SULFADIAZINE Tablets (2015)
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Περιεχόμενα
Name of the medicinal product
Sulfadiazine 500mg Tablets.
Qualitative and quantitative composition
Sulfadiazine 500mg.
Pharmaceutical form
Tablet. Sulfadiazine tablets are plain white, biconvex tablets, with CP on one face.
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, ...
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 ...
Contraindications
Known hypersensitivity to any sulphonamide. Severe renal or hepatic failure. Acute porphyria. Jaundice or blood disorders. Neonates Concomitant use with clozapine.
Special warnings and precautions for use
Caution in elderly, renal or hepatic impairment and jaundice. Use with caution in patients with predisposition to folate deficiency. Sulfonamides inhibit the absorption and metabolism of folic acid and ...
Interaction with other medicinal products and other forms of interaction
Anaesthetics, general: sulphonamides may potentiate the effect of thiopentone anaesthetics. Anti-infectives: Like other sulphonamides, Sulfadiazine demonstrated synergy with the difolate reductase release ...
Pregnancy and lactation
Pregnancy There is epidemiological evidence of the safety of Sulfadiazine in human pregnancy, but the clinician should assess the risk benefit factors before recommending Sulfadiazine to pregnant women. ...
Effects on ability to drive and use machines
Not known.
Undesirable effects
These are common to all sulphonamides and more likely in slow acetylators. Blood and lymphatic system disorders: Occasional blood disorders include, agranulocytosis, aplastic anaemia, thrombocytopenia, ...
Overdose
Symptoms: Nausea, diarrhoea. Treatment: Continuous forced fluids may be necessary and the urine should be rendered alkaline. Otherwise treatment is symptomatic.
Pharmacodynamic properties
Sulphonamides (including sulphadiazine) are structural analogues and competitive antagonists of p-aminobenzoic acid preventing bacterial utilisation of PABA in the synthesis of folic acid.
Pharmacokinetic properties
Sulfadiazine is rapidly absorbed from the gastrointestinal tract after oral dosage. Peak blood concentrations are reached within three to six hours, and about 50% is bound to plasma protein. The serum ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber that are additional to those included in other sections.
List of excipients
Maize starch Pre-gelatinised starch Microcrystalline cellulose Sodium starch glycollate Talc Magnesium stearate
Incompatibilities
Not applicable.
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.
Marketing authorization holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Marketing authorization number(s)
PL 29831/0191
Date of first authorization / renewal of the authorization
01/05/2008
Date of revision of the text
28/09/2015
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