Indicatios:

Amoxicillin and Clavulanate Potassium Tablets is indicated for the treatment of the following infections in adults and children:

• Acute bacterial sinusitis (adequately diagnosed)

• Acute otitis media

• Acute exacerbations of chronic bronchitis (adequately diagnosed)

• Community acquired pneumonia

• Cystitis

• Pyelonephritis

• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.

• Bone and joint infections, in particular osteomyelitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Dosage and administration：

For adult dose:

One Amoxicillin and Clavulanate Potassium Tablet per 12h.

Pediatric Patients

Pediatric patients weighing 40 kg or more should be dosed according to the adult commendations.

The Amoxicillin and Clavulanate Potassium Tablets should not be used until the pediatric patient weighs at least 40 kg or more.

If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Amoxicillin and Clavulanate Potassium Tablets is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.

The duration of therapy should be determined by the response of the patient.  Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review .

Contraindications:

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

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

History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.

Precautions:

Before initiating therapy with amoxicillin/clavulanic acid, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents .

Convulsions may occur in patients with impaired renal function or in those receiving high doses (see section 4.8).

Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Prolonged use may occasionally result in overgrowth of non-susceptible organisms.

Periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is advisable during prolonged therapy.

In patients with renal impairment, the dose should be adjusted according to the degree of impairment.

Drug interactions:

Oral anticoagulants

If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin.

Methotrexate

Penicillins may reduce the excretion of methotrexate causing a potential increase in toxicity.

Probenecid

Concomitant use of probenecid is not recommended.   Probenecid decreases the renal tubular secretion of amoxicillin. Concomitant use of probenecid may result in increased and prolonged blood levels of amoxicillin but not of clavulanic acid.

Mycophenolate mofetil

In patients receiving mycophenolate mofetil, reduction in pre-dose concentration of the active metabolite mycophenolic acid (MPA) of approximately 50% has been reported following commencement of oral amoxicillin plus clavulanic acid. Close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.

Storage:

Store in the original package in order to protect from light.

Do not store above 25°C.