Medicinal Products

AMOXICILLIN / AC CLAV ALTER N 100 mg / 12.5 mg / mL

Generic medicinal product of the Ciblor Nourrisson
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
laboratory: Alter

Powder for oral suspension
Box of 1 vial (+ syringe for oral administration) of 30 ml
All forms

Indication

- They proceed 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 sensitive organisms, especially in certain situations where the bacterial species responsible for the infection can be multiple and / or resistant to the antibiotics currently available.
- This dosage is indicated for infants under 30 months old in:
. acute otitis media,
. low respiratory infections,
. urinary tract infections.
- Official recommendations regarding the proper use of antibacterials should be taken into account.

Dosage AMOXICILLIN / AC CLAV ALTER N 100 mg / 12.5 mg / mL Powder for oral suspension Box of 1 vial (+ syringe for oral administration) of 30 ml

Dosages expressed as amoxicillin :
INFANTS :
80 mg / kg / day in three doses. The three doses are recommended in order to obtain sufficient serum concentrations during the nycthemeron.
Mode of administration :
- This medicine is administered orally.
- The administration is done with the syringe for oral administration graduated in kg of body weight.
- The dose per dose is indicated, according to 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 5 is the dose to be administered per dose for a 5-kg infant, three times a day .
- Take the medicine preferably at the beginning of the meal.

Against indications

CONTRAINDICATED:
- This medicine MUST NEVER BE USED in case of:
. allergy to antibiotics of the beta-lactam family (penicillins, cephalosporins): take into account the risk of cross-allergy with antibiotics of the cephalosporin group,
. allergy to one of the constituents of the drug,
. history of liver injury related to amoxicillin / clavulanic acid,
. phenylketonuria, due to the presence of aspartame (E951). - Due to the presence of maltodextrin (glucose source), this drug is contraindicated in case of glucose and galactose malabsorption syndrome. NOT RECOMMENDED :
This medicine IS GENERALLY NOT RECOMMENDED when combined with methotrexate (see interactions).

Adverse effects Amoxicillin / AC Clav Alter N

- Infections and infestations:
Common : Cutaneous and mucous candidiasis
- Hematologic and lymphatic system disorders:
. Cases of eosinophilia have been reported.
. Rare : 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 vasculitis.
- disorders of the nervous system:
. Uncommon : Dizziness, headache.
. Very rare : Convulsions.
- Gastrointestinal disorders:
. Common : Diarrhea, loose stools, nausea, vomiting.
. Uncommon : Dyspepsia and abdominal pain.
. Very rare : Pseudomembranous colitis and hemorrhagic colitis.
Superficial dental stains, usually reversible after brushing, have been reported very rarely in children with oral suspension forms.
- Hepatobiliary disorders:
. Uncommon : 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:
. Uncommon : Rash, pruritus and urticaria.
. Rare : Erythema multiforme
. Very rare : Stevens-Johnson syndrome, Lyell's syndrome, bullous or exfoliative dermatitis, and generalized acute exanthematous pustulosis (see Warnings and Precautions / Warnings section).
- Renal and urinary disorders:
Cases of acute interstitial nephritis, crystalluria have been reported.

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