Sulfadiazine 500mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sulfadiazine

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

J01EC02

INN (International Name):

Sulfadiazine

Dosage:

500mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010800

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Regulatory text amends
• Removed pre-print L.I.No. from front side (pg1/2)
PACKAGE LEAFLET: INFORMATION FOR THE USER
SULFADIAZINE 500MG TABLETS
SULFADIAZINE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE.
- Keep this leaflet. You may need to
read it again.
- If you have further questions, please
ask your doctor or pharmacist.
- This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
- If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
The name of your medicine is Sulfadiazine 500mg Tablets. In the
rest of this leaflet it is called Sulfadiazine Tablets.
IN THIS LEAFLET:
1. What Sulfadiazine Tablets are and what they are used for
2. Before you take Sulfadiazine Tablets
3. How to take Sulfadiazine Tablets
4. Possible side effects
5. How to store Sulfadiazine Tablets
6. Further information
1. WHAT SULFADIAZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in Sulfadiazine Tablets is sulfadiazine,
which belongs to a group of medicines called sulphonamides.
These are antibiotics that work by preventing the growth and
multiplication of bacteria that cause infections.
Sulfadiazine Tablets are used in the treatment of a wide range of
infections including food poisoning and meningitis.
2. BEFORE YOU TAKE SULFADIAZINE TABLETS
DO NOT TAKE SULFADIAZINE TABLETS IF YOU:
•
are allergic to sulfadiazine or sulphonamides or any of the
other ingredients contained in Sulfadiazine Tablets (see list
under heading ‘What Sulfadiazine Tablets contain’ in section 6)
•
have a kind of meningitis caused by meningococcus bacteria
unless your doctor decides it is appropriate
•
suffer from severe liver or kidney problems
•
have jaundice (yellowing of the skin and/or whites of the eyes)
or blood

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sulfadiazine 500mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfadiazine BP 500mg
3
PHARMACEUTICAL FORM
Tablet
Sulfadiazine tablets are plain white, biconvex tablets, with CP on one
face.
4
CLINICAL PARTICULARS
4.1
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. _
4.2
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.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any sulphonamide.
Severe renal or hepatic failure.
Acute porphyria.
Jaundice or blood disorders.
Neonates _ _
Concomitant use with clozapine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Caution in elderly, renal or hepatic impairment_ _and jaundice. Use
with caution in
patients