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.
This form 1 g is reserved for dosages greater than or equal to 2 g per day.
There are other presentations of amoxicillin suitable for lower dosages, 2 g per day for adults, and other presentations more suited to the child

Dosage

In the subject with normal renal function

ADULT

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

Angina: 2 g / day in 2 daily intakes The duration of treatment of angina is 6 days

· Acute pneumonitis: 3 g / day, ie 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 per day for 3 additional weeks in case of duodenal ulcer Or 3 to 5 weeks in the event of 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 effectiveness of the treatment depends on the respect of the dosage regimen, in particular of the taking of the triple therapy during the first 7 days

CHILD

· 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 dosage is 80 mg / kg / day 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 Streptococcus pneumoniae of reduced sensitivity to penicillin G, the recommended dosage is 150 mg / kg / day in 3; 10 days. Updated clinical data showed bacterial eradication for strains of S. pneumoniae with amoxicillin MIC ≤ 2 mg / l at this dosage. >
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 inadequate subject, renal

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

Scheme
Greater than 30 ml / min.

Adjustment: Continue treatment with the usual dose, and the recommended frequency

Of 10 to 30 ml / min.

Do / 2, every 12 hours

Less than 10 ml / min.

Do / 2, every 24 hours

Hemodialysis: Do and Do / 2 per day Dialysis days, administer Do / 2 after the dialysis session

Mode of administration

ORAL WAY.

This medication can be taken during or between meals

The tablets may be swallowed directly with a glass of water or dispersed in half a glass of water before ingestion.
Pharmacotherapeutic group: BROAD SPECTRUM PENICILLINES, ATC code: J01CA04.

Amoxicillin is an antibiotic of the beta-lactam family of the group of aminopenicillins.


Critical concentrations separate sensitive strains from strains of intermediate sensitivity and the latter from resistant strains

S $ 4; mg / l; and R> 16; mg / l
MIC, 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 resistance prevalence 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)

SENSITIVE SPECIES

Gram-positive aerobes

Corynebacterium diphtheriae

Enterococcus faecalis

Erysipelothrix rhusiopathiae

Listeria monocytogenes

Nocardia asteroids

50 - 80%

Streptococcus

Streptococcus bovis

Streptococcus pneumoniae

15 - 35%

Gram-negative Aerobes

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 sensitivity, intermediate)

Gram-positive aerobic

Enterococcus, faecium

40 - 80%

SPECIES, RESISTANTS

Gram-positive aerobic

Staphylococcus

Gram-negative aerobic

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

· In the case of an allergy to antibiotics of the family of beta-lactams (penicillins and cephalosporins) or to one of the other constituents

This medication MUST NOT BE GENERALLY NOT USED in combination with methotrexate (see section Interaction with other medicinal products and other forms of interaction). Code>
Special warnings

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


· 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 suspected acute exanthematous pustulosis (see section 4.4), discontinuation of treatment and Contraindicates any new, administration of amoxicillin alone or in combination.

Due to the presence of lactose, this drug is contraindicated in cases of galactosemia, congenital, glucose and galactose malabsorption syndrome or lactase deficiency. Br>

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 Dosage and Mode 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

· The use of a dispersible tablet without dispersing it in water is contraindicated in children under 6 years of age because it may lead to a false road. >

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

· This medicinal product contains 14.35 mg sodium per tablet: take this into account in people under strict diet.

Paraclinical examinations

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

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.

Not applicable.

The manifestations of overdose may be neuropsychic, renal (crystalluria - see Warnings and precautions for use) and gastrointestinal symptoms.
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 combination with another antibiotic (clarithromycin or imidazole) and an antisecretory, the eradication of Helicobacter pylori in the case of a disease, the gastroduodenal ulcer of the adult. Account of the official recommendations concerning the appropriate use of antibacterials.

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 the undesirable effects used is as follows:

· Very common: ≥1 / 10

· Frequent: ≥1 / 100,