AUGMENTIN FOR ORAL SUSPENSION 228 MG/5 ML

SMITHKLINE BEECHAM LIMITED TRADING AS SMITHKLINE BEECHAM PHARMACEUTICALS - UNITED KINGDOMGLAXO WELLCOME PRODUCTION (FRANCE)🇸🇬 Health Sciences Authority

Approval Date: Jun 19, 1998
Approval ID: 18a64b38f6981c7b
Company: SMITHKLINE BEECHAM LIMITED TRADING AS SMITHKLINE BEECHAM PHARMACEUTICALS - UNITED KINGDOMGLAXO WELLCOME PRODUCTION (FRANCE)
Type: Therapeutic

Approval Details

Approval Id: 18a64b38f6981c7b
Drug Name: AUGMENTIN FOR ORAL SUSPENSION 228 MG/5 ML
Product Name: AUGMENTIN FOR ORAL SUSPENSION 228 MG/5 ML
Approval Number: SIN09831P
Approval Date: 1998-06-19
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: POWDER, FOR SUSPENSION
Dosage: Dosage and Administration Pharmaceutical form: Powder for oral suspension. Dosage depends on the age, weight and renal function of the patient and the severity of the infection. Dosages are expressed throughout in terms of amoxicillin/clavulanate content except when doses are stated in terms of an individual component. To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of AUGMENTIN is optimised when taken at the start of a meal. Treatment should not exceed 14 days without review. Therapy can be started parenterally and continued with an oral preparation. AUGMENTIN bottle presentations for suspension may be supplied with a plastic dosing device. For preparation of the suspensions, see Instructions for Use/Handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. The usual recommended daily dosage is: <ul> <li>25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).</li> <li>45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).</li> </ul> No clinical data are available on doses above 45/6.4 mg/kg/day in children under 2 years. There are no clinical data for AUGMENTIN suspension 228 mg/5 mL and 457 mg/5 mL to make dosage recommendations for children under 2 months old. The tables below give dosage guidance for children. Children 2 years and over <img src="/TGIF/AugmentinSuspension-Table1_130224.png" alt="Augmentin Suspension Dosage Table 1" /> Children aged 2 months to under 2 years Children under 2 years should be dosed according to body weight. <img src="/TGIF/AugmentinSuspension-Table2_250722.png" alt="Augmentin Suspension Dosage Table 2" /> Renal Impairment No adjustment in dose is required in patients with creatinine clearance greater than 30 mL/min. AUGMENTIN suspension 228 mg/5 mL and 457 mg/5 mL are not recommended in patients with a creatinine clearance of less than 30 mL/min. Hepatic Impairment Administer with caution; monitor hepatic function at regular intervals. There are insufficient data on which to base a dosage recommendation.
Route Of Administration: ORAL
Indication Info: Indications AUGMENTIN should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data. AUGMENTIN suspension (228 mg/5 mL and 457 mg/5 mL), for twice daily oral dosing, is indicated for short term treatment of bacterial infections at the following sites when amoxicillin resistant beta-lactamase producing strains are suspected as the cause. In other situations, amoxicillin alone should be considered. Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media. Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia. Urinary tract infections e.g. cystitis, urethritis, pyelonephritis. Skin and soft tissue infections e.g. cellulitis, animal bites. Susceptibility to AUGMENTIN will vary with geography and time (see Pharmacological Properties, Pharmacodynamics for further information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary. Mixed infections caused by amoxicillin-susceptible organisms in conjunction with AUGMENTIN susceptible beta-lactamase producing organisms may be treated with AUGMENTIN suspension 228 mg/5 mL and 457 mg/5 mL. These infections should not require the addition of another antibiotic resistant to beta-lactamases.
Contraindications: Contraindications AUGMENTIN is contraindicated <ul class="dash"> <li>in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins.</li> <li>in patients with a previous history of AUGMENTIN-associated jaundice/hepatic dysfunction.</li> </ul>
Atc Code: J01CR02
Atc Item Name: amoxicillin and beta-lactamase inhibitor
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD

Active Ingredients

AMOXYCILLIN TRIHYDRATE 229.58mg/5ml EQV AMOXYCILLIN

200 mg/5 ml

POTASSIUM CLAVULANATE 33.95mg/5ml EQV CLAVULANIC ACID

28.5 mg/5 ml

AMOXYCILLIN TRIHYDRATE 229.58mg/5ml EQV AMOXYCILLIN

200 mg/5 ml

POTASSIUM CLAVULANATE 33.95mg/5ml EQV CLAVULANIC ACID

28.5 mg/5 ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 19, 1998

Approval ID

18a64b38f6981c7b

Type

Therapeutic

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