Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**RECOMMENDED DOSAGE:** Dosage depends on the age and renal function of the patient and the severity of the infection. To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of amoxicillin/clavulanic acid is optimised when taken at the start of a meal. Treatment should not be extended beyond 14 days without review. Therapy can be started parenterally and continued with an oral preparation. Amoxicillin/clavulanic acid tablets are not recommended in children of 12 years and under. _**Adults and Children over 12 years**_ The usual recommended daily dosage is:  **Renal Impairment** No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. The amoxicillin/clavulanic acid 1g tablet should only be used in patients with a creatinine clearance (CrCl) rate of more than 30 mL/min. **Hepatic Impairment** Dose with caution; monitor hepatic function at regular intervals.
ORAL
Medical Information
**INDICATIONS:** Amoxicillin/clavulanic acid is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. Amoxicillin/clavulanic acid should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data. Amoxicillin/clavulanic acid oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites: _Upper respiratory tract infections (including ENT)_ e.g. tonsillitis, sinusitis, otitis media. _Lower respiratory tract infections_ e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia. _Genito-urinary tract infections_ e.g. cystitis, urethritis, pyelonephritis. _Skin and soft tissue infections_ e.g. boils, abscesses, cellulitis, wound infections. _Bone and joint infections_ e.g. osteomyelitis. _Dental infections_ e.g. dentoalveolar abscess, pericoronitis, acute periodontitis. _Other infections_ e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis. Susceptibility to amoxicillin/clavulanic acid 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.
**CONTRAINDICATIONS:** Amoxicillin/clavulanic acid is contraindicated in patients with a history of hypersensitivity to beta-lactams, e.g. penicillins and cephalosporins. Amoxicillin/clavulanic acid is contraindicated in patients with a previous history of amoxicillin/clavulanic acid -associated jaundice/hepatic dysfunction.
J01CR02
amoxicillin and beta-lactamase inhibitor
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
Micro Labs Limited