Dosage/Direction for Use
Oral Ear, nose and/or throat infections Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Genitourinary infections Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Acute otitis media Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Skin and soft tissue infections Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Pyelonephritis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Cystitis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Acute bacterial sinusitis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 250-500 mg 8 hourly or 500-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Dental abscesses Adult: 3 g, repeated once after 8 hours. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Uncomplicated acute urinary tract infections Adult: 3 g, repeated once after 10-12 hours. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Uncomplicated gonorrhoea Adult: In patients with susceptible non-penicillinase producing N. gonorrhoeae strains: 3 g as a single dose in combination with probenecid. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Acute exacerbations of chronic bronchitis Adult: 250-500 mg 8 hourly or 750-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Asymptomatic bacteriuria in pregnancy Adult: 250-500 mg 8 hourly or 750-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Tonsillitis Adult: In acute streptococcal cases: 500 mg 8 hourly or 750-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly for 10 days. Consideration must be given to local treatment guidelines. Child: <40 kg: 40-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Pharyngitis Adult: In acute streptococcal cases: 500 mg 8 hourly or 750-1,000 mg 12 hourly. For severe infections: 750-1,000 mg 8 hourly for 10 days. Consideration must be given to local treatment guidelines. Child: <40 kg: 40-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Community-acquired pneumonia Adult: 500-1,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-90 mg/kg daily in divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Typhoid fever Adult: 500-2,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: <40 kg: 100 mg/kg daily in 3 divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Paratyphoid fever Adult: 500-2,000 mg 8 hourly. Consideration must be given to local treatment guidelines. Child: <40 kg: 100 mg/kg daily in 3 divided doses; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Prophylaxis of endocarditis Adult: 2 g as single dose 30-60 minutes prior to procedure. Consideration must be given to local treatment guidelines. Child: <40 kg: 50 mg/kg as single dose 30-60 minutes prior to procedure; ≥40 kg: Same as adult dose. Oral Eradication of H. pylori associated with peptic ulcer disease Adult: In combination with PPI (e.g. omeprazole, lansoprazole) and another antibiotic (e.g. clarithromycin, metronidazole): 750-1,000 mg bid for 7-14 days depending on therapy regimen. Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Oral Lyme disease Adult: In early stages: 500-1,000 mg 8 hourly for 14 days (range: 10-21 days). Max: 4,000 mg daily in divided doses. In late stages (systemic involvement): 500-2,000 mg 8 hourly for 10-30 days. Max: 6,000 mg daily in divided doses. Consideration must be given to local treatment guidelines. Child: <40 kg: In early stages: 25-50 mg/kg daily in 3 divided doses for 10-21 days. In late stages (systemic involvement): 100 mg/kg daily in 3 divided doses for 10-30 days. ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and/or patients on peritoneal dialysis: Adults and children ≥40 kg: Max: 500 mg daily; Children <40 kg: 15 mg/kg daily (max: 500 mg daily). GFR 10-30 mL/min: Adults and children ≥40 kg: Max: 500 mg bid; Children <40 kg: 15 mg/kg bid (max: 500 mg bid). In patients receiving haemodialysis: Adults and children ≥40 kg: 500 mg 24 hourly, and give an additional 500 mg dose prior to and after dialysis; Children <40 kg: 15 mg/kg once daily (max: 500 mg daily), and give an additional 15 mg/kg dose prior to and after dialysis. Parenteral Cystitis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Community-acquired pneumonia Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Acute exacerbations of chronic bronchitis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Ear, nose and/or throat infections Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Skin and soft tissue infections Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Pyelonephritis Adult: Individualise dosing based on expected susceptible pathogens, severity and site of infection, age, weight and renal function of the patient. 500 mg 8 hourly via slow IV or IM inj. Severe infections: May increase to 1,000 mg 6 hourly via slow IV inj over 3-4 minutes or by IV infusion over 20-60 minutes. Alternatively, 750-2,000 mg 8 hourly or 2,000 mg 12 hourly via slow IV inj or IV infusion. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Child: >3 months <40 kg: 20-200 mg/kg daily given in 2-4 equally divided doses of up to 25 mg/kg or infusions of up to 50 mg/kg; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Endocarditis Adult: Treatment in combination with another antibiotic if needed: 1-2 g 4-6 hourly via slow IV inj over 3-4 minutes or IV infusion over 20-60 minutes. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Prophylaxis in patients at highest risk of infective endocarditis: 2 g as single IV dose 30-60 minutes prior to procedure. Consideration must be given to local treatment guidelines. Child: Treatment: ≥40 kg: Same as adult dose. Prophylaxis in patients at highest risk of infective endocarditis: <40 kg: 50 mg/kg as single IV dose 30-60 minutes prior to procedure; ≥40 kg: Same as adult dose. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). Parenteral Bacterial meningitis Adult: In combination with another antibiotic if needed: 1-2 g 4-6 hourly via slow IV inj over 3-4 minutes or IV infusion over 20-60 minutes. Doses may be also be given via IM inj if IV route is impossible or less appropriate for the patient. Max: 12 g daily (IV); 4 g daily (IM); 1 g (single IM dose). Consideration must be given to local treatment guidelines. Renal impairment: GFR <10 mL/min and patients on peritoneal dialysis: Adults and children ≥40 kg: 1,000 mg as IV loading dose then 500 mg daily via IV, or 500 mg daily as single IM dose; Children <40 kg: 25 mg/kg daily as single IV dose, or 15 mg/kg daily as single IM dose. GFR 10-30 mL/min: Adults and children ≥40 kg: 1,000 mg as IV loading dose followed by 500-1,000 mg bid via IV, or 500 mg 12 hourly via IM; Children <40 kg: 25 mg/kg bid via IV, or 15 mg/kg 12 hourly via IM. In patients receiving haemodialysis: Adults and children ≥40 kg: 1,000 mg at the end of dialysis then 500 mg 24 hourly via IV, or 500 mg during and at the end of dialysis then 24 hourly via IM; Children <40 kg: 25 mg/kg as IV loading dose, followed by 25 mg/kg daily, and additional 12.5 mg/kg dose at the end of dialysis via IV; alternatively, 15 mg/kg during and at the end of dialysis, then 15 mg/kg 24 hourly via IM. Reconstitution: Powder for solution for inj or infusion: IV inj: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj to make a final volume of 10.4 mL. IV infusion: Further dilute prepared solution to 50 mL of suitable IV fluid (e.g. sterile water for inj, NaCl). IM: Reconstitute vial labelled as 500 mg with 2.5 mL of sterile water for inj to make a final volume of 2.9 mL. Shake the vial vigorously; administer within 30 minutes of reconstitution. Refer to detailed product guideline for further compatible infusion fluids and their stability. Incompatibility: Powder for solution for inj or infusion: Incompatible with blood products, other proteinaceous fluids (e.g. protein hydrolysates), IV lipid emulsions, infusions containing dextran or bicarbonate; aminoglycosides (in same syringe or IV fluid container). |
Administration
Amoxicillin: May be taken with or without food. May be taken w/ meals for better absorption & to reduce GI discomfort.
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Contraindications
Hypersensitivity or history of severe allergic reactions (e.g. anaphylaxis, Stevens-Johnson syndrome) to amoxicillin or other β-lactams (e.g. penicillins, cephalosporins, carbapenems, monobactams). Infectious mononucleosis (suspected or confirmed).
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Special Precautions
Patient with reduced urine output, history of seizures, treated epilepsy or meningeal disorders; lymphatic leukaemia. Atopic individuals. Renal and hepatic impairment. Children. Pregnancy and lactation. Monitoring Parameters Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor renal, hepatic, and haematologic (e.g. CBC with differential) functions periodically with prolonged therapy; electrolyte balance. Assess patient for infection throughout therapy; signs or symptoms of anaphylaxis (during initial dose), opportunistic infections, and antibiotic-associated diarrhoea.
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Adverse Reactions
Significant: Convulsion (high doses), Jarisch-Herxheimer reaction (in treatment of Lyme disease). Rarely, crystalluria (high parenteral doses); prolonged prothrombin time.
Blood and lymphatic system disorders: Rarely, thrombocytopenia, leucopenia.
Gastrointestinal disorders: Nausea, diarrhoea, vomiting; tooth discolouration (brown, yellow, grey) particularly in children.
Investigations: Elevated liver enzymes, changes in blood counts (prolonged therapy).
Nervous system disorders: Headache, dizziness, agitation.
Psychiatric disorders: Reversible hyperactivity, anxiety, insomnia, confusion, behavioural changes.
Reproductive system and breast disorders: Vulvovaginal infection.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.
Potentially Fatal: Hypersensitivity reactions including anaphylaxis, anaphylactoid and severe cutaneous adverse reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms); C. difficile-associated diarrhoea or pseudomembranous colitis. Rarely, cholestatic hepatitis. |
Overdosage
Symptoms: Nausea, vomiting, diarrhoea, disturbance of fluid and electrolyte balances; crystalluria leading to renal failure (in some cases) and convulsions. Management: Symptomatic and supportive treatment. Monitor water or electrolyte balance. Maintain adequate fluid intake and diuresis. May consider haemodialysis for removal from the circulation.
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Drug Interactions
Decreased renal tubular secretion resulting in increased and prolonged serum concentration with probenecid. Increased risk of allergic reactions (e.g. rashes) with allopurinol. Tetracyclines, chloramphenicol, macrolides, and sulfonamides may interfere with the bactericidal effect of amoxicillin. May prolong prothrombin time or increase INR when used with oral anticoagulants (e.g. warfarin, acenocoumarol). May reduce the excretion and increase the toxicity of methotrexate. May reduce the efficacy of oral contraceptives (e.g. estrogen/progesterone combination).
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Lab Interference
May interfere with the result in assay for estriol in pregnant women. May result in false-positive reactions with urinary glucose tests using Benedict's solution or Fehling's solution.
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Action
Amoxicillin is a semisynthetic aminopenicillin that inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls by binding to 1 or more of the penicillin-binding proteins (PBPs), thereby inhibiting cell wall biosynthesis and causing eventual bacterial lysis.
Absorption: Rapidly and well absorbed from the gastrointestinal tract. Bioavailability: Approx 70% (oral). Time to peak plasma concentration: 1-2 hours (oral). Distribution: Readily distributed in gall bladder, abdominal tissue, lungs, liver, prostate, middle ear effusions, maxillary sinus secretions, skin, fat, bone, muscle tissues, peritoneal and synovial fluids, bile, pus; poor penetration into the brain and CSF (except when meninges are inflamed). Crosses the placenta and enters breast milk (small amounts). Volume of distribution: Approx 0.3-0.4 L/kg. Plasma protein binding: Approx 20%. Metabolism: Metabolised via hydrolysis (small amount) to inactive penicilloic acid. Excretion: Via urine (60% as unchanged drug). Elimination half-life: Approx 1 hour. |
Storage
Oral: Store between 20-25°C. Protect from moisture and light. Reconstituted oral susp: Store below 25°C or between 2-8°C. Do not freeze. Parenteral: Store between 20-25°C. Protect from moisture and light.
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CIMS Class
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ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
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