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PINACLAV 500 MG/125 MG TABLETS

Information leaflet

                                                     Irish Medicines Board




                                Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Pinaclav 500mg/125mg Tablets

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 500 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium
 clavulanate.
 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Film-coated Tablets
 Yellowish-white or light yellow oblong-formed, biconvex tablet with ‘625’ on one side and an engraved line on the
 other side.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 • Pinaclav is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and
   5.1):
 • 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.

 4.2 Posology and method of administration

 Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms
 of an individual component.

 The dose of Pinaclav that is selected to treat an individual infection should take into account:

 • The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)
 • The severity and the site of the infection
 • The age, weight and renal function of the patient as shown below.

 The use of alternative presentations of Pinaclav (e.g. those that provide higher doses of amoxicillin and/or different
 ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).




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Date Printed 19/09/2011                               CRN 2099252                                         page number: 1
                                                    Irish Medicines Board




 For adults and children 40 kg, this formulation of Pinaclav provides a total daily dose of 1500 mg amoxicillin/375
 mg clavulanic acid, when administered as recommended below. For children <40 kg, this formulation of Pinaclav
 provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended
 below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation
 of Pinaclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see
 sections 4.4 and 5.1).

 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 (see section 4.4
 regarding prolonged therapy).

 Adults and children    40 kg

 One 500 mg/125 mg dose taken three times a day.

 Children < 40 kg

 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.

 Children may be treated with Pinaclav tablets, or suspensions. Children aged 6 years and below should preferably be
 treated with Pinaclav suspension.

 No clinical data are available on doses of Pinaclav 4:1 formulations higher than 40 mg/10 mg/kg
 per day in children under 2 years.

 Elderly

 No dose adjustment is considered necessary.

 Renal impairment

 Dose adjustments are based on the maximum recommended level of amoxicillin.
 No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.

 Adults and children   40 kg

             CrCl: 10-30 ml/min         500 mg/125 mg twice daily
             CrCl < 10 ml /min          500 mg/125 mg once daily

             Haemodialysis              500 mg/125 mg every 24 hours, plus 500 mg/125 mg
                                        during dialysis, to be repeated at the end of dialysis (as
                                        serum concentrations of both amoxicillin and clavulanic
                                        acid are decreased)




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Date Printed 19/09/2011                               CRN 2099252                                         page number: 2
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