Generic drug of Adult Augmentin
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
Powder for solution for injection
Box of 10 flasks of powder of 1 g
- 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,
- This drug is indicated in adults for prophylaxis of postoperative infections:
. percutaneous endoscopic gastrostomies,
. in submesicic digestive surgery,
. in ENT oncological surgery with opening of the oropharyngeal tract.
- Official recommendations regarding the proper use of antibacterials should be taken into account.
Dosage AMOXICILLIN / AC CLAV SANDOZ Ad 1 g / 200 mg powder for solution for injection Box of 10 vials of powder of 1 g
Dosages expressed as amoxicillin .
IN SUBJECTS WITH NORMAL RENAL FUNCTIONS:
- Usual dosage: 1 g, 2 to 4 times daily in IV very slow or fast infusion.
- In septicemia and severe infections, the dosage can be increased to 6 g / day and even up to 12 g / day, without ever exceeding ADULT: 200 mg of clavulanic acid per injection and 1200 mg of clavulanic acid daily:
. up to 6 g / day, use the 1 g / 200 mg dosage.
. from 6 g to 12 g / day, use the 2 g / 200 mg dosage.
- Prophylaxis of postoperative infections in surgery:
. a single dose of 2 g / 200 mg (or 1 g / 200 mg + 1 g amoxicillin) at anesthetic induction,
. followed by a reinjection of a dose of 1 g / 200 mg if the intervention lasts more than 4 hours.
For digestive surgery, the duration of antibiotic prophylaxis should not exceed that of the intervention. In the case of percutaneous endoscopic gastrostomies, the duration of the intervention not exceeding 2 hours, no reinjection is necessary.
On the other hand, for ENT oncology, antibiotic prophylaxis can last 24 hours sometimes, but never more than 48 hours, depending on an administration of 1 gram 2 to 4 times a day.
IN RENAL INSUFFICIENT SUBJECTS:
Creatinine clearance: Dosage regimen .
- greater than 30 ml / min : No dose adjustment necessary.
- between 10 and 30 ml / min : Initial dose 1 g, then 500 mg every 12 hours, ie 1/2 vial of 1 g / 200 mg.
- less than 10 ml / min : Initial dose 1 g, then 500 mg / day.
Hemodialysis : initial dose 1 g, then 500 mg / day with an additional dose of 500 mg after dialysis.
Take into account the administration procedures described below.
Administration mode :
- Intravenous strict 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 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 .
. Direct IV very slow 3 min: 20 ml / 15 min.
. 30 min infusion: 50 ml / 60 min.
- Do not administer more than 1 g / 200 mg in direct IV.
To administer 2 g / 200 mg by infusion, use the 2 g / 200 mg dosage.
- For a direct injection IV: dissolve the powder of the vial with 20 ml of water for injections, this volume of solvent corresponds exclusively to a direct injection IV.
- In the case of administration by infusion: the reconstitution in the final volume (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 interactions).
Adverse effects Amoxicillin / AC Clav Sandoz AD
- 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 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 warnings and precautions for use).
- Possibility of phlebitis or pain at the injection site, due to the presence of potassium.