Amoxicillin and Clavulanate Potassium

● Treatment of acute bacterial sinusitis (adequately diagnosed); acute otitis media; acute exacerbations of chronic bronchitis (adequately diagnosed); community-acquired pneumonia ● Cystitis and pyelonephritis; skin and soft tissue infections (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

● Oral use: administer at the start of a meal to minimise gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid ● Reconstitute the dry powder with water as directed; shake the bottle well before each dose and measure with the calibrated oral dosing syringe ● Complete the full prescribed course; treatment should not be extended beyond 14 days without review

For children weighing under 40 kg, the recommended daily dose is 25 mg/3.6 mg to 45 mg/6.4 mg per kg body weight, given as two divided doses (every 12 hours). Up to 70 mg/10 mg per kg per day in two divided doses may be considered for some infections such as otitis media, sinusitis and lower respiratory tract infections . Children weighing 40 kg or more should be treated with the adult formulations

● Contraindicated in hypersensitivity to the active substances, to any penicillin or to any excipient; in a history of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent; and in a history of jaundice/hepatic impairment due to amoxicillin/clavulanic acid [1] ● Ask about previous hypersensitivity to penicillins, cephalosporins or other beta-lactams before treatment; serious, occasionally fatal allergic reactions may occur — stop the medicine at once if an allergic reaction appears [1] ● Hepatic events (mainly cholestatic jaundice and hepatitis) have been reported mostly in males and elderly patients and may be associated with prolonged treatment; they are usually reversible. Use with caution in hepatic impairment and monitor hepatic function [1] ● Convulsions may occur in patients with renal impairment or receiving high doses; avoid in suspected infectious mononucleosis (risk of morbilliform rash) [1] ● Prolonged use may cause overgrowth of non-susceptible organisms; periodic assessment of renal, hepatic and haematopoietic function is advisable [1] ● Antibiotic-associated colitis may occur with any antibacterial — consider this diagnosis in patients presenting with diarrhoea during or after treatment [1] ● Interactions: monitor prothrombin time with oral anticoagulants (e.g. warfarin); probenecid not recommended; penicillins may increase methotrexate toxicity [1] ● Pregnancy: avoid unless considered essential by the physician. Breastfeeding: only after a benefit/risk assessment by the physician in charge [1] ● Most common side effects: diarrhoea, nausea and vomiting; uncommon: dizziness, headache, indigestion, skin rash, pruritus, urticaria, transient rises in liver enzymes; rare or not known: anaphylaxis, angio-oedema, convulsions, hepatitis, Stevens-Johnson syndrome [1] ● Contains aspartame (a source of phenylalanine) — use with caution in phenylketonuria [1] ● Storage: keep the dry powder below 25 °C in the original container, protected from moisture; after reconstitution, refrigerate at 2–8 °C and use within 7 days. Keep out of the reach of children; prescription-only medicine [1][2] For full prescribing information, refer to the approved package insert (Summary of Product Characteristics) of the product concerned [1].