Amoxiclav tablets 875 mg+125 mg 14 pcs.

Amoxiclav: composition

Amoxiclav is a successful combination of clavulanic acid and amoxicillin. Each formulation of the drug may use various additional components, including:

aspartame;
hydrogenated oil;
flavorings;
talc;
silica;
iron oxide.

Amoxiclav can be taken orally or used intravenously. Most often, tablets are prescribed for treatment of various bacterial infections, since the vast majority of diseases are transmitted by patients at home.

The dosage of tablets can be different: from 250 mg to 875 mg amoxicillin + 125 mg clavulanic acid in each dose of antibiotic.

Amoxiclav tablets 875mg+125mg No. 14

Amoxiclav tablets 875mg+125mg No. 14
Amoxiclav Buy Amoxiclav in pharmacies
DOSAGE FORMS film-coated tablets 875mg/125mg film-coated tablets 875mg+125mg

MANUFACTURERS Lek dd. (Slovenia)

GROUP Combined antimicrobial agents

COMPOSITION Active ingredients: 875 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of potassium salt.

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 The drug is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthesis pathway of peptidoglycan, an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually causes lysis and death of microbial cells. Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of activity of amoxicillin alone 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 broadens its spectrum of activity to include bacteria usually resistant to amoxicillin, as well as other penicillins and cephalosporins. Clavulanic acid itself does not have a clinically significant antibacterial effect. The drug 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 influenza, Klebsiella species, Moraxella catarrhalis (Branhamella catarrhalis). The drug has a bactericidal effect in vitro on the following microorganisms (however, the clinical dependence is still unknown). Gram-positive aerobes. BacilHs anthracis. Species of the genus Corynebacterium, Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Nocardia asteroids, Coagulase-negative staphylococci (including Staphylococcus epidermidis) Streptococcus agalaciiae. Other species of the genus Streptococcus Streptococcus viridians. 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 meningitides, 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. Other: Borrella burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum. Some strains of these bacterial species produce beta-lactamases, which contributes to their insensitivity to amoxicillin monotherapy. 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 orally, they are quickly and completely absorbed from the gastrointestinal tract (GIT). Absorption of the active substances amoxicillin and clavulanic acid is optimal if 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 administration. The maximum concentration values for amoxicillin (depending on the dose) are 3-12 μg/ml, for clavulanic acid - about 2 μg/ml. When using the drug, plasma concentrations of amoxicillin/clavulanic acid are similar to those when taking corresponding doses of amoxicillin or clavulanic acid orally in equivalent doses. Both components are characterized by a good volume of distribution in various organs, tissues and fluids of the body (including the lungs, abdominal organs; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; skin, bile, urine, purulent discharge, sputum, interstitial fluid). Plasma protein binding is moderate: 25% for clavulanic acid and 18% for amoxicillin. 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 are also found in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier. Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of one tablet of 250 mg/125 mg or 500 mg/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 half-life of amoxicillin/clavulanic acid is approximately one hour, and the average total clearance is approximately 25 L/h in healthy patients. Various studies have found that urinary excretion of amoxicillin within 24 hours is approximately 50-85%, and that of clavulanic acid is 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration. Patients with impaired liver function. In patients with severe renal impairment, the half-life increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid. For patients with impaired liver function, the dose of the drug should be selected with caution, and constant monitoring of the condition of the liver is necessary. Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

INDICATIONS FOR USE Infections caused by sensitive strains of microorganisms: infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis); lower respiratory tract infections (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); urinary tract infections; infections in gynecology; skin and soft tissue infections, as well as wounds from human and animal bites; infections of bone and connective tissue; biliary tract infections (cholecystitis, cholangitis); odontogenic infections.

CONTRAINDICATIONS Hypersensitivity to the components of the drug; history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics, cholestatic jaundice and/or other liver dysfunction caused by a history of taking amoxicillin/clavulanic acid; infectious mononucleosis and lymphocytic leukemia.

SIDE EFFECTS 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 , impaired liver function, increased activity of alanine aminotransferase, aspartate aminotransferase, 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), platelets, hemolytic anemia, reversible increase in prothrombin over time (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), hyperactivity. Feelings of anxiety, insomnia, behavior changes, agitation. From the urinary system: interstitial nephritis, crystalluria, hematuria. Other: candidiasis and other types of superinfection.

INTERACTION Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption. Diuretics, allopurinol, phenylbutazone; non-steroidal anti-inflammatory drugs 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 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 para-aminobenzoic acid is formed, ethinyl estradiol - the risk of breakthrough bleeding. The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If simultaneous use with anticoagulants and prothrobinated time or MHO is necessary, it must be carefully repeated when prescribing or discontinuing the drug. The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug. The drug reduces the effectiveness of oral contraceptives.

METHOD OF APPLICATION AND DOSAGE Orally. 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. It is recommended to take the drug at the beginning of a meal for optimal absorption and to reduce possible side effects from the digestive system. The course of treatment is 5 - 14 days. The duration of treatment is determined by the attending physician. The course should not last more than 14 days without repeated medical examination. Children under 12 years old. The dose is prescribed depending on age and body weight. Recommended dosage regimen: 40 mg/kg/day in 3 divided doses. Children weighing 40 kg or more should be prescribed the same doses as adults. For children under 6 years of age, taking a suspension of the drug is more preferable. Adults and children over 12 years of age (or more than 40 kg body weight). The usual dose in case of mild to moderate infection is 1 tablet every 12 hours, in case of severe infection and respiratory tract infections - 1 tablet every 8 hours. Since amoxicillin and clavulanic acid combination tablets of 250 mg + 125 mg and 500 mg-125 mg contain the same amount of clavulanic acid -125 mg, then 2 tablets of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg. Dosage for odontogenic infections: 1 tablet every 12 hours for 5 days. Patients with impaired renal function. Dose adjustments are based on the maximum recommended dose of amoxicillin and are based on creatinine clearance (CC) values. Adults and children over 12 years of age (or more than 40 kg body weight). QC > 30 ml/min: no dose adjustment required. For anuria, the interval between dosing should be increased to 48 hours or more. Tablets 875 mg + 125 mg should be used only in patients with CC > 30 ml/min. Patients with impaired liver function. The drug should be taken with caution. It is necessary to regularly monitor liver function.

OVERDOSE There are no reports of death or life-threatening side effects due to drug overdose. In most cases, symptoms of overdose include gastrointestinal disorders (abdominal pain, diarrhea, vomiting). Anxiety, insomnia, dizziness, and in isolated cases seizures are also possible. In case of overdose, the patient should be under medical supervision, treatment is symptomatic. In case of recent use (less than 4 hours), it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/clavulanic acid is removed by hemodialysis.

SPECIAL INSTRUCTIONS Use caution. History of pseudomembranous colitis, diseases of the gastrointestinal tract, liver failure, severe renal dysfunction, pregnancy, lactation, when used simultaneously with anticoagulants. Use during pregnancy and breastfeeding. During pregnancy and lactation, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child. 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 severely impaired renal function, adequate dose adjustment or increased intervals between doses is required. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. 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. Laboratory 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. Special precautions when disposing of unused medicinal products. There is no need for special precautions when disposing of unused drug. Impact on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment you should be careful when driving and engaging in other activities that require concentration and speed of psychomotor reactions.

STORAGE CONDITIONS Store in a dry place, out of reach of children, at a temperature not exceeding 25 C.

Description of the antibiotic Amoxiclav

The substance belongs to the group of penicillins. A wide spectrum of action makes it possible to achieve positive dynamics in the treatment of many diseases of bacterial etiology. When it enters the body, Amoxiclav destroys the cell wall of the bacterium, and it dies. Efficacy was noted against a wide group of enterobacteria, Haemophilus influenzae, staphylococcus, streptococcus, enterococcus, listeria, clostridia, and salmonella. In addition, this medicine can treat infections caused by most resistant strains of bacteria.

Clavulonic acid, in turn, protects amoxicillin from the influence of beta-lactamases of microorganisms.

After absorption from the gastrointestinal tract, the active components are quickly distributed into the bloodstream. Food does not interfere with absorption. However, in order to reduce the risk of possible negative reactions from the digestive system, it is still not recommended to take the medicine on an empty stomach.

From the gastrointestinal tract: very often: diarrhea; often: nausea, vomiting. Nausea is most often observed with high doses taken orally. If gastrointestinal disorders are confirmed, they can be eliminated if the drug is taken at the beginning of a meal. uncommon: indigestion; very rare: antibiotic-associated colitis (including hemorrhagic colitis and pseudomembranous colitis), black “hairy” tongue, gastritis, stomatitis. From the liver and biliary tract: uncommon: increased activity of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST). This reaction has been observed in patients receiving beta-lactam antibiotic therapy, but its clinical significance is unknown. very rarely: cholestatic jaundice, hepatitis, increased alkaline phosphatase activity, increased bilirubin activity in the blood plasma. Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rarely observed in children. The listed signs and symptoms usually occur during or immediately after completion of therapy, but in some cases they may not appear for several weeks after completion of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, and deaths have been reported in extremely rare cases. In almost all cases, these were persons with serious comorbidities or persons receiving concomitantly potentially hepatotoxic drugs. From the immune system: very rarely: angioedema, anaphylactic reactions, allergic vasculitis; From the blood and lymphatic system: rarely: reversible leukopenia (including neutropenia), thrombocytopenia; very rare: reversible agranulocytosis, hemolytic anemia, reversible increase in prothrombin time, reversible increase in bleeding time, eosinophilia, thrombocytosis. From the nervous system: infrequently: dizziness, headache; very rarely: convulsions (may occur in patients with impaired renal function, as well as when taking high doses of the drug), reversible hyperactivity, aseptic meningitis, anxiety, insomnia, behavioral changes, agitation. From the skin and subcutaneous tissues: uncommon: skin rash, itching, urticaria; rarely: exudative erythema multiforme; very rare: exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, serum sickness-like syndrome, toxic epidermal necrolysis. From the kidneys and urinary tract: very rarely: interstitial nephritis, crystalluria, hematuria. Infectious and parasitic diseases: often: candidiasis of the skin and mucous membranes. Other: frequency unknown: growth of non-susceptible microorganisms.

Indications for use of Amoxiclav

The use of the drug is so widespread that some doctors starting their therapeutic practice prescribe it at every opportunity. In the situation with diseases of the otolaryngology organs, this is:

otitis, including purulent;
tonsillitis;
sinusitis;
pharyngolaryngitis.

When the urinary system is affected, Amoxiclav can also be prescribed. These diseases include chronic cystitis, prostatitis, and urethritis.

Diseases of the respiratory system are rarely treated without amoxicillin. For bronchitis of bacterial etiology and pneumonia, this particular drug is used. In addition, the antibiotic has shown its effectiveness against:

infections affecting bones and connective tissue;
soft tissue diseases caused by bacterial infection;
cholecystitis;
diseases of the pelvic organs.

Some types of surgery require the patient to take a course of antibiotics to prevent superinfection.

Amoxiclav: instructions for adults

The main rule of taking antibiotics is to follow the prescribed course of treatment. The mistake patients make is that at the first sign of a retreat in the symptoms of the disease, many give up treatment, believing that long-term antibiotic therapy causes irreparable damage to all body systems. However, in fact, this is precisely how resistant colonies of microorganisms are formed, which over time adapt to life even under the influence of an antibiotic. For example, for cystitis, a one-time dose of the drug relieves pain and pain already on the second day of treatment. But this is only the absence of symptoms.

The bacteria that caused this damage to the urinary system have not yet died, they have only lost their ability to provoke unpleasant symptoms of the disease. Stopping treatment early will allow the surviving bacteria to evolve so that the next time taking the same drug does not prevent them from multiplying and being active.

A single and daily dose is prescribed by the attending physician, because it depends on the severity of the disease and the patient’s condition. As a rule, the maximum dosage of Amoxiclav in the amount of 875 + 125 does not exceed twice the dose of the drug per day with an interval of 12 hours. To achieve maximum effect, you need to stick to the same hour of taking the drug. The duration of the course, regardless of the single dose and the number of prescribed doses, cannot be shorter than 7 days.