pharmachologic effect
Antibiotic , belongs to the group of aminopenicillins , has a wide spectrum of action. By inhibiting the synthesis of cell walls, it has a bactericidal effect. Active against staphylococci , streptococci , corynebacteria diphtheria , enterococci, Escherichia coli and Haemophilus influenzae , Neisseria gonorrhea and meningitis , Proteus , Salmonella and Shigella; and anaerobes - clostridia , peptostreptococci and peptococci.
When used simultaneously with metronidazole, it is effective against Helicobacter pylori. Microorganisms capable of producing penicillinase are resistant to the drug.
Amoxil is inactive against mycoplasmas , mycobacteria , fungi , rickettsia , plasmodium , amoebas , viruses , as well as Pseudomonas aeruginosa and Proteus.
Pharmacological properties of the drug Amoxil
Pharmacodynamics . Amoxicillin is a broad-spectrum antibiotic of the aminopenicillin group. It has a bactericidal effect, inhibiting the synthesis of the cell wall of bacteria sensitive to the drug. Active against gram-positive cocci - Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp. , anaerobic streptococci ( Peptostreptococcus , Peptococcus ), microaerophilic streptococci ( Streptococcus faecalis ), as well as gram-positive bacilli - Bacillum anthracis , most strains of Corynebacterium diphtheriae , Clostridium perfringens , Clostridium tetani , Listeria monocytogenes , Erysepelothrix rhusiopathia e and Eubacterium . Acts on gram-negative aerobic microorganisms: cocci - Neisseria gonorrhoeae , Neisseria meningitidis ; sticks - Escherichia coli , Shigella spp. , Salmonella spp. , Proteus mirabilis , most strains of Klebsiella spp. , Haemophilus influenazae , Moraxella catarrhalis ; spirochetes - Treponema pallidum , Treponema pertenue , Leptospira spp. , Borrelia burgdorferi ; chlamydia - Chlamydia trachomatis . In combination with metronidazole, it is active against Helicobacter pylori . Microorganisms that produce penicillinase are resistant to the drug. Inactive against mycobacteria, mycoplasmas, rickettsia, fungi, amoebas, plasmodia, viruses, as well as Pseudomonas aeruginosa and Proteus spp. (except for P. mirabillis ). Pharmacokinetics. After oral administration, amoxicillin is well absorbed, reaching maximum serum concentrations 2 hours after administration. The half-life is 1.5 hours. It is excreted unchanged from the body by the kidneys (60-70%).
Side effects
Allergic reaction in the form of itching , urticaria , fever , hyperemia , Stevens syndrome , hyperkeratosis , epidermal necrolysis , eczema , bullous dermatitis , angioedema , vasculitis , serum sickness , anaphylactic shock .
Digestive tract: decreased appetite, nausea, dry mouth, vomiting, diarrhea, flatulence , colitis, upward changes in liver enzymes, hepatitis and jaundice.
Nervous system: insomnia, anxiety, loss of consciousness, dizziness , hyperkinesis , headache. If kidney function is affected, seizures may occur.
Hematopoietic organs: thrombocytopenia , leukopenia , hemolytic anemia , increased prothrombin index.
Urinary system: interstitial nephritis .
Other reactions may include superinfections, candidiasis , general weakness, false-positive reactions to the determination of glucose in the urine and urobilinogen.
Amoxil tablets 500 mg No. 10x2
Name
Amoxil.
Description
Tablets are white with a yellowish tint, flat-cylindrical with a chamfer and a score. The risk is intended only for breaking to facilitate swallowing, and not for dividing into equal doses.
Main active ingredient
Amoxicillin.
Release form
Pills.
Dosage
500 mg.
special instructions
No studies have been conducted on the effect on the ability to drive vehicles and other machinery. However, adverse reactions may occur (for example, allergic reactions, dizziness, convulsions), which may affect the ability to drive vehicles or use other machinery (see section "Side effects").
pharmachologic effect
Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often called penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually accompanied by lysis and cell death. Amoxicillin is inactivated by beta-lactamases produced by resistant bacteria, and therefore the spectrum of activity of amoxicillin alone does not include organisms that produce these enzymes.
Indications for use
Amoxil is indicated for the treatment of the following infections in adults and children (see sections “Dosage and Administration” and “Precautions” and “Pharmacodynamics”): • Acute bacterial sinusitis • Acute otitis media • Acute streptococcal tonsillitis and pharyngitis • Exacerbation of chronic bronchitis • Community-acquired pneumonia • Acute cystitis • Asymptomatic bacteriuria during pregnancy • Acute pyelonephritis • Typhoid and paratyphoid fever • Dental abscess with spreading cellulitis • Infections of joint prostheses • Helicobacter pylori eradication • Lyme disease Amoxil is also indicated for the prevention of endocarditis. Official guidelines for the appropriate use of antibacterial agents should be considered.
Directions for use and doses
The dose of Amoxil is determined by the doctor taking into account: • The expected pathogen and its likely susceptibility to antibacterial agents (see section “Precautions”) • the severity and location of the infectious process • the patient’s age, weight and renal function The duration of treatment should be determined by the type of infection and the patient’s response for treatment and, as a rule, should be as short as possible. Some infections require longer treatment (see Precautions section regarding long-term treatment).
Use during pregnancy and lactation
Pregnancy Animal studies do not indicate direct or indirect reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin may be used during pregnancy when the potential benefits outweigh the potential risks associated with treatment. Breastfeeding Amoxicillin is excreted in small quantities into breast milk with a possible risk of sensitization. Consequently, a breastfed baby may develop diarrhea and fungal infections of the mucous membranes, so breastfeeding may have to be stopped. The use of amoxicillin during breastfeeding is possible only after a benefit/risk assessment by a doctor. Fertility There are no data on the effects of amoxicillin on fertility in humans. Reproductive toxicity studies in animals have shown no effects on fertility.
Precautionary measures
Hypersensitivity reactions Before starting amoxicillin therapy, previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam drugs should be carefully reviewed (see sections "Contraindications" and "Side Effects"). Serious and sometimes fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving penicillin therapy. These reactions are more common in people with a history of penicillin hypersensitivity and in people with atopy. If an allergic reaction occurs, treatment with amoxicillin should be discontinued and appropriate alternative therapy should be instituted. Non-susceptible organisms Amoxicillin is not suitable for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible, or there is a very high likelihood that the pathogen will be suitable for treatment with amoxicillin (see Pharmacodynamics section). This is especially true when considering the treatment of patients with urinary tract infections and severe ear, nose and throat infections. Seizures Seizures may occur in patients with impaired renal function, or in patients receiving high doses of amoxicillin, or in patients with predisposing factors (for example, a history of seizures, epilepsy or meningeal disorders (see section "Side effects")). Renal failure patients with renal failure, the dose should be adjusted depending on the degree of impairment (see section "Dosage and Administration").Skin reactions The occurrence at the beginning of treatment of febrile generalized erythema, with pustules, may be a symptom of acute generalized exanthemal pustulosis (AGEP, see section "Side effect") If this reaction occurs, stop taking amoxicillin and subsequent use is contraindicated. Amoxicillin should be avoided if infectious mononucleosis is suspected, since the occurrence of a morbilliform rash has been associated with this disease after the use of amoxicillin. Jarisch-Herxheimer reaction Jarisch-Herxheimer reaction Herxheimer's disease has been described following treatment with amoxicillin for Lyme disease (see. section "Side effects"). This is directly related to the bactericidal activity of amoxicillin against the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. Manifested by increased temperature, chills, decreased blood pressure, tachycardia, nausea, headache, muscle pain, aggravation of existing symptoms or the appearance of new symptoms of the underlying disease. The patient should be warned that this is a common occurrence and is usually self-limiting and is considered a normal consequence of antibiotic treatment for Lyme disease. Overgrowth of non-susceptible organisms Prolonged use may sometimes result in overgrowth of non-susceptible organisms. Antibiotic-associated colitis has been reported with almost all antibiotics and can range in severity from mild to life-threatening (see Side Effects section). Therefore, it is important to consider this diagnosis in patients with diarrhea during or after taking any antibiotics. If antibiotic-associated colitis occurs, amoxicillin should be stopped immediately, consult a physician, and initiate appropriate therapy. Medicines that slow down peristalsis are contraindicated in this situation. Long-term therapy During long-term therapy, periodic assessment of the functions of certain organs and systems is recommended: including renal, hepatic and hematopoietic function. Increased levels of liver enzymes and changes in blood counts have been reported (see section "Side effects"). Anticoagulants There are isolated reports of prolongation of prothrombin time in patients receiving amoxicillin. When used together with anticoagulants, proper monitoring is necessary. To maintain the desired level of anticoagulation, dose adjustment of oral anticoagulants may be necessary (see sections "Interaction with other drugs and other types of interactions" and "Side effects"). Crystalluria Crystalluria is observed very rarely, mainly during parenteral therapy, in patients with reduced urine output. During administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urination to reduce the likelihood of amoxicillin crystalluria. In patients with bladder catheterization, patency should be checked regularly (see Section "Side effects" and "Overdose"). Effect on Diagnostic Tests Elevated levels of amoxicillin in serum and urine may interfere with some laboratory tests. Due to the high concentration of amoxicillin in urine, false-positive results are possible when using chemical methods. When testing for the presence of glucose in urine during treatment with amoxicillin, it is recommended to use the enzymatic glucose oxidase method. The presence of amoxicillin may distort the results of the test for the presence of estriol in pregnant women. Excipients Amoxil contains less than 1 mmol (23 mg)/dose of sodium, that is, it is practically free of sodium.
Interaction with other drugs
Probenecid Concomitant use of probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Concomitant use of probenecid may increase and prolong the level of amoxicillin in the blood. Allopurinol Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic skin reactions. Tetracyclines Tetracyclines and other bacteriostatic drugs may reduce the bactericidal effect of amoxicillin. Oral anticoagulants Oral anticoagulants and penicillin antibiotics have been widely used in practice without reports of interaction. However, the literature has described cases of increased international normalized ratio in patients receiving acenocoumarol or warfarin concomitantly with amoxicillin. If coadministration is necessary, carefully monitor prothrombin time or international normalized ratio with amoxicillin dosage adjustments. In addition, dose adjustment of oral anticoagulants may be necessary (see sections "Precautions" and "Side Effects"). Methotrexate Penicillins may decrease the excretion rate of methotrexate, potentially causing increased toxicity.
Contraindications
Hypersensitivity to the active substance, to any of the penicillins or to any of the excipients included in the drug. History of severe immediate hypersensitivity reactions (eg, anaphylaxis) to another beta-lactam drug (eg, cephalosporin, carbapenem, or monobactam).
Compound
Symptoms: dysfunction of the gastrointestinal tract - nausea, vomiting, diarrhea, which may result in water and electrolyte imbalance. Cases of crystalluria have been reported, sometimes leading to renal failure. Patients with impaired renal function or those who have received high doses of amoxicillin may experience seizures (see Precautions and Side Effects sections). Treatment: induce vomiting or rinse the stomach, then take activated charcoal and an osmotic laxative. Water and electrolyte balance should be maintained. Amoxicillin is removed from the blood using hemodialysis. A specific antidote is unknown.
Overdose
Symptoms: dysfunction of the gastrointestinal tract - nausea, vomiting, diarrhea, which may result in water and electrolyte imbalance. Cases of crystalluria have been reported, sometimes leading to renal failure. Patients with impaired renal function or those who have received high doses of amoxicillin may experience seizures (see Precautions and Side Effects sections). Treatment: induce vomiting or rinse the stomach, then take activated charcoal and an osmotic laxative. Water and electrolyte balance should be maintained. Amoxicillin is removed from the blood using hemodialysis. A specific antidote is unknown.
Side effect
The most frequently reported adverse reactions were diarrhea, nausea and skin rash. Undesirable adverse reactions recorded during clinical trials and post-marketing surveillance of amoxicillin are presented according to systemic organ classes and frequency of occurrence. Infections and infestations: Very rare: Candidiasis of the skin and mucous membranes. Blood and lymphatic system disorders: Very rare: Reversible leukopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia. Prolongation of bleeding time and prothrombin time (see section "Precautions"). Immune system disorders: Very rare: Severe allergic reactions including angioedema, anaphylaxis, serum sickness and allergic vasculitis (see Precautions section). Frequency unknown: Jarisch-Herxheimer reaction (see Precautions section). Nervous system disorders: Very rare: Hyperkinesia, dizziness and convulsions (see section "Precautions"). Gastrointestinal disorders: Common: Diarrhea and nausea. Uncommon: Vomiting. Post-marketing data: Very rare: Antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis, see Precautions section). Coloring the tongue black. Liver and biliary tract disorders: Very rare: Hepatitis and cholestatic jaundice. Moderate increase in AST and/or ALT. Skin and subcutaneous tissue disorders: Common: Skin rash. Uncommon: Urticaria and itching. Post-marketing data: Very rare: Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) (see Precautions section) and drug reactions with eosinophilia and systemic symptoms (DRESS). From the kidneys and urinary tract: Very rarely: Interstitial nephritis. Crystalluria (see section “Precautions” and “Overdose”). *The incidence of these adverse reactions was obtained from clinical studies of approximately 6,000 adults and children taking amoxicillin. Reporting of adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product to ensure continuous monitoring of the benefit/risk profile of the medicinal product. Health care professionals are encouraged to report any suspected adverse drug reactions through national adverse reaction and drug failure reporting systems. If the patient experiences any adverse reactions, he is advised to consult a doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the Adverse Drug Events Information Database, including reports of drug failure. By reporting adverse reactions, you can help provide more information about the safety of the drug.
Storage conditions
To protect from light and moisture, store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
Buy Amoxil tab. 500 mg per bl. in pack No. 10x2 in the pharmacy
Price for Amoxil tablet. 500 mg per bl. in pack №10x2
Instructions for use for Amoxil tab. 500 mg per bl. in pack №10x2
Instructions for use of Amoxil (Method and dosage)
Take the tablets as prescribed by your doctor, regardless of food.
Dosage for diseases of moderate and mild severity:
- adults and children over 10 years old - 500-750 mg 2 times a day;
- children from 3 to 10 years: 750 mg per day in 3 divided doses;
- from 1 to 3 years 250 mg twice a day.
In the case of chronic recurrent diseases and in severe cases, adults take 3 g per day; children - 60 mg/kg body weight, divided into 3 doses.
The daily dose for adults is a maximum of 6 g.
The course of treatment is continued for another 3 days after the cessation of symptoms. Mild to moderate infections require a course of treatment of about 1 week. In case of infection with beta-hemolytic streptococcus, treatment is for at least 10 days.
For the treatment of acute uncomplicated gonorrhea, a single dose of 3 g is prescribed in combination with probenecid in an amount of 1 g.
For peptic ulcers to eradicate Helicobacter pylori, the instructions for Amoxil 500 mg provide regimens that should be prescribed in combination with other drugs:
- Amoxil 2 g per day in two doses in combination with clarithromycin 500 mg twice daily and omeprazole 40 mg per day.
- Amoxil 2 g per day with metronidazole 400 mg three times a day and omeprazole 40 mg per day.
The course of treatment is 1 week.
In case of renal failure, it is prescribed taking into account the level of glomerular filtration and the level of creatinine .
AMOXIL-K 1000
Compound:
active ingredients
: amoxicillin and clavulanic acid;
1 tablet contains amoxicillin (in the form of amoxicillin trihydrate) 875 mg, clavulanic acid (in the form of potassium clavulanate) 125 mg;
Excipients
: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silica, magnesium stearate, coating mixture (contains: hydroxypropyl methylcellulose, titanium dioxide (E 171), copovidone, polydextrose, polyethylene glycols (macrogols), medium chain triglycerides).
Dosage form.
Film-coated tablets.
Basic physical and chemical properties
: film-coated tablets, white or almost white with a yellowish tint, oval in shape with a biconvex surface, scored on one side.
Pharmacotherapeutic group.
Antimicrobial agents for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins with beta-lactamase inhibitors. Amoxicillin and enzyme inhibitor. ATX code J01C R02.
Pharmacological properties.
Pharmacodynamics.
Amoxicillin is a semisynthetic antibiotic with a wide spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and breaks down under its influence, therefore the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. Clavulanic acid has a β-lactam structure similar to penicillins, as well as the ability to inactivate β-lactamase enzymes characteristic of microorganisms resistant to penicillins and cephalosporins. In particular, it has pronounced activity against clinically important plasmid β-lactamases, which are often responsible for the emergence of cross-resistance to antibiotics.
The presence of clavulanic acid in the composition of the drug "Amoxil-K 1000" protects amoxicillin from degradation under the action of β-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin, including many microorganisms resistant to amoxicillin and other penicillins and cephalosporins.
The microorganisms listed below are classified according to in vitro
.
Sensitive microorganisms.
Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans,
other β-hemolytic species of
Streptococcus, Staphylococcus aureus
(methicillin-sensitive strains),
Staphylococcus saprophyticus
(methicillin-sensitive strains), coagulase-negative staphylococci (methicillin-sensitive strains).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenza, Haemophilus parainfluenzae, Helicobacter pylori, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholera.
Others: Borrelia burgdorferi, Leptospirosa ictterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: Clostridium species, Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros
,
Peptostreptococcus
.
Gram-negative anaerobes: Bacteroides
(including
Bacteroides fragilis
),
Capnocytophaga spp., Eikenella corrodens
,
Fusobacterium spp
.,
Porphyromonas spp
.,
Prevotella
spp.
Strains that can acquire resistance.
Gram-negative aerobes: Escherichia
coli, Klebsiella oxytoca, Klesiella pneumonia
,
Proteus mirabilis, Proteus vulgaris
,
Proteus
,
Salmonella
.,
Shigella spp
.
Gram-positive aerobes: Corynebacterium species, Enterococcus
faecium
.
Insensitive microorganisms.
Gram-negative aerobes: Acinetobacter species, Citrobacter
freundii
,
Enterobacter species, Hafnia alvei, Legionella pneumophila, Morganella morganii
,
Providencia
species,
Pseudomonas species
,
Serratia species, Stenotrophomas maltophilia, Yesinia enterolitica
.
Others: Chlamydia
pneumonia, Chlamydia psittaci
,
Chlamydia species, Coxiella burnetti
,
Mycoplasma
.
Pharmacokinetics
.
The pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Peak serum concentrations of both components are achieved 1 hour after taking the drug. The optimal level of absorption is achieved if the drug is taken at the beginning of a meal.
Doubling the dose of Amoxil-K 1000 approximately doubles the drug level in the blood serum.
Both components of the drug, both clavulanate and amoxicillin, have a low level of binding to plasma proteins, approximately 70% of them remain in the blood serum in an unbound state.
Clinical characteristics.
Indications.
Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the drug "Amoxil-K 1000":
- acute bacterial sinusitis;
- acute otitis media;
- confirmed exacerbation of chronic bronchitis;
— community-acquired pneumonia;
- cystitis;
- pyelonephritis;
- infections of the skin and soft tissues, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
- infections of bones and joints, including osteomyelitis.
Contraindications
.
Hypersensitivity to the components of the drug, to any antibacterial agents of the penicillin group.
A history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other β-lactam agents (including cephalosporins, carbapenems or monobactams).
History of jaundice or liver dysfunction associated with amoxicillin/clavulanate use.
Interaction with other drugs and other types of interactions.
Concomitant use of probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Its simultaneous use with the drug "Amoxil-K 1000" can lead to an increase in the level of the drug in the blood for a long time, but does not affect the level of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin increases the likelihood of allergic reactions. There are no data on the simultaneous use of a combination drug of amoxicillin and clavulanic acid with allopurinol.
Like other antibiotics, Amoxil-K 1000 can affect intestinal flora by reducing the reabsorption of estrogens and the effectiveness of combined oral contraceptives.
There is evidence of an increase in the international normalized ratio (INR) in patients treated with acenocoumarol or warfarin and taking amoxicillin. If such use is necessary, the prothrombin time or international normalized ratio should be carefully monitored and, if necessary, treatment with Amoxil-K 1000 should be discontinued.
In patients treated with mycophenolate mofetil, predose concentrations of the active metabolite of mycophenolic acid may decrease by approximately 50% after initiation of oral amoxicillin with clavulanic acid. This change in predose level may not accurately correspond to the change in total mycophenolic acid exposure.
Penicillins can reduce the elimination of methotrexate, which can lead to increased toxicity of the latter.
Features of application.
Before starting therapy with Amoxil-K 1000, it is necessary to accurately determine whether there is a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and sometimes even fatal cases of hypersensitivity (anaphylactic reactions) have been observed in patients during penicillin therapy. These reactions are more likely in individuals with a history of similar reactions to penicillin (see Contraindications section). If allergic reactions occur, therapy with Amoxil-K 1000 should be discontinued and alternative therapy should be started.
If it is proven that the infection is caused by microorganisms sensitive to amoxicillin, it is necessary to weigh the possibility of switching from the amoxicillin/clavulanic acid combination to amoxicillin according to official recommendations.
This dosage form of Amoxil-K 1000 should not be used if there is a high probability that the pathogens are resistant to β-lactams, and should not be used to treat pneumonia caused by penicillin-resistant strains of S. pneumoniae.
"Amoxil-K 1000" should not be prescribed if infectious mononucleosis is suspected, since cases of measles-like rash have been reported with the use of amoxicillin for this pathology.
Long-term use of the drug can cause excessive growth of microflora that is insensitive to the drug Amoxil-K 1000.
The development of polymorphic erythema associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis (see section "Adverse reactions"). In this case, it is necessary to stop treatment, and further use of amoxicillin is contraindicated.
"Amoxil-K 1000" should be prescribed with caution to patients with signs of liver failure (see sections "Method of administration and dosage", "Contraindications", "Adverse reactions"). Adverse liver reactions occurred primarily in men and elderly patients and were associated with long-term treatment with the amoxicillin/clavulanic acid combination drug. Such events have been reported very rarely in children. In all patient groups, symptoms usually occurred during or immediately after treatment, but in some cases they appeared several months after stopping treatment.
In general, these phenomena were reversible. Liver side effects can be severe and very rarely fatal. They always occurred in patients with severe concomitant diseases or with simultaneous use of drugs that can adversely affect the liver (see section "Adverse reactions").
Antibiotic-associated colitis, ranging from mild to life-threatening colitis, has been reported with the use of almost all antibacterial drugs (see section "Adverse Reactions"). This is important to keep in mind if patients experience diarrhea during or after antibiotic use. If antibiotic-associated colitis occurs, treatment with Amoxil-K 1000 should be stopped immediately and appropriate treatment initiated.
Rarely, patients taking Amoxil-K 1000 and oral anticoagulants may experience an increase in prothrombin time [increase in the international normalized ratio (INR)]. When taking anticoagulants simultaneously, appropriate monitoring of laboratory parameters is necessary. Dosage adjustment of oral anticoagulants may be required to maintain the required level of coagulation.
For patients with impaired renal function, the dose must be adjusted according to the degree of renal impairment (see section "Dosage and Administration").
In patients with reduced urine excretion, crystalluria can very rarely be observed, mainly with parenteral administration of the drug. Therefore, to reduce the risk of crystalluria during treatment with high doses, it is recommended to ensure fluid balance in the body (see section “Overdose”).
When treating with amoxicillin, enzymatic reactions with glucose oxidase should be used to determine the level of glucose in urine, since other methods may give false-positive results.
The presence of clavulanic acid in the drug may cause nonspecific binding of immunoglobulin G and albumin on red blood cell membranes, which may result in a false positive result when performing the Coombs test.
There have been reports of false positive test results for Aspergillus
in patients treated with amoxicillin/clavulanic acid (using the Bio-Rad Laboratories Platelis Aspergillus EIA test). Therefore, such positive results in patients receiving amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
Use during pregnancy or breastfeeding.
Reproduction studies in animals (at doses 10 times higher than human doses) of oral and parenteral forms of the combination of amoxicillin and clavulanic acid did not reveal any teratogenic effects. One study in women with premature rupture of membranes reported that prophylactic use of amoxicillin and clavulanic acid increased the risk of necrotizing enterocolitis in neonates. The use of the drug should be avoided during pregnancy, especially in the first trimester, unless the benefit of the drug outweighs the potential risk.
Both active components of the drug are excreted into breast milk (there is no information regarding the effect of clavulanic acid on breast-fed children). Accordingly, diarrhea and fungal infections of the mucous membranes may occur in infants, so breastfeeding should be stopped.
The drug "Amoxil-K 1000" can be used during breastfeeding only when, in the opinion of the doctor, the benefits of use will outweigh the risks.
The ability to influence the reaction rate when driving vehicles or other mechanisms.
No studies have been conducted to study the ability of the drug to influence the reaction rate when driving vehicles or other mechanisms. However, adverse reactions may occur (eg, allergic reactions, dizziness, seizures) that may affect your ability to drive or operate machinery.
Method of administration and dose.
The drug should be used in accordance with official recommendations for antibiotic therapy and local antibiotic sensitivity data. Sensitivity to amoxicillin/clavulanate varies between regions and may change over time. Local susceptibility data should be consulted, if available, and microbiological determination and susceptibility testing performed if necessary.
The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient.
For adults and children weighing ≥ 40 kg, the daily dose is 1750 mg amoxicillin / 250 mg clavulanic acid (2 tablets), divided into 2 doses.
For children with body weight - 2800 mg amoxicillin / 143 - 400 mg clavulanic acid (see below for details).
If large doses of amoxicillin are required for treatment, other forms of the drug should be used to avoid unnecessary high doses of clavulanic acid.
The duration of treatment is determined by the patient's clinical response to treatment. Some infections (such as osteomyelitis) require long-term treatment.
Overweight children
Dose from 25 mg / 3.6 mg/kg/day to 45 mg / 6.4 mg/kg/day, divided into 2 doses.
Elderly patients
No dose adjustment is required for elderly patients. If necessary, the dose is adjusted depending on renal function.
Dosing for liver dysfunction.
Use with caution; liver function must be regularly monitored. There are insufficient data to make dosage recommendations.
Dosing for renal impairment.
The drug "Amoxil-K 1000" is prescribed only for the treatment of patients with creatinine clearance more than 30 ml/minute. In case of renal failure with creatinine clearance less than 30 ml/minute, Amoxil-K 1000 is not used.
The tablet should be swallowed whole without chewing. If necessary, the tablet can be broken in half and swallowed without chewing.
For optimal absorption and to reduce possible gastrointestinal side effects, the drug should be taken at the beginning of a meal.
The duration of treatment is determined individually. Treatment should not be continued for more than 14 days without assessing the patient's condition.
Treatment can be started with parenteral administration and then switched to oral administration.
Children.
The drug in this dosage and dosage form is not recommended for the treatment of children under 12 years of age.
Overdose
.
An overdose may be accompanied by symptoms from the gastrointestinal tract and disturbances in water and electrolyte balance. These phenomena should be treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, which sometimes led to renal failure (see section "Peculiarities of application"). The drug "Amoxil-K 1000" can be removed from the bloodstream by hemodialysis.
Adverse reactions.
Side effects were classified according to their frequency of occurrence: very common ≥1/10; often ≥ 1/100 and
Infections and infestations.
Often – candidiasis of the skin and mucous membranes.
Unknown - excessive increase in the number of non-susceptible microorganisms.
Hematopoietic and lymphatic systems.
.
Rarely – reversible leukopenia (including neutropenia) and thrombocytopenia.
Very rarely - reversible agranulocytosis and hemolytic anemia. Increased bleeding time and prothrombin index.
From the immune system.
Very rarely - angioedema, anaphylaxis, serum syndrome, allergic vasculitis.
From the nervous system.
Uncommon: dizziness, headache.
Very rarely - reversible hyperactivity, aseptic meningitis and convulsions. Seizures may occur in patients with impaired renal function or in those receiving high doses of the drug, unknown - aseptic meningitis.
From the gastrointestinal tract.
Adults
Very often - diarrhea.
Often - nausea, vomiting.
Children
Often – diarrhea, nausea, vomiting.
Nausea is more often associated with high doses of the drug. The above mentioned gastrointestinal symptoms can be reduced by taking the drug at the beginning of meals.
Uncommon: indigestion.
Very rarely - antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis - see section “Peculiarities of use”), black “hairy” tongue.
From the hepatobiliary system.
Uncommon – a moderate increase in the level of aspartate aminotransferase and/or alanine aminotransferase is observed in patients treated with β-lactam antibiotics.
Very rarely - hepatitis and cholestatic jaundice. These phenomena occur with the use of other penicillins and cephalosporins.
Hepatitis occurs mainly in men and elderly patients, and their occurrence may be associated with long-term treatment.
In children, such phenomena occurred very rarely.
Symptoms of the disease occur during or immediately after treatment, but in some cases they may occur several weeks after the end of treatment. These phenomena are usually reversible. Deaths occur very rarely and always occur in patients with severe underlying disease or in patients simultaneously receiving drugs that adversely affect the liver.
From the skin and its derivatives.
Uncommon: skin rash, itching, urticaria.
Rarely – polymorphic erythema.
Very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
If any allergic dermatitis occurs, treatment should be discontinued.
From the kidneys and urinary system.
Very rarely – interstitial nephritis, crystalluria (see section “Overdose”).
Best before date.
1.5 years.
Storage conditions.
Store in original packaging at a temperature not exceeding 25 ºС.
Keep out of the reach of children.
Package.
7 tablets per blister, 2 blisters per pack.
Vacation category.
On prescription.
.
The location of the manufacturer and its address of place of business.
Ukraine, 01032, Kyiv, st. Saksaganskogo, 139.
Interaction
Amoxil tablets, when taken simultaneously with oral contraceptives, can reduce the effect of contraception and increase the likelihood of bleeding.
of digoxin increases and the toxicity of methotrexate .
When used simultaneously with probenecid, phenylbutazone, sulfinperazone, indomethacin and acetylsalicylic acid, the excretion of Amoxil by the kidneys slows down.
Drugs that have a bacteriostatic effect ( chloramphenicol , macrolides , tetracycline ) neutralize the effect of Amoxil.
Combined use with allopurinol increases the likelihood of allergic skin reactions.
The simultaneous administration of antacids reduces the absorption of Amoxil.
Combination with anticoagulants increases the likelihood of bleeding, so you need to monitor the prothrombin time.
Diarrhea reduces drug absorption.
In pregnant women, the medicine reduces the concentration of estradiol in the urine.
special instructions
The possibility of developing an allergy to cephalosporin and penicillin antibiotics should be excluded before starting treatment.
Repeated and long-term use leads to the development of resistance and superinfections.
Vomiting and diarrhea reduce the absorption of the drug; in these conditions it should not be prescribed.
Prescribed with caution to patients with asthma and allergic diathesis .
Taking the drug in high doses causes the development of crystalluria , so for prevention it is necessary to take a sufficient amount of fluid.
The drug can change the color of tooth enamel in children, so you need to ensure proper dental and oral hygiene.
In case of anaphylactic shock, artificial ventilation of the lungs is performed, epinephrine , antihistamines , glucocorticoids and oxygen .
Special instructions for the use of the drug Amoxil
Before starting therapy, it is necessary to exclude the patient's hypersensitivity to penicillin and cephalosporin drugs. Long-term or repeated use can lead to the rapid growth of resistant microflora and the development of superinfection. Patients with severe gastrointestinal disorders accompanied by diarrhea and vomiting should not use oral forms of amoxicillin, which is associated with the risk of reduced absorption. Amoxil should be prescribed with caution to patients with allergic diathesis and a history of asthma. Also, caution should be used in patients with viral infections and acute lymphatic leukemia due to the increased risk of erymatous skin rash. Patients with impaired renal function require dose adjustment (see APPLICATION). High concentrations of amoxicillin in the urine may cause sediment to form in the catheter. Therefore, catheters must be flushed regularly. In patients with reduced diuresis taking amoxicillin (mainly parenterally), there is a possibility of developing crystalluria. When taking amoxicillin in high doses, it is recommended to take enough fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. In children, amoxicillin can change the color of tooth enamel, so strict adherence to oral hygiene by the patient is necessary. In the event of the development of anaphylactic shock and other serious allergic reactions, it is necessary to carry out appropriate emergency measures - artificial respiration, intravenous administration of epinephrine, the use of antihistamines, corticosteroids, oxygen therapy, mechanical ventilation. Patients should be under medical supervision. Use during pregnancy and lactation . A teratogenic effect of amoxicillin has not been identified. However, if it is necessary to prescribe the drug during pregnancy, the ratio of the potential risk to the fetus and the expected benefit to the woman should be assessed in advance. Amoxicillin passes into breast milk in small quantities. Use during breastfeeding is possible, however, to prevent possible sensitization of the child, it is recommended to stop breastfeeding. Children. The drug is contraindicated for use in children under 1 year of age. The ability to influence the reaction rate when driving a vehicle or working with other mechanisms. People who drive vehicles or operate other machinery should take the drug with caution due to the risk of developing possible adverse reactions from the nervous system.
Amoxil's analogs
Level 4 ATC code matches:
Hiconcil
Ampioks
Ampicillin Trihydrate
Ampicillin
Ospamox
Amoxicar
Penicillin
Flemoxin Solutab
Amoxicillin
Amosin
Ecoball
Ospamox , Flemoxin Solutab , Ampiox , Amoxicillin
Reviews about Amoxil
By studying reviews about Amoxil, you can be sure that it is a fairly affordable and effective drug. There are a lot of good opinions about its use for bronchitis , pneumonia and tonsillitis , both in adults and children. Patients who used the drug noted rapid recovery.
There are also several positive reviews of use for streptoderma and other pustular skin lesions.
The disadvantage is that some patients experience side effects such as skin rashes or gastrointestinal upset.
Another advantage is that, due to its safety, Amoxil tablets are allowed to be used by pregnant and lactating women.
Amoxil price, where to buy
In Ukraine, Amoxil is sold at an average price of 19 UAH. for 20 tablets of 250 mg. The price of Amoxil in a dose of 500 mg ranges from 29 to 34 UAH.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
LuxPharma* special offer
- Amoxil tablet
No. 20 500 mg 1600 rub. order
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Pharmacy24
- Amoxil-K 1000 875 mg/125 mg No. 14 tablets PAT "Kievmedpreparat", Ukraine
94 UAH.order - Amoxil-KMP 250 mg No. 20 tablets PAT "Kievmedpreparat", Ukraine
41 UAH order
- Amoxil-KMP 500 mg No. 20 tablets PAT "Kievmedpreparat", Ukraine
57 UAH order
- Amoxil-K 1.2 g No. 1 powder PAT "Kievmedpreparat", Ukraine
38 UAH order
- Amoxil DT 500 mg No. 20 tablets PAT "Kievmedpreparat", Ukraine
57 UAH order
