Shared Care
Guideline
Sulfasalazine tablets
For the treatment of:
Inflammatory arthritis in adults ( 16 years old)
For the latest information on interactions and adverse affects, always consult the latest version
of the Summary of Product Characteristics (SmPC), which can be found at:
www.medicines.org.uk
These guidelines are based on the monitoring criteria of the British Society of Rheumatology,
published in the following reference:
Chakravarty, K., McDonald, H., Pullar, T. et al. (2008) BSR/BHPR guideline for diseasemodifying anti-rheumatic drug (DMARD) therapy in consultation with the British Association of
Dermatologists. Rheumatology 47(6), 924-925.
Authors: Dr Kelsey M Jordan (Consultant Rheumatologist, BSUH NHS Trust)
Dr Stewart E Glaspole (Pharmacist, BSUH NHS Trust/BHCPCT)
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 1 of 8
Drug Name
Sulfasalazine 500 mg enteric coated tablets.
Indications for use within the protocol
Inflammatory arthritis diagnosed by a Rheumatologist, usually supported by indices
of inflammation.
Duration – most drugs require up to 3 to 4 months trial to assess efficacy (including
the time required for dose stabilisation). Therapy is continued providing the drug is
working and that any side effects are tolerated by the patient. Relapse is common
after withdrawal of therapy.
Background
Sulfasalazine is used as a disease modifying agent to induce and maintain remission
in several types of rheumatic disease. It can reduce inflammation and affect the
immune system and is therefore used for a number of other conditions.
Pharmacology
Sulfasalazine is cleaved by intestinal bacteria to equal amounts of 5-ASA and
sulfapyridine. Sulfapyridine is thought to be the more active element in rheumatoid
arthritis. Plausable explanations for sulfasalazine’s action center on inhibition of
bacterial gut antigens and a general anti-inflammatory effect caused by 5-ASA.
Dosage and administration
500 mg/day orally increasing by 500mg weekly to 2.0–3.0 g/day.
Occasionally doses above 3.0 g/day are prescribed.
Contraindications to use
Sulfasalazine is contra-indicated in patients:

Hypersensitive to sulphonamides/co-trimoxazole

Hypersensitive to aspirin.
Cautions

Glucose-6-phosphate dehydrogenase deficiency: May cause haemolysis. Seek
specialist advice.

Renal impairment (moderate - GFR 10-20ml/min): May cause significant
crystalluria and must ensure high fluid intake. In case of severe renal failure
(GFR <10ml/min) do not use.

Slow–acetylators of the drug: May cause drug-induced lupus-like syndrome. It is
not necessary to assess acetylator phenotype.

May impair folate absorption.
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 2 of 8
Monitoring
The British Society for Rheumatology (BSR) recommends precise monitoring to be
carried out for this drug. The requirements are summarised in the following table.
a. Pre-treatment
assessment

FBC, U&E, LFTs

These tests will be carried out by the initiating
hospital specialist.
b. Ongoing Monitoring

FBC and LFTs (including AST/ALT) monthly for the
first 3 months and 3 monthly thereafter

If, following the first year, dose and blood results have
been stable, frequency of blood tests can be reduced
to every 6 months for the second year of treatment

Thereafter, monitoring of blood for toxicity may be
discarded

Patients should be asked about the presence of rash
or oral ulceration at each visit.

Repeat FBC, LFT one month after dose increases.
c. Following dose
changes
Additional monitoring
not required but useful
ESR and/or CRP every three months.
Actions to be taken
9
WBC<3.5x10 /l
Withhold until discussed with specialist team.
9
Neutrophils<2.0x10 /l
Withhold until discussed with specialist team.
9
Platelets<150x10 /l
AST, ALT>twice
reference range
Withhold until discussed with specialist team.
upper
limit
of
Withhold until discussed with specialist team.
MCV>105 fl
Check B12, folate and TSH. If abnormal, treat
any underlying abnormality. If normal, discuss
with the specialist team.
Nausea/dizziness/headache
If possible continue, may have to reduce dose
or stop if symptoms severe. Discuss with
specialist team
Abnormal bruising or severe
Check FBC immediately and withhold until
results available. Discuss with the specialist
team, if necessary.
sore throat
Unexplained acute widespread rash
Withhold seek urgent specialist (preferably
dermatological) advice.
Oral ulceration
Withhold until discussed with specialist team.
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 3 of 8
Undesirable effects
The main adverse effects include:

Permanent staining of certain types of extended wear soft contact lenses

Generalised skin eruptions

Oligospermia, reversible on discontinuance of drug

GI disturbance
Pregnancy and Lactation

If sulfasalazine is to be prescribed during pregnancy, an analysis of risks and
benefits to the mother should be undertaken, against the possible small risk
related to the unborn child and doses should not exceed 2 g/day.

Folic acid: a supplement should be prescribed to those trying to conceive and
during pregnancy.

Small amounts of the drug may be excreted in breast milk although these are not
thought to be a risk to a healthy infant.
Interactions

Cardiac glycosides—possibly reduces absorption of digoxin

Combination therapy with azathioprine may contribute to bone marrow toxicity.
Consultant / hospital responsibilities
It is the hospital team’s responsibility to:

Identify those patients who will benefit from treatment with sulfasalazine

Undertake pre-treatment monitoring as detailed above

Provide the first month’s prescription for sulfasalazine and provide written
information on treatment to the patient and/or carers

Provide the patient with monitoring blood forms whilst on treatment with copies of
results sent to the GP (unless the GP chooses to take responsibility for both
prescribing and monitoring)

Undertake responsibility to act on pathology lab results (unless the GP chooses
to take responsibility)

Review efficacy of treatment at regular intervals and ensure any drug treatment
changes are communicated to the GP

Provide access to back up and support facilities

Report any adverse events to the CSM

Evaluate any adverse events reported by the GP.
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 4 of 8
GP responsibilities
It is the GP’s responsibility to:

Return the shared care agreement letter to the consultant to indicate agreement
with this guideline. If for any reason the GP is unhappy with the arrangements
they should contact the appropriate hospital specialist

Prescribe sulfasalazine at the dose recommended by the specialist. Any decision
to alter or discontinue treatment should be taken after discussion with the
hospital specialist

Check for possible drug interactions when newly prescribing or stopping
concurrent medication (see interaction section)

Report any suspected or actual adverse drug reactions to the hospital specialist
and the CSM
Patient responsibilities
It is the patient’s responsibility to:

Report side effects to any member of the health care team

Attend for blood testing when required to do so.
Information to the patient
The outpatient clinic will provide the patient with information about their treatment.
Information about the patient to be received by the GP from the consultant
Please refer to the shared care request letter attached. Two copies of this letter will
be sent to the GP for each patient initiated on therapy.
Patient information to be received by the consultant from the GP
In order for GPs to agree formally to this shared care protocol, it is requested that
both the shared care request letters attached be signed and one returned to the
hospital specialist requesting shared care.
Contacting secondary care
If the patient’s Consultant is not available, one of the other Consultants or the
Specialist Registrar will be able to help. Please call the Rheumatology department at
RSCH on 01273 696955 x4631/3553 or PRH on 01444 441881 x 5432/5984
Out of hours
Urgent problems should be referred to the medical team on call, contacted via RSCH
switchboard on 01273 696955 or the PRH switchboard on 01444 441881
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 5 of 8
References
1 British National Formulary 54. Pharmaceutical Press, 2007.
2 Salazopyrin summary of Product characteristics http://emc.medicines.org.uk/emc/
assets/c/html/DisplayDoc.asp?DocumentID=3344 (18 October 2007, date last
accessed).
3 Sweetman S. Martindale: the complete drug reference. Pharmaceutical Press,
2002.
4 Nørga°rd B, Czeizel AE, Rockenbauer M, Olsen J, Sørensen HT. Populationbased case control study of the safety of sulfasalazine use during pregnancy.
Aliment Pharmacol Ther 2001;15:483–6.
5 Ostensen M, Ramsey-Goldman R. Treatment of inflammatory rheumatic disorders
in pregnancy: what are the safest treatment options? Drug Saf 1998;19:389–410.
6 Preston S, Needs C. Guidelines on the use of antirheumatic drugs in women
during pregnancy and child-bearing age. Ballieres Clin Rheumatol 1990;4:687–98.
7 Herna´ndez-Dı´az S, Werler MM, Walker AM, Mitchell AA. Folic Acid antagonists
during pregnancy and the risk of birth defects. New Engl J Med 2002;343:1608–14.
8 Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory
medications on fertility, pregnancy, and lactation. Arch Intern Med 2000;160:610–9.
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 6 of 8
Confidential shared care request
Consultant name
Consultant address
Date
GP Name
GP Address
Sulfasalazine in inflammatory arthritis in adults ( 16 years old)
Patient Name: Patient Hospital number: Patient Address: Patient NHS Number: Dear Dr.
Your patient has been commenced on:
Sulfasalazine, at a dose of:
It would be appropriate for this patient’s therapy to be shared between primary and
secondary care. The enclosed Shared Care Guideline provides additional
information to support you in this. Please sign both copies of this letter to indicate
your agreement and return one copy to my office; the other should be placed in the
patient’s notes at your practice.
Yours sincerely,
Consultant name
GP signature
Print name
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 7 of 8
Date
Confidential shared care request
Consultant name
Consultant address
Date
GP Name
GP Address
Sulfasalazine in inflammatory arthritis in adults ( 16 years old)
Patient Name: Patient Hospital number: Patient Address: Patient NHS Number: Dear Dr.
Your patient has been commenced on:
Sulfasalazine, at a dose of:
It would be appropriate for this patient’s therapy to be shared between primary and
secondary care. The enclosed Shared Care Guideline provides additional
information to support you in this. Please sign both copies of this letter to indicate
your agreement and return one copy to my office; the other should be placed in the
patient’s notes at your practice.
Yours sincerely,
Consultant name
GP signature
Print name
SSZ SCG
Document status Final/Draft: Final 13 Jan 2009
Date of next review if final: 13 Jan 2010
Page 8 of 8
Date