Amoxiclav Quiktab - description of the drug, instructions for use, reviews. Amoxiclav Quiktab: instructions for use What does amoxiclav dispersible tablets mean
- active substances: amoxicillin trihydrate - 574 mg (equivalent to 500 mg of amoxicillin); potassium clavulanate - 148.87 mg (equivalent to 125 mg of clavulanic acid);
- excipients: flavor tropical mixture - 26 mg; sweet orange flavor - 26 mg; aspartame - 6.5 mg; silicon dioxide colloidal anhydrous - 13 mg; iron (III) oxide yellow (E172) - 3.5 mg; talc - 13 mg; hydrogenated castor oil - 26 mg; MCC silicon-containing - up to 1300 mg.
Dispersible tablets - 1 tab.:
Dispersible tablets, 500 mg + 125 mg or 875 mg + 125 mg. 2 tab. in a blister. 5 or 7 blisters are placed in a cardboard pack.
Description of the dosage form
Dispersible tablets: oblong, octagonal, light yellow with brown patches, with a fruity odor.
pharmachologic effect
Bactericidal, broad spectrum antibacterial.
Pharmacokinetics
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid are highly soluble in aqueous solutions with a physiological pH value and after taking the drug Amoxiclav ® orally are quickly and completely absorbed from the gastrointestinal tract. The absorption of active substances - amoxicillin and clavulanic acid - is optimal if the drug is taken at the beginning of a meal.
The bioavailability of amoxicillin and clavulanic acid after oral administration is about 70%.
Peak plasma concentrations are reached approximately 1 hour after ingestion. Cmax values are for amoxicillin (depending on the dose) 3–12 μg / ml, for clavulanic acid - about 2 μg / ml.
C max in plasma after a bolus injection at a dose of 1.2 g (1000+200 mg) of the drug is 105.4 mg/l for amoxicillin and 28.5 mg/l for clavulanic acid.
When using the drug Amoxiclav ®, plasma concentrations of amoxicillin / clavulanic acid are similar to those with oral administration of the corresponding doses of amoxicillin or clavulanic acid separately in equivalent doses.
Both components are characterized by sufficient V d in various bodies, tissues and body fluids (including in the lungs, abdominal organs; fatty, bone and muscle tissue; pleural, synovial and peritoneal fluids; in skin, bile, urine, purulent discharge, sputum, interstitial fluid).
Plasma protein binding is moderate - 25% for clavulanic acid and 18% for amoxicillin.
V d 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 cross the blood-brain barrier in non-inflamed meninges.
Amoxicillin (like most penicillins) is excreted in breast milk. V breast milk trace amounts of clavulanic acid were also found. Amoxicillin and clavulanic acid cross the placental barrier.
Amoxicillin is excreted primarily by the kidneys, while clavulanic acid is eliminated via both renal and extrarenal mechanisms. After a single oral administration of one tablet of 250 + 125 mg or 500 + 125 mg, approximately 60–70% of amoxicillin and 40–65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours. About 10-25% of the initial dose of amoxicillin is excreted in the urine as inactive 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 in urine and feces.
The average T 1/2 of amoxicillin / clavulanic acid is approximately 1 hour, the average total clearance is approximately 25 l / h in healthy patients. In the course of various studies, it was found that the excretion of amoxicillin in the urine within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The greatest amount of clavulanic acid is excreted during the first 2 hours after ingestion.
The pharmacokinetic parameters of amoxicillin and clavulanic acid are summarized in Table 1.
Patients with impaired liver function
In patients with severe kidney failure T 1/2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.
For patients with impaired liver function, the dose of the drug should be selected with caution: constant monitoring of the liver is necessary.
Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.
Pharmacodynamics
Amoxiclav® is a combination of amoxicillin and clavulanic acid.
Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the peptidoglycan biosynthesis pathway, which is an integral structural component cell wall of bacteria. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually leads to lysis and death of microorganism cells.
Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of activity of amoxicillin does not include microorganisms that produce these enzymes.
Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits some beta-lactamases, thereby preventing the inactivation of amoxicillin and extending its spectrum of activity, including bacteria normally resistant to amoxicillin, as well as to other penicillins and cephalosporins. By itself, clavulanic acid does not have a clinically significant antibacterial effect.
The drug Amoxiclav® has a bactericidal effect in vivo on the following microorganisms:
- gram-positive aerobes - Staphylococcus aureus *, Streptococcus pneumoniae, Streptococcus pyogenes;
- gram-negative aerobes - Enterobacter spp.**, Escherichia coli*, Haemophilus influenzae*, species of the genus Klebsiella*, Moraxella catarrhalis* (Branhamella catarrhalis).
The drug Amoxiclav® has a bactericidal effect in vitro on the following microorganisms (however, the clinical significance is still unknown):
- gram-positive aerobes - Bacillis anthracis*, species of the genus Corynebacterium, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides, coagulase-negative staphylococci* (including Staphylococcus epidermidis), Streptococcus agalactiae, other species of the genus Streptococcus, Streptococcus viridans;
- gram-positive anaerobes - species of the genus Clostridium, species of the genus Peptococcus, species of the genus Peptostreptococcus;
- gram-negative aerobes - Bordetella pertussis, species of the genus Brucella, Gardnerella vaginalis, Helicobacter pylori, species of the genus Legionella, Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, species of the genus Salmonella*, species of the genus Shigella*, Vibrio cholerae, Yersinia enterocolitica*;
- gram-negative anaerobes - species of the genus Bacteroides* (including Bacteroides fragilis), species of the genus Fusobacterium*;
- others - Borrelia burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum.
* Some strains of these bacterial species produce beta-lactamase, which contributes to their insensitivity to amoxicillin monotherapy.
** Most strains of these bacteria are resistant to the amoxicillin/clavulanic acid combination in vitro, but this combination has been shown to be clinically effective in the treatment of urinary tract infections caused by these strains.
Indications for use Amoxiclav Quiktab
Infections caused by susceptible strains of microorganisms:
- upper departments respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
- lower respiratory tract (incl. acute bronchitis with bacterial superinfection, Chronical 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 to the use of Amoxiclav Quiktab
- hypersensitivity to the components of the drug;
- hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics in history;
- cholestatic jaundice and / or other abnormal liver function caused by taking amoxicillin / clavulanic acid in history;
- infectious mononucleosis and lymphocytic leukemia;
- children under 12 years of age or weighing less than 40 kg;
- phenylketonuria;
- renal failure (Cl creatinine
With caution: history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal dysfunction, pregnancy, lactation, simultaneous use with anticoagulants.
Amoxiclav quicktab Use in pregnancy and children
During pregnancy and lactation, Amoxiclav® is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.
Amoxiclav Quiktab can be prescribed during pregnancy if there are clear indications.
Amoxicillin and clavulanic acid pass into breast milk in small amounts.
Amoxiclav quicktab side effects
From the side of the hematopoietic organs and the lymphatic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - eosinophilia, thrombocytosis, reversible agranulocytosis, an increase in bleeding time and a reversible increase in PT, anemia, incl. reversible hemolytic anemia.
From the side immune system: frequency unknown - angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.
From the side nervous system: infrequently - dizziness, headache; very rarely - insomnia, agitation, anxiety, behavior change, reversible hyperactivity, convulsions; convulsions may occur in patients with impaired renal function, as well as in those receiving high doses of the drug.
From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea. Nausea is more commonly observed when high doses are ingested. If gastrointestinal disorders are confirmed, they can be eliminated if the drug is taken at the beginning of a meal; infrequently - indigestion; very rarely - antibiotic-associated colitis induced by antibiotics (including pseudomembranous and hemorrhagic colitis), black "hairy" tongue, gastritis, stomatitis. In children, a change in the color of the surface layer of tooth enamel was very rarely noted. Oral care helps prevent discoloration of tooth enamel.
From the side skin: infrequently - skin rash, itching, urticaria; rarely - erythema multiforme exudative; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
From the urinary system: very rarely - crystalluria, interstitial nephritis, hematuria.
On the part of the liver and biliary tract: infrequently - increased activity of ALT and / or AST (this phenomenon is observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown); Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare in children.
The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases there have been reports of death. In almost all cases, these were patients with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs. Very rarely - an increase in the activity of alkaline phosphatase, an increase in the level of bilirubin, hepatitis, cholestatic jaundice (noted with concomitant therapy with other penicillins and cephalosporins).
Other: often - candidiasis of the skin and mucous membranes; frequency unknown - growth of insensitive microorganisms.
drug interaction
For all dosage forms
Antacids, glucosamine, laxatives, aminoglycosides slow 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 the drug Amoxiclav® and methotrexate increases the toxicity of methotrexate.
Appointment in conjunction with allopurinol increases the incidence of exanthema. Avoid concomitant use with disulfiram.
Reduces the effectiveness of drugs, during the metabolism of which PABA is formed; ethinylestradiol - risk of breakthrough bleeding.
The literature describes rare cases increase in INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, simultaneous use with anticoagulants, 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.
For dispersible tablets
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). In some cases, taking the drug may prolong the PT, in this regard, care should be taken when using anticoagulants and Amoxiclav Quiktab at the same time.
Probenecid reduces the excretion of amoxicillin by increasing its serum concentration.
In patients treated with mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.
Dosage of Amoxiclav Quiktab
inside. The dosage regimen is set individually depending on the age, body weight, kidney function of the patient and the severity of the infection.
The tablets must be dissolved in half a glass of water (minimum 30 ml) and mixed thoroughly, then drink or hold the tablets in the mouth until completely dissolved, then swallow.
In order to reduce the risk of developing side effects on the part of the gastrointestinal tract, the drug should be taken at the beginning of a meal.
Dispersible tablets of the drug Amoxiclav ® Quiktab 500 mg / 125 mg:
For treatment lung infections and medium degree severity - 1 tab. (500 mg/125 mg) every 12 hours (2 times a day).
For the treatment of severe infections and infections of the respiratory system - 1 table. (500 mg/125 mg) every 8 hours (3 times a day).
Maximum daily dose the drug Amoxiclav ® Quiktab is 1500 mg of amoxicillin / 375 mg of clavulanic acid.
Patients with impaired renal function. In patients with Cl creatinine above 30 ml / min, there is no need for dose adjustment.
Adults and children over 12 years of age weighing ≥40 kg (the indicated dosing regimen is used for moderate to severe infections):
Dispersible tablets of the drug Amoxiclav ® Quiktab 875 mg / 125 mg:
Adults and children over 12 years of age weighing ≥40 kg
In severe infections and infections of the respiratory system - 1 table. (875 mg/125 mg) every 12 hours (2 times a day).
The daily dose of the drug Amoxiclav ® Quiktab when used 2 times a day is 1750 mg of amoxicillin / 250 mg of clavulanic acid.
Patients with impaired renal function. In patients with Cl creatinine more than 30 ml / min, there is no need for dose adjustment.
For patients with Cl creatinine less than 30 ml / min, the use of dispersible tablets of the drug Amoxiclav ® Quiktab, 875 mg / 125 mg is contraindicated.
Such patients should take the drug at a dosage of 500 mg / 125 mg after dose adjustment corresponding to the level of Cl creatinine.
Patients with impaired liver function. Caution should be exercised when taking the drug Amoxiclav ® Quiktab. It is necessary to conduct regular monitoring of liver function. In the case of starting treatment with parenteral administration of the drug, therapy may be continued by taking Amoxiclav ® Quiktab tablets.
The duration of the course of treatment is determined by the attending physician!
Minimum exchange rate antibiotic therapy is 5 days. Treatment should not be continued for more than 14 days without a review of the clinical situation.
Overdose
Posts about lethal outcome or the occurrence of life-threatening side effects due to an overdose of the drug is not present.
Symptoms: in most cases - disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), anxiety, insomnia, dizziness are also possible, in isolated cases - convulsive seizures.
Treatment: in case of overdose, the patient should be under the supervision of a physician, treatment is symptomatic.
In case of a recent intake (less than 4 hours) of the drug, it is necessary to carry out a gastric lavage and prescribe Activated carbon to reduce absorption. Amoxicillin/clavulanate potassium is removed by hemodialysis.
Precautionary measures
For all dosage forms
During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, kidneys.
In patients with severely impaired renal function, an adequate dose adjustment or an increase in the intervals between doses is required.
Perhaps the development of superinfection due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.
In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
In women with premature rupture of membranes, it has been found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of neonatal necrotizing colitis.
In patients with reduced diuresis, crystalluria very rarely occurs. During the use of large doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation.
Laboratory tests. High concentrations of amoxicillin give a false positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. Enzymatic reactions with glucosidase are recommended.
For dispersible tablets additionally
Before starting treatment, it is necessary to interview the patient to identify a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics.
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken before or during meals.
When using high doses of Amoxiclav Quiktab, patients with crystalluria need to adequately replenish fluid loss.
If antibiotic-associated colitis occurs, Amoxiclav Quiktab should be discontinued immediately, a doctor should be consulted and appropriate treatment initiated. Drugs that inhibit peristalsis are contraindicated in such situations.
Treatment necessarily continues for another 48-72 hours after disappearance clinical signs diseases. With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, other or additional methods contraception.
Amoxicillin and clavulanic acid can provoke non-specific binding of immunoglobulins and albumins to the erythrocyte membrane, which may be the cause of a false positive reaction in the Coombs test.
The use of amoxicillin and clavulanic acid is contraindicated in infectious mononucleosis, because. may cause a measles-like rash.
Special precautions for disposal of unused medicinal product. There is no need for special precautions when destroying unused Amoxiclav®.
Influence on the ability to drive a car or perform work requiring increased speed 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.
For film-coated tablets, dispersible tablets, powder for suspension for oral administration
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals.
Information for patients on a low sodium diet: Each 600 mg vial (500+100 mg) contains 29.7 mg sodium. Each vial of 1.2 g (1000+200 mg) contains 59.3 mg of sodium. The amount of sodium in the maximum daily dose exceeds 200 mg.
Producer: Sandoz Gmbh (Sandoz Gmbh) Germany
ATC code: J01CR02
Farm group:
Release form: Solid dosage forms. Tablets.
General characteristics. Compound:
Active substances: amoxicillin trihydrate 574 mg 1004.5 mg (equivalent to 500 or 875 mg of amoxicillin, respectively) potassium clavulanate 148.87 mg (equivalent to 125 mg of clavulanic acid for both dosages);
excipients: flavor "Tropical mix"; flavor "Sweet orange"; aspartame; silicon dioxide colloidal anhydrous; iron (III) oxide yellow E172; talc; castor oil hydrogenated; MCC silicon-containing;
Description of the dosage form
Oblong octagonal tablets of light yellow color with brown patches, with a fruity odor.
Pharmacological properties:
Amoxiclav is a combination of amoxicillin (a semi-synthetic broad-spectrum penicillin antibiotic) and clavulanic acid (an irreversible β-lactamase inhibitor that forms inactive complex compounds with enzymes and prevents the destruction of amoxicillin). Potassium clavulanate has weak antibacterial activity and does not affect the mechanism of action of amoxicillin. Since clavulanic acid inhibits β-lactamase, which normally inactivate amoxicillin, the combination of amoxicillin and clavulanic acid is effective against many amoxicillin-resistant β-lactamase-producing microorganisms.
Amoxiclav has a wide spectrum of antibacterial activity. The combination is active both in vitro and in the case of clinical infections of relatively non-producing and producing penicillinase gram-positive and gram-negative microorganisms:
.gram-positive aerobes: penicillin-sensitive strains of Streptococcus pneumonie, Streptococcus pyogenes, methicillin-sensitive strains of Staphylococcus aureus, Listeria spp., Enterococcus faecalis, Enterococcus faecium, Corynebacterium spp.;
.gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium perfringens, Actinomyces israelli;
Gram-negative aerobes: Haemophillus influenzae, Moraxella catarrhalis, Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Neisseria meningitidіs, Pasteurella multocida, Salmonella spp., Shigella spp., Vibrio cholerae, Helicobacter pylori, Bordetella pertussis;
Gram-negative anaerobes: Bacteroides spp., Fusobacterium spp., Prevotella spp.
Pseudomonas aeruginosa is resistant to Amoxiclav, strains of Staphylococcus aureus, Legionella spp., Chlamydia spp., Mycoplasma spp. are resistant to methicillin.
Pharmacokinetics. The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar; their combination does not affect the pharmacokinetics of each other. Both components are well absorbed after oral intake; food slightly affects the degree of absorption (if the drug is used at the beginning of a meal, the absorption of clavulanic acid increases).
Cmax in plasma when using the drug Amoxiclav in the form of a powder for oral suspension is achieved approximately 1-2 hours after taking the drug and is for amoxicillin (depending on the dose) 3-12 μg / ml, for clavulanic acid - about 2 μg / ml.
Cmax in plasma after a bolus injection of the drug Amoxiclav (when using the drug) 1000 mg / 200 mg is 105.4 μg / ml for amoxicillin and 28.5 μg / ml for clavulanic acid.
Amoxiclav 2X: Cmax in blood plasma is reached 1-2.5 hours after administration.
Amoxiclav Quiktab: Cmax in plasma is reached approximately 1-2 hours after taking the drug.
Both components are characterized by a large volume of distribution in body fluids and tissues (lungs, middle ear exudate, maxillary sinus secretion, paranasal sinus secretion, pleural and peritoneal fluid, prostate gland, tonsils, sputum, bronchial secretions, liver, gallbladder, uterus, ovaries, synovial fluid), with the exception of the brain and CSF (amoxicillin and clavulanic acid do not cross the BBB in non-inflamed meninges). A high concentration of the drug in the urine is achieved.
Both components cross the placental barrier and are present in small amounts in breast milk.
Amoxicillin and clavulanic acid are characterized by low plasma protein binding (17-20 and 22-30%, respectively).
Both components are excreted by the kidneys; amoxicillin is metabolized by 10-20%, and clavulanic acid by almost 50%. A small amount can be excreted through the intestines and lungs. T½ of amoxicillin and clavulanic acid is 78 and 60-70 minutes, respectively, increasing to 7.5 and 4.5 hours, respectively, in patients with severely impaired renal function. Both substances are well excreted by hemodialysis, but insignificantly - by peritoneal dialysis.
Indications for use:
Treatment bacterial infections caused by strains of microorganisms sensitive to the combination of amoxicillin / clavulanic acid:
.infections of the upper respiratory tract (including infections of the upper respiratory tract), including recurrent tonsillitis, sinusitis, otitis media;
.infections of the lower respiratory tract (bronchitis, pneumonia);
.infections of the urinary system (cystitis, urethritis, pyelonephritis);
.infections of the female genital organs (septic abortion, postpartum sepsis, sepsis of the pelvic organs);
.abdominal infections and postoperative intra-abdominal complications, including intra-abdominal sepsis;
.infections of the biliary tract (cholecystitis, cholangitis);
.infections of the skin and soft tissues (burns, abscesses, inflammation of the subcutaneous tissue, wound infections);
.odontogenic infections, including dentoalveolar abscesses;
.infections of bones, joints and connective tissue (including osteomyelitis);
.prophylaxis of infectious complications after surgical interventions on the organs of the digestive tract, pelvis, head and neck, heart, kidneys, amputation of limbs, joint replacement.
Amoxiclav is used to treat mixed infections caused by both amoxicillin-sensitive microorganisms and β-lactamase-producing microorganisms.
Important! Check out the treatment
Dosage and administration:
Amoxiclav powder for oral suspension
Doses are in units of amoxicillin/clavulanic acid.
When choosing a dose of Amoxiclav, you should consider:
.anticipated pathogenic microorganisms and their likely susceptibility to the active substances;
.heaviness and localization of infection;
.age, body weight and kidney function status of the patient.
If necessary, the advisability of using alternative forms of Amoxiclav (for example, those containing higher doses of amoxicillin and / or a different ratio of amoxicillin and clavulanic acid) should be considered.
The duration of therapy depends on the course of the disease. Treatment should not be continued for more than 14 days without medical advice.
Adults and children weighing ≥40 kg: a single dose of 500/125 mg 3 times a day.
Children with body weight<40 кг: от 20/5 мг на 1 кг массы тела в сутки (при инфекциях легкой и средней тяжести) до 60/15 мг на 1 кг массы тела в сутки (при тяжелых инфекциях) в виде 3 отдельных доз.
Clinical data on the use of Amoxiclav with a ratio of amoxicillin and clavulanic acid 4:1 in children under 2 years of age at a dose of more than 40/10 mg/kg of body weight per day are not available.
There are no clinical data on the use of Amoxiclav in the form of a suspension for the treatment of children under 2 months of age, so there are no dosage recommendations. In this age group, the parenteral form of Amoxiclav should be used.
Dosing recommendations for children are given in the table below.
2 months-2 years
(5-12 kg) 1.7-4.0 ml suspension 125/31.25 mg 3 times a day
Moderate infections - 2-6 years
25/6.25 mg/kg/day (13-21 kg) 4.3-7.0 ml suspension 125/31.25 mg 3 times a day
7-12 years old
(22-40 kg) 7.3-13.3 ml suspension 125/31.25 mg 3 times a day
2-6 years old
Severe infections - (13-21 kg) 7.8-12.6 ml of suspension 125 / 31.25 mg 3 times a day
45/11.25 mg/kg/day 7-12 years
(22-40 kg) 13.2-24.0 ml suspension 125/31.25 mg 3 times a day
To measure the suspension, a piston pipette with a volume of 5 ml with a division value of 0.1 ml is attached. Exact daily doses are calculated according to the child's body weight, not his age!
Elderly patients
Dose adjustment is not required.
Impaired kidney function
Dose adjustment is based on the maximum recommended dose of amoxicillin and depends on the glomerular filtration rate. For patients with a creatinine clearance of 30 ml / min, dose adjustment is not required.
Adults and children weighing ≥40 kg
Creatinine clearance 10-30 ml / min 500/125 mg 2 times a day
Creatinine clearance<10 мл/мин 500/125 мг в таблетках 1 раз в сутки
Hemodialysis 500/125 mg once a day + 500/125 mg during
dialysis and after the end of the procedure
Children with body weight<40 кг
Creatinine clearance 10-30 ml/min 15/3.75 mg/kg twice daily (maximum 500/125 mg twice daily)
Creatinine clearance<10 мл/мин 15/3,75 мг/кг 1 раз в сутки (максимум 500/125 мг)
Hemodialysis 15/3.75 mg/kg once a day. Before and after graduation
hemodialysis procedures - 15 / 3.75 mg / kg
Impaired liver function
The drug is used with caution. Liver function should be monitored regularly.
Mode of application
For optimal absorption and to reduce possible side effects from the digestive tract, the drug should be taken at the beginning of a meal.
You can start treatment with parenteral administration of the drug, and continue with the form of the drug for oral use.
Preparation of 100 ml suspension: shake the vial to separate the powder from the walls and bottom. Add drinking water in two portions (first up to ⅔, and then up to the mark on the bottle), shaking each time. Shake well before each use.
Amoxiclav powder for injection
Before using the drug, it is necessary to test the tolerance of amoxicillin and clavulanic acid.
The dose depends on the age, body weight, kidney function of the patient, and the severity of the infection. Doses are in units of amoxicillin/clavulanate. Amoxiclav is injected intravenously (slowly, over 3-4 minutes) or drip (infusion period - 30-40 minutes). This form of Amoxiclav is not used for intramuscular injections. Treatment should not be continued for more than 14 days without evaluating the results of the application and the clinical picture.
adults
Standard dose: 1000/200 mg every 8 hours.
Severe infections: 1000/200 mg every 4-6 hours.
Prevention of complications in surgical interventions
Operation duration<1 ч: 1 доза 1000/200 мг вводится перед введением анестезии.
Duration of surgery >1 hour: as above and up to 4 doses of 1000/200 mg administered as directed over 24 hours.
The purpose of the use of Amoxiclav in surgical interventions is to protect the patient during the period of risk of postoperative infectious complications.
The presence of clear clinical signs of infectious complications requires a full course of intravenous or oral administration of Amoxiclav after surgery.
Impaired kidney function
Creatinine clearance >
Creatinine clearance 10-30 ml / min: 1000/200 mg, then 500/100 mg 2 times a day.
Creatinine clearance<10 мл/мин: 1000/200 мг, затем 500/100 мг каждые 24 ч.
Hemodialysis
The first dose is 1000/200 mg, then 500/100 mg every 24 hours. Since amoxicillin is excreted by hemodialysis, another 1 dose should be administered after the end of hemodialysis.
With peritoneal dialysis, dose adjustment is not required.
Impaired liver function
Caution in dosing, continuous monitoring of liver function at regular intervals.
Elderly patients
Dose adjustment is not required.
Children
Dosage for children with body weight<40 кг зависит от массы тела.
Up to 3 months: baby's body weight<4 кг — 25/5 мг/ кг каждые 12 ч; масса тела ребенка >4 kg - up to 25/5 mg / kg every 8 hours, depending on the course of the disease.
Children 3 months to 12 years: 25/5 mg/kg every 6 to 8 hours depending on the course of the disease.
Impaired kidney function
Dosing adjustments are based on the maximum recommended doses of amoxicillin.
Creatinine clearance> 30 ml / min: dose adjustment is not required.
Creatinine clearance 10-30 ml / min: 25/5 mg / kg 2 times a day.
Creatinine clearance<10 мл/мин: 25/5 мг/кг 1 раз в сутки.
Hemodialysis
Enter 25/5 mg/kg 1 time per day. Given the need to restore the effective concentration, another 1 dose should be administered after the end of hemodialysis.
Impaired liver function
Available data are insufficient to make recommendations regarding dosing, so care should be taken when dosing; continuous monitoring of liver function at regular intervals.
Preparation of solution and features of administration
Amoxiclav is administered by intravenous injection (bolus) or by periodic infusion (drip). Amoxiclav should not be administered intramuscularly.
500/100 mg vial: Dissolve contents in 10 ml water for injection (final volume 10.5 ml).
1000/200 mg vial: Dissolve contents in 20 ml water for injection (final volume 20.9 ml).
Reconstituted solutions have a yellowish (pale straw) color. Use only transparent solutions.
IV injection. Amoxiclav solution should be applied within 20 minutes after recovery and administered slowly over 3-4 minutes. Amoxiclav can be administered directly into a vein or through a catheter drip.
IV infusion. Amoxiclav can be administered intravenously as an infusion. Add the reconstituted solution of Amoxiclav 500/100 mg to 50 ml of infusion fluid or add the reconstituted solution of Amoxiclav 1000/200 mg to 100 ml of infusion fluid (it is better to use a mini-container or a burette). Conduct infusion for 30-40 minutes.
The stability of the prepared solution. For IV infusions, various solutions can be used. A satisfactory concentration of the antibiotic is maintained at 5 ° C and at room temperature (25 ° C) in the recommended volumes of the infusion solutions indicated below. When the drug is dissolved and it stays at room temperature, infusions must be carried out for the time indicated below.
Solution for IV infusion Stability period at 25 °C, h
Water for injection 4
0.9% solution of sodium chloride 4
Ringer's solution with lactate 3
Solution of potassium chloride and sodium chloride 3
When stored at 5 °C, the 1000/200 mg and 500/100 mg solutions can be added to a pre-chilled infusion solution (in a sterile plastic container) and the resulting preparation can be stored at this temperature for up to 8 hours.
Solution for IV infusion Stability period at 5 °C, h
Water for injection 8
0.9% solution of sodium chloride 8
When heated to room temperature, the solution should be used immediately.
Amoxiclav is less stable in solutions of glucose, dextran and bicarbonate, so solutions based on this basis must be used within 3-4 minutes after dissolution.
Any unused solution should be destroyed.
Amoxiclav should not be mixed in a syringe or infusion bottle with other medicines.
Amoxiclav 2X, Amoxiclav Quicktab
Adults and children over 12 years of age weighing >40 kg: the recommended dose is 875/125 mg 2 times a day or 500/125 mg 2-3 times a day (for mild or moderate infections, 500/125 mg every 12 hours , with severe infections - 500/125 mg every 8 hours).
Impaired kidney function
With a mild violation (creatinine clearance> 30 ml / min), dose adjustment is not required.
With moderate impairment (creatinine clearance 10-30 ml / min) - 500/125 mg 2 times a day.
In severe impairment (creatinine clearance<10 мл/мин) препарат Амоксиклав 2X не применяют, Амоксиклав Квиктаб — 500/125 мг 1 раз в сутки.
Amoxiclav Quiktab, dosing for hemodialysis. 500/125 mg 1 time per day + 500/125 mg during dialysis and at the end of the procedure (taking into account the decrease in the concentration of amoxicillin and clavulanic acid in the blood serum).
Impaired liver function
There are insufficient data on dosing recommendations in these patients. Use with caution and monitor hepatic function at regular intervals.
Elderly patients. Dose adjustment is not required.
For optimal absorption and to reduce possible side effects from the digestive tract, the drug should be taken at the beginning of a meal. Amoxiclav Quiktab tablet must be dissolved in ½ glass of water (at least 100 ml), mixed thoroughly before taking or chewed before swallowing.
The duration of the course of treatment depends on the indications, is determined individually and should not exceed 14 days without assessing the patient's condition. It is recommended to continue treatment for at least 3-4 days after the disappearance of acute symptoms of the disease and the improvement of the patient's condition. When infected with beta-hemolytic streptococci, to prevent late complications (eg rheumatism, glomerulonephritis), the drug should be taken for at least 10 days.
Application Features:
Before starting therapy with Amoxiclav, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens. Severe allergic reactions (including anaphylactoid) often occur in patients with a history of hypersensitivity to penicillins. In the event of allergic reactions, Amoxiclav therapy should be discontinued and appropriate alternative therapy initiated.
In the case where it is proved that the infection is caused by microorganisms sensitive to amoxicillin, it is necessary to reconsider the possibility of switching from the combination of amoxicillin / clavulanic acid to amoxicillin according to official recommendations.
Prolonged use of the drug can cause excessive growth of microflora insensitive to Amoxiclav. The drug should not be used to treat penicillin-resistant S. pneumoniae.
Seizures may occur in patients with impaired renal function or in those receiving high doses of the drug.
The development of generalized erythema at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. In this case, it is necessary to stop the use of Amoxiclav.
Amoxiclav should be discontinued if you suspect Infectious mononucleosis and lymphocytic leukemia, since the occurrence of a measles-like rash in this disease may be associated with the use of amoxicillin.
Occasionally, patients taking Amoxiclav may experience an increase in prothrombin time. When taking anticoagulants at the same time, appropriate monitoring is necessary.
Amoxiclav should be used with caution in patients with hepatic dysfunction. Adverse reactions from the liver occur mainly in men and elderly patients, their occurrence may be associated with prolonged use of the drug. Signs and symptoms of the disease occur during or immediately after treatment, but in some cases may occur several weeks after the end of treatment. These phenomena are usually reversible. Extremely rare deaths have occurred in patients with a severe underlying disease or in those who were simultaneously treated with drugs that have a negative effect on the liver.
The use of antibiotics can cause the development pseudomembranous colitis of varying severity. In the presence of severe persistent diarrhea after the use of antimicrobial agents, it is important to ensure that it is not associated with this pathology. Drugs that suppress peristalsis are contraindicated.
In the case of long-term treatment, regular checks of renal and hepatic function and hematological studies are indicated.
For patients with impaired renal function, it is necessary to adjust the dose according to the degree of impairment. In patients with a decrease in the amount of urine excreted, crystalluria can very rarely occur, mainly with parenteral administration of the drug. Therefore, when using high doses of amoxicillin, adequate fluid intake and control of appropriate urinary excretion are recommended in order to reduce the risk of amoxicillin crystalluria (see OVERDOSE).
In the treatment of amoxicillin, it is recommended to use enzymatic reactions with glucose oxidase to determine the level of glucose in the blood, since other methods may give false positive results.
The presence of clavulanic acid in the preparation can cause non-specific binding of IgG and albumin on erythrocyte membranes, therefore, as a result, a false positive result is possible during the Coombs test.
There are reports of false-positive Aspergillus test results in patients treated with amoxicillin/clavulanic acid.
If parenteral administration of high doses of the drug is necessary, attention should be paid to the sodium content in solutions in the treatment of patients on a sodium-controlled diet.
Use during pregnancy and lactation
There is no data on the teratogenic effect of the drug (amoxicillin and clavulanic acid are classified as category B according to the FDA classification). The use of the drug during pregnancy, especially in the first trimester, should be avoided, unless the benefit of the drug outweighs the potential risk.
Amoxicillin and clavulanic acid pass into breast milk in small amounts, so the risk of developing hypersensitivity in a breastfed child cannot be excluded. The use of Amoxiclav during lactation is possible only after a thorough assessment of the benefit / risk ratio.
Children. The drug in the form of a suspension is prescribed to children from the age of 2 months. For children up to 2 months, the parenteral form of Amoxiclav is used. Amoxiclav 2X and Amoxiclav Quiktab are not recommended for children under 12 years of age weighing up to 40 kg.
The ability to influence the reaction rate when driving vehicles or working with mechanisms. There was no negative effect on the reaction rate when driving vehicles or working with mechanisms, but the likelihood of such a side effect as dizziness should be taken into account.
Side effects:
The generally accepted classification of adverse reactions by frequency: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000), неизвестно (не может быть оценено из-за отсутствия данных).
Infections and invasions: often - candidiasis of the genital organs, skin and mucous membranes; unknown - the development of superinfection.
From the hematopoietic and lymphatic system: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia; very rarely - reversible agranulocytosis and hemolytic anemia, eosinophilia, pancytopenia, myelosuppression, increased bleeding time and prothrombin index.
From the immune system: very rarely - angioedema, anaphylaxis, serum syndrome, allergic.
From the nervous system: often - dizziness, headache, insomnia, agitation; very rarely - reversible hyperactivity and convulsions. Seizures may occur in patients with impaired renal function or in those receiving high doses of the drug.
Mental disorders: very rarely - hyperactivity, anxiety, insomnia, confusion, aggressive behavior.
From the digestive tract: often - diarrhea, nausea, vomiting, anal itching; rarely - digestive disorders, abdominal pain, stomatitis, antibiotic-associated colitis (including hemorrhagic and pseudomembranous colitis); very rarely - black staining of the tongue, discoloration of the teeth, which can be eliminated by brushing your teeth.
From the hepatobiliary system of the system: infrequently - a moderate increase in the level of AsAT and / or AlAT, LDH and alkaline phosphatase; very rarely - hepatitis and cholestatic jaundice.
Skin and subcutaneous tissues: infrequently - skin rash, itching, urticaria; rarely - polymorphic erythema; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis. In the event of any allergic dermatitis, treatment should be discontinued.
From the urinary system: very rarely - interstitial nephritis, crystalluria, hematuria.
Amoxiclav powder for injection
Local reactions: rarely - thrombophlebitis, pain, redness at the injection site.
Interaction with other drugs:
The drug should not be used together with bacteriostatic chemotherapeutic agents / antibiotics (chloramphenicol, macrolides, tetracyclines or sulfonamides), since in vitro reactions with such combinations an antagonistic effect was observed.
With simultaneous use with allopurinol, the risk of skin rashes increases.
The simultaneous use of Amoxiclav and methotrexate can increase the toxicity of the latter (leukopenia, thrombocytopenia, skin ulceration).
Probenecid reduces the tubular secretion of amoxicillin, therefore, with the simultaneous use of probenecid with Amoxiclav, an increase in the content of the drug in the blood is possible. Elevated amoxicillin levels may persist for a long time. This does not apply to clavulanic acid.
Like other broad-spectrum antibiotics, Amoxiclav may reduce the effectiveness of oral contraceptives.
In some cases, when taking Amoxiclav with oral anticoagulants, an increase in prothrombin time is possible, so their simultaneous use requires caution. Amoxicillin may reduce the plasma concentration of sulfasalazine.
With simultaneous use with digoxin, an increase in the degree of absorption of the latter is possible.
Amoxiclav should not be used together with disulfiram.
Influence on the results of diagnostic laboratory tests: when the drug is taken orally, its content in the urine can be quite high, which, in turn, can lead to false positive reactions when analyzing glucose using Benedict's reagent or Fehling's solution. In this case, it is recommended to use the enzymatic glucose oxidase method to determine the glucose content.
Reception of Amoxiclav may also affect the results of the determination of urobilinogen. A false-positive result is possible during the Coombs test.
When prescribing ampicillin to pregnant women, a transient decrease in the content of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol in blood plasma is possible. Amoxicillin can cause a similar effect.
Contraindications:
Hypersensitivity to amoxicillin, clavulanic acid, other β-lactam antibiotics, including penicillins and cephalosporins.
Having a history of severe liver dysfunction, cholestatic jaundice associated with the use of the drug; contraindicated in patients with infectious mononucleosis and lymphocytic leukemia (see SPECIAL INSTRUCTIONS).
For Amoxiclav 2X also: children under 12 years old weighing up to 40 kg.
Overdose:
An overdose may be accompanied by gastrointestinal symptoms and a disorder of water and electrolyte balance. These phenomena are treated symptomatically, paying attention to the correction of water and electrolyte balance. Sometimes with an overdose, skin rashes, hypersensitivity reactions, drowsiness, convulsions, short-term loss of consciousness, involuntary muscle contractions, clonic convulsions, coma, hemolytic reactions, kidney failure and acidosis. In exceptional cases, shock may occur after 20-40 minutes.
Cases of crystalluria have been reported, sometimes leading to kidney failure. There are reports of precipitation of amoxicillin in the urinary catheter when using intravenous Amoxiclav in high doses.
Convulsions may occur in patients with impaired renal function or receiving high doses of the drug.
Treatment: discontinuation of the drug; symptomatic therapy. The patient must be under medical supervision.
Amoxiclav can be removed from the bloodstream by hemodialysis.
Storage conditions:
Store at a temperature not exceeding 25 ° C, out of the reach of children. Shelf life - 2 years. Do not use after the expiration date.
Leave conditions:
On prescription
Package:
AMOXYCLAV®
since. d/oral. susp. 156.25 mg/5 ml vial, d/p 100 ml sus., No. 1
since. d/n susp. d / peror. approx. 312.5 mg/5 ml vial, d/p 100 ml sus., No. 1
since. d / p r-ra for in / in in. 600 mg vial, No. 5
since. d / p r-ra for in / in in. 1200 mg vial, No. 5
AMOXYCLAV® 2X
tab. p / captivity. shell 500 mg + 125 mg, No. 14
tab. p / captivity. shell 875 mg + 125 mg, No. 14
AMOXYCLAV® QUIKTAB
tab. dispersion 500 mg + 125 mg blister, № 10
tab. dispersion 875 mg + 125 mg blister, No. 10.
Thank you
The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!
Compound
The composition of the drug Amoxiclav includes the antibiotic amoxicillin trihydrate and the potassium salt of clavulanic acid, which is an enzyme inhibitor. Belongs to the pharmacological group of penicillins. Release form
Available in the form:- film-coated tablets;
- powder for suspensions;
- lyophilized powder for injection.
The 625 mg tablet contains 500 mg of amoxicillin, 125 mg of clavulonic acid.
Auxiliary substances are:
- silicon dioxide (colloidal);
- croscarmellose (sodium salt);
- magnesium stearate;
- talc;
- hypromellose;
- ethylcellulose;
- polysorbate;
- titanium dioxide;
- triethyl citrate.
Powder for suspension is available in dark glass bottles, one per box. There is also a measuring spoon. The composition of the usual finished suspension includes 125 and 31.25 mg of active ingredients, respectively. When preparing the suspension "Amoxiclav Forte", 5 ml contains twice as much active ingredients - 250 and 62.5 mg, respectively. Auxiliary substances are:
- lemon acid;
- sodium citrate;
- sodium benzoate;
- carmellose sodium;
- silica colloid;
- sodium saccharin;
- mannitol;
- strawberry and wild cherry flavors.
pharmachologic effect
The combination of amoxicillin with clavulanic acid is unique in its kind. Amoxicillin and other antibiotics of the penicillin group cause the death of bacterial cells by binding to their surface receptors. However, most bacteria during the use of the drug have learned to destroy this antibiotic using the beta-lactamase enzyme. Clavulanic acid reduces the activity of this enzyme, so this drug has a very wide spectrum of action. It even kills strains of bacteria that are resistant to amoxicillin. The drug has a pronounced bacteriostatic and bactericidal effect on all types of streptococci (with the exception of methicillin-resistant strains), echinococci, listeria. Sensitive to amoxiclav and gram-negative bacteria: - bordetella;
- brucella;
- klebsiella;
- moraxella;
- Proteus;
- shigella;
- clostridium and others.
Indications
The use of this antibiotic is prescribed for the treatment of various infectious diseases:- Respiratory tract diseases - sinusitis (acute or chronic), inflammation of the middle ear, retropharyngeal abscess, bronchitis, tonsillopharyngitis, pneumonia and others.
- Diseases of the urinary tract - cystitis, pyelonephritis, urethritis and others.
- Gynecological infections, endometritis, septic abortion, salpingitis, and others.
- Inflammation of the biliary tract (cholangitis, cholecystitis).
- Connective and bone tissue infections.
- Infections of soft tissues and skin (bites, phlegmon, wound infection).
- Odontogenic infections, in which the pathogen enters the body through cavities in the teeth.
Amoxiclav tablets and powder - instructions for use
Amoxiclav is prescribed in different ways. The method of administration depends on the age and weight of the patient, the severity of the infection, the condition of the kidneys and liver. The optimal time for the use of the drug is the beginning of a meal. The course of taking this medication lasts from 5 to 14 days, it can not be used longer. For children under 12- 40 mg per kilogram of body weight per day.
For children whose weight exceeds 40 kg, the drug is prescribed as adults.
Adults are prescribed: 375 mg tablets are taken every 8 hours around the clock, 625 mg tablets every 12 hours. When prescribing a drug for the treatment of severe infections, doses of 625 mg every 8 hours, or 1000 mg every 12 hours, are used.
It should be noted that tablets may differ in the proportions of active ingredients. Therefore, you cannot replace a 625 mg tablet (500 g amoxicillin and 125 g clavulanic acid) with two 375 mg tablets (250 g amoxicillin and 125 g clavulanic acid).
For the treatment of odontogenic infections, the following scheme is used. The 375 mg tablets are taken every 8 hours, around the clock. Tablets 625 mg every 12 hours.
If it is necessary to use a drug for the treatment of patients with kidney disease, the content of creatinine in the urine must be taken into account. In patients with liver disease, constant monitoring of its function is necessary.
Powder for the preparation of suspensions is used for newborns and children up to 3 months. Dosing is carried out using a special measuring pipette or spoon. Dosage - 30 mg of amoxicillin per kilogram of body weight, twice a day.
For children over three months old for mild and moderate infections - 20 mg / kg of body weight, and for severe infections - 40 mg / kg. The second dose is also used in the treatment of deep infections - inflammation of the middle ear, sinusitis, bronchitis, pneumonia. Instructions are attached to this medicine, in which there are special tables that allow you to calculate the doses of the drug necessary for children as accurately as possible.
The maximum allowable daily dose of amoxicillin for children is 45 mg / kg of body weight, for adults - 6 grams. Clavulanic acid can be taken per day no more than 600 mg for adults and 10 mg/kg for children.
Description of release forms
Suspension
Powder for oral suspension is used for children. Five milliliters of the finished suspension contains amoxicillin trihydrate 250 mg and potassium salt of clavulanic acid - 62.5 mg. Or 5 ml may contain 125 mg of amoxicillin and 31.5 mg of clavulanic acid. To give the suspension a pleasant taste, it contains sweet substances and fruit flavors. The powder for the preparation of the suspension is packaged in dark glass bottles. The volume of bottles is 35, 50, 70 or 140 ml. A dosing spoon is included in the box with the bottle. Tablets
This medicine is available in the form of film-coated tablets that are white or beige-white in color. Tablets have an oval biconvex shape.One 625 mg tablet contains 500 mg of amoxicillin trihydrate with 125 mg of clavulanic acid (potassium salt).
Tablets can be produced in plastic jars (15 tablets each) or in aluminum blisters of 5 or 7 pieces.
Tablets of 1000 mg are also coated, have an oblong shape with beveled edges. They are stamped "AMS" on one side and "875/125" on the other. They contain 875 mg of the antibiotic and 125 mg of clavulanic acid.
Amoxiclav 125
This is the name of the powder for the preparation of a suspension containing 5 ml of 125 mg of amoxicillin and 31.5 mg of clavulanic acid. Produced in bottles of 100 ml, in a cardboard box with a dosing spoon. The dosage is indicated in the section "Amoxiclav - instructions for use".Amoxiclav 250 ("Amoxiclav Forte")
This is also a suspension powder, but it contains a double dose of amoxicillin - 250 mg in 5 ml and 62.5 mg of clavulanic acid. This suspension is called "Amoxiclav Forte" because of the increased dose of the antibiotic in its composition. The dosage is indicated in the section "Amoxiclav - instructions for use".Amoxiclav 500
These are Amoxiclav tablets - 625 mg, containing 500 mg of the antibiotic itself. Application and doses are indicated in the section "Amoxiclav instructions for use", and the composition and properties - in the section "Amoxiclav tablets".Amoxiclav 875
These are Amoxiclav tablets - 1000 mg, containing 875 mg of the antibiotic itself, and 125 mg of clavulanic acid. Application and doses are indicated in the section on the method of application of the drug, and the composition and properties - in the section "Amoxiclav tablets".Amoxiclav 625
The tablets contain 500 mg of amoxicillin and 125 mg of clavulanic acid. Application and doses are indicated in the section on the method of application of the drug, and the composition and properties - in the section "Amoxiclav tablets".Amoxiclav 1000
The tablets contain 875 g of amoxicillin and 125 mg of clavulanic acid. Application and doses are indicated in the section on the method of application of the drug, and the composition and properties - in the section "Amoxiclav tablets".Amoxiclav Quiktab
Fruit flavored fast-dissolving tablets containing either 500 mg amoxicillin and 125 mg clavulanic acid or 875 mg amoxicillin and 125 mg clavulanic acid. Contraindications
When taking the drug, liver dysfunction and jaundice (cholestatic) may occur if this drug has already been used before and the patient has an increased sensitivity to the components of the drug, or to all penicillins.Nervous system may respond to the drug with headaches, dizziness, agitation, insomnia, convulsions, inappropriate behavior or hyperactivity.
Liver. Increases in liver function tests, including asymptomatic increases in the activity of AST and / or ALT, alkaline phosphatase and serum bilirubin levels.
Leather. The skin can react to taking amoxiclav with a rash, urticaria, angioedema, rarely develops erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, Stevens-Johnson syndrome.
urinary system
- there is the appearance of blood in the urine and interstitial nephritis.
With prolonged use of the drug, fever, oral candidiasis, and candidal vaginitis may occur.
Amoxiclav during pregnancy
Amoxiclav should not be used during pregnancy. The exception is those cases where the benefit of taking the drug is higher than the harm it causes. Taking this medicine during pregnancy increases the risk of necrotizing colitis in newborns.Amoxiclav for children
For children, powder for suspensions, regular and Amoxiclav Forte, is used. The method of application is described in the section Amoxiclav - method of application.Amoxiclav with angina
Antibiotics for angina are prescribed only in cases of moderate and high severity. Amoxiclav, as an antibiotic of the penicillin series, is often prescribed for tonsillitis. Its use is indicated only when the bacterial form of the infection is confirmed, and the pathogenic microflora is tested for sensitivity to this drug. In the treatment of angina in children, suspensions are used, in adults - tablets. In severe cases, injections of the drug are used. It must be remembered that antibiotics should not be used for a long time, as this increases the resistance of pathogenic microflora to them.
Compatibility with other medicines
- It is undesirable to simultaneously use Amoxiclav and preparations of indirect anticoagulants. This may cause an increase in prothrombin time.
- The interaction of Amoxiclav and allopurinol causes the risk of exanthema.
- Amoxiclav enhances the toxicity of methotrexate.
- You can not use amoxicillin and rifampicin at the same time - these are antagonist drugs, the combined use weakens the antibacterial effect of both.
- You can not prescribe amoxiclav together with tetracyclines or macrolides (these are bacteriostatic antibiotics), as well as with sulfonamides due to a decrease in the effectiveness of this medication.
- Taking Amoxiclav reduces the effectiveness of contraceptive pills.
Comparison with other drugs
What is better than Amoxiclav?
When choosing an antibiotic for the treatment of any infection, it is necessary to be guided by the results of testing pathogenic microflora for sensitivity to a particular antibiotic. It makes no sense to use a drug that does not kill bacteria - that is, it does not heal. Therefore, the antibiotic to which the pathogenic microflora of the patient is sensitive will be better.Amoxiclav or amoxicillin?
Amoxiclav is a more effective drug than amoxicillin, since many pathogenic microorganisms have developed immunity to this antibiotic and have learned to destroy it, preventing it from showing its bactericidal effect. The addition of clavulanic acid to amoxicillin made this antibiotic much more active, expanding its range of action.Amoxiclav or Augmentin?
Augmentin is an analogue of Amoxiclav, contains the same active ingredients.Amoxiclav or Flemoxin?
Flemoxin is a drug containing only amoxicillin. Without the use of clavulonic acid, it has a smaller spectrum of action, therefore, it is used only if the bacterial microflora is sensitive to this antibiotic.Amoxiclav or Sumamed?
The composition of Sumamed includes the antibiotic azithromycin, which has a wide spectrum of action. The choice should be made on the basis of testing the sensitivity of pathogenic microflora to these two antibiotics. Side effects are similar.Alcohol compatibility
During treatment with Amoxiclav, it is forbidden to take alcohol. The intake of alcoholic beverages significantly reduces the antibacterial effect of the drug. Synonyms and analogues
Synonyms:- Augmentin;
- Clavocin;
- Moksiklav.
- Amovicomb;
- Arlet;
- Bactoclav;
- Klamosar;
- Verclave;
- Medoklav;
- Liklav;
- Panklav;
- ranclave;
- Rapiclav;
- Toromentin;
- Flemoklav;
- Ecoclave;
- Amoxicillin + clavulanic acid (Fizer) and others.
Reviews
Reviews of doctors
Anna Leonidovna, therapist, Vitebsk.
Amoxiclav is much more effective in the treatment of various respiratory diseases than its counterpart, amoxicillin. I prescribe a course of 5 days, after which it is obligatory to take drugs that restore the microflora. Veronika Pavlovna, urologist. city of Krivoy Rog. This drug is excellent for bacterial infections of the genital tract. Rarely gives side effects, in parallel I prescribe antifungal drugs, after taking probiotics to restore normal microflora.
Andrey Evgenievich, ENT doctor, Polotsk. The use of this drug by injection allows you to quickly stop the manifestations of severe and moderate diseases of the upper respiratory tract. The drug well treats inflammation of the middle ear. In addition, patients take the sweet fruit suspension well.
1 tablet contains
- amoxicillin (as trihydrate) 250 mg
- clavulanic acid (as potassium salt) 62.5 mg
Release form
Dispersible tablets 20 pieces per pack
pharmachologic effect
Broad spectrum antibiotic; contains semi-synthetic penicillin amoxicillin and β-lactamase inhibitor clavulanic acid. Clavulanic acid provides a stable inactivated complex with these enzymes and provides amoxicillin resistance to the effects of β-lactamases produced by microorganisms.
Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity.
Amoxiclav has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive strains, including strains producing β-lactamase, incl. aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp.; aerobic Gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida. spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.
Indication for use
Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis);
- infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
- urinary tract infections;
- gynecological infections;
- skin and soft tissue infections, including human and animal bites;
- bone and connective tissue infections;
- biliary tract infections (cholecystitis, cholangitis);
- odontogenic infections.
Methods of application and doses
inside. The dosage regimen is set individually, depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.
The tablets must be dissolved in half a glass of water (minimum 30 ml) and mixed thoroughly, then drink or hold the tablets in the mouth until completely dissolved, then swallow.
In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.
In the case of starting treatment with parenteral administration of the drug, it is possible to continue therapy by ingestion of Amoxiclav Quiktab tablets.
Contraindications
- a history of indications of cholestatic jaundice and / or other abnormal liver function caused by taking amoxicillin / clavulanic acid;
- children under the age of 12 or weighing less than 40 kg;
- hypersensitivity to the components of the drug;
- phenylketonuria;
- history of hypersensitivity to any antibiotic from the group of penicillins, cephalosporins and other beta-lactam antibiotics.
- due to the fact that in a large number of patients suffering from infectious mononucleosis and lymphocytic leukemia treated with ampicillin, the appearance of an erythematous rash was observed, the use of antibiotics of the ampicillin group for such patients is not recommended.
special instructions
Amoxiclav Quiktab can be used during pregnancy if there are clear indications.
Amoxicillin and clavulanic acid are excreted in breast milk in small amounts.
During the course of treatment, the functions of hematopoiesis, liver and kidneys should be monitored.
In order to reduce the risk of developing adverse reactions from the gastrointestinal tract, the drug should be taken at the beginning of a meal.
Storage conditions
The drug should be stored out of the reach of children, in a dry place at a temperature not exceeding 25°C.
Lek D.D.Country of origin
SloveniaProduct group
Antibacterial drugsBroad-spectrum penicillin antibiotic with beta-lactamase inhibitor
Release form
- pack of 14 tablets
Description of the dosage form
- Dispersible tablets
pharmachologic effect
Broad spectrum antibiotic; contains semi-synthetic penicillin amoxicillin and beta-lactamase inhibitor clavulanic acid. Clavulanic acid provides a stable, inactivated complex with these enzymes and makes amoxicillin resistant to the effects of beta-lactamases produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Amoxiclav® is active against amoxicillin-sensitive strains, including beta-lactamase producing strains, incl. aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp.; aerobic Gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida. spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.Pharmacokinetics
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Absorption After taking the drug inside, both components are well absorbed from the gastrointestinal tract, food intake does not affect the degree of absorption. The bioavailability of amoxicillin and clavulanic acid is 90% and 70%, respectively. Cmax in blood plasma is reached 1 hour after taking the drug and is (depending on the dose) for amoxicillin 3-12 mcg / ml, for clavulanic acid - about 2 mcg / ml. Distribution Both components have a good volume of distribution in body fluids and tissues (sinus secretions, synovial fluid, palatine tonsils, middle ear, pleural fluid, saliva, bronchial secretions, lungs, uterus, ovaries, liver, prostate gland, muscle tissue, biliary bladder, peritoneal fluid). In the urine, the drug is present in high concentrations. Amoxicillin and clavulanic acid do not penetrate the BBB in non-inflamed meninges. Active substances penetrate the placental barrier and are excreted in breast milk in trace concentrations. The degree of binding to plasma proteins is low. Metabolism Amoxicillin is partially metabolized, clavulanic acid is extensively metabolized. Withdrawal Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly as metabolites. Small amounts can be excreted through the intestines and lungs. T1 / 2 of amoxicillin is about 1 hour. T1 / 2 of clavulanic acid is about 1 hour. Pharmacokinetics in special clinical situations In severe renal failure, T1 / 2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.Special conditions
Due to the fact that in a large number of patients with infectious mononucleosis and lymphocytic leukemia treated with ampicillin, the appearance of an erythematous rash was observed, the use of antibiotics of the ampicillin group for such patients is not recommended. During the course of treatment, the functions of the hematopoietic organs, liver and kidneys should be monitored. In patients with severely impaired renal function, an adequate correction of the dosing regimen or an increase in the intervals between doses of the drug is required. In order to reduce the risk of developing adverse reactions from the gastrointestinal tract, the drug should be taken with meals. When using Amoxiclav Quiktab, a false positive reaction is possible when determining the level of glucose in the urine using Benedict's reagent or Felling's solution (enzymatic reactions with glucosidase are recommended). Influence on the ability to drive vehicles and control mechanisms There are no data on the negative effect of Amoxiclav Quiktab at recommended doses on the ability to drive vehicles and control mechanisms.Compound
- amoxicillin trihydrate 1004.5 mg, which corresponds to the content of amoxicillin 875 mg potassium clavulanate 148.87 mg, which corresponds to the content of clavulanic acid 125 mg , talc, hydrogenated castor oil, microcrystalline cellulose containing amoxicillin trihydrate 574 mg, which corresponds to the content of amoxicillin 500 mg potassium clavulanate 148.87 mg, which corresponds to the content of clavulanic acid 125 mg (III) yellow oxide (E172), talc, hydrogenated castor oil, silicon-containing microcrystalline cellulose
Amoxiclav Quiktab indications for use
- Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and upper respiratory tract (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis); - infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); - urinary tract infections - gynecological infections; - skin and soft tissue infections, including human and animal bites; - infections of bone and connective tissue; - infections of the biliary tract (cholecystitis, cholangitis); - odontogenic infections
Amoxiclav Quiktab contraindications
- - an indication of a history of cholestatic jaundice or abnormal liver function caused by taking amoxicillin / clavulanic acid; - children's age up to 12 years (with body weight
Amoxiclav Quiktab dosage
- 500 mg + 125 mg 875 mg + 125 mg
Amoxiclav Quiktab side effects
- From the digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely - an increase in the activity of liver enzymes (ALT, AST), an increase in the level of alkaline phosphatase, abnormal liver function; in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. From the side of the central nervous system: dizziness, headache; very rarely - convulsions (may occur in patients with impaired renal function when taking the drug in high doses). From the hematopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - hemolytic anemia, a reversible increase in prothrombin time (when used together with anticoagulants). From the urinary system: very rarely - interstitial nephritis, crystalluria. Allergic reactions: erythematous rash, itching, urticaria; rarely - erythema multiforme exudative, angioedema, anaphylactic shock; in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis. Others: rarely - the development of superinfection (including candidiasis). Side effects are mostly mild and transient.
drug interaction
With the simultaneous use of Amoxiclav Quiktab with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid it increases. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). With the simultaneous use of Amoxiclav Quiktab and anticoagulants, an increase in prothrombin time is noted. Therefore, this combination is prescribed with caution. Co-administration of Amoxiclav Quiktab increases the toxicity of methotrexate. With the simultaneous use of Amoxiclav Quiktab with allopurinol, the risk of developing exanthema increases. The simultaneous use of Amoxiclav Quiktab with disulfiram should be avoided. The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial action)Overdose
abdominal pain, diarrhea, vomiting; anxiety, insomnia, dizziness are also possible; in some cases - convulsionsStorage conditions
- keep away from children