No. 20 capsule 0,5g amoxicillin
Producer: CJSC Lekhim-Kharkiv Ukraine
Code of automatic telephone exchange: J01C A04
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: amoxicillin; (2S,5R,6R)-6-[[(2R) - 2-amino-2-(4 hydroxyphenyl) acetyl] amine] - 3,3-dimethyl-7-oxo-4-thia-1-azabitsiklo [3.2.0] of heptane-2-carboxylic acid; 1 capsule contains trihydrate amoxicillin – 500 mg.osnovny physical and chemical svoystva:tverdy capsules with a lid of red color and the case of white color. Capsule contents – powder of white or almost white color.
Pharmacological properties:
Pharmacodynamics. Amoxicillin – an antibiotic of a broad spectrum of activity from group of semi-synthetic penicillin. Active rather gram-positive and gram-negative microorganisms. To the gram-negative microorganisms sensitive to Amoksitsillin, Haemophilus influenzae, Bordetella pertussis, Proteus mirabilis, strains of Brucella, Neisseria gonorrhoeae and N. meningitidis belong, it is a lot of Salmonella spp strains., Shigella spp., Esherichia coli, Borrelia burgdorfery, Helicobacter pylori. To the gram-positive microorganisms sensitive to Amoksitsillin, hemolitic and not hemolitic streptococci, staphylococcus which do not develop a penicillinase belong; strains of clostridiums, Streptococcus pneumoniae, Bacillus anthracis, Corynebacterium diphteriae and majority of strains of enterococci. Only those strains of bacteria, sensitive to Amoksitsillin, which do not develop some b-lactamazu.
Pharmacokinetics. Amoxicillin remains stable in acid medium of a gastric juice, that is the small intestine is reached by all dose. About 90% of the accepted dose are soaked up in a small intestine.
The highest level of concentration in plasma is reached in 1–2 hours after internal reception. If to increase a dose, concentration level in plasma will increase.
The elimination half-life makes 60–90 min. At patients with an acute disorder of renal function the elimination half-life proceeds to the 7th hour.
The minimum concentration of Amoxicillin in plasma after reception of a single dose define in the 8th hour after reception.
Amoxicillin does not accumulate in an organism.
15–20% of Amoxicillin contact proteins of plasma.
Amoxicillin well gets into fabrics and liquids of an organism. The highest concentration in liquids of an organism are reached in 1 hour after achievement of the highest concentration in plasma. Therapeutic concentration are defined in lungs, a liver, lymphatic glands, a uterus, ovaries, mucous membranes of nasal bosoms. Gets into exudate of a middle ear. Concentration of Amoxicillin in purulent exudate is higher, than in a mucous secret of respiratory tracts.
In bile concentration of Amoxicillin is 10 times higher, than in plasma.
Amoxicillin poorly gets into a brain and liquor. Does not get into a prostate.
Amoxicillin is removed generally by kidneys, 50–70% of the accepted dose (250 mg) are removed in not changed state with urine. 10–20% of Amoxicillin are metabolized. b-laktamnoye a ring is metabolized to penicillic acid which is emitted with urine.
The minimum quantity is removed with bile.
The Amoxicillin pharmacokinetics at children is more senior than 2 years practically same, as well as at adults. Children at the age of 1–2 years have an Amoxicillin absorption slightly quicker.
At newborns Amoxicillin is removed more slowly, than at adults. The elimination half-life at them makes 3,7–4 hour.
Indications to use:
The infections caused by the microorganisms sensitive to Amoksitsillin:
- infections of ENT organs (average otitis, sinusitis, pharyngitis, tonsillitis);
- respiratory infections (acute bacterial bronchitis, bacterial exacerbation of chronic bronchitis, pneumonia);
- digestive tract infections (a salmonellosis, in case of sensitivity to Amoxicillin);
- destruction of Helicobacter pylori at stomach ulcer and a duodenum (in a combination with other drugs);
- infections of bodies of urinogenital system;
- gonorrhea;
- infections of skin and hypodermic fabric;
- borreliosis (Lyme's disease);
- some other infections (brucellosis and leptospirosis);
- prevention of a bacterial endocarditis at surgical interventions in an oral cavity and upper respiratory tracts.
Route of administration and doses:
The dose, frequency of reception and duration of a disease are defined by the doctor depending on a disease.
Adults and children are more senior than 10 years with body weight over 40 kg accept from 500 mg to 1000 mg of Amoxicillin twice a day. At sinusitis, pneumonia and other heavy infections accept from 500 mg to 1000 mg three times a day. A daily daily dose it is possible to increase a maximum to 6 g.
Children with body weight accept less than 40 kg from 20 mg to 40 mg on body weight kg daily in three steps or from 25 mg to 45 mg/kg/days in two steps. To children with a high probability of the infection caused by resistant Streptococcus pneumonias, medicine is recommended to appoint in high doses, that is on 80 mg/kg of body weight of the child daily in three steps or on 90 mg/kg of body weight of the child daily in two steps. The maximum daily dose for children makes 100 mg/kg of body weight.
Borreliosis (Lyme's disease): adults and children with body weight accept over 40 kg from 500 mg to 1000 mg three times a day, and the dose for children with body weight less than 40 kg makes 50 mg/kg of body weight in three steps.
Amoxicillin is recommended to be applied to Helicobacter pylorі destruction in combination with other drugs. Adults accept 1000 mg of Amoxicillin twice a day, and children – 50 mg/kg of body weight daily in two steps.
For prevention of an endocarditis appoint adult 3 g of Amoxicillin in 1 hour prior to surgical intervention and 1,5 in about 6 g hour after such intervention. To children appoint 50 mg/kg of body weight prior to a procedure and 25 mg/kg of body weight after it.
Patients can apply amoxicillin with a renal failure. At a renal failure of heavy degree (the clearance of creatinine <10 ml/min. and/or 0,16 ml / c) is recommended to increase an interval between administration of drug till 12-24 o'clock.
Features of use:
There is a probability of development of cross hypersensitivity to penicillin, other b-laktamnym to antibiotics and cephalosporins though similar cases were observed very seldom. During treatment changes in an indestinal flora can happen Amoxicillin. It can lead to increase in quantity of Cl. difficile and pseudomembranous colitis. In that case use of Amoxicillin needs to be stopped and carried out the corresponding treatment. The quantity of mushrooms, especially in a vagina can also increase. Patients with an infectious mononucleosis, a lymphoid leukosis often have enanthesis which is not caused by hypersensitivity to penicillin. Existence of such rashes in the anamnesis is not a contraindication to purpose of penicillin. Patients with a strong renal failure are recommended to increase an interval between administration of drug.
Ability to influence speed of response at control of motor transport or works with other mechanisms. Amoxicillin does not influence ability of the patient to drive the car and other mechanical means.
Use during pregnancy or feeding by a breast. In the conducted researches it is established that Amoxicillin has no harmful effect on a fruit. Pregnant women can use this drug, but at the same time it is necessary to weigh expediency of such treatment carefully. A small amount of drug gets to breast milk, but despite it, Amoxicillin can be applied during feeding by a breast.
Children. To children Amoxicillin is appointed in other dosage form (in the form of syrup).
Side effects:
At use of Amoxicillin such side effects as nausea, vomiting, disturbance of flavoring feelings, abdominal distention, diarrhea, erythematic and makulopapulezny rashes, urticaria, an itch, a Quincke's disease, bronkho-can be observed
spasm, anaphylactic reaction. In case of allergic reaction it is necessary to stop treatment immediately. At a small tortoiseshell it is enough to appoint antihistaminic drugs. At anaphylactic reaction it is necessary to appoint immediately adrenaline, if necessary – oxygen and corticosteroids (intravenously). It is necessary to provide free access of air in respiratory tracts.
Pseudomembranous colitis arises very seldom.
During treatment stomatitis, an esophagitis, intersticial nephrite, anemia, thrombocytopenia, an eosinophilia and a leukopenia, an agranulocytosis in some cases can be observed.
Very seldom at use of high doses of drug can arise sputyvany consciousnesses, hallucinations and spasms, dizziness, a hyperkinesia, tranzitorny increase in hepatic transaminases.
Interaction with other medicines:
Amoxicillin can weaken action of some oral contraceptives.
Simultaneous use of antacids reduces Amoxicillin absorption.
Simultaneous use with Allopyrinolum can cause skin rashes.
Simultaneous use with clavulanic acid strengthens effect of Amoxicillin.
Antibiotics with bacteriostatic action reduce efficiency of Amoxicillin.
At simultaneous use toxicity of a methotrexate increases.
Effect of anticoagulants at their use together with Amokistsillin amplifies that can cause bleeding.
Simultaneous use with aminoglycosides, digoxin results in synergy effect.
During treatment by Amoxicillin it is possible to receive false positive results of reaction of Koombs and false positive results when determining concentration of glucose in urine.
Simultaneous use with probenetsidy, phenylbutazone, oxyphenylbutazone, acetylsalicylic acid, indometacin, Sulfinpyrazonum can lead to increase in concentration of Amoxicillin in plasma.
Contraindications:
Hypersensitivity to Amoxicillin, other antibiotics of group of penicillin or to other ingredients of drug; infectious mononucleosis and malignant diseases of lymphatic glands; diathesis, etc. Cross sensitivity to β-laktamny antibiotics. Children up to 10 years (for this dosage form).
Overdose:
Overdoses of drug can make sick, vomiting, diarrhea, a crystalluria, excitement of the central nervous system, the confused consciousness and spasms. Treatment is symptomatic.
At reception of high doses concentration of Amoxicillin in urine considerably increases. Usually patients with normal renal function have no complications if they accept enough liquid, however the crystalluria can develop. At patients with a renal failure Amoxicillin is removed from an organism by means of a hemodialysis.
Storage conditions:
To store in the unavailable to children, protected from light place at a temperature from +15 °C to +30 °C.
Period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
On 10 capsules in the blister; on 1 or 2 blisters in a pack cardboard.
