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, angina, documented with streptococcus A, beta-hemolytic) and stomatological
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 pathway, injectable endocarditis, septicemia

· For prophylactic treatment of bacterial endocarditis

In adults only

· In association with another antibiotic (clarithromycin or imidazole) and antisecretory, eradication of Helicobacter, pylori in case of ulcer disease, gastroduodenal in adults. >

Official recommendations concerning the appropriate use of antibacterials should be taken into account.
A measuring spoon (5 ml) contains 125 mg of amoxicillin.

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

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 doses daily The duration of treatment of tonsillitis is 6 days

Acute Pneumonia: 3 g / day, 1 g every 8 hours
· Lyme disease

O chronic migrating erythema, strictly isolated: 4 g / day.

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

Endocarditis and septicemia (relay of the injectable route): dosage may be increased up to 6 g per 24 hours in at least three catches.
· Prophylaxis of endocarditis, bacterial

O oral protocol: 3 g single-dose administered in the hour prior to the gesture

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

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

O amoxicillin 1 g morning and evening with clarithromycin 500 mg morning and evening and omeprazole 20 mg morning and evening for 7 days followed by 20 mg omeprazole per day for an additional 3 weeks in case of duodenal ulcer Or 3 to 5 weeks in the event of gastric ulcer, or

Amoxicillin 1 g morning and evening together with clarithromycin 500 mg morning and evening and lansoprazole 30 mg morning and evening for 7 days then 30 mg lansoprazole daily for an additional 3 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, 100 mg / kg / day in 3 doses at 8-hour intervals Code>
O for children over 30 months: 25 mg / kg / day, 50 mg / kg / day in 2 or better 3 doses without exceeding the dose of 3 g / day
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· In other infections, the recommended dosage is 80 to 100 mg / kg / day in 3 taken.

O Acute otitis media, in the event of a 72-hour probabilistic treatment failure and bacteriological documentation of a Streptococcus pneumoniae with reduced sensitivity to penicillin G the recommended dosage is 150 mg / kg / Day in 3 doses for 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 Dosage of 6 g / day.
Special cases

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

· Lyme disease

O: chronic migrating erythema, strictly isolated: 50 mg / kg / day

In cases of systemic manifestations suggestive of hematogenous dissemination of Borrelia burgdorferi the 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 endocarditis, bacterial

O oral protocol: 75 mg / kg once-a-day administered within the hour prior to the procedure,
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

Use the supplied measuring spoon with the bottle.

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: £ 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

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

This medication MUST NOT BE GENERALLY NOT USED in combination with methotrexate (see section 4.4 Interactions with other medicinal products and other forms of interaction). Code>
Because of the presence of aspartame (8.5 mg per measuring spoon), this drug is contraindicated in cases of phenylketonuria.
Warnings

· The occurrence of any allergic manifestation requires cessation of treatment and the establishment of a suitable treatment.

· Immunoallergic reactions, including severe and sometimes fatal hypersensitivity reactions (anaphylaxis), have been observed exceptionally in patients treated with beta-lactam antibiotics. Br>
Their administration therefore requires a prior interrogation.

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

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


Precautions for use

· As with all beta-lactam antibiotics, regularly check the blood supply in case of administration of high doses of amoxicillin

· The administration of high doses of beta-lactams in renal insufficiency or in patients with predisposing factors such as a history of seizures, epilepsy, treatment or meningeal involvement may exceptionally result in convulsions. Code>
In patients with renal insufficiency, adjust dosage according to creatinine clearance or serum creatinine (see Dosage and Mode of Administration).
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· The existence of a low urine output is a risk factor for the occurrence of crystalluria

In case of administration of high doses of amoxicillin, adequate water intake must be ensured to reduce the risk of crystalluria.


· This medication contains 6.26 mg sodium per-spoon-measure. To be taken into account in patients under a strict low-sodium diet.

Paraclinical examinations

Effects on biological parameters

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

A of very high concentrations, amoxicillin, tends to

· Decrease the results of blood glucose measurements

Interfering in the determinations of the total protein level of the serum by color reaction

· Give a colored reaction, false positive in the assays of glycosuria by the semi-quantitative colorimetric 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, angina, documented with streptococcus A, beta-haemolytic) And stomatological disorders o urinary infections o male genital infections o gynecological infections o digestive and biliary infections o Lyme disease: treatment of the primary phase (chronic erythema migrans) and phase, primary and secondary (Chronic erythema migrate, associated with general signs, asthenia, headache, fever, arthralgia ...), in treatment of relay of the way, injectable endocarditis, septicemia, in prophylactic treatment of bacterial endocarditis , In combination with another antibiotic (clarithromycin or imidazole) and antisecretory, eradication of Helicobacter, pylori in the case of ulcer disease, gastroduodenal in adults. To take into account 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,