Medicinal Products

AMOXICILLIN / AC CLAV EG LAB In 100 mg / 12.5 mg / mL

Generic drug of Augmentin Child
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
laboratory: EG Labo

Powder for oral suspension
Box of 1 vial (+ syringe for oral administration) of 60 ml
All forms


They arise from the antibacterial activity and pharmacokinetic characteristics of this drug. They take into account both the clinical studies it has given and its place in the range of antibacterial products currently available.

They are limited to infections due to known sensitive organisms, especially in certain situations where the bacterial species responsible for the infection can be multiple and / or resistant to the currently available antibiotics.

On this basis, this drug is of particular interest in the following indications:

· Acute otitis media of young children, recurrent ear infections,

· Sinusitis,

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

· Superinfections of chronic bronchopulmonary diseases,

· Recurrent or complicated urinary tract infections excluding prostatitis,

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

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage AMOXICILLIN / AC CLAV EG LAB In 100 mg / 12.5 mg / mL Powder for oral suspension Box of 1 vial (+ syringe for oral administration) of 60 ml

Dosages expressed as amoxicillin

CHILDREN older than 30 months

In patients with normal renal function

80 mg / kg / day in three doses, without exceeding the dosage of 3 g per day.

In patients with renal insufficiency older than 30 months

Clearance of creatinine

Dosage scheme

greater than 30 ml / min.

No dose adjustment necessary.

between 10 and 30 ml / min.

15 mg / kg / intake maximum, twice daily.

less than 10 ml / min.

15 mg / kg / day maximum.

Hemodialysis: 15 mg / kg / day and 15 mg / kg added during and after dialysis.

Administration mode

This medicine is administered orally.

The administration is done with the graduated oral syringe in kg of body weight.

The dose per dose is indicated, based on the weight of the child, on the plunger of the graduated oral syringe in kg. The dose is therefore read directly on the graduations of the syringe for oral administration. Thus, the indicated weight corresponds to the dose for a catch. Three takes a day are needed.

For example, graduation number 20 corresponds to the dose to be administered per dose for a child of 20 kg, three times a day.

Take the medicine preferably at the beginning of the meal.

Against indications

This medicine MUST NEVER BE USED in case of:

· Allergy to beta-lactam antibiotics (penicillins, cephalosporins): take into account the risk of cross-allergy with cephalosporin antibiotics,

· Allergy to any component of the drug,

· History of liver injury associated with amoxicillin / clavulanic acid.

This medicine is usually not recommended for use with methotrexate (see section 4.5 ).

Adverse effects Amoxicillin / AC Clav EG Lab EN

Infections and infestations


Cutaneous and mucosal candidiasis.

Blood and lymphatic system disorders

Cases of eosinophilia have been reported.


Leukopenia (neutropenia), agranulocytosis, thrombocytopenia and reversible haemolytic anemia.

Immune system disorders

Allergic manifestations including urticaria, angioedema, respiratory discomfort, very rare anaphylaxis (including anaphylactic shock), serum sickness, hypersensitivity vascularity.

Nervous system disorders


Vertigo, headache.

Very rare:


Gastrointestinal disorders


Diarrhea, loose stools, nausea, vomiting.


Dyspepsia and abdominal pain.

Very rare:

Pseudo-membranous colitis and hemorrhagic colitis. Superficial dental stains, usually reversible after brushing, have been reported very rarely in children with oral suspension forms.

Hepatobiliary disorders


Moderate and asymptomatic increase in ASAT, ALT or alkaline phosphatase.

Very rare:

Jaundice and / or cholestatic or mixed hepatitis. These cases seem to occur more often in elderly and male patients and during prolonged treatment (more than 10 days and in particular for treatments longer than 15 days).
These effects occur during treatment, but in some cases may occur only several weeks after stopping. Histopathological examination of the liver usually reveals centrilobular cholestasis.
The evolution is generally favorable but can be prolonged by a few weeks. Very rare cases of fatal evolution have been observed.

Skin and subcutaneous tissue disorders


Rash, pruritus and urticaria.


Erythema multiforme

Very rare:

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

Urinary tract and urinary disorders

Cases of acute interstitial nephritis, crystalluria have been reported.

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