Amoxicillin is a broad spectrum antibiotic indicated for the treatment of commonly-occurring bacterial infections including:

Acute and chronic bronchitis

Pneumonia

Ear, nose and throat infections

Otitis media

Urinary tract infection

Gonorrhoea

Invasive salmonellosis

Gynaecological infections

Peritonitis

Osteomyelitis

Meningitis

Endocarditis

Typhoid fever

Prophylaxis of endocarditis in patients at risk from such procedures as dental extractions.

In some of these infections initiation of treatment or indeed the whole course of treatment may need to be by the parenteral route.

In children with urinary tract infection, the need for further clinical investigation should be considered.

Posology:

5ml of 250mg/5ml suspension three times daily, increasing to 10ml of 250mg/5ml suspension three times daily for more severe infections.

High dose and short course therapies, requiring doses of up to 6gm, daily, a more appropriate dosage form is recommended.

Children

Children weighing more than 40 kg should be given the usual adult dosage. Children weighing < 40 kg

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).

*PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Special dosage recommendation

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations.

Prophylaxis for endocarditis: 50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2).

Glomerular filtration rate >30ml/min: No adjustment necessary

Glomerular filtration rate 10-30ml/min: Amoxicillin max. 500mg BID

Glomerular filtration rate <10ml/min: Amoxicillin max. 500mg/day

Renal impairment in children under 40 kg:

Route of Administration: Oral

Prolonged use of anti-infective agent may result in superinfection by organisms resistant to that anti- infective.

In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in persons with a history of penicillin hypersensitivity and/ or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of severe reactions when treated with cephalosporin. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.

Erythematous (mornilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

If allergic reaction occurs, amoxicillin should be discontinued and appropriate therapy should be instituted and discontinuance of amoxicillin therapy considered.

Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.

In patients with reduced urine output crystalluria has been observed very rarely predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria

Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

When administered concurrently, the following drugs may interact with amoxicillin:

Oral Contraceptives:

In common with other broad spectrum antibiotics, amoxicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.

Bacteriostatic antibiotics:

Chloramphenicol, erythromycins, sulfonamides or tetracyclines may interfere with the bactericidal effects of penicillins. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.

Probenecid:

Probenecid may decrease renal tubular secretion of amoxicillin resulting in increased blood levels and/or amoxicillin toxicity.

Drug/Laboratory Test Interactions:

After treatment with amoxicillin, a false-positive reaction for glucose in the urine may occur with copper sulphate tests (Benedict's solution, fehling's solution, or Clinitest tablets) but not with enzyme based tests..

Allopurinol

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

Methotrexate

Excretion of methotrexate is reduced by penicillins; increased risk of toxicity. Oral typhoid vaccine

The oral typhoid vaccine is inactivated by antibacterials Sulfinpyrazone

Excretion of penicillins is reduced by sulfinpyrazone.

Anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Muscle relaxants: Piperacillin (and possibly other penicillins) enhance the effects of non- depolarising muscle relaxants and suxamethonium.

Antibacterials: Absorption of phenoxymethylpenicillin (and possibly other penicillins) reduced by neomycin.

Guar Gum: Reduced absorption of penicillins.

Digoxin: An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin.

Animal studies with amoxicillin have shown no teratogenic effects. Amoxicillin has been in extensive clinical use and its suitability in human pregnancy has been well documented in clinical studies. The product should only be used during pregnancy where potential benefits outweigh the potential risks associated with treatment.

Amoxicillin may be administered during the period of lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant

None

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000,

<1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxicillin and may occur when using other pencillins.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure has been observed (see section 4.4 Special warnings and precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis

Amoxicillin is a broad spectrum antibiotic which is bactericidal for both gram positive and gram negative bacteria.

Amoxicillin is well absorbed by the oral route. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which the food is taken. Amoxicillin gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic. It is rapidly bactericidal and possesses the safety profile of a penicillin.

Amoxicillin is rapidly absorbed from the gastro-intestinal tract; it is not converted to ampicillin. It is widely distributed and is reported to product peak antibiotic plasma concentrations that are up to twice as high as those from the same dose of ampicillin. Peak plasma-amoxicillin concentration of about 5 mcg/ml have been observed 2 hours after a dose of 250mg, with detectable amounts present for up to 8 hours. Doubling the dose can produce double the concentration. The presence of food in the stomach does not appear to diminish absorption significantly.

Up to 20% is bound to plasma proteins in the circulation and plasma half-lives of about one hour have been reported. Amoxicillin diffuses across the placenta: little appears to be excreted in breast milk. It penetrates well into purulent and mucoid sputum and low concentrations have been found in ocular fluid. About 60% of an oral dose is excreted in the urine in six hours

In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.

Not applicable

Colloidal silicone dioxide

Disodium EDTA

Sodium Saccharine

Sodium Benzoate

Color Sunset yellow

Xanthan gum

Mixed fruit flavor

Orange dry flavor

Sugar

None known

Store below 25°C. After reconstitution, keep the contents tightly closed in a refrigerator and use within 14 days. Discard unused portion.

125 ml amber glass bottle with mark at 100 ml sealed with plastic cap having PE wads.

No special requirements for storage.