SULFADIAZINE Tablets Ref.[7862] Active ingredients: Sulfadiazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Therapeutic indications

Sulfadiazine is a short-acting sulphonamide with bacteriostatic activity against a broad spectrum of organisms.

Gram-positive – particularly group A Streptococci and some strains of Streptococcus pneumoniae, Bacillus ant hracis, Nocardia (especially N.asteroides) and, to a lesser extent, Staphylococci and Clostridium perfringens.

Gram-negative – Haemophilus influenzae and H.ducreyi are often sensitive, sensitivity varies among the enterobacteriae-Escherichia coli, Klebsiella, proteus, Salmonella and Serratia and Vibrio cholerae are sometimes sensitive. Other organisms reported to be sensitive include, Actinomyces spP., Brucella, Calymmatobacterium granulomatis, Legionella, Yersinia pestis, Chlamydia, Pseudomonas pseudomallei.

Posology and method of administration

For oral administration.

Adults and elderly

The initial dose is usually 2-4 grams followed by a maintenance dose of up to 4 grams daily in divided doses for a maximum of seven days.

Dosage reduction may be necessary in renal impairment.

Children

Initially 75mg/kg, followed by a maintenance dose of 150mg/kg daily in divided doses. Maximum of 6 grams daily.

Sulphonamides should not be used for initial treatment of meningococcal meningitis although oral Sulfadiazine may be substituted for parenteral penicillin once susceptibility to sulphonamides has been established.

Overdose

Symptoms: Nausea, diarrhoea.

Treatment: Continuous forced fluids may be necessary and the urine should be rendered alkaline. Otherwise treatment is symptomatic.

Shelf life

Shelf life: 36 months.

Special precautions for storage

Do not store above 25°C Protected from light.

Store in the original container.

Nature and contents of container

Polypropylene or polyethylene containers of 500 and 100 tablets.

Polypropylene or polyethylene securipac in cartons of 56 tablets.

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