugs and can range in severity from mild to life-threatening. Therefore, it is important to recognize this diagnosis in patients with diarrhea during or after taking any antibiotic. In case of colitis caused by an antibiotic, Amoxiclav should be stopped immediately, a doctor should be consulted, and appropriate therapy should be started. Antiperistaltic drugs are contraindicated in this situation.
In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. In patients with a catheter installed in the bladder, it is necessary to regularly monitor its patency.
The presence of clavulanic acid in Amoxiclav may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may lead to false-positive Coombs test results.
When taking Amoxiclav orally, amoxicillin is detected in the urine. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucose oxidase.
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 receiving Amoxiclav® should be interpreted with caution and confirmed by other diagnostic methods.
Amoxiclav® 1000 mg/200 mg powder for injection solution contains 1 mmol of potassium (39 mg). This should be considered in patients with impaired renal function or in patients on a controlled potassium diet.
Amoxiclav® 500 mg/100 mg powder for injection solution contains less than 1 mmol of potassium (less than 39 mg), i.e. contains virtually no potassium.
Amoxiclav® 1000 mg/200 mg powder for injection solution contains approximately 2.7 mmol sodium (63 mg). This should be considered in patients on a sodium-controlled diet.
Amoxiclav® 500 mg/100 mg powder for injection solution contains approximately 1.4 mmol sodium (31.5 mg). This should be considered in patients on a sodium-controlled diet.
Impact on the ability to drive vehicles and operate machinery
Undesirable effects may develop (for example, allergic reactions, dizziness, convulsions), potentially affecting the performance of these functions.
Side effects
When taking this antibiotic, patients may experience the following side effects:
- Digestive system: loss of appetite, vomiting, nausea, diarrhea ; in rare cases, abdominal pain and liver dysfunction may occur; isolated manifestations - hepatitis, jaundice, pseudomembranous colitis.
- Hematopoietic system: in rare cases - reversible leukopenia , thrombocytopenia ; in very rare cases - eosinophilia , pancytopenia .
- Allergic manifestations: itching , erythematous rash, urticaria ; in rare cases - anaphylactic shock , exudative erythema, edema , allergic vasculitis; isolated manifestations - Stevens-Johnson syndrome, pustulosis, exfoliative dermatitis.
- Functions of the nervous system: dizziness , headache ; in rare cases - convulsions, anxiety, hyperactivity, insomnia .
- Urinary system: crystalluria , interstitial nephritis .
- In rare cases, superinfection may occur.
It is noted that such treatment, as a rule, does not provoke significant side effects.
Instructions for use of Amoxiclav (Method and dosage of Amoxiclav for adults)
Medicine in tablets is not prescribed to children under 12 years of age. When prescribing the drug, it should be taken into account that the permissible dose per day of clavulanic acid is 600 mg (adults) and 10 mg per 1 kg of weight (child). The permissible daily dose of amoxicillin is 6 g for an adult and 45 mg per 1 kg of weight for a child.
The agent for parenteral administration is prepared by dissolving the contents of the vial in water for injection. To dissolve 600 mg of the product, you need 10 mol of water, to dissolve 1.2 g of the product - 20 ml of water. The solution should be administered slowly over 3-4 minutes. The intravenous infusion should continue for 30-40 minutes. The solution must not be frozen.
Before anesthesia, to prevent purulent complications, 1.2 g of drugs should be administered intravenously. If there is a risk of complications, the drug is administered intravenously or taken orally in the period after surgery. The duration of the appointment is determined by the doctor.
Amoxiclav tablets, instructions for use
As a rule, adults and children (who weigh more than 40 kg) receive 1 tablet every eight hours. (375 mg), provided the infection is mild or moderate. Another acceptable treatment regimen in this case is to take 1 tablet every 12 hours. (500 mg+125 mg). For severe infectious diseases, as well as for infectious diseases of the respiratory tract, taking 1 tablet every eight hours is recommended. (500 mg+125 mg) or taken every 12 hours 1 tablet. (875 mg+125 mg). Depending on the disease, you need to take an antibiotic from five to fourteen days, but the doctor must individually prescribe a treatment regimen.
Patients with odontogenic infections should take 1 tablet every 8 hours. (250 mg + 125 mg) or once 12 hours, 1 tablet. (500 mg + 125 mg) for five days.
People suffering from moderate renal failure are advised to take 1 tablet. (500 mg + 125 mg) every twelve hours. Severe renal failure is a reason to increase the interval between doses to 24 hours.
Amoxiclav suspension, instructions for use
The patient's childhood involves calculating the dose taking into account the child's weight. Before preparing the syrup, shake the bottle well. In two doses you need to add 86 ml of water to the bottle, each time you need to shake its contents well. Please note that the measuring spoon contains 5 ml of product. Prescribed in a dose depending on the age and weight of the child.
Instructions for use Amoxiclav for children
Children from birth to three months are prescribed the drug at the rate of 30 mg per 1 kg of weight (dose per day), this dose should be divided equally and administered at equal intervals. From the age of three months, Amoxiclav is prescribed at a dose of 25 mg per 1 kg of weight, which is similarly divided equally into two administrations. For infectious diseases of moderate severity, the dose is prescribed at the rate of 20 mg per 1 kg of weight, divided into three administrations. For severe infectious diseases, the dose is prescribed at the rate of 45 mg per 1 kg of weight, divided into two doses per day.
Instructions for use Amoxiclav Quiktab
Before taking, the tablet must be dissolved in 100 ml of water (the amount of water may be more). Before taking, you need to stir the contents well. You can also chew the tablet; it is better to take the drug before meals. Adults and children after reaching 12 years of age should take 1 tablet per day. 625 mg 2-3 times a day. For severe infectious diseases, 1 tablet is prescribed. 1000 mg 2 times a day. Treatment should not last more than 2 weeks.
Sometimes a doctor may prescribe analogues of the drug, for example, Flemoclav Solutab , etc.
Amoxiclav for sore throat
The drug Amoxiclav for angina for an adult is prescribed 1 tablet. 325 mg once every 8 hours. Another treatment regimen involves taking 1 tablet once every 12 hours. A doctor may prescribe a higher dose of an antibiotic if the disease in an adult is severe. Treatment of sore throat in children involves the use of a suspension. As a rule, 1 spoon is prescribed (a dosage spoon is 5 ml). The frequency of administration is determined by the doctor, whose recommendations are important to follow. How to take Amoxiclav for children with sore throat depends on the severity of the disease.
Dosage of Amoxiclav for sinusitis
Whether Amoxiclav helps with sinusitis depends on the causes and characteristics of the course of the disease. The dosage is determined by the otolaryngologist. It is recommended to take 500 mg tablets three times a day. How many days to take the medicine depends on the severity of the disease. But after the symptoms disappear, you need to take the drug for two more days.
Amoxiclav 250mg+62.5mg/5ml 25g 100ml powder for oral suspension
pharmachologic effect
Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.
Composition and release form Amoxiclav 250 mg + 62.5 mg/5 ml 25 g 100 ml powder for the preparation of suspension for oral administration
Powder for the preparation of a suspension for oral administration - 5 ml of suspension:
- active ingredients: amoxicillin (in the form of trihydrate) - 250 mg; clavulanic acid (in the form of potassium salt) - 62.5 mg;
- excipients: citric acid (anhydrous) - 2.167 mg; sodium citrate (anhydrous) - 8.335 mg; sodium benzoate - 2.085 mg; MCC and carmellose sodium - 28.1 mg; xanthan gum - 10 mg; colloidal silicon dioxide - 16.667 mg; silicon dioxide - 0.217 g; sodium saccharinate - 5.5 mg; mannitol - 1250 mg; wild cherry flavor - 4 mg.
Powder for the preparation of suspension for oral administration 250 mg + 62.5 mg/5 ml. Primary packaging - 25 g of powder (100 ml of finished suspension) in a dark glass bottle with a ring mark (100 ml). The bottle is closed with a screw-on metal cap with a control ring, inside the cap there is a LDPE gasket.
Secondary packaging - 1 fl. with a dosing spoon with ring marks in the cavity for 2.5 and 5 ml (“2.5 SS” and “5 SS”), a maximum filling mark of 6 ml (“6 SS”) on the handle of the spoon in a cardboard box. Or 1 fl. together with a graduated dosage pipette in a cardboard box.
Description of the dosage form
Powder for oral suspension: white to yellowish-white powder. The finished suspension is an almost white to yellow homogeneous suspension.
Directions for use and doses
Inside
The daily dose of suspensions is 125+31.25 mg/5 ml and 250+62.5 mg/5 ml (to facilitate correct dosing, a dosage pipette is inserted into each package of suspensions 125+31.25 mg/5 ml and 250+62.5 mg/5 ml, graduated at 5 ml, with a scale of division of 0.1 ml or a dosing spoon with a capacity of 5 ml, with ring marks in the cavity at 2.5 and 5 ml).
Newborns and children up to 3 months - 30 mg/kg/day (for amoxicillin), divided into 2 doses (every 12 hours).
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of infections in newborns and children up to 3 months (Table 3).
Table 3
| Body weight, kg | 2 | 2,2 | 2,4 | 2,6 | 2,8 | 3 | 3,2 | 3,4 | 3,6 | 3,8 | 4 | 4,2 | 4,4 | 4,6 | 4.8 |
| Suspension 156.25, ml (2 times a day) | 1,2 | 1,3 | 1,4 | 1,6 | 1,7 | 1,8 | 1,9 | 2 | 2,2 | 2,3 | 2,4 | 2,5 | 2,6 | 2,8 | 2,9 |
| Suspension 312.5, ml (2 times a day) | 0,6 | 0,7 | 0,7 | 0,8 | 0,8 | 0,9 | 1 | 1 | 1,1 | 1,1 | 1,2 | 1,3 | 1,3 | 1,4 | 1,4 |
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 h).
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of mild and moderate infections in children over 3 months (at the rate of 20 mg/kg/day (for amoxicillin) (Table 4).
Table 4
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Suspension 312.5, ml (3 times a day) | 0,7 | 0,8 | 0,9 | 1,1 | 1,2 | 1,3 | 1,5 | 1,6 | 1,7 | 1,9 | 2 | 2,1 | 2,3 | 2,4 | 2,5 | 2,7 | 2,8 | 2,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 | |
| Suspension 312.5, ml (3 times a day) | 3,1 | 3,2 | 3,3 | 3,5 | 3,6 | 3,7 | 3,9 | 4 | 4,1 | 4,3 | 4,4 | 4,5 | 4,7 | 4,8 | 4,9 | 5,1 | 5,2 |
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of severe infections in children over 3 months (at the rate of 40 mg/kg/day (for amoxicillin) (Table 5).
Table 5
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 2,7 | 3,2 | 3,7 | 4,3 | 4,8 | 5,3 | 5,9 | 6,4 | 6,9 | 7,5 | 8 | 8,5 | 9,1 | 9,6 | 10,1 | 10,7 | 11,2 | 11,7 |
| Suspension 312.5, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 12,3 | 12,8 | 13,3 | 13,9 | 14,4 | 14,9 | 15,5 | 16 | 16,5 | 17,1 | 17,6 | 18,1 | 18,7 | 19,2 | 19,7 | 20,3 | 20,8 | |
| Suspension 312.5, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 |
Dosing of the drug Amoxiclav® with a dosing spoon (in the absence of a dosing pipette) - recommended doses of suspensions depending on the child’s body weight and the severity of the infection (Table 6).
Table 6
| Body weight, kg | Age (approx.) | Mild/moderate course | Severe course | ||
| 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | ||
| 5–10 | 3–12 months | 3 × 2.5 ml (½ spoon) | 3 × 1.25 ml | 3 × 3.75 ml | 3 × 2 ml |
| 10–12 | 1–2 years | 3 × 3.75 ml | 3 × 2 ml | 3 × 6.25 ml | 3 × 3 ml |
| 12–15 | 2–4 years | 3 × 5 ml (1 spoon) | 3 × 2.5 ml (½ spoon) | 3 × 7.5 ml (1½ spoons) | 3 × 3.75 ml |
| 15–20 | 4–6 years | 3 × 6.25 ml | 3 × 3 ml | 3 × 9.5 ml | 3 × 5 ml (1 spoon) |
| 20–30 | 6–10 years | 3 × 8.75 ml | 3 × 4.5 ml | — | 3 × 7 ml |
| 30–40 | 10–12 years | — | 3 × 6.5 ml | — | 3 × 9.5 ml |
| ≥40 | ≥12 years | Amoxiclav® tablets | |||
Daily dose of suspension 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.
Suspension 400 mg+57 mg/5 ml is used in children over 3 months.
Table 7
Recommended dose of suspension depending on the child’s body weight and severity of infection
| Body weight, kg | Age (approx.) | Recommended dose, ml | |
| Severe course | Moderate course | ||
| 5–10 | 3–12 months | 2×2,5 | 2×1,25 |
| 10–15 | 1–2 years | 2×3,75 | 2×2,5 |
| 15–20 | 2–4 years | 2×5 | 2×3,75 |
| 20–30 | 4 years - 6 years | 2×7,5 | 2×5 |
| 30–40 | 6–10 years | 2×10 | 2×6,5 |
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 for children.
In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin.
Patients with creatinine Cl >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 Cl 10-30 ml/min - 500/125 mg 2 times a day.
With Cl creatinine
For patients on hemodialysis, the recommended dose is 500/125 mg every 24 hours, plus 500/125 mg during dialysis and another dose at the end of dialysis (since serum concentrations of amoxicillin and clavulanic acid are reduced).
Children weighing less than 40 kg
With creatinine Cl 10–30 ml/min, the recommended dose is 15/3.75 mg/kg 2 times a day (maximum 500/125 mg 2 times a day).
With Cl creatinine
For hemodialysis, the recommended dose is 15/3.75 mg/kg once a day. Before hemodialysis - 15/3.75 mg/kg. To restore appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15/3.75 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 repeated medical examination.
Pharmacodynamics
Mechanism of action
Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.
Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type I chromosomal beta-lactamases, which are not inhibited by clavulanic acid.
The presence of clavulanic acid in the drug protects amoxicillin from destruction by enzymes - beta-lactamases, which expands the antibacterial spectrum of amoxicillin.
Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.
Grampore-positive aerobes: Bacillus Anthracis, Enterococcus Faecalis, Listeria MonocyTogenes, NoCardia Asteroides, Streptococcus Pyogenes1,2, Streptococcus Agalactiae1,2, other beta-heemolytic statococci1, 2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: species of the genus Clostridium, Peptococcus niger, Peptostrepiococcus magnus, Peptostreptococcus micros, species of the genus Pepto streptococcus.
Gram-negative anaerobes: Bcicteroides fragilis, species of the genus Bacteroides, species of the genus Capnocytophaga, Eikenella corrodens, Fusobacterium nucleatum, species of the genus Fusobacterium, species of the genus Porphyromonas, species of the genus Prevotella.
Bacteria for which acquired resistance to the combination of amoxicillin and clavulanic acid is likely
Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae, species of the genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of the genus Proteus, species of the genus Salmonella, species of the genus Shigella. Streptococcus pneumoniae1,2, streptococci of the Viridans group.
Gram-positive aerobes: species of the genus Corynebacterium, Enterococcus faecium.
Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid
Gram-negative aerobes: species of the genus Acinetobacter, Citrobacter freundii, species of the genus Enterobacter, Hafhia alvei, Legionella pneumophila, Morganella morganii, species of the genus Providencia, species of the genus Pseudomonas, species of the genus Serratia, Stenotrophomonas maltophilia, Yersinia enterocolitica.
Other: Chlamydia pneumoniae, Chlamydia psittaci, species of the genus Chlamydia, Coxiella burnetii, species of the genus Mycoplasma.
1For these bacteria, the clinical effectiveness of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 strains of these types of bacteria do not produce beta-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.
Pharmacokinetics
Suction
The active ingredients of the drug are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of active ingredients is optimal when the drug is used with food.
The following are the pharmacokinetic parameters of amoxicillin and clavulanic acid after administration at a dose of 45 mg/6.4 mg/kg, divided into two doses, by patients under 12 years of age.
Average value of pharmacokinetic parameters
| Cmax (mg/ml) | T max (h) | AUC (mg in h/l) | T1/2 (h) | |
| Amoxicillin | 11,99±3,28 | 1,0 (1,0-2,0) | 35,2±5,0 | 1,22±0,28 |
| Clavulanic acid | 5,49±2,71 | 1,0 (1,0-2,0) | 13,26±5,88 | 0,99±0,14 |
- Cmax - maximum concentration in blood plasma;
- Tmax is the time to reach the maximum concentration in the blood plasma;
- AUC—area under the concentration-time curve;
- T1/2 - half-life.
Metabolism
About 10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys, through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.
Distribution
As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) .
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.
The volume of distribution is approximately 0.3-0.4 L/kg for amoxicillin and approximately 0.2 L/kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed. Amoxicillin (like most penicillins) is excreted in breast milk.
Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, diarrhea and candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants.
Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.
Removal
Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of 875 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged by the kidneys during the first 6 hours. The average half-life (T1/2) of amoxicillin/clavulanic acid is approximately 1 hour, and the average total clearance is approximately 25 L/h in healthy patients. In various studies, it was found that amoxicillin excretion by the kidneys within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration.
The pharmacokinetics of amoxicillin/clavulanic acid does not depend on the gender of the patient.
Patients with impaired renal function
The total 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, because Most amoxicillin is excreted by the kidneys. Doses of the drug for renal failure should be selected taking into account the undesirability of amoxicillin accumulation while maintaining normal levels of clavulanic acid.
Patients with liver dysfunction
In patients with impaired liver function, the drug is used with caution. It is necessary to constantly monitor liver function.
Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.
Indications for use Amoxiclav 250 mg + 62.5 mg/5 ml 25 g 100 ml powder for the preparation of suspension for oral administration
Infections caused by sensitive strains of microorganisms:
- upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
- lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
- urinary tract (eg cystitis, urethritis, pyelonephritis);
- in gynecology;
- skin and soft tissues, including human and animal bites;
- bone and connective tissue;
- biliary tract (cholecystitis, cholangitis);
- odontogenic.
Contraindications
- hypersensitivity to the components of the drug;
- history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics;
- history of cholestatic jaundice and/or other liver dysfunction caused by taking amoxicillin/clavulanic acid;
- infectious mononucleosis and lymphocytic leukemia;
With caution: history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal impairment, pregnancy, lactation, simultaneous use with anticoagulants.
Application Amoxiclav 250mg+62.5mg/5ml 25g 100ml powder for the preparation of suspension for oral administration during pregnancy and breastfeeding
During pregnancy and lactation, Amoxiclav® is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Amoxicillin and clavulanic acid pass into breast milk in small quantities.
special instructions
During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys.
In patients with severe renal impairment, adequate dose adjustment or increased intervals between doses is required.
It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.
In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
In women with premature rupture of membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of developing necrotizing colitis in the newborn.
Crystalluria very rarely occurs in patients with reduced diuresis. During the use of large doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation.
Lab tests. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucosidase.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment, care should be taken when driving and other activities that require concentration and speed of psychomotor reactions.
Overdose
There are no reports of death or life-threatening side effects due to drug overdose.
Symptoms: in most cases - gastrointestinal disorders (abdominal pain, diarrhea, vomiting), anxiety, insomnia, dizziness are also possible, and in isolated cases - seizures.
Treatment: in case of overdose, the patient should be under medical supervision, treatment should be symptomatic.
In case of recent use (less than 4 hours) of the drug, it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/potassium clavulanate is removed by hemodialysis.
Side effects Amoxiclav 250mg+62.5mg/5ml 25g 100ml powder for suspension for oral administration
From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, darkening of tooth enamel, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomembranous colitis, disorder liver function, increased activity of ALT, AST, alkaline phosphatase and/or bilirubin levels in the blood plasma, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis.
Allergic reactions: itching, urticaria, erythematous rashes, erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness, toxic epidermal necrolysis.
From the hematopoietic system and lymphatic system: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PT (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis.
From the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug).
From the urinary system: interstitial nephritis, crystalluria, hematuria.
Other: candidiasis and other types of superinfection.
From the side of the central nervous system: hyperactivity. Feelings of anxiety, insomnia, behavior changes, agitation.
Drug interactions
Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion (probenecid) increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
The simultaneous use of Amoxiclav® and methotrexate increases the toxicity of methotrexate.
Prescription together with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided.
Reduces the effectiveness of drugs, during the metabolism of which PABA is formed; ethinyl estradiol - risk of breakthrough bleeding.
The literature describes rare cases of increased INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If simultaneous use with anticoagulants is necessary, PT or INR should be carefully monitored when prescribing or discontinuing the drug.
The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug Amoxiclav®.
The drug Amoxiclav® reduces the effectiveness of oral contraceptives.
The drug Amoxiclav® and aminoglycoside antibiotics are chemically incompatible.
Amoxiclav® should not be mixed in a syringe or infusion bottle with other drugs.
Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate, as well as with solutions containing blood, proteins, lipids.
Overdose
To avoid overdose, the prescribed dosage for children and the dosage of Amoxiclav for adults must be strictly observed. It is recommended to carefully study the instructions or watch a video on how to dilute the suspension.
Wikipedia indicates that an overdose of the drug may result in a number of unpleasant symptoms, but there is no data on life-threatening conditions for the patient. , abdominal pain , vomiting , diarrhea may occur . In severe cases, seizures may occur.
If the drug has been taken recently, gastric lavage is performed, activated charcoal . The patient must be monitored by a doctor. In this case, hemodialysis .
Interaction
When taking the drug simultaneously with some drugs, undesirable manifestations may occur, which is why tablets, syrup and intravenous administration of the drug should not be used in parallel with a number of drugs.
The simultaneous use of the drug with Glucosamine , antacids, aminoglycosides, and laxatives slows down the absorption of Amoxiclav; when taken simultaneously with Ascorbic acid , the absorption accelerates.
With simultaneous treatment with Phenylbutazone , diuretics, NSAIDs, Allopurinol and other drugs that block tubular secretion, the concentration of amoxicillin increases.
If anticoagulants and Amoxiclav are taken simultaneously, the prothrombin time increases. Therefore, drugs in such a combination must be prescribed with caution.
Amoxiclav increases the toxicity of Methotrexate when taken simultaneously.
When taking Amoxiclav and Allopurinol , the likelihood of exanthema increases.
You should not take Disulfiram and Amoxiclav at the same time.
Antagonists when taken together are amoxicillin and Rifampicin . The drugs mutually weaken the antibacterial effect.
You should not take Amoxiclav and bacteriostatic antibiotics (tetracyclines, macrolides), as well as sulfonamides at the same time, as these drugs can reduce the effectiveness of Amoxiclav.
Probenecid increases the concentration of amoxicillin and slows down its elimination.
When using Amoxiclav, the effectiveness of oral contraceptives may decrease.
special instructions
Since most people with lymphocytic leukemia and infectious mononucleosis who received Ampicillin subsequently noted the appearance of an erythematous rash, such people are not recommended to take ampicillin antibiotics.
It is prescribed with caution to people with a tendency to allergies .
If a course of treatment with the drug is prescribed for adults or children, it is important to monitor the functions of the kidneys, liver, and the process of hematopoiesis.
People who have impaired renal function need a dose adjustment of the drug or an increase in the interval between taking the drug.
It is optimal to take the product during meals to reduce the likelihood of side effects from the digestive system.
Patients undergoing treatment with Amoxiclav may experience a false positive reaction when determining glucose levels in urine when using Felling's solution or Benedict's reagent .
There is no data on the negative impact of Amoxiclav on the ability to drive vehicles and work with precision machinery.
Patients who are interested in whether Amoxiclav is an antibiotic or not should keep in mind that the product is an antibacterial drug.
It is recommended to drink plenty of water and other liquids during the course of treatment with the drug.
If Amoxiclav is prescribed, the patient's childhood age must be taken into account when prescribing the medication form and dosage.
Amoxiclav 156mg/5ml 100ml Suspension
Trade name Amoxiclav International nonproprietary name No Dosage form Powder for the preparation of suspension for oral administration 156.25 mg/5ml and 312.5 mg/5ml Composition 5 ml suspension (1 measuring spoon) contains active substances: amoxicillin in the form of amoxicillin trihydrate 125 mg, clavulanic acid in the form of potassium clavulanate 31.25 mg (for a dosage of 156.25 mg/5 ml) or amoxicillin in the form of amoxicillin trihydrate 250 mg, clavulanic acid in the form of potassium clavulanate 62.5 mg (for a dosage of 312.5 mg/5 ml). excipients: anhydrous citric acid, anhydrous sodium citrate, microcrystalline cellulose, sodium carboxymethyl cellulose, xanthan gum, anhydrous colloidal silicon dioxide, silicon dioxide, strawberry flavor (for a dosage of 156.25 mg/5 ml), wild cherry flavor (for dosage 312.5 mg/5 ml), sodium benzoate, sodium saccharin, mannitol Description White to yellow-white crystalline powder. The prepared suspension is a homogeneous suspension from almost white to yellow. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Amoxicillin in combination with beta-lactamase inhibitors. Pharmacological properties Pharmacokinetics The main pharmacokinetic properties of amoxicillin and clavulanic acid are similar. The combination of amoxicillin and clavulanic acid does not change the pharmacokinetics of the individual components. Both components are well absorbed after oral administration; food has no effect on the degree of absorption. Maximum serum concentrations are achieved 1 hour after administration. Approximately 17–20% of amoxicillin and 22–30% of clavulanic acid are bound to plasma proteins. Amoxicillin and clavulanic acid easily penetrate into most tissues and body fluids (lungs, middle ear tissue, secretions of the lower sinuses, pleural and peritoneal fluids, uterus, ovaries), and into the brain and cerebrospinal fluid - only with inflammation of the meninges. High concentrations in body tissues are created 1 hour after reaching maximum serum concentrations. Both components easily pass through the placenta. In low concentrations, both components also pass into breast milk. Amoxicillin is excreted in the urine mainly unchanged, clavulanic acid undergoes active metabolism and is excreted mainly in the urine and partly in feces and exhaled air. The half-life of amoxicillin is 1-1.3 hours, and clavulanic acid is 0.8-1.2 hours.
Pharmacodynamics Amoxiclav is a combination of amoxicillin, an antibiotic from the penicillin group with a wide spectrum of bactericidal activity, and clavulanic acid, an irreversible β-lactamase inhibitor that forms a stable inactive complex with this enzyme and thus protects amoxicillin from degradation. Like other semisynthetic penicillins, amoxicillin inhibits cell wall synthesis. Type of action – bactericidal. Amoxiclav has a wide spectrum of activity. It is active against amoxicillin-sensitive microorganisms, as well as the following resistant, β-lactamase-producing bacteria: - Gram-positive aerobes (S.pneumonia, S.pyogenes, S.viridans, S.bovis, S.aureus, S.epidermidis, Listeria spp., Enterococcus spp.), - Gram-negative aerobes (H.influenzae, Moraxella catarrhalis, E.coli, Proteus spp., Klebsiella spp., N.gonorrhoeae, N.meningitidis, Pasteurella multocida), - Anaerobes (Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinonomices israelli). Indications for use - upper respiratory tract infections (acute and chronic sinusitis, acute and chronic otitis, tonsillopharyngitis, peritonsillar abscess) - lower respiratory tract infections (acute and chronic bronchitis, pneumonia) - urinary tract infections - salpingitis, salpingo-oophoritis, endometritis , pelvioperitonitis - infections of bones and joints - infections of the skin and soft tissues (phlegmon, infected wounds) - infections of the biliary tract (cholangitis, cholecystitis) - sexually transmitted diseases (chancroid, gonorrhea) - odontogenic infections (periodontitis) - abdominal infections, postoperative complications in the abdominal cavity. Method of administration and doses Doses are calculated taking into account the content of amoxicillin/clavulanic acid. When choosing the dose of Amoxiclav® for the treatment of individual infections, the following should be taken into account: - the sensitivity of the pathogen to the antibiotic - the severity and location of the infection - the age, weight and renal function of the patient, as shown below. It is also necessary to consider other ways of using the drug Amoxiclav®, for example, using higher doses of amoxicillin and/or prescribing amoxicillin and clavulanic acid in different ratios. The suspension should be taken orally before meals to reduce possible gastrointestinal disturbances and increase the absorption of amoxicillin/clavulanic acid. For children weighing less than 40 kg, the maximum daily dose of Amoxiclav® is 2400 mg amoxicillin/600 mg clavulanic acid. It should be taken into account that if it is necessary to use a higher daily dose of amoxicillin, it is recommended to take other forms of the drug Amoxiclav® with a higher dose in order to avoid the use of an excessively high daily dose of clavulanic acid. The duration of treatment depends on the patient's response. Some infections (such as osteomyelitis) require a longer period of treatment. The maximum duration of therapy should not exceed 14 days (information regarding the duration of treatment is presented in the Special Instructions section). Children weighing more than 40 kg For children, amoxicillin/clavulanic acid can be prescribed in the form of a suspension or tablets. Typically, the suspension is not prescribed to children weighing more than 40 kg; this group of patients is recommended to prescribe the drug in tablets. Children weighing less than 40 kg Dosage from 20 mg/5 mg/kg per day to 60 mg/15 mg/kg per day (maximum dose, prescribed in severe cases), divided into three doses. There are no clinical data on the use of Amoxiclav® 156.25 mg/5 over 40 mg/10 mg/kg/day in children under 2 years of age. For children aged 6 years and younger, it is preferable to give the suspension. In children, exact doses are calculated based on body weight. A dispenser (dosing pipette) for dosing the suspension is included. Table for selecting a single dose of the drug Amoxiclav® 156.25 mg/5 ml depending on body weight Body weight (kg) Daily dose of amoxicillin 20 mg/kg/day 40 mg/kg/day 60 mg/kg/day 2 to 0.5 ml 3 times a day 1.0 ml 3 times a day 1.6 ml 3 times a day 3 x 0.8 ml 3 times a day 1.6 ml 3 times a day 2.4 ml 3 times a day 4 x 1 ,1 ml 3 times a day 2.1 ml 3 times a day 3.2 ml 3 times a day 5 1.3 ml 3 times a day 2.7 ml 3 times a day 4 ml 3 times a day 6 to 1 .6 ml 3 times a day 3.2 ml 3 times a day 4.8 ml 3 times a day 7 1.9 ml 3 times a day 3.7 ml 3 times a day - 8 2.1 ml 3 times per day 4.3 ml 3 times a day - 9 2.4 ml 3 times a day 4.8 ml 3 times a day - 10 2.7 ml 3 times a day 5.3 ml 3 times a day - 11 3.0 ml 3 times a day — — 12 3.2 ml 3 times a day — — 13 3.5 ml 3 times a day — — 14 3.7 ml 3 times a day — — 15 4 .0 ml 3 times a day — — 16 4.3 ml 3 times a day — — 17 4.5 ml 3 times a day — — 18 4.8 ml 3 times a day — — 19 5.1 ml 3 times a day — — Table for selecting a single dose of Amoxiclav® 312.5 mg/5 ml depending on body weight Body weight (kg) Daily dose of amoxicillin 20 mg/kg/day 40 mg/kg/day 60 mg/kg/day 19 2.5 ml 3 times a day 5.0 ml 3 times a day 7.6 ml 3 times a day 20 2.7 ml 3 times a day — — 25 3.3 ml 3 times a day — — 30 4.0 ml 3 times a day - - 35 4.7 ml 3 times a day - - 40 5.3 ml 3 times a day - - Elderly patients No dose adjustment is required. Renal failure Dose adjustments are based on the maximum recommended dose of amoxicillin. No dose adjustment is required when prescribing the drug to patients with creatinine clearance (CrCl) more than 0.5 ml/sec (30 ml/min). Children weighing less than 40 kg Creatinine clearance: 0.17-0.5 ml/sec. (10-30ml/min) 15mg/3.75mg/kg (1.2 ml) twice daily (maximum dose: 500mg/125mg (20 ml) twice daily) Creatinine clearance Hemodialysis 15mg/3.75mg/kg (1.2 ml) once a day every day. Before hemodialysis 15 mg/3.75 mg/kg (1.2 ml). To restore drug levels, 15 mg/3.75 mg/kg (1.2 ml) must be taken after a hemodialysis session. Liver failure Use with caution. Liver function should be checked regularly. Method of preparing the suspension Amoxiclav suspension 156.25 mg/5 ml: you need to shake the bottle with the powder well, to loosen the powder, add 86 ml of water (first 2/3 and then up to the mark) in two doses, shaking well each time. Amoxiclav suspension 312.5 mg/5 ml: shake the bottle with powder well to loosen the powder, add 85 ml of water (first 2/3 and then up to the mark) in two doses, shaking well each time. The contents of the bottle must be shaken before use. Side effects Very common: - diarrhea Common: - candidiasis (skin and mucous membranes) - nausea - vomiting Uncommon: - dizziness, headache - indigestion - increased levels of AST and/or ALT - skin rash, itching, urticaria Rarely: - transient leukopenia (including neutropenia), thrombocytopenia - erythema multiforme Unknown: - growth of non-susceptible organisms - transient agranulocytosis, hemolytic anemia, increased bleeding time and prothrombin time - angioedema, anaphylaxis, serum-like syndrome10, allergic vasculitis - transient hyperactivity, convulsions - antibiotic associated colitis, black “villous” tongue, tooth discoloration - hepatitis6, cholestatic jaundice - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis7, acute generalized exanthematous pustulosis (AGEP)9 - interstitial nephritis - crystalluria Contraindications - hypersensitivity to amoxicillin, clavulanic acid or any auxiliary component of the drug - history of an allergic reaction to antibiotics from the group of penicillins and cephalosporins - cholestatic jaundice, hepatitis, severe liver dysfunction - lymphocytic leukemia - infectious mononucleosis - children under 3 months of age Drug interactions Simultaneous administration of Amoxiclav and methotrexate increases toxicity methotrexate. Prescription together with allopurinol increases the incidence of exanthema. Amoxiclav is physically and chemically incompatible with aminoglycosides. Probenecid slows down the elimination of amoxicillin, thereby increasing its plasma concentration. The combination with rifampicin is antagonistic. Amoxiclav may reduce the effectiveness of oral contraceptives. Concomitant use with disulfiram should be avoided. Co-administration with macrolides, chloramphenicol, tetracyclines and sulfonamides is not recommended. This combination reduces the effectiveness of amoxicillin. In some cases, the drug may prolong prothrombin time; therefore, caution should be exercised when prescribing oral anticoagulants and Amoxiclav simultaneously. Concomitant use with allopurinol may increase the risk of skin rash. Avoid mixing with solutions containing glucose, dextran or bicarbonate, as well as with blood, protein or lipid preparations. Special instructions With long-term use of Amoxiclav, it is recommended to periodically check the functions of the kidneys, liver and hematopoietic system. Renal dysfunction affects the pharmacokinetic properties of both amoxicillin and clavulanic acid. When creatinine clearance is less than 30 ml/min, the dose of the drug must be reduced depending on the severity of the disorder and the patient’s body weight. Amoxiclav should be used with caution in patients with a history of allergic reactions and bronchial asthma. In patients with liver damage, liver function should be periodically monitored. It is not recommended to use the drug to treat patients with severe gastrointestinal disorders accompanied by vomiting and/or diarrhea, since in this situation adequate absorption of the drug cannot be guaranteed. In patients suffering from persistent severe diarrhea, when using Amoxiclav, pseudomembranous colitis may develop in both mild and severe, life-threatening forms. If a superinfection occurs caused by bacteria and fungi resistant to this drug, treatment should be stopped and replacement or maintenance therapy should be performed. During treatment, the patient is advised to drink plenty of fluids to avoid the possible occurrence of crystalluria. Effect on laboratory test results When using Benedict's reagent, Amoxiclav causes a false-positive reaction to glucose in the urine and a positive Coombs test. It is recommended to test for glucose using enzymatic glucose oxidase reactions. When using Amoxiclav in pregnant women, a transient decrease in the concentration of the total amount of conjugated estriol, estriol glucuronide, conjugated estrion, and estradiol in plasma is possible. Pregnancy and lactation There are no data on the teratogenic effect. The safety of using Amoxiclav during pregnancy and breastfeeding has not been established. Amoxiclav can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. Trace amounts of the drug may pass into breast milk. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms In rare cases, Amoxiclav can cause undesirable reactions such as confusion, dizziness, and convulsions. If any adverse reactions occur, you should refrain from driving a vehicle or using potentially dangerous machinery. Overdose Symptoms: dyspeptic disorders (nausea, vomiting, diarrhea), agitation, insomnia, dizziness, and in some cases, convulsions. Treatment is symptomatic: gastric lavage, use of activated carbon. Amoxiclav can be removed from the body using hemodialysis. Release form and packaging 25 g of drug powder are placed in 100 ml transparent glass bottles, sealed with screw-on polyethylene caps with first opening control. The bottle, along with a measuring spoon and instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 25°C in a dry place. Store the prepared suspension at a temperature of 2 to 8? C in a tightly closed bottle. Keep out of the reach of children! Shelf life 2 years. Store the prepared suspension for no more than 7 days. Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies By prescription
Analogues of Amoxiclav
Level 4 ATX code matches:
Arlet
Ecoclave
Panclave
Oxamp-Sodium
Oxamp
Amoxicillin + Clavulanic acid
Augmentin
Ampisid
Amoxil K 625
Flemoklav Solutab
Sultasin
There are a number of analogues of this drug. The price of analogues depends, first of all, on the manufacturer of the drug. There are analogues on sale that are cheaper than Amoxiclav. For patients interested in what can replace this antibiotic, experts offer a large list of medications. These are Moxiclav , Co-Amoxiclav , Augmentin , Clavocin , Flemoclav , Medoclav , Baktoklav , Ranclave , Amoviklav , etc. However, any substitute should only be prescribed by a doctor. You can choose a cheaper analogue in tablets, for example, Augmentin. You can also choose a Russian analogue, for example, Amoxicillin .
Flemoklav Solutab and Amoxiclav - the difference between the drugs
The active components of the drugs are similar. The difference between drugs is in the dosage of the active components in the release forms of these drugs. Both drugs fall into approximately the same price category.
Which is better: Amoxiclav or Augmentin?
What is the composition of Amoxiclav and Augmentin , what is the difference between these drugs? Both of these products contain similar active ingredients, that is, in fact they are the same thing. Accordingly, the pharmacological action of the drugs is almost identical, as are the side effects. Only the manufacturers of these drugs differ.
Which is better: Sumamed or Amoxiclav?
Sumamed contains azithromycin, which is a broad-spectrum antibiotic. Before prescribing any of the drugs, it is important to check the sensitivity of the microflora to their action.
Which is better: Flemoxin Solutab or Amoxiclav?
Flemoxin contains only amoxicillin. Accordingly, its spectrum of influence is smaller than that of the drug Amoxiclav, which also contains clavulonic acid .
Reviews about Amoxiclav
In the process of discussing the drug Amoxiclav, reviews from doctors and patients are predominantly positive. It is noted that the antibiotic is effective in the treatment of respiratory tract diseases, and it is suitable for both adults and children. Reviews mention the effectiveness of the product for sinusitis, otitis media, and genital tract infections. As a rule, adult patients take 875 mg + 125 mg tablets; if the dosage is correct, relief occurs quickly. Reviews note that after a course of antibiotic treatment, it is advisable to take drugs that restore normal microflora .
Reviews of the Amoxiclav suspension are also positive. Parents write that it is convenient to give the product to children, as it has a pleasant taste and is normally perceived by children.
Amoxiclav price, where to buy
- The price of Amoxiclav tablets 250 mg + 125 mg is on average 250 rubles for 15 pieces. You can buy the antibiotic Amoxiclav 500 mg + 125 mg at a price of 350 – 400 rubles for 15 pcs. How much 875 mg + 125 mg tablets cost depends on the place of sale. On average, their cost is 400 - 500 rubles for 14 pieces.
- Price Amoxiclav Kviktab 625 mg – from 350 rubles for 14 pcs.
- The price of Amoxiclav suspension for children is 300 rubles (100 ml).
- The price of Amoxiclav 1000 mg in Ukraine (Kyiv, Kharkov, etc.) is from 300 hryvnia for 14 pieces.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Amoxiclav powder for suspension.
for internal approx. 400mg+57mg/5ml 17.5gLek dd RUB 205 order - Amoxiclav tablets p.p.o. 500mg+125mg 15 pcs. Lek dd
RUB 198 order
- Amoxiclav Quiktab dispersible tablets 250mg+62.5mg 20 pcs. Lek dd
RUB 272 order
- Amoxiclav powder for suspension. for internal approx. 400mg+57mg/5ml 35gLek dd
RUB 295 order
- Amoxiclav tablets p.p.o. 875mg+125mg 14 pcs.Lek dd
RUB 342 order
Pharmacy Dialogue
- Amoxiclav Quiktab (dispersible tablet 625 mg No. 14)Lek
RUR 326 order
- Amoxiclav Quiktab (dispersible tablet 1000 mg No. 14)Lek
402 rub. order
- Amoxiclav powder for suspension 400mg+57mg/5ml 140ml(35g)Lek
RUB 287 order
- Amoxiclav bottle 1200 mg powder No. 5Lek
RUR 771 order
- Amoxiclav (tablet p/o 625 mg No. 15 (blister sheet)) Lek
RUB 215 order
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Pharmacy24
- Amoxiclav 125 mg/31.25 mg 5 ml 100 ml powder for oral suspension Lek pharmaceutical company d.d., Slovenia
131 UAH. order - Amoxiclav 500mg/100mg No. 5 powder for the preparation of solution for injection Sandoz GmbH, Austria
379 UAH. order
- Amoxiclav Quiktab 875mg/125mg N14 tablets Lek pharmaceutical company d.d. Slovenia / Sandoz Ilac Sanay ve Tikaret A.S., Turecchina
164 UAH order
- Amoxiclav 2x 875 mg / 125 mg No. 14 tablets Lek pharmaceutical company d.d., Slovenia
189 UAH order
- Amoxiclav 2S 400 mg/57 mg 5 ml 17.5 70 ml powder for oral suspension Lek pharmaceutical company d.d., Slovenia
115 UAH order
PaniPharmacy
- Amoxiclav 2 tablets Amoxiclav 2 film-coated tablets 875/125 mg No. 14 Slovenia, Lek
217 UAH. order
- Amoxiclav Quiktab tablets Amoxiclav Quiktab dispersible tablets 500mg/125mg No. 10 Slovenia, Lek
87 UAH order
- Amoxiclav bottle Amoxiclav lyophilized powder for injection 1.2g No. 5 Slovenia, Lek
454 UAH. order
- Amoxiclav liquid Amoxiclav powder for suspension 250mg/62.5mg (312.5mg)/5ml 100ml Slovenia, Lek
167 UAH order
- Amoxiclav liquid Amoxiclav powder for suspension 125mg/31.25mg (156.25mg)/5ml 100ml Slovenia, Lek
131 UAH order
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Amoxiclav 125mg+31.25mg/5ml 25g 100ml powder for oral suspension
pharmachologic effect
Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.
Composition and release form Amoxiclav 125 mg + 31.25 mg/5 ml 25 g 100 ml powder for the preparation of suspension for oral administration
Powder for the preparation of a suspension for oral administration - 5 ml of suspension:
- active ingredients: amoxicillin (in the form of trihydrate) - 125 mg; clavulanic acid (in the form of potassium salt) - 31.25 mg;
- excipients: citric acid (anhydrous) - 2.167 mg; sodium citrate (anhydrous) - 8.335 mg; sodium benzoate - 2.085 mg; MCC and carmellose sodium - 28.1 mg; xanthan gum - 10 mg; colloidal silicon dioxide - 16.667 mg; silicon dioxide - 0.217 g; sodium saccharinate - 5.5 mg; mannitol - 1250 mg; strawberry flavoring - 15 mg.
Powder for the preparation of suspension for oral administration, 125 mg + 31.25 mg/5 ml. Primary packaging - 25 g of powder (100 ml of finished suspension) in a dark glass bottle with a ring mark (100 ml). The bottle is closed with a screw-on metal cap with a control ring, inside the cap there is a LDPE gasket.
Secondary packaging - 1 fl. with a dosing spoon with ring marks in the cavity for 2.5 and 5 ml (“2.5 SS” and “5 SS”), a maximum filling mark of 6 ml (“6 SS”) on the handle of the spoon in a cardboard box. Or 1 fl. together with a graduated dosage pipette in a cardboard box.
Description of the dosage form
Powder for oral suspension: white to yellowish-white powder. The finished suspension is an almost white to yellow homogeneous suspension.
Directions for use and doses
Inside
The daily dose of suspensions is 125+31.25 mg/5 ml and 250+62.5 mg/5 ml (to facilitate correct dosing, a dosage pipette is inserted into each package of suspensions 125+31.25 mg/5 ml and 250+62.5 mg/5 ml, graduated at 5 ml, with a scale of division of 0.1 ml or a dosing spoon with a capacity of 5 ml, with ring marks in the cavity at 2.5 and 5 ml).
Newborns and children up to 3 months - 30 mg/kg/day (for amoxicillin), divided into 2 doses (every 12 hours).
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of infections in newborns and children up to 3 months (Table 3).
Table 3
| Body weight, kg | 2 | 2,2 | 2,4 | 2,6 | 2,8 | 3 | 3,2 | 3,4 | 3,6 | 3,8 | 4 | 4,2 | 4,4 | 4,6 | 4.8 |
| Suspension 156.25, ml (2 times a day) | 1,2 | 1,3 | 1,4 | 1,6 | 1,7 | 1,8 | 1,9 | 2 | 2,2 | 2,3 | 2,4 | 2,5 | 2,6 | 2,8 | 2,9 |
| Suspension 312.5, ml (2 times a day) | 0,6 | 0,7 | 0,7 | 0,8 | 0,8 | 0,9 | 1 | 1 | 1,1 | 1,1 | 1,2 | 1,3 | 1,3 | 1,4 | 1,4 |
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 h).
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of mild and moderate infections in children over 3 months (at the rate of 20 mg/kg/day (for amoxicillin) (Table 4).
Table 4
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Suspension 312.5, ml (3 times a day) | 0,7 | 0,8 | 0,9 | 1,1 | 1,2 | 1,3 | 1,5 | 1,6 | 1,7 | 1,9 | 2 | 2,1 | 2,3 | 2,4 | 2,5 | 2,7 | 2,8 | 2,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 | |
| Suspension 312.5, ml (3 times a day) | 3,1 | 3,2 | 3,3 | 3,5 | 3,6 | 3,7 | 3,9 | 4 | 4,1 | 4,3 | 4,4 | 4,5 | 4,7 | 4,8 | 4,9 | 5,1 | 5,2 |
Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of severe infections in children over 3 months (at the rate of 40 mg/kg/day (for amoxicillin) (Table 5).
Table 5
| Body weight, kg | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 |
| Suspension 156.25, ml (3 times a day) | 2,7 | 3,2 | 3,7 | 4,3 | 4,8 | 5,3 | 5,9 | 6,4 | 6,9 | 7,5 | 8 | 8,5 | 9,1 | 9,6 | 10,1 | 10,7 | 11,2 | 11,7 |
| Suspension 312.5, ml (3 times a day) | 1,3 | 1,6 | 1,9 | 2,1 | 2,4 | 2,7 | 2,9 | 3,2 | 3,5 | 3,7 | 4 | 4,3 | 4,5 | 4,8 | 5,1 | 5,3 | 5,6 | 5,9 |
| Body weight, kg | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | |
| Suspension 156.25, ml (3 times a day) | 12,3 | 12,8 | 13,3 | 13,9 | 14,4 | 14,9 | 15,5 | 16 | 16,5 | 17,1 | 17,6 | 18,1 | 18,7 | 19,2 | 19,7 | 20,3 | 20,8 | |
| Suspension 312.5, ml (3 times a day) | 6,1 | 6,4 | 6,7 | 6,9 | 7,2 | 7,5 | 7,7 | 8 | 8,3 | 8,5 | 8,8 | 9,1 | 9,3 | 9,6 | 9,9 | 10,1 | 10,4 |
Dosing of the drug Amoxiclav® with a dosing spoon (in the absence of a dosing pipette) - recommended doses of suspensions depending on the child’s body weight and the severity of the infection (Table 6).
Table 6
| Body weight, kg | Age (approx.) | Mild/moderate course | Severe course | ||
| 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | 125+31.25 mg/5 ml | 250+62.5 mg/5 ml | ||
| 5–10 | 3–12 months | 3 × 2.5 ml (½ spoon) | 3 × 1.25 ml | 3 × 3.75 ml | 3 × 2 ml |
| 10–12 | 1–2 years | 3 × 3.75 ml | 3 × 2 ml | 3 × 6.25 ml | 3 × 3 ml |
| 12–15 | 2–4 years | 3 × 5 ml (1 spoon) | 3 × 2.5 ml (½ spoon) | 3 × 7.5 ml (1½ spoons) | 3 × 3.75 ml |
| 15–20 | 4–6 years | 3 × 6.25 ml | 3 × 3 ml | 3 × 9.5 ml | 3 × 5 ml (1 spoon) |
| 20–30 | 6–10 years | 3 × 8.75 ml | 3 × 4.5 ml | — | 3 × 7 ml |
| 30–40 | 10–12 years | — | 3 × 6.5 ml | — | 3 × 9.5 ml |
| ≥40 | ≥12 years | Amoxiclav® tablets | |||
Daily dose of suspension 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.
Suspension 400 mg+57 mg/5 ml is used in children over 3 months.
Table 7
Recommended dose of suspension depending on the child’s body weight and severity of infection
| Body weight, kg | Age (approx.) | Recommended dose, ml | |
| Severe course | Moderate course | ||
| 5–10 | 3–12 months | 2×2,5 | 2×1,25 |
| 10–15 | 1–2 years | 2×3,75 | 2×2,5 |
| 15–20 | 2–4 years | 2×5 | 2×3,75 |
| 20–30 | 4 years - 6 years | 2×7,5 | 2×5 |
| 30–40 | 6–10 years | 2×10 | 2×6,5 |
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 for children.
In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin.
Patients with creatinine Cl >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 Cl 10-30 ml/min - 500/125 mg 2 times a day.
With Cl creatinine
For patients on hemodialysis, the recommended dose is 500/125 mg every 24 hours, plus 500/125 mg during dialysis and another dose at the end of dialysis (since serum concentrations of amoxicillin and clavulanic acid are reduced).
Children weighing less than 40 kg
With creatinine Cl 10–30 ml/min, the recommended dose is 15/3.75 mg/kg 2 times a day (maximum 500/125 mg 2 times a day).
With Cl creatinine
For hemodialysis, the recommended dose is 15/3.75 mg/kg once a day. Before hemodialysis - 15/3.75 mg/kg. To restore appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15/3.75 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 repeated medical examination.
Pharmacodynamics
Mechanism of action
Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.
Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type I chromosomal beta-lactamases, which are not inhibited by clavulanic acid.
The presence of clavulanic acid in the drug protects amoxicillin from destruction by enzymes - beta-lactamases, which expands the antibacterial spectrum of amoxicillin.
Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.
Grampore-positive aerobes: Bacillus Anthracis, Enterococcus Faecalis, Listeria MonocyTogenes, NoCardia Asteroides, Streptococcus Pyogenes1,2, Streptococcus Agalactiae1,2, other beta-heemolytic statococci1, 2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: species of the genus Clostridium, Peptococcus niger, Peptostrepiococcus magnus, Peptostreptococcus micros, species of the genus Pepto streptococcus.
Gram-negative anaerobes: Bcicteroides fragilis, species of the genus Bacteroides, species of the genus Capnocytophaga, Eikenella corrodens, Fusobacterium nucleatum, species of the genus Fusobacterium, species of the genus Porphyromonas, species of the genus Prevotella.
Bacteria for which acquired resistance to the combination of amoxicillin and clavulanic acid is likely
Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae, species of the genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of the genus Proteus, species of the genus Salmonella, species of the genus Shigella. Streptococcus pneumoniae1,2, streptococci of the Viridans group.
Gram-positive aerobes: species of the genus Corynebacterium, Enterococcus faecium.
Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid
Gram-negative aerobes: species of the genus Acinetobacter, Citrobacter freundii, species of the genus Enterobacter, Hafhia alvei, Legionella pneumophila, Morganella morganii, species of the genus Providencia, species of the genus Pseudomonas, species of the genus Serratia, Stenotrophomonas maltophilia, Yersinia enterocolitica.
Other: Chlamydia pneumoniae, Chlamydia psittaci, species of the genus Chlamydia, Coxiella burnetii, species of the genus Mycoplasma.
1For these bacteria, the clinical effectiveness of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 strains of these types of bacteria do not produce beta-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.
Pharmacokinetics
Suction
The active ingredients of the drug are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of active ingredients is optimal when the drug is used with food.
The following are the pharmacokinetic parameters of amoxicillin and clavulanic acid after administration at a dose of 45 mg/6.4 mg/kg, divided into two doses, by patients under 12 years of age.
Average value of pharmacokinetic parameters
| Cmax (mg/ml) | T max (h) | AUC (mg in h/l) | T1/2 (h) | |
| Amoxicillin | 11,99±3,28 | 1,0 (1,0-2,0) | 35,2±5,0 | 1,22±0,28 |
| Clavulanic acid | 5,49±2,71 | 1,0 (1,0-2,0) | 13,26±5,88 | 0,99±0,14 |
- Cmax - maximum concentration in blood plasma;
- Tmax is the time to reach the maximum concentration in the blood plasma;
- AUC—area under the concentration-time curve;
- T1/2 - half-life.
Metabolism
About 10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys, through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.
Distribution
As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) .
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.
The volume of distribution is approximately 0.3-0.4 L/kg for amoxicillin and approximately 0.2 L/kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed. Amoxicillin (like most penicillins) is excreted in breast milk.
Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, diarrhea and candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants.
Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.
Removal
Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of 875 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged by the kidneys during the first 6 hours. The average half-life (T1/2) of amoxicillin/clavulanic acid is approximately 1 hour, and the average total clearance is approximately 25 L/h in healthy patients. In various studies, it was found that amoxicillin excretion by the kidneys within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration.
The pharmacokinetics of amoxicillin/clavulanic acid does not depend on the gender of the patient.
Patients with impaired renal function
The total 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, because Most amoxicillin is excreted by the kidneys. Doses of the drug for renal failure should be selected taking into account the undesirability of amoxicillin accumulation while maintaining normal levels of clavulanic acid.
Patients with liver dysfunction
In patients with impaired liver function, the drug is used with caution. It is necessary to constantly monitor liver function.
Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.
Indications for use Amoxiclav 125 mg + 31.25 mg/5 ml 25 g 100 ml powder for the preparation of suspension for oral administration
Infections caused by sensitive strains of microorganisms:
- upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
- lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
- urinary tract (eg cystitis, urethritis, pyelonephritis);
- in gynecology;
- skin and soft tissues, including human and animal bites;
- bone and connective tissue;
- biliary tract (cholecystitis, cholangitis);
- odontogenic.
Contraindications
- hypersensitivity to the components of the drug;
- history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics;
- history of cholestatic jaundice and/or other liver dysfunction caused by taking amoxicillin/clavulanic acid;
- infectious mononucleosis and lymphocytic leukemia;
With caution: history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal impairment, pregnancy, lactation, simultaneous use with anticoagulants.
Application Amoxiclav 125mg+31.25mg/5ml 25g 100ml powder for the preparation of suspension for oral administration during pregnancy and breastfeeding
During pregnancy and lactation, Amoxiclav® is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.
Amoxicillin and clavulanic acid pass into breast milk in small quantities.
special instructions
During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys.
In patients with severe renal impairment, adequate dose adjustment or increased intervals between doses is required.
It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.
In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
In women with premature rupture of membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of developing necrotizing colitis in the newborn.
Crystalluria very rarely occurs in patients with reduced diuresis. During the use of large doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation.
Lab tests. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucosidase.
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment, care should be taken when driving and other activities that require concentration and speed of psychomotor reactions.
Overdose
There are no reports of death or life-threatening side effects due to drug overdose.
Symptoms: in most cases - gastrointestinal disorders (abdominal pain, diarrhea, vomiting), anxiety, insomnia, dizziness are also possible, and in isolated cases - seizures.
Treatment: in case of overdose, the patient should be under medical supervision, treatment should be symptomatic.
In case of recent use (less than 4 hours) of the drug, it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/potassium clavulanate is removed by hemodialysis.
Side effects Amoxiclav 125mg+31.25mg/5ml 25g 100ml powder for suspension for oral administration
From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, darkening of tooth enamel, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomembranous colitis, disorder liver function, increased activity of ALT, AST, alkaline phosphatase and/or bilirubin levels in the blood plasma, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis.
Allergic reactions: itching, urticaria, erythematous rashes, erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness, toxic epidermal necrolysis.
From the hematopoietic system and lymphatic system: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PT (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis.
From the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug).
From the urinary system: interstitial nephritis, crystalluria, hematuria.
Other: candidiasis and other types of superinfection.
From the side of the central nervous system: hyperactivity. Feelings of anxiety, insomnia, behavior changes, agitation.
Drug interactions
Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion (probenecid) increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
The simultaneous use of Amoxiclav® and methotrexate increases the toxicity of methotrexate.
Prescription together with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided.
Reduces the effectiveness of drugs, during the metabolism of which PABA is formed; ethinyl estradiol - risk of breakthrough bleeding.
The literature describes rare cases of increased INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If simultaneous use with anticoagulants is necessary, PT or INR should be carefully monitored when prescribing or discontinuing the drug.
The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug Amoxiclav®.
The drug Amoxiclav® reduces the effectiveness of oral contraceptives.
The drug Amoxiclav® and aminoglycoside antibiotics are chemically incompatible.
Amoxiclav® should not be mixed in a syringe or infusion bottle with other drugs.
Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate, as well as with solutions containing blood, proteins, lipids.
