Generic drug of Augmentin Infant Child
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
Powder for solution for injection IV
Box of 10 vials of 500 mg powder
- 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. On this basis, this drug is of particular interest in the following indications:
. lower respiratory
. digestive and intra-abdominal, especially peritonitis,
. renal and urogenital
. septicemic, endocardial,
. cutaneous and soft tissues,
- Official recommendations regarding the proper use of antibacterials should be taken into account.
Dosage AMOXICILLIN / AC CLAV MYLAN NE 500 mg / 50 mg powder for solution for injection IV box of 10 vials of 500 mg powder
Dosages expressed as amoxicillin .
CHILDREN, INFANTS AND NEW-NES :
IN SUBJECTS WITH NORMAL RENAL FUNCTIONS:
- Children and infants from 3 months:
. 100 mg / kg / day, in 4 administrations per day in very slow direct IV or infusion;
. in severe infections: 200 mg / kg / day, in 4 infusions per day.
- Newborns over 8 days and infants up to 3 months:
100 mg to 150 mg / kg / day, in 3 infusions per day.
- Premature infants and newborns less than 8 days old:
100 mg / kg / day, in 2 infusions per day.
IN RENAL INSUFFICIENT SUBJECTS:
Creatinine clearance: Dosage regimen .
. greater than 30 ml / min : No dose adjustment necessary.
. between 10 and 30 ml / min : 25 mg / kg / dose, twice daily.
. less than 10 ml / min : 25 mg / kg / day.
Hemodialysis : 25 mg / kg every 24 hours with an additional dose of 12.5 mg / kg at the end of dialysis, followed by 25 mg / kg / day.
Take into account the administration procedures described below.
Mode of administration :
- Intravenous strict route.
Do not administer IM.
- Prepare the solution only at the time of injection.
- When the solution is dissolved, a slight transient rosé coloration may be observed which turns pale yellow, or a weak opalescence.
- Do not keep an opened vial.
- The powder must be redissolved in water for injections or 0.9% sodium chloride injection.
For administration by infusion, it is also possible to use an injectable solution of Ringer or Hartmann.
- Do not use as a solvent: injectable solutions based on glucose, sodium bicarbonate or dextran. In the case of infusion of glucose solutes, block the infusion prior to injection of this drug.
- In general, it is strongly discouraged to mix this product in the same syringe or in the same vial of infusion with another product, in particular a corticosteroid or an aminoglycoside.
- Respect the following modalities (the deadlines indicated below are imperative):
Method of administration: Reconstitution volume / Maximum time between reconstitution and end of administration .
. Bottle 500 mg / 50 mg Child and Infant:
. IV direct very slow 3 min: 10 ml / 15 min.
. 30 min infusion: 25 ml / 60 min.
. Bottle 1 g / 100 mg Child:
. Direct IV very slow 3 min: 20 ml / 15 min.
. 30 min infusion: 50 ml / 60 min.
Method of administration: Number of injections / unit dose (expressed as amoxicillin) and dose distribution .
. Premature and newborn less than 8 days old:
30 min infusion: 2/50 mg / kg every 12 h.
. Newborn of more than 8 days and Infant until 3 months:
30 min infusion: 3/30 to 50 mg / kg every 8 h.
. 3 months to 12 years (From a weight greater than or equal to 20 kg, possibility of using the dosage 1 g / 100 mg Child):
. Direct IV very slow 3 min or infusion: 4/25 mg / kg every 6 h.
. 30 min infusion: 4/25 to 50 mg / kg every 6 hours.
Do not administer more than 25 mg / kg in direct IV.
Do not administer more than 50 mg / kg by infusion.
For a direct injection IV: the amount of solvent to be used is 10 ml (500 mg / 50 mg) and 20 ml (1 g / 100 mg).
- In the case of administration by infusion: reconstitution in the final volume (500 mg / 50 mg in 25 ml, 1 g / 100 mg in 50 ml) must be immediately following the dissolution of the powder in the vial.
- When administering high doses of amoxicillin:
. a sufficient volume of liquid should be provided to ensure adequate diuresis,
. in patients with a urethral catheter, it is recommended to check its functioning regularly because at room temperature, amoxicillin, if it reaches high urinary concentrations, may precipitate in the probe.
- 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 associated with amoxicillin / clavulanic acid.
- Do not administer IM.
NOT RECOMMENDED :
This medicine IS GENERALLY NOT RECOMMENDED when combined with methotrexate (see section on interactions).
Adverse Reactions Amoxicillin / AC Clav Mylan NE
- Gastrointestinal manifestations: nausea, vomiting, possibility of gastrointestinal overinfections with Candida, diarrhea, loose stools, dyspepsia and abdominal pain.
Some cases of pseudomembranous colitis and haemorrhagic colitis have been reported.
- Allergic manifestations: including urticaria, eosinophilia, angioedema, respiratory discomfort, serum sickness, vasculitis, exceptionally anaphylactic shock.
- Maculopapular rashes of allergic origin or not.
Very occasionally, 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 section on warnings and precautions for use).
- Other events have been reported more rarely:
. 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.
. moderate and asymptomatic increases in ASAT, ALT or alkaline phosphatase;
. acute interstitial nephritis;
. leukopenia, neutropenia, agranulocytosis, hemolytic anemia, reversible thrombocytopenia.
- Cases of convulsions have been exceptionally reported (see section on warnings and precautions for use).
- Possibility of phlebitis or pain at the injection site, due to the presence of potassium.