They are based on the antibacterial activity and pharmacokinetic characteristics of amoxicillin. They take account both of the clinical studies to which this drug has given rise and of its place in the range of antibacterial products currently available.

They are limited to infections due to germs defined as sensitive

In the adult and the child

· In initial processing of

O acute pneumonitis

O superinfections of acute bronchitis and exacerbations of chronic bronchitis

OT infections (otitis, sinusitis, documented angina, streptococcus A beta-hemolytic) and stomatologic
Urinary infections

O male genital infections and gynecological infections

O; digestive and biliary infections

(Chronic erythema migrant, associated with general signs, asthenia, headache, fever, arthralgia ...) Lyme disease: treatment of the primary phase (chronic erythema migrant)

· In relay treatment of the injectable route of endocarditis, septicemia

· For prophylactic treatment of endocarditis, bacterial.

In adults only

· In association with another antibiotic (clarithromycin or imidazole) and an antisecretory · eradication of Helicobacter pylori in case of disease, gastroduodenal ulcer of the adult
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Official recommendations concerning the appropriate use of antibacterials should be taken into account.


There are other presentations of amoxicillin which are more suitable for the adult and other presentations more adapted in some cases to the child (important doses, large children)

Dosage

In the subject with normal renal function

POPULATION ADULT

The usual dosage is 1-1.5 or 2 g / day in 2 to 3 doses.
Special cases

· Angina: 2 g / day in 2 daily intakes.

The duration of treatment of angina is 6 days.

· Acute pneumonitis: 3 g / day, that is 1 g every 8 hours

· Lyme disease

O strictly isolated migrating chronic erythema 4 g / day

In case of systemic manifestations suggestive of a haematogenous spread of Borrelia, burgdorferi, dosages may be increased to 6 g / day.
The processing time will be 15 to 21 days.

· Endocarditis and septicemia (injectable route), dosage can be increased up to 6 g, per 24 hours in at least three doses

· Prophylaxis of bacterial endocarditis

O oral protocol: 3 g single-dose, administered in the hour before the risk action

O relay of the parenteral protocol: 1 g per os 6 hours after parenteral administration

· Eradication of Helicobacter pylori in cases of gastroduodenal ulcer disease: the following regimens are recommended

O amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and omeprazole 20 mg morning and evening for 7 days then 20 mg omeprazole daily for 3 weeks supplementary in case of duodenal ulcer , Evolutionary or 3 to 5 more weeks in case of evolutionary gastric ulcer

Or

O amoxicillin 1 g morning and evening, combined with clarithromycin 500 mg morning and evening and lansoprazole 30 mg morning and evening for 7 days then 30 mg lansoprazole daily for 3 additional weeks in case of ulcer duodenal Evolutionary or 3 to 5 weeks, additional in case of gastric ulcer, evolutionary

The efficacy of the treatment depends on the respect of the dosage regimen, in particular the taking of the triple therapy during the first 7 days.
PEDIATRIC POPULATION

· The usual dosage is as follows

O for children under 30 months: 50 mg / kg / day to 100 mg / kg / day in 3 doses spaced 8 hours apart >
O for children over 30 months: 25 mg / kg / day to 50 mg / kg / day in 2 or better 3 dosages not exceeding 3 g / day
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· In other infections, the recommended dose is 80 to 100 mg / kg / day in 3 doses.
O Otitis Medium Acute

In the event of failure of a 72-hour probabilistic treatment and bacteriological documentation of a Streptococcus pneumoniae of decreased sensitivity to penicillin G, the recommended dosage is 150 mg / kg / day in 3 doses during 10 days. Up-to-date clinical data have shown bacterial eradication for strains of S. pneumoniae with an MIC to amoxicillin ≤ 2 mg / l.


O Pneumonia.

· For more severe infections, as well as for endocarditis and septicemia (in the injectable route): the dosage may be increased, up to 150 mg / kg / day in 3 or 4 doses, without exceeding The dosage of 6 g / day.

Special cases

· Angina: in children over 30 months: 50 mg / kg / day, in 2, daily intake. The duration of treatment of angina is 6 days.

· Lyme disease

O migrant chronic erythema strictly isolated 50 mg / kg / day

In case of systemic manifestations suggestive of hematogenous spread of Borrelia burgdorferi, dosages may be increased to 100 mg / kg / day without exceeding 6 g / day.
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The processing time will be 15 to 21 days.

· Prophylaxis of bacterial endocarditis

O oral protocol: 75 mg / kg single-dose administered in the hour prior to the risk action

O relay of the parenteral protocol: 25 mg / kg per os 6 hours after parenteral administration

In the subject, renal insufficiency

Administer a first dose of (Do) equivalent to the dose normally prescribed and then, depending on the degree of severity of the pathology

Clearance of creatinine

Dosage Scheme

Greater than 30 ml / min.

No adaptation: continue treatment with usual dose and frequency, recommended

Of 10 to 30 ml / min.

Do / 2, every 12 hours

Less than 10 ml / min.

Do / 2, every 24 hours

Hemodialysis: Do then Do / 2 per day. On dialysis days, administer Do / 2 after the dialysis session.

Mode of administration

ORAL WAY.

This medication can be taken during or between meals

Use the supplied measuring spoon with the bottle.

No information in the marketing authorization.

Class: Pharmacotherapeutic: BROAD SPECTRUM PENICILLINES, code: ATC: J01CA04.
Amoxicillin is an antibiotic of the beta-lactam family of the group of aminopenicillins.


Critical concentrations separate sensitive strains from intermediate susceptibility strains and resistant strains

S $ 4; mg / l; and R> 16; mg / l
CMI pneumococcus: S £ 0.5; mg / l; and R> 2; mg / l

The prevalence of acquired resistance may vary according to geography and time for some species. It is therefore useful to have information on the prevalence of local resistance, especially for the treatment of severe infections. These data can only provide guidance on the probabilities of the susceptibility of a bacterial strain to this antibiotic.

When the variability of the prevalence of resistance in France is known for a bacterial species, it is indicated in the table below
Categories

Frequency of resistance acquired in France (> 10%) (extreme values)

SPECIES, SENSITIVE

Gram aerobics, positive

Corynebacterium, diphtheriae

Enterococcus, faecalis

Erysipelothrix, rhusiopathiae

Listeria, monocytogenes

Nocardia, asteroids

50 - 80%

Streptococcus

Streptococcus bovis

Streptococcus pneumoniae

15 - 35%

Gram aerobics, negative

Actinobacillus, actinomycetemcomitans

Bordetella; pertussis

Capnocytophaga

Eikenella

Escherichia coli

30 - 50%

Haemophilus, influenzae

20 - 35%

Haemophilus, para-influenzae

10 - 20%

Helicobacter pylori

Neisseria, gonorrhoeae

Neisseria, meningitidis

Pasteurella; multocida

Proteus mirabilis

10 - 40%

Salmonella

0 - 40%

Shigella

0 - 30%

Streptobacillus, moniliformis

Vibrio cholerae

Anaerobes

Actinomyces

Clostridium

Eubacterium

Fusobacterium

Peptostreptococcus

Porphyromonas

Prevotella

60 - 70%

Propionibacterium, acnes

Veillonella

Categories

Frequency of resistance acquired in France (> 10%) (extreme values)

Other

Bartonella

Borrelia

Leptospira

Treponema

SPECIES, MODERATELY SENSITIVE

(In vitro of intermediate sensitivity)

Gram aerobics, positive

Enterococcus, faecium

40 - 80;%

SPECIES, RESISTANTS

Gram aerobics, positive

Staphylococcus

Gram aerobics, negative

Acinetobacter

Alcaligenes

Branhamella catarrhalis

Campylobacter

Citrobacter; freundii

Citrobacter koseri

Enterobacter

Klebsiella oxytoca

Klebsiella pneumoniae

Legionella

Morganella, morganii

Proteus rettgeri

Proteus vulgaris

Providencia

Pseudomonas

Serratia

Yersinia; enterocolitica

Anaerobes

Bacteroides, fragilis

Other

Chlamydia

Mycobacterium

Mycoplasma

Rickettsia

Not applicable.

This medicinal product MUST NEVER BE USED

· If you are allergic to antibiotics in the family of beta-lactams (penicillins and cephalosporins) or to any of the other constituents

· In case of phenylketonuria, due to the presence of aspartame

This medicinal product MUST NOT GENERALLY BE USED in combination with methotrexate (see section Interactions with other medicinal products and other forms of interaction).



Warnings, special

· The occurrence of any allergic manifestation requires cessation, treatment, and implementation of a treatment, adapted.


Their administration therefore requires an examination for discovery.

In the presence of a history of allergy typical of these products, the contraindication is formal.

· Allergy to penicillins is crossed with allergy to cephalosporins in 5 to 10% of cases This leads to the proscription of penicillins when the subject is a known allergic to cephalosporins. >

The occurrence of generalized febrile erythema at the onset of treatment with pustules should give rise to suspicion of acute exanthematous pustulitis (see section 4.4). Contraindicates any new, administration of amoxicillin alone or in combination.

Precautions for use

· As with all beta-lactams, regularly check the blood formula in case of administration of high doses of amoxicillin

The administration of high doses of beta-lactams in patients with renal insufficiency or in patients with predisposing factors such as a history of seizures, epilepsy, or treatment with meningeal disease may exceptionally lead to convulsions. Code>
· In case of renal insufficiency, adjust the dose according to creatinine clearance or serum creatinine (see section Posology and method of administration). >

· The existence of a weak urinary flow is a risk factor for the occurrence of crystalluria.

· When administering high doses of amoxicillin, adequate water intake should be provided to reduce the risk of crystalluria

· Treatment of Lyme Disease: Jarish-Herxheimer reactions may occur.

· This medicinal product contains 5 mg sodium per tsp measure: take this into account in the following people: a strict sodium diet

Examinations, paraclinics

Impact on biological parameters

A positivity of the direct Coombs test was obtained during treatment with beta-lactams. This could also occur in subjects treated with amoxicillin.

A very high concentrations, amoxicillin tends to

· Decrease the results of blood glucose measurements

· Interferes in the determinations of the total serum protein by color reaction

· Give a false positive color reaction in the glycosuria assays by the colorimetric semi-quantitative method

Associations, deprecated

+ Methotrexate

Increased hematological effects and toxicity of methotrexate by inhibition of renal tubular secretion by penicillins

Associations to be taken into account

+; Allopurinol

Increased risk of skin reactions

They are based on the antibacterial activity and pharmacokinetic characteristics of amoxicillin. They take into account both the clinical studies to which this drug has given rise and its place in the range of antibacterial products currently available and are limited to infections due to the germs defined as sensitive In adults And acute respiratory infections, acute bronchitis surgeries and chronic bronchitis exacerbations, ENT infections (otitis, sinusitis, documented angina, beta-haemolytic streptococcus), and O stomatologic o urinary infections o male genital infections and infections gynecological o digestive and biliary infections o Lyme disease: treatment of the primary phase (chronic migrant erythema) and phase, primary and secondary (Migrant chronic erythema, associated with general signs, asthenia, headache, fever, arthralgia ...), in treatment of injectable route of endocarditis, septicemia, prophylactic treatment of endocarditis, bacterial In adults only, in combination with another antibiotic (clarithromycin or imidazole) and an antisecretory, eradication of Helicobacter pylori in case of disease, gastroduodenal ulcer of the adult. Take account of official recommendations concerning the appropriate use of antibacterials.

Special Problems of the INR imbalance

Many cases of increased oral anticoagulant activity have been reported in patients receiving antibiotics. The marked infectious or inflammatory context, age and general condition of the patient appear as risk factors. In these circumstances, it is difficult to distinguish between infectious pathology and its treatment in the onset of INR imbalance, although some classes of antibiotics are more involved: these include fluoroquinolones , Macrolides, cyclins, cotrimoxazole and certain cephalosporins.

Without object.

The manifestations of overdosage may be neuropsychic, renal (crystalluria - see section 4.4), and gastrointestinal symptoms.
The treatment is symptomatic in; monitoring especially the balance, hydro-electrolyte.

Amoxicillin can be eliminated by hemodialysis.

Pregnancy

Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been found to be teratogenic in animals in well-conducted studies of two species

Clinically, analysis of a high number of exposed pregnancies apparently did not reveal any malformative or foetotoxic effects, particularly amoxicillin. However, only epidemiological studies could verify the absence of risk.

As a result, amoxicillin may be prescribed during pregnancy if necessary.
Breastfeeding

The passage of amoxicillin in maternal milk is low and the amounts ingested are much lower than the therapeutic doses. Accordingly, breast-feeding is possible if this antibiotic is taken.

However, discontinue breast-feeding (or medication) in the event of diarrhea, candidiasis or rash in the infant.
The classification of undesirable effects used is as follows

· Very common: ≥1 / 10

· Frequent: ≥1 / 100,