Medicinal Products

AMOXICILLIN / AC CLAV ZYDUS Ad 1 g / 125 mg

Generic drug of Adult Augmentin
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
laboratory: Zydus France

Powder for oral suspension
Box of 12 sachets-dose
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:

· 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 Precautions for use),

· Periodontitis,

· 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 ZYDUS Ad 1g / 125mg Powder for oral suspension Box of 12 Sachets-dose

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,

o periodontitis.

· 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 Precautions for use),

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

Dosage scheme

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 creatinine clearance is ≤ 30 ml / min. (see "Dosage in patients with renal impairment").

Administration mode

Oral way.

The contents of the sachet-dose is to be dispersed in half a glass of water before ingestion.

Take the medicine preferably at the beginning of the meal.

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,

· Due to the presence of aspartame (E951), this medicine is contraindicated in cases of phenylketonuria.

This medicine is usually not recommended for use with methotrexate (see section 4.5 ).

Adverse effects Amoxicillin / AC Clav Zydus AD

Infections and infestations

Frequent

Cutaneous and mucosal candidiasis.

Blood 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.

Nervous system disorders

Rare :

Vertigo, headache.

Very rare :

Convulsions.

Gastrointestinal disorders

Very common :

Diarrhea, loose stools.

Frequent

Nausea, vomiting.

Rare :

Dyspepsia and abdominal pain.

Very rare :

Pseudo-membranous colitis and hemorrhagic colitis.

Hepatobiliary disorders

Rare :

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

Rare :

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 section Warnings ). These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia.

Renal and urinary disorders

Cases of acute interstitial nephritis, crystalluria have been reported.

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