Structure and form of release

Structure

Active ingredient: amoxicillin;

1 tablet contains

trihydrate amoxicillin, in terms of amoxicillin – 250 mg;

Excipients: sodium krokhmalglikolit (type A), povidone, calcium stearate.

release Form

Tablet.

Pharmacological properties

Pharmacodynamics. amoxicillin — a semi-synthetic aminopenitsillinovy antibiotic of a broad spectrum of activity for oral administration. suppresses synthesis of a cell wall of bacteria. possesses a wide range of antimicrobic action.

such species of microorganisms are sensitive

To drug:

• gram-positive aerobes: Corinebacterium diphteriae, Enterococcus faecalis, Listeria monocytogenes, Streptococcus agalactiae, Streptococcus bovis, Streptococcus pyogenes;
• gram-negative aerobes: Helicobacter pylori;
• anaerobe bacterias: Peptostreptococci;
• others: Borrelia.

Non-constantly sensitive (the acquired resistance can complicate treatment): Corinebacterium spp., Enterococcus faecium, Streptococcus pneumoniae, Streptococcus viridans, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Proteus mirabilis, Prevotella, Fusobacterium spp.

Steady types: Staphylococcus aureus, Acinetobacter, Citrobacter, Enterobacter, Klebsiella, Legionella, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas, Serratia, Bacteroides fragilis, Chlamidia, Mycoplasma, Rickettsia.

Pharmacokinetics

Absorption. After reception, amoxicillin is soaked up in a small intestine quickly and almost completely (85–90%). Meal practically does not influence medicine absorption. After reception of a single dose of 500 mg the concentration of amoxicillin in blood plasma made 6–11 mg/l. The C _max in blood plasma is reached in 1–2 h

Distribution. About 20% of amoxicillin contact proteins of blood plasma. Amoxicillin gets into mucous membranes, a bone tissue and intraocular liquid, a phlegm in therapeutic effective concentration. Concentration of medicine in bile exceeds its concentration in blood by 2–4 times. Amoxicillin badly diffuses in SMZh; however at inflammation of a meninx (for example at meningitis) concentration in SMZh makes about 20% of concentration in blood plasma.

Metabolism. Amoxicillin is partially metabolized, the majority of its metabolites are inactive.

Removal. Amoxicillin is emitted mainly with kidneys. About 60-80% of the accepted dose eliminirut in 6 h in not changed look. The t _½ medicine makes 1-1.5 h. In a renal failure of T _½ medicine increases and reaches 8.5 h at an anury.

T _½ medicine does not change at an abnormal liver function.

Indication

Infection of respiratory organs, an urinogenital system, a digestive tract (including in a combination with metronidazole or klaritromitsiny apply to treatment of the diseases associated with helicobacter pylori), skin and soft tissues, caused by microorganisms, sensitive to drug.

Use

Range of doses at use of medicine amoksit

is very wide. the doctor establishes a dose, frequency of introduction and duration of treatment individually.

to Adults and children with body weight more than 40 kg to accept

from 250 mg to 500 mg Amoksil 3 times a day or from 500 mg to 1000 mg 2 times a day. In sinusitis, pneumonia and other heavy infections it is necessary to accept from 500 mg to 1000 mg 3 times a day. A daily dose it is possible to raise a maximum to 6 g

to Children with body weight less than 40 kg generally to accept 40–90 mg/kg/days of the medicine Amoksil daily in 3 receptions or from 25 mg to 45 mg/kg/days in 2 receptions. The maximum daily dose for children makes 100 mg/kg of body weight.

in case of an infection easy and moderate severity to take the medicament within 5–7 days. However in case of the infections caused by a streptococcus, duration of treatment has to be not less than 10 days.

have to be defined by

At treatment of chronic diseases, local infectious defeats, infections with a heavy course of a dose with a clinical picture of a disease.

Administration of medicament should be continued by

during 48 h after disappearance of symptoms of a disease.

Amoksil can be applied at patients with a renal failure. In a heavy renal failure (clearance of creatinine of 10 ml/min., that is 0.16 ml / c) intervals between receptions of a dose have to make 12–24 h, and the dose of medicine should be lowered by 15–50%. it is not required by

In an abnormal liver function of dose adjustment to p.

Amoksil can be accepted irrespective of meal. It is necessary to swallow of a tablet, washing down with liquid. During treatment by Amoksil the patient is recommended to drink more liquid, than usually.

Contraindication

Hypersensitivity to components of medicine and/or any antibacterial agents of group of penicillin. existence in the anamnesis of the heavy reactions of hypersensitivity (including an anaphylaxis) connected with application of others beta laktamnykh agents (including cephalosporins, karbapenem or monobaktam).

Infectious mononucleosis and leukemoid tests of lymphatic type.

Side effects

• Infection and invasion: candidiasis of skin and mucous membranes, development of superinfection.
• from the system of blood and lymphatic system: hemolytic anemia, thrombocytopenia, an eosinophilia, a leukopenia (including a heavy neutropenia and the Agranulocytosis) and also increase in a bleeding time and prothrombin time. These manifestations are reversible at the treatment termination.
• from the immune system: as well as for all antibiotics — heavy allergic reactions, including an anaphylaxis, a Quincke's disease, an acute anaphylaxis, a serum disease and an allergic vasculitis, enanty, hyperaemia, fever.
should begin with
• At development of anaphylactic reaction the corresponding therapy immediately.
• from nervous system: insomnia, loss of consciousness, headache, hyperkinesia, confusion of consciousness, dizziness, spasms. These effects arise at the patients applying very high doses more often.
• from a GIT: diarrhea, loss of appetite, dryness in a mouth, violation of taste, an abdominal distension, discomfort and an abdominal pain, nausea of naggers in the place of an anus; vomiting, intestines candidiasis, superficial discoloration of teeth, coloring of language in black color which disappear either during treatment, or right after completion of therapy, antibiotikassotsiirovanny colitis (including pseudomembranous and hemorrhagic colitis).
• Gepatobiliarnaya system: hepatitis, cholestatic jaundice, moderate increase in concentration of liver enzymes (AsAT, AlAT).
• from skin and hypodermic fabrics: itch, rash, including erythematic and makulopapulezny; a small tortoiseshell, a multiformny erythema, Stephens's syndrome — Johnson, a toxic epidermal necrolysis, bullous or exfoliative dermatitis and sharp generalized exanthematous pustulez.
• from kidneys and an urinary system: interstitial nephrite, crystalluria. In case of severe side effects, medicine needs to be cancelled.
• Others: general weakness.

Special instructions

amoxicillin needs to carry out by

before therapy the preliminary test for possibility of reaction of hypersensitivity for penicillin and cephalosporins. there can be a cross hypersensitivity and cross resistance (10–15%) between penicillin and cephalosporins.

to Patients with the heavy violations from a digestive tract which are followed by diarrhea and vomiting should not apply oral forms of amoxicillin that is connected with risk of reduction of absorption.

amoxicillin can change

At children color of enamel of teeth therefore strict observance by the patient of hygiene of an oral cavity is necessary.

Heavy and sometimes lethal cases of hypersensitivity (anaphylactic reaction) noted

at the patients who were on penicillinic therapy. Such reactions arise more often at patients with the known heavy allergic reactions in the anamnesis. Drug treatment needs to be stopped and replaced with other corresponding treatment. Elimination of symptoms of anaphylactic reaction, for example, immediate introduction of epinephrine, steroids (in / c) and emergency treatment of respiratory insufficiency can be required.

At patients with renal failures discharge of amoxicillin slows down and, depending on extent of violation, it is necessary to stop treatment by amoxicillin, or to lower a daily dose of medicine.

Prolonged use of medicine can lead

to the excess growth of insensitive microorganisms or yeast. Emergence of superinfection is possible that demands careful observation of such patients.

At application of high doses of medicine needs to use enough liquid for prevention of a crystalluria which can be caused by amoxicillin. Presence of high concentration of amoxicillin in urine can cause loss of a deposit of medicine in an uric catheter therefore it should be checked visually through certain intervals of time.

When developing the heavy diarrhea characteristic of pseudomembranous colitis (in most cases the caused Clostridium difficile), use of medicine is recommended to stop

and to take the appropriate measures. Use of antiperistaltic means is contraindicated.

is not recommended to apply Amoxicillin to treatment of patients with a sharp lymphoid leukosis or an infectious mononucleosis in view of the increased risk of developing of an erythematic enanthesis.

during therapy by high doses should control blood indicators regularly.

Therapy by high doses of amoxicillin of patients with a renal failure or patients with epilepsy and meningitis in the anamnesis can lead

to spasms in rare instances.

Emergence of a generalized erythema with fever and pustules in an initiation of treatment can demonstrate development of a sharp generalized eczematic pustulez that demands therapy cancellation by amoxicillin.

Use during pregnancy or feeding by a breast. The teratogenic effect of amoxicillin is not revealed. However in need of prescribing of the medicine Amoksil during pregnancy it is in advance necessary to carry out the assessment of the relation of potential risk for a fruit and the expected advantage for the woman. Amoxicillin in insignificant quantity is emitted in breast milk. Use during feeding by a breast perhaps, however for prevention of a possible sensitization of the child feeding by a breast it is recommended to stop.

Children. Amoksil — to children under 5 years appoint other dosage forms of amoxicillin.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Before clarification of individual reaction to medicine (there can be dizziness) it is recommended to be careful at control of vehicles or work with mechanisms.

Interaction

Probenetsid, phenylbutazone, oksifenbutazon, to a lesser extent acetylsalicylic acid and Sulfinpyrazonum suppress canalicular secretion of medicines of a penicillinic row that leads to increase in t½ and increase in concentration of amoxicillin in blood plasma.

Drugs having bacteriostatic action (antibiotics of a tetracycline row, macroleads, chloramphenicol) can neutralize bactericidal effect of amoxicillin. Simultaneous use of aminoglycosides is possible (synergy effect).

not recommended combinations

Allopyrinolum. Simultaneous application with amoxicillin leads to emergence of allergic reactions.

Digoksin. Digoxin absorption increases therefore dose adjustment is necessary.

Disulfiramum. Simultaneous application with amoxicillin is contraindicated.

Anticoagulants. Simultaneous use of amoxicillin and anticoagulants of a class of coumarins can extend a bleeding time. Dose adjustment of anticoagulants is necessary. The patients receiving amoxicillin had messages about increase in activity of oral anticoagulants.

Methotrexate. Use of amoxicillin with a methotrexate leads to increase in toxic action of the last. Amoxicillin reduces kidney clearance of a methotrexate therefore it is necessary to control the level of its concentration in blood plasma.

Amoxicillin should be applied with care together with oral hormonal contraceptives — the plasma level of estrogen and progesterone can temporarily decrease that can reduce efficiency of hormonal contraceptives. Therefore it is recommended to use additional non-hormonal contraceptives.

Concomitant use with antacids reduces amoxicillin absorption.

Other types of interactions. The artificial diuresis leads to decrease in concentration of medicine in blood by increase in its elimination.

Diarrhea can lead

to reduction of absorption of other medicines and it is adverse to affect their efficiency.

Influence on results of diagnostic laboratory tests: at test for availability of glucose in urine it is recommended to use an enzymatic glyukozooksidazny method. At application of chemical methods usually note false positive results.

Amoxicillin can reduce amount of estriol in urine at pregnant women.

At high concentrations amoxicillin can reduce glycemia level. Amoxicillin can influence protein definition by a colorimetric method.

Overdose

Symptoms: dysfunction of a digestive tract — nausea, vomiting, diarrhea; violation of water and electrolytic balance can be a consequence of vomiting and diarrhea.

crystalluria Possible cases sometimes leading to a renal failure.

Treatment: it is necessary to cause vomiting or to carry out gastric lavage then to accept activated carbon and osmotic depletive. It is necessary to maintain water and electrolytic balance.

Storage conditions

In original packing at a temperature not above 25 °C.