Medicinal Products

AMOXICIL / AC CLAV CRISTERS Ad 1 g / 125 mg

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

Powder for oral suspension
Sachets-dose Box of 12
All forms

Indication

AMOXICILLIN / CLAVULANIC ACID CRISTERS is indicated for the treatment of the following infections in adults and children (see section 4.2 Posology and method of administration, Warnings and precautions for use, and Pharmacodynamic properties ):

· Acute bacterial sinusitis (appropriately diagnosed),

· Acute otitis media,

· Exacerbation of chronic bronchitis (diagnosed appropriately),

· Acute community pneumonia,

· Cystitis,

· pyelonephritis,

· Infections of the skin and soft tissues, in particular cellulitis, animal bites, severe dental abscess with spread of cellulite,

· Infections of bones and joints, especially osteomyelitis.

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

Dosage AMOXICIL / AC CLAV CRISTERS Ad 1g / 125mg Powder for oral suspension Sachets-dose Box of 12

Doses are expressed as amoxicillin / clavulanic acid except when indicated by reference to an individual component.

The dose of AMOXICILLIN / CLAVULANIC ACID CRISTERS chosen to treat a particular infection should take into account:

· The expected pathogens and their likely susceptibility to antibacterial agents (see Warnings and Precautions for Use section ),

· Severity and focus of the infection,

· The patient's age, weight and renal function (see below).

Use of other AMOXICILLIN / CLAVULANIC ACID CRISTERS formulations (eg, providing higher doses of amoxicillin and / or different amoxicillin / clavulanic acid ratios) should be considered, if necessary (see Warnings and Precautions sections). precautions for use and pharmacodynamic properties ).

For adults and children ³ 40 kg, this formulation of AMOXICILLIN / CLAVULANIC ACID CRISTERS provides a total daily dose of 2000 mg amoxicillin / 250 mg clavulanic acid, twice daily, and 3000 mg daily. amoxicillin / 375 mg clavulanic acid, taken in three divided doses daily, when administered as recommended below. For children <40 kg, this formulation of AMOXICILLIN / CLAVULANIC ACID CRISTERS provides a maximum daily dose of 1600-3000 mg amoxicillin / 200-400 mg clavulanic acid, when administered in accordance with the recommendations below. below. If a higher daily dose of amoxicillin is considered necessary, it is recommended that another formulation of AMOXICILLIN / CLAVULANIC ACID CRISTERS be used to avoid the unnecessary administration of high daily doses of clavulanic acid (see Warnings and Precautions sections). precautions for use and pharmacodynamic properties ).

The duration of treatment will depend on the patient's response to treatment. Some infections (eg, osteomyelitis) require prolonged treatment. Treatment should not be prolonged beyond 14 days without medical advice (see Warnings and Precautions for prolonged treatment).

Adults and children ³ 40 kg

Recommended doses:

· Standard dose (for all indications): 1000 mg / 125 mg three times a day;

· Lower dose - (especially for infections of the skin and soft tissues, and non-severe sinusitis): 1000 mg / 125 mg twice daily.

Children <40 kg

In children, use AMOXICILLIN / CLAVULANIC ACID CRISTERS in tablet, suspension or pediatric sachet.

Recommended dose:

· From 40 mg / 5 mg / kg / day to 80 mg / 10 mg / kg / day (not to exceed 3000 mg / 375 mg daily) in three divided doses, depending on the severity of the infection.

Elderly patients

No dosage adjustment is considered necessary.

Patients with renal insufficiency

No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml / min.

In patients whose creatinine clearance is less than 30 ml / min, the use of AMOXICILLIN / CLAVULANIC ACID CRISTERS formulations with a ratio of amoxicillin to clavulanic acid of 8/1 is not recommended as no recommendation dose adjustment is not available.

Hepatic insufficiency patients

Use with caution and monitor liver function regularly (see sections Contraindications and Warnings and Precautions ).

Administration mode

AMOXICILLIN / CLAVULANIC ACID CRISTERS is for oral administration.

Take the drug at the beginning of the meal, to minimize the risk of gastrointestinal intolerance and improve absorption of amoxicillin / clavulanic acid.

The treatment can be started parenterally according to the SPC of formulation IV and continued with a formulation for oral administration.

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

Against indications

· Hypersensitivity to the active substances, penicillins or any of the excipients.

· History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to another beta-lactam (eg, cephalosporin, carbapenem or monobactam).

· History of jaundice / liver damage related to amoxicillin / clavulanic acid (see section 4.8 ).

Adverse Reactions Amoxicil / AC Clav Cristers AD

The most common side effects are diarrhea, nausea and vomiting.

Adverse reactions identified in clinical studies and since the marketing of AMOXICILLIN / CLAVULANIC ACID medicinal products are listed below according to the MedDRA system organ classification.

The following terminology is used to classify adverse reactions according to their frequency:

Very common (³ 1/10)

Frequent (³ 1/100 to <1/10)

Uncommon (1/1000 to <1/100)

Rare (1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data)

Infections and infestations

Cutaneous and mucosal candidiasis

Frequent

Excessive development of non-susceptible organisms

Not known frequency

Blood and lymphatic system disorders

Reversible leukopenia (including neutropenia)

Rare

thrombocytopenia

Rare

Reversible agranulocytosis

Not known frequency

Hemolytic anemia

Not known frequency

Prolongation of bleeding time and Quick 1 time

Not known frequency

Immune system disorders 10

Angioedema

Not known frequency

anaphylaxis

Not known frequency

Serum sickness

Not known frequency

Hypersensitivity vasculitis

Not known frequency

Nervous system disorders

dizziness

Rare

headaches

Rare

Reversible hyperactivity

Not known frequency

Convulsions 2

Not known frequency

Aseptic meningitis

Not known frequency

Gastrointestinal disorders

Diarrhea

Very common

Nausea 3

Frequent

vomiting

Frequent

Indigestion

Rare

Colitis associated with antibiotics 4

Not known frequency

Glossophytie

Not known frequency

Hepatobiliary disorders

Elevations of ASAT and / or ALAT 5 rates

Rare

Hepatitis 6

Not known frequency

Cholestatic jaundice 6

Not known frequency

Skin and subcutaneous tissue disorders 7

Skin rash

Rare

itching

Rare

Urticaria

Rare

Erythema multiforme

Rare

Stevens-Johnson Syndrome

Not known frequency

Epidermolysis necrotizing hyperacute

Not known frequency

Bullous dermatitis or exfoliator

Not known frequency

Generalized acute exanthematous pustulosis (PEAG) 9

Not known frequency

Renal and urinary disorders

Interstitial nephritis

Not known frequency

Crystalline 8

Not known frequency

1 See section Warnings and precautions for use

2 See section Warnings and precautions for use

3 Nausea is more often associated with higher oral doses. Gastrointestinal manifestations may be reduced by taking AMOXICILLIN / CLAVULANIC ACID CRISTERS at the beginning of a meal.

4 Including pseudomembranous colitis and haemorrhagic colitis (see Warnings and precautions for use )

A moderate increase in ASAT and / or ALT levels has been noted in patients treated with beta-lactam antibiotics, but the significance of these increases is unknown.

6 These effects have been observed with other penicillins and cephalosporins (see Warnings and Precautions ).

7 If hypersensitivity dermatitis occurs, treatment should be discontinued (see Warnings and Precautions section ).

8 See Overdose section

9 See warnings and precautions for use

10 See sections Contraindications and Warnings and precautions for use

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers. Website: //www.ansm.sante.fr

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