HEALEY PHARMA (UK) LIMITED
HEALEY PHARMA (UK) LIMITED
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AMOXICILLIN 500 MG TABLETS
COMPOSITION
Each Tablet contains 500 mg amoxicillin.
PHARMACOLOGICAL ACTION
Amoxycillin is rapidly absorbed after oral administration and provides high blood levels and very high
concentrations in the tissues and urine. Amoxycillin does not readily diffuse into the brain and spinal
fluid except when the meninges are inflamed.
The ingestion of food does not greatly reduce the absorption of amoxycillin. Amoxycillin does not appear
to be metabolized in the body. Urinary excretion is rapid, and only unchanged amoxycillin is recovered in
the urine. Its excretion can be delayed by concurrent administration of probenecid. Approximately 17%
of amoxycillin is bound by serum proteins.
INDICATIONS
Amoxycillin is indicated in the treatment of all infections caused by susceptible (non-penicillinase producing) micro-organisms.
Respiratory infections
Skin and soft tissue infections
Gastro-intestinal infections
CONTRA-INDICATIONS
Patients hypersensitive to penicillins and cephalosporins. Patients with infectious mononucleosis are
susceptible to skin rashes.
WARNINGS
Amoxycillin may cause reactions typical of penicillin allergy, especially in sensitive patients. Should an
allergic reaction occur, the drug should be discontinued and the patient treated with the usual agents.
DOSAGE AND DIRECTIONS FOR USE
The usual oral dose in Amoxicillin 250 to 500 mg every 8 hours. Children up to 10 years of age may be
given 125 to 250 mg every 8 hours; under 20 kg body weight a dose of 20 to 40 mg per kg daily has
been suggested.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Adverse events associated with amoxycillin are allergic reactions which commonly include urticarial or
maculopapular skin rashes.
Amoxycillin may cause reactions typical of penicillin allergy in patients sensitive to penicillin.
Gastro- intestinal adverse effects particularly diarrhoea and also nausea and vomiting occur quite
frequently, usually following administration by mouth. Glossitis, stomatitis and black -"hairy" tongue have been reported. Pseudomembranous colitis has also been reported. Supra-infections with non-susceptible organisms may occur particularly with prolonged use.
Precautions:
Amoxycillin should not be given to patients with infectious mononucleosis, lymphatic leukaemia and
patients with hyperuricaemia being treated with allopurinol, since these patients appear to have a
higher incidence of skin rashes.
Anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis
have been reported during therapy with the penicillins. These reactions are usually reversible on
discontinuation of therapy and are believed to be hypersensitivity phenomena.
Amoxycillin may decrease the efficacy of oestrogen-containing oral contraceptives and it may also affect the absorption of other drugs due to its effect on
the gastro-intestinal flora.
Safety of use during pregnancy has not been established.
STORAGE INSTRUCTIONS:
Store below 25°C. Protect from mositure. Keep out of reach of children.