HEALEY PHARMA (UK) LIMITED
HEALEY PHARMA (UK) LIMITED
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AMOXICILLIN 500 MG Capsules
COMPOSITION
Each capsule contains amoxycillin trihydrate equivalent to 500 mg amoxycillin.
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.Amoxycillin does not resist destruction by penicillinase and is thus not effective against
penicillinase-producing bacteria, particularly resistant Staphylococci. All strains of Pseudomonas
and most strains of Klebsiella, indole-positive Proteus, Serratia, Acinetobacter and Enterobacter
are resistant to amoxycillin.
INDICATIONS:
Amoxycillin is indicated in the treatment of all infections caused by susceptible (non-penicillinase producing) micro-organisms.
Respiratory infections such as:-
Acute typical pneumonia, acute and chronic bronchitis and epiglottitis, tonsillitis, pharyngitis, laryngitis,
otitis media, and sinusitis.
Urinary tract infections and uncomplicated gonococcal infections.
Bacteraemia, enteric fever.
Meningitis (sensitivity tests must be performed).
Skin and soft tissue infections such as:-
Pyoderma, erysipelas, lymphangitis, cellulitis.
Gastro-intestinal infections such as:-
Typhoid, Salmonella (uncomplicated gastro-enteritis).
Indicated surgical procedures should be performed.
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 moisture.
The potency of reconstituted suspensions will be maintained for one week at temperatures not
exceeding 25°C and for two weeks under refrigeration(2°C–8°C).
KEEP OUT OF REACH OF CHILDREN.