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Amoxicillin inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell wall by binding to one or more of the penicillin-binding proteins (PBPs), thus inhibiting cell wall biosynthesis resulting in bacterial lysis.

Absorption
Rapidly and completely absorbed from the GI tract with peak plasma concentrations after 1-2 hours (oral). Not inactivated by gastric acid and presence of food does not impair absorption.

Distribution
Widely distributed, CSF (small concentrations except when the meninges are inflamed), bile (high concentrations); crosses the placenta and enters the breast milk (small amounts). Protein-binding: 20%.

Metabolism
Converted to a limited extent to penicilloic acid.

Excretion
Via the urine within 6 hours by glomerular filtration and tubular secretion (as penicilloic acid and 60% unchanged drug); via the faeces. May be removed by haemodialysis; 1-1.5 hours (elimination half-life).

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Hyperactivity, agitation, insomnia, dizziness; maculopapular rash, exfoliative dermatitis, urticaria, hypersensitivity vasculitis; diarrhoea, nausea, vomiting; anaemia, thrombocytopenia, leucopenia, agranulocytosis.

Potentially Fatal: Neuromuscular hypersensitivity; pseudomembranous colitis.

Monitor
Periodically assess renal, hepatic, and hematopoietic function during prolonged therapy. Patients diagnosed with gonorrhea should have a serologic test for syphilis at the time of treatment and a follow-up serologic test after 3 months. In the treatment of UTI, frequent bacteriological and clinical appraisals are necessary.

Renal and hepatic disease; pregnancy, lactation; infectious mononucleosis.

Increased levels with disulfiram and probenecid. Decreased effects with tetracyclines and chloramphenicol.

Potentially Fatal: Increase effects of oral anticoagulants.

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Oral
Endocarditis
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Biliary tract infections
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours.. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Gonorrhoea
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours: <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Otitis media
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours
<10                  250-500 every 24 hours.

Oral
Pneumonia
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8 hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Urinary tract infections
Adult: 250-500 mg every 8 hr or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours
<10                  250-500 every 24 hours

Oral
Mouth infections
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hoursMax dose: Infant <3 months: 30 mg/kg daily  in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Spleen disorders
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Actinomycosis
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Bronchitis
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Typhoid and paratyphoid fever
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Gastroenteritis
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Lyme disease
Adult: 250-500 mg every 8 hours or 500-875 mg  every 12 hours.
Child: ≤10 years: 125-250 mg every 8 hours; <40  kg: 20-40 mg/kg daily in divided doses every 8  hours. Max dose: Infant <3 months: 30 mg/kg  daily in divided doses every 12 hours.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 every 12 hours.
<10                  250-500 every 24 hours.

Oral
Uncomplicated gonorrhoea
Adult: 3 g as a single dose with probenecid 1 g.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24  hours.

Oral
Dental abscesses
Adult: Initially, 3 g, repeat once after 8 hours.
Renal impairment: Dose reduction may be required.

Oral
Uncomplicated acute urinary tract infections
Adult: Initially, 3 g, repeat once after 10-12  hours.
Renal impairment: Dose reduction may be  required.

Oral
Prophylaxis of endocarditis
Adult: 2 or 3 g as a single dose, 1 hour before  dental procedure.
Child: Single dose of 50 mg/kg. To be taken 1 hour prior to dental procedure. Max: 2 g/dose.
Renal impairment: Dose reduction may be  required.

Oral
Severe or recurrent respiratory tract infections
Adult: 3 g bid.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24  hours.

Oral
Otitis media
Child: 3-10 years: 750 mg bid for 2 days.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24  hours.

Oral
H.pylori infection
Adult: 0.75 or 1 g bid or 500 mg tid in  combination with either metronidazole or  clarithromycin and a bismuth compound or an  antisecretory drug.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24  hours.

Intravenous
Listerial meningitis
Adult: 2 g every 4 hours for 10–14 days via IV  infusion, to be used with other antibiotics.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24 hours.

Parenteral
Susceptible infections
Adult: 500 mg every 8 hours via IM or slow IV injection.  Severe infections: May increase to 1 g every 6 hours via slow IV injection over 3-4 minutes or infuse over  30-60 minutes.
Child: ≤10 years: 50-100 mg/kg daily in divided  doses.
Renal impairment: Patients on haemodialysis should  receive 250-500 mg every 24 hours and an  additional dose during and after each dialysis  session.
CrCl (ml/min)    Dosage Recommendation
10-30               250-500 mg every 12 hours.
<10                  250-500 mg every 24 hours.

May be taken with or without food. (May be taken with meals for better absorption & to reduce GI discomfort.)

Caution when used during pregnancy

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Caution when used during lactation

Moxatag
Safety and efficacy not established in children younger 12 years of age.

Differences in response between elderly patients (65 years of age and older) and younger patients have not been identified.

Hypersensitivity

Intravenous
Store at 20-25°C.

Parenteral
Store at 20-25°C.

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