1 capsule contains 250 mg or 500 mg of Amoxicillin in the form of a trihydrate; after dissolving the powder - 5 ml of suspension contains 125 mg or 250 mg of amoxicillin in the form of a trihydrate - the suspension contains aspartame.
Action:
Β-lactam antibiotic from the aminopenicillin group, sensitive to β-lactamase. Species usually sensitive to amoxicillin - Gram-positive aerobic bacteria:Bacillus anthracis, Listeria monocytogenes, Streptococcus agalactiae, Streptococcus bovis, Streptococcus pyogenes; Gram-negative aerobic bacteria:Brucella spp., Helicobacter pylori, Neisseria meningitidis, Vibrio cholerae; anaerobic bacteria:Clostridium spp. Bacteria that may have acquired resistance:Corynebacterium spp., Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus viridans, Brucella spp., Escherichia coli, Haemophilus influenza, Haemophilus parainfluenzae, Neisseria gonorrhoeae, Proteus mirabilis, Salmonella spp., Shigella spp., Bacteroides melaninogenicus, Fusobacterium spp.. Microbes with innate resistance:staphylococcus (β-lactamase producing strains),Acinetobacter spp., Citrobacter spp., Enterobacter spp., Klebsiella spp., Moraxella catarrhalis, Proteus spp. (Indole-positive),Proteus vulgaris, Providencia spp., Pseudomonas spp., Serratia spp., Bacteroides fragilis, Chlamydia, Mycoplasma, Rickettsia. Amoxicillin is rapidly and independently absorbed from the gastrointestinal tract, reaching Cmax within 1-2 h. Bioavailability is 75-90%. In 17% it is associated with plasma proteins. He quickly achieves therapeutic concentration, among others in serum, lung tissue, bronchial secretions, secretions of the middle ear, bile and urine. It can penetrate into the inflamed meninges and it penetrates into the cerebrospinal fluid. It passes through the placenta and in small amounts it is excreted into breast milk. 7 to 25% of the administered dose is metabolised to inactive penicillic acid. It is excreted mainly by the kidneys. T0,5 is about 1-1.5 hours. In patients with end stage renal disease T0,5 it is 5-20 h. It can be removed from the body by hemodialysis.
Contraindications:
Hypersensitivity to Amoxicillin, any of penicillins, other β-lactam antibiotics or other components of the preparation.
Precautions:
Before administration of the drug, an accurate medical history should be conducted regarding the patient's tendency to hypersensitivity reactions to penicillins, cephalosporins or other allergens due to the possibility of anaphylactic reactions. The probability of hypersensitivity reactions is greater in patients with a history of hypersensitivity to β-lactam antibiotics. Carefully use in patients prone to allergies and bronchial asthma. In the event of an immediate and / or severe allergic reaction, antibiotics should be discontinued and appropriate emergency procedures initiated. Particular care should be taken in premature infants, newborns and children (control of renal function, liver function and haematological parameters); in patients with viral infections, acute lymphocytic leukemia or infectious mononucleosis (increased risk of erythematous skin rash); in patients with renal insufficiency (dosage modification indicated); in patients with gastrointestinal disease, especially with previous colitis. Patients with severe gastrointestinal disorders, with vomiting and diarrhea should not use the preparation due to the risk of malabsorption of the drug (a parenteral form is recommended). Prolonged use of amoxicillin may cause excessive growth of resistant bacteria or yeasts - care should be taken to ensure that the patient does not show signs of superinfection.In any patient who has experienced diarrhea due to the use of an antibiotic, the possibility of pseudomembranous colitis should be considered - once the diagnosis of this disease is established, the antibiotic should be discontinued and appropriate treatment instituted. When using high doses of amoxicillin, appropriate amounts of fluids should be given and appropriate diuresis should be maintained to minimize the possibility of precipitation of amoxicillin crystals in the urine. In catheterized patients, the patency of the catheter should be checked regularly. Capsules contain azorubine (a dye) that can cause allergic reactions. The suspension contains aspartame - be cautious in patients with phenylketonuria; in patients with a homozygous form of phenylketonuria, the amount of phenylalanine provided by aspartame should be included in the diet.
Pregnancy and lactation:
During pregnancy and breastfeeding, use in case of extreme necessity. Current data indicate that amoxicillin has no adverse effect on pregnancy or on the health of the fetus and newborn. A small amount of amoxicillin is excreted in breast milk - there is a risk of diarrhea, sensitization and colonization of fungi on mucous membranes in a child.
Side effects:
Common: stomach disorders (nausea, loss of appetite, vomiting, flatulence, loose diarrhea, diarrhea), rash on mucous membranes (especially in the mouth), dry mouth, taste disturbances, skin reactions (rash, pruritus, urticaria; typical polymorphic rash occurs within 5 to 11 days after the start of treatment, the immediate occurrence of urticaria indicates an allergic reaction to the drug and it is necessary to discontinue amoxicillin). Uncommon: superinfection and colonization with resistant microbes or yeast (including candidiasis of the oral mucosa, vaginal candidiasis), moderate and transient increase in liver enzymes. Rare: eosinophilia, hemolytic anemia, laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis, anaphylactic shock, hyperkinesia, dizziness, convulsions, superficial discoloration of the teeth (especially when using a suspension), hepatitis, cholestatic jaundice, angioneurotic edema, erythema exudative multiforme, acute generalized pustular exanthema, Stevens-Johnson syndrome, toxic epidermal necrolysis, bladder and exfoliative dermatitis, acute interstitial nephritis, crystalluria, drug-induced fever. Very rare: black tongue, pseudomembranous colitis. In isolated cases: leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, bone marrow suppression, agranulocytosis, prolonged bleeding time, prolonged prothrombin time.
Dosage:
Orally. Adults and children> 12 years or about > 40 kg: 250-500 mg 3 times a day (every 8 hours); children (in the form of a suspension) - from 2 to 12 years: 125-250 mg 3 times a day (every 8 h), up to 2 years: 20-40 mg / kg / day in 3 equal divided doses (every 8 h ). It is recommended to continue treatment for 2-3 days after the symptoms of infection disappear. In infections caused by β-haemolytic streptococci, at least 10 days should be used.Special groups of patients. No dose adjustment is required in patients with hepatic impairment or in the elderly. In patients with renal insufficiency, the dose should be adjusted for creatinine clearance (CCr).Adults patients with renal failure - CCr> 30 ml / min: no dose adjustment is necessary; CCr 10-30: 500 mg every 12 hours; CCr <10 ml / min: 500 mg every 24 hours.Children with kidney failure - CCr> 30 ml / min: no dose adjustment is necessary; CCr 10-30: 15 mg / kg every 12 hours; CCr <10 ml / min: 15 mg / kg every 24 hours.Way of giving. The drug can be taken regardless of the meal. The capsule should be swallowed with plenty of liquid. The suspension should be given to children without dilution, and after taking the drug the child should be given milk or tea to drink.
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