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

They are limited to infections caused by organisms known to be sensitive, in particular to certain situations where the bacterial species responsible for infection can be multiple and / or resistant to the antibiotics currently available.
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On this basis, this medicinal product is of particular interest in the following indications:

Acute otitis media of the young child, otitis, recurrent

· Sinusitis

· Lower respiratory infections of the child from 30 months to 5 years

· Superinfections of chronic bronchopneumonia

· Recurrent or complicated urinary tract infections, excluding prostatitis

· Severe stomatal infections: abscesses, phlegmons, cellulitis, periodontitis.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Posology expressed in amoxicillin

CHILDREN over 30 months

In the patient with normal renal function

80 mg / kg / day in three doses, not exceeding the dosage of 3 g per day.
In patients with renal insufficiency greater than 30 months

Creatinine clearance

Dosage Scheme

Greater than 30 ml / min.

No dosage adjustment required

Between 10 and 30 ml / min.

15 mg / kg / take maximum, twice a day.

Less than 10 ml / min.

15 mg / kg / day maximum.

Hemodialysis: 15 mg / kg / day and 15 mg / kg supplement during and after dialysis.
Mode of administration

This medicinal product is administered orally.
Administration is done with the syringe, for oral administration graduated in kg body weight

The dosage per dose is given, depending on the weight of the infant, on the syringe plunger for oral administration graduated in kg. The dose therefore reads directly on the graduations of the syringe for oral administration. Thus, the indicated weight corresponds to the dose for a catch. Three outlets per day are needed.

For example, Grade No. 20 corresponds to the dose to be administered per dose for a 20 kg child three times a day.
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Take the medication preferably at the beginning of the meal.
Powder for oral suspension (white, to beige, crystalline powder).

After reconstitution, suspension, homogeneous practically white to very slightly beige

Pharmacotherapeutic group: ANTIBACTERIANS FOR SYSTEMIC USE

ATC Code: J01CR02.

This drug is a combination of amoxicillin and clavulanic acid, a potent, beta-lactamase inhibitor. Clavulanic acid rapidly and irreversibly inhibits most beta-lactamases produced by Gram-positive and Gram-negative bacteria.
SPECTRUM OF ACTIVITY, ANTIBACTERIAL

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

Staphylococcus méti-S

Streptococcus

Streptococcus bovis

Streptococcus pneumoniae

15 - 35%

Gram-negative Aerobes

Actinobacillus actinomycetemcomitans

Bordetella pertussis

Branhamella catarrhalis

Burkholderia pseudo-mallei

Campylobacter

Capnocytophaga

Citrobacter koseri

Eikenella

Escherichia coli

10 - 30%

Haemophilus influenzae

Haemophilus para-influenzae

Klebsiella

0 - 20%

Neisseria gonorrhoeae

Neisseria meningitidis

Pasteurella multocida

Proteus, mirabilis

10 - 20%

Proteus, vulgaris

Salmonella

0 - 40%

Shigella

0 - 30%

Vibrio cholerae

Categories

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

Anaerobes

Actinomyces

Bacteroides

Clostridium

Eubacterium

Fusobacterium

Peptostreptococcus

Porphyromonas

Prevotella

Propionibacterium acnes

Veillonella

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, meti-R *

Gram-negative aerobic

Acinetobacter

Citrobacter; freundii

Enterobacter

Legionella

Morganella, morganii

Proteus rettgeri

Providencia

Pseudomonas

Serratia

Yersinia; enterocolitica

Categories

Other

Chlamydia

Coxiella

Mycobacterium

Mycoplasma

Rickettsia

* The frequency of resistance to methicillin is approximately 30 to 50% of all staphylococci and is found mainly in hospital.
Not applicable.

This medicinal product should NEVER be used in cases of

· Allergy to antibiotics of the beta-lactam family (penicillins, cephalosporins): take into account the risk of cross-allergicity with the antibiotics in the group, cephalosporins

· Allergy to any component of the drug

· A history of hepatic involvement related to the association of amoxicillin / clavulanic acid

This medication is GENERALLY NOT RECOMMENDED for use in combination with methotrexate (see section Interactions with other medicinal products and other forms of interaction). Code>
Special warnings

The occurrence of any manifestation, allergic necessitates the cessation of treatment and the setting up of a suitable treatment.

Immuno-allergic reactions, of which severe and sometimes fatal hypersensitivity reactions (anaphylaxis) have been observed exceptionally in patients treated with beta-lactam antibiotics. Code>
Their administration therefore requires an examination for discovery.

In the face of a history of a typical allergy to 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-lactams, regularly check the blood formula when administering 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, treatment or meningeal involvement may exceptionally lead to convulsions

In renal insufficiency, for creatinine clearances less than or equal to 30 ml / min., Adjust the dosage.
The existence of a low urinary flow is a risk factor for the occurrence of crystalluria.

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

The risk of occurrence of a hepatic adverse effect (cholestasis) is increased, with treatment greater than 10 days and all, especially after 15 days.
In case of prolonged treatment, it is recommended to monitor the liver and kidney functions.

The combination of amoxicillin / clavulanic acid should be used with caution, in case of hepatic impairment

Paraclinical examinations

Effects on biological parameters

A positivity of the direct Coombs test was obtained during treatment with beta-lactams. This may also occur in subjects treated with amoxicillin / clavulanic acid. False positivations of this test linked to the presence of clavulanic acid have also been observed.

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 (and extrapolation, other inhibitors of uricosynthesis)

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 section 4.4), and / or gastrointestinal symptoms. >
The treatment is symptomatic in monitoring the balance, hydroelectrolyte. Amoxicillin and clavulanic acid can be eliminated by hemodialysis

Not applicable.

Infections and infestations

Common

Candidiasis cutaneo-mucosa.

Blood and lymphatic system disorders

Cases of eosinophilia have been reported

Rare

Leucopenia (neutropenia), agranulocytosis, thrombocytopenia and hemolytic anemia, reversible

Immune system disorders

(Including anaphylactic shock), serum sickness, hypersensitivity vasculitis.



Little, frequent

Dizziness, Headache.

Very rare

Convulsions.

Gastrointestinal disorders

Common

Diarrhea, loose stools, nausea, vomiting.

Little, frequent

Dyspepsia and abdominal pain

Very rare

Pseudomembranous colitis and haemorrhagic colitis. Superficial dental colorations, generally reversible after brushing, have been reported very rarely in children with forms for oral suspension.


Uncommon

Moderate and asymptomatic increase in ASAT, ALAT or alkaline phosphatase

Very rare

Jaundice and / or cholestatic or mixed hepatitis. These cases appear to occur more readily in elderly and male patients and in prolonged treatment (more than 10 days and especially for treatments longer than 15 days). Treatment, but in some cases may appear only several weeks after the cessation of treatment. The histopathological examination of the liver usually shows a cholestasis, which is generally favorable, but can be prolonged for a few weeks. Very rare cases of fatal outcome have been observed.

Skin and tissue disorders, subcutaneous

Little, frequent

Eruption, skin, pruritus and urticaria.
Rare

Erythema multiforme.

Very rare

Stevens-Johnson Syndrome, Lyell's syndrome, bullous dermatitis, or exfoliative and acute exanthematous pustulosis, generalized (see Warnings and Precautions / Warnings). These cutaneous manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or lymphoid leukemia in evolution.


They are based on the antibacterial activity and pharmacokinetic characteristics of this drug. They take into account both the clinical studies to which it gave rise and its place in the range of antibacterial products currently available, and are limited to infections caused by organisms recognized as sensitive, The bacterial species responsible for the infection may be multiple and / or resistant to the antibiotics currently available, and on this basis it is of particular interest in the following indications: otitis medicaments of the young child, Recurrent infections · sinusitis · low respiratory infections of the child from 30 months to 5 years · superinfections of chronic bronchopneumopathies · recurrent or complicated urinary infections, excluding prostatitis · infections

The official recommendations on the appropriate use of antibacterials should be taken into account.
Cases of acute interstitial nephritis, crystalluria have been reported.