Medicinal Products

AMOXICILLIN / AC CLAV ZTV LAB E 100 mg / 12.5 mg / mL

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

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

Indication

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 ZTV LAB E 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,

· Phenylketonuria, due to the presence of aspartame (E951).

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

Adverse effects Amoxicillin / AC Clav Ztv Lab E

· Digestive manifestations: nausea, vomiting, possibility of gastrointestinal overinfections with Candida, diarrhea, loose stools, dyspepsia and abdominal pain.
Some cases of pseudo-membranous colitis and haemorrhagic colitis have been reported.

· Allergic manifestations: including urticaria, eosinophilia, angioedema, respiratory discomfort, serum sickness, vasculitis, exceptionally anaphylactic shock.

· Maculopapular rash of allergic origin or not.
Very rarely, some cases of Lyell's syndrome and Stevens-Johnson, erythema multiforme, and exfoliative dermatitis have been reported.
These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia.
Very rare cases of acute generalized exanthematous pustulosis (see Warnings and precautions for use ).

· Other events have been reported more rarely:

o Cases of hepatitis, usually cholestatic or mixed, have occasionally been reported. These cases seem to be more likely to occur in elderly and male patients, and for more than 10 days of treatment and especially for treatments longer than 15 days. Symptoms, including jaundice that appears consistent, occur during or at the end of treatment, but may occur a few 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.
Some extremely rare cases of fatal evolution have been observed.

o moderate and asymptomatic increases in ASAT, ALT or alkaline phosphatase;

o acute interstitial nephritis;

o leukopenia, neutropenia, agranulocytosis, hemolytic anemia, reversible thrombocytopenia.

· Cases of seizures have been reported exceptionally (see Warnings and Precautions section ).

· Very rare cases of superficial dental stains, usually reversible after brushing, have been reported with forms for oral suspension.

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