Clavulanic acid has a high affinity for and binds to certain β-lactamases that generally inactivate amoxicillin by hydrolyzing its β-lactam ring. Combining clavulanate potassium with amoxicillin extends the antibacterial spectrum of amoxicillin to include many bacteria normally resistant to amoxicillin and other penicillins and cephalosporins.

Distribution
Protein binding: About 25% (Clavulanic acid); about 18% (Amoxicillin). Amoxicillin distributes readily into most body tissues and fluids except the brain and spinal fluid.

Excretion
Half-life after oral admin: 1.3 hours (Amoxicillin); 1 hour (Clavulanic acid). About 50-70% of amoxicillin and 25-40% of clavulanic acid are excreted unchanged in urine during the 1st 6 hours after admin.

Information Not Available

Nausea, vomiting, diarrhoea, indigestion, rash and urticaria, candida superinfection.

Potentially Fatal: Anaphylactic reaction with CV collapse esp with parenteral use.

Prescribing amoxicillin and clavulanate potassium tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. While amoxicillin and clavulanate potassium tablets possess the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic and hematopoietic function, is advisable during prolonged therapy.

A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.

History of allergy especially to cephalosporins, infectious mononucleosis, severe renal impairment.

Allopurinol may reduce renal tubular secretion of amoxicillin thus increasing the serum levels of amoxicillin. Concurrent use may reduce the efficacy of oral contraceptives.

Food Interaction
None on absorption. But incidence and severity of GI effects may be reduced.

Oral
Upper and lower respiratory tract infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hours. Infants <3 months: up to 30 mg/kg/day in divided doses every 12 hours.

Oral
Otitis media
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 months: up to 30 mg/kg/day in divided doses every 12 hours.

Oral
Sinusitis
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hr. Infants <3 months: up to 30 mg/kg/day in divided doses every 12 hours.

Oral
Skin and soft tissue infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hours. Infants <3 months: up to 30 mg/kg/day in divided doses every 12 hours.

Oral
Susceptible infections
Adult: Based on amoxicillin dose, 250-500 mg every 8 hours or 500-750 mg every 12 hours.
Child: Based on amoxicillin dose: 125-250 mg every 8 hours. Children weighing <40 kg: 20-40 mg/kg/day in divided doses every 8 hours. Infants <3 months: up to 30 mg/kg/day in divided doses every 12 hours.

Oral
Dental abscesses
Adult: Based on amoxicillin dose: 3 g as a single dose, followed by another dose 8 hours later.

Oral
Acute uncomplicated urinary tract infections
Adult: Based on amoxicillin dose: 3 g as a single dose, followed by another dose 10-12 hours later.

Oral
Severe or recurrent respiratory tract infections
Adult: Based on amoxicillin dose: 3 g bid.

Oral
Uncomplicated gonorrhoea
Adult: Based on amoxicillin dose: 3 g as a single dose with 1 g of oral probenecid.

Oral
Prophylaxis of endocarditis
Adult: Based on amoxicillin dose: 2 or 3 g as a single dose. To be taken 1 hour before the dental procedure.

Oral
H.pylori infection
Adult: Based on amoxicillin dose: 0.75-1 g bid or 500 mg tid. To be taken with metronidazole or claithromycin and a PPI or ranitidine bismuth citrate.

Parenteral
Susceptible infections
Adult: Based on amoxicillin dose: 500 mg every 8 hr. In severe infections, may increase to 1 g every 6 hours. Can be given via IM inj or slow IV injection over 3-4 minutes or IV infusion over 30-60 minutes.
Child: <10 years: 50-100 mg/kg/day in divided doses.

Reconstitution
Powder for oral suspension: Reconstitute with appropriate amount of water as specified on the bottle. Shake vigorously until suspended.

Information Not Available

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

Ampicillin-class antibiotics are excreted in human milk; therefore, caution should be exercised when Amoxicillin and Clavulanate Potassium is administered to a nursing woman.

Safety and efficacy of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL in infants younger than 3 months have not been established. Safety and efficacy of Amoxicillin and Clavulanate Potassium for Oral Suspension 600 mg/42.9 mg per 5 mL have been demonstrated for treatment of acute otitis media in infants and children 3 months to 12 years

Information Not Available

Penicillin allergy

Oral
Store below 25°C.

Parenteral
Store below 25°C.

Information Not Available