Generic drug of Adult Augmentin
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
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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 adults,
· Acute maxillary sinusitis and other forms of sinusitis,
· Superinfections of acute bronchitis of the patient at risk, especially chronic ethyl, smoking, aged over 65 years, in case of risk evolution or second-line,
· Exacerbations of chronic bronchopneumopathies,
· Acute pneumonitis of the patient at risk, particularly chronic ethyl, smoking, over 65 years of age or with swallowing disorders,
· Recurrent acute cystitis, uncomplicated cystitis in women and uncomplicated acute pyelonephritis due to susceptible organisms,
· High gynecological infections, in combination with another antibiotic active on Chlamydiae (see Warnings and Precautions for Use section ),
· Severe stomatologic infections: abscesses, phlegmons, cellulitis,
· Relay treatment of the injectable route.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage AMOXICILLIN / AC CLAV ZENT L Ad 500 mg / 62.5 mg Film-coated tablet Box of 24
Dosages expressed as amoxicillin
ADULTS (weight ≥ 40 kg)
In patients with normal renal function
· 2 g / day in 2 doses in the following indications:
o acute maxillary sinusitis,
o superinfections of acute bronchitis of the patient at risk, in particular chronic ethyl, smoking, aged over 65 years, in case of evolutionary risk or second-line,
o exacerbations of chronic bronchopneumopathies,
· 3 g / day in 3 doses in the following indications:
o other forms of sinusitis,
acute otitis media,
o recurrent acute cystitis, uncomplicated cystitis in women, and uncomplicated acute pyelonephritis due to susceptible organisms,
o high gynecological infections, in combination with another antibiotic active on Chlamydiae (see Warnings and Precautions for Use section ),
o severe stomatologic infections: abscess, phlegmons, cellulitis,
o acute pneumonitis of the patient at risk, including chronic ethyl, smoking, over 65 years of age or with swallowing disorders,
o Relay treatment of the injectable route.
In patients with renal insufficiency
Clearance of creatinine
Greater than 30 ml / min.
No dose adjustment necessary.
Between 10 and 30 ml / min.
1 g / 125 mg every 12 to 24 hours.
Less than 10 ml / min.
For patients treated or not with hemodialysis, the conditions of use have not been established.
In the elderly patient:
No dosage adjustment unless clearance of creatinine is infregal 30 ml / min. (see Dosage in patients with renal insufficiency).
At each dose, the 2 tablets contained in one cell should be taken simultaneously.
Take the medicine preferably at the beginning of the meal.
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 Zent L AD
· 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 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 ).