Medicinal Products

AMOXICILLIN / AC CLAV PANPHAR E 1 g / 100 mg

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

Powder for solution for injection IV
Box of 10 flasks of powder of 1 g
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:

· Low breathing,

· ENT,

· Gynecological,

· Digestive and intra-abdominal, especially peritonitis,

· Renal and urogenital,

· Septicemic, endocardial,

· Cutaneous and soft tissues,

· Osteoarticulars,

excluding meningitis.

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

AMOXICILLIN / AC CLAV DOSAGE PANPHAR E 1 g / 100 mg Powder for solution for injection IV Box of 10 vials of 1 g powder

Dosages expressed as amoxicillin

children, infants and newborns

In subjects with normal renal function

Children and infants from 3 months :

· 100 mg / kg / day in 4 administrations daily 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 patients with renal insufficiency

Clearance of creatinine

Dosage scheme

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.

Administration mode

Strict intravenous route.

Do not administer IM.

Prepare the solution only at the time of injection.

During dissolution, a slight transient rosé coloration may be observed which turns pale yellow, or low opalescence.

Do not keep an opened vial.

The powder should 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 conditions (the deadlines indicated below are imperative):

Bottle

Administration mode

Reconstitution volume

Maximum delay

between reconstitution and end of administration

500 mg / 50 mg

Child and Infant

IV direct very slow: 3 min.

10 ml

15 min.

Infusion of 30 min.

25 ml

60 min.

1 g / 100 mg

Child

IV direct very slow: 3 min.

20 ml

15 min.

Infusion of 30 min.

50 ml

60 min.

Age

Administration mode

Number of injections

Unit dose (expressed as amoxicillin) and dose distribution

Premature and newborn less than 8 days old

Infusion of 30 min.

2

50 mg / kg every 12 hours

Newborn of more than 8 days and Infant until 3 months

Infusion of 30 min.

3

30 to 50 mg / kg every 8 h

3 months to

12 years*

IV direct very slow: 3 min. or infusion

4

25 mg / kg every 6 hours

Infusion of 30 min.

4

25 to 50 mg / kg every 6 hours

* From a weight greater than or equal to 20 kg, possibility of using the dosage 1 g / 100 mg Child.

Do not administer more than 25 mg / kg in direct IV.

Do not administer more than 50 mg / kg by infusion.

For a direct IV injection: 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 definitive 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.

In case of administration of 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 regularly check the function because at room temperature, amoxicillin, if it reaches high urinary concentrations, may precipitate in the probe.

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 Panphar 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 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 4.4 Special 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 section 4.4 Special warnings and precautions for use ).

· Possibility of phlebitis or pain at the injection site, due to the presence of potassium.

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