Medicinal Products

AUGMENTIN Infant Child 500 mg / 50 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
laboratory: Glaxosmithkline

Powder for solution for injection IV
Box of 10 vials of 500 mg powder
All forms

Indication

AUGMENTIN is indicated for the treatment of the following infections in adults and children (see sections Posology and method of administration, Warnings and precautions for use and Pharmacodynamic properties ):

· Severe ENT infections (such as mastoiditis, peritonsillar infections, epiglottitis and sinusitis, when accompanied by severe systemic signs and symptoms),

· 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, in particular osteomyelitis,

· Intra-abdominal infections,

· Female genital infections.

Prophylaxis of post-operative infections in adults involving:

· The digestive system,

· The pelvic cavity,

· The head and the neck,

· The biliary system.

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

Dosage AUGMENTIN Infant Child 500 mg / 50 mg Powder for solution for injection IV Box of 10 vials of 500 mg powder

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

The dose of AUGMENTIN 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).

The use of other Augmentin formulations (eg, providing higher doses of amoxicillin and / or different amoxicillin / clavulanic acid ratios) should be considered, if necessary (see Warnings and Precautions sections). and pharmacodynamic properties ).

AUGMENTIN Powder for Solution for Injection or Infusion provides a total daily dose of 6000 mg amoxicillin and 600 mg clavulanic acid when administered as recommended below. If a higher daily dose of amoxicillin is considered necessary, it is recommended that another intravenous formulation of AUGMENTIN be chosen to avoid the unnecessary administration of large daily doses of clavulanic acid.

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).

Local recommendations regarding the frequency of amoxicillin / clavulanic acid intake should be considered.

Adults and children ³ 40 kg

Doses recommended for the treatment of infections, as indicated in the section Therapeutic indications :

· 1000 mg / 100 mg every 8 to 12 hours or

· 2000 mg / 200 mg every 12 hours.

In case of very serious infection, the dose may be increased to a maximum of 2000 mg / 200 mg given every 8 hours.

In surgical prophylaxis

For interventions lasting less than 1 hour, the recommended dose of AUGMENTIN is 1000 mg / 100 mg to 2000 mg / 200 mg administered at the induction of anesthesia.

For interventions lasting longer than 1 hour, the recommended dose of AUGMENTIN is 1000 mg / 100 mg to 2000 mg / 200 mg administered at the induction of anesthesia, up to 3 doses of 1000 mg / day. 100 mg in 24 hours.

Clinical signs of infection during the procedure will require postoperative administration of intravenous or oral curative therapy.

Children <40 kg

Recommended doses:

· Children 3 months and older : 50 mg / 5 mg per kg every 8 hours

· Children under 3 months of age or weighing less than 4 kg : 50 mg / 5 mg per kg every 12 hours.

Elderly patients

No dosage adjustment is considered necessary.

Patients with renal insufficiency

Dosage adjustments are based on the maximum recommended concentration of amoxicillin.

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

In patients with creatinine clearance less than 30 ml / min, the use of AUGMENTIN formulations with a ratio of amoxicillin to clavulanic acid of 10/1 is not recommended as no dose adjustment is available. . In these patients, AUGMENTIN formulations having a ratio of amoxicillin to clavulanic acid of 5: 1 are recommended.

Hepatic insufficiency patients

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

Administration mode

AUGMENTIN is intended for intravenous administration.

AUGMENTIN can be administered either by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by infusion over 30 to 40 minutes. AUGMENTIN is not suitable for intramuscular administration .

In children less than 3 months of age, AUGMENTIN should be given as an infusion only.

Treatment with AUGMENTIN may be started with an intravenous formulation and supplemented with an appropriate oral formulation, depending on the patient.

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 effects Augmentin Infant Child

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

Adverse reactions identified in clinical studies and since the commercialization of Augmentin 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

Convulsions 2

Not known frequency

Aseptic meningitis

Not known frequency

Vascular disorders

Thrombophlebitis 3

Rare

Gastrointestinal disorders

Diarrhea

Frequent

Nausea

Rare

vomiting

Rare

Indigestion

Rare

Colitis associated with antibiotics 4

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 At the injection site

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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