Drug reference

Sulfasalazine

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 69, 70

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Treatment of acute attack of mild to moderate and severe ulcerative colitis | Active Crohn’s disease ▶BY MOUTH ▶Adult: 1–2 g 4 times a day until remission occurs, corticosteroids may also be given, if necessary ▶BY RECTUM ▶Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement Maintenance of remission of mild to moderate and severe ulcerative colitis ▶BY MOUTH ▶Adult: 500 mg 4 times a day ▶BY RECTUM ▶Adult: 0.5–1 g twice daily, administered alone or in conjunction with oral therapy, morning and night after a bowel movement Active rheumatoid arthritis (administered on expert advice) ▶BY MOUTH ▶Adult: Initially 500 mg daily, increased in steps of 500 mg every week, increased to 2–3 g daily in divided doses, enteric coated tablets to be administered

PDF page 69

Cautions

Acute porphyrias p. 1120. G6PD deﬁciency. history of allergy. history of asthma. maintain adequate ﬂuid intake. risk of haematological toxicity. risk of hepatic toxicity. slow acetylator status

PDF page 69

Safety

Important Safety Information

SAFE PRACTICE Sulfasalazine has been confused with sulfadiazine; care must be taken to ensure the correct drug is prescribed and dispensed.

PDF page 69

Interactions

→Appendix 1: sulfasalazine

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Side Effects

▶Common or very common Insomnia. stomatitis. taste altered. tinnitus. urine abnormalities ▶Uncommon Face oedema. seizure. vasculitis. vertigo ▶Frequency not known Anaemia. appetite decreased. ataxia . cyanosis. encephalopathy. haematuria. hallucination. hepatic failure. hypoprothrombinaemia. lymphadenopathy. macrocytosis. meningitis aseptic. methaemoglobinaemia. nephrotic syndrome. parotitis. periorbital oedema. pseudomembranous enterocolitis. Gastro-intestinal system serum sickness. severe cutaneous adverse reactions (SCARs). smell disorders. systemic lupus erythematosus (SLE). yellow discolouration of body ﬂuids SIDE-EFFECTS, FURTHER INFORMATION Incidence of side- effects increases with higher doses. Blood disorders Haematological abnormalities occur usually in the ﬁrst 3 to 6 months of treatment— discontinue if these occur.

PDF pages 69, 70

Pregnancy

Theoretical risk of neonatal haemolysis in third trimester; adequate folate supplements should be given to mother.

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Breast Feeding

Small amounts in milk (1 report of bloody diarrhoea); theoretical risk of neonatal haemolysis especially in G6PD-deﬁcient infants.

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Hepatic Impairment

Manufacturer advises caution.

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Renal Impairment

Risk of toxicity, including crystalluria, in moderate impairment—ensure high ﬂuid intake. Avoid in severe impairment.

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Monitoring Requirements

▶Blood disorders Close monitoring of full blood counts (including differential white cell count and platelet count) is necessary initially, and at monthly intervals during the ﬁrst 3 months. ▶Renal function Although the manufacturer recommends renal function tests in rheumatic diseases, evidence of practical value is unsatisfactory. ▶Liver function Liver function tests should be performed at monthly intervals for ﬁrst 3 months.

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension Oral suspension CAUTIONARY AND ADVISORY LABELS 14 EXCIPIENTS: May contain Alcohol ▶Sulfasalazine (Non-proprietary) Sulfasalazine 50 mg per 1 ml Sulfasalazine 250mg/5ml oral suspension sugar free sugar-free | 500 ml P £50.67 DT = £47.13 Gastro-resistant tablet CAUTIONARY AND ADVISORY LABELS 5, 14, 25 ▶Sulfasalazine (Non-proprietary) Sulfasalazine 500 mg Sulfasalazine 500mg gastro-resistant tablets | 112 tablet P £10.11 DT = £8.01 ▶Salazopyrin EN (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin EN-Tabs 500mg | 112 tablet P £8.43 DT = £8.01 ▶Sulazine EC (Genesis Pharmaceuticals Ltd) Sulfasalazine 500 mg Sulazine EC 500mg tablets | 112 tablet P £6.74 DT = £8.01 Tablet CAUTIONARY AND ADVISORY LABELS 14 ▶Sulfasalazine (Non-proprietary) Sulfasalazine 500 mg Sulfasalazine 500mg tablets | 112 tablet P £8.94 DT = £6.21 ▶Salazopyrin (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin 500mg tablets | 112 tablet P £6.97 DT = £6.21 Suppository CAUTIONARY AND ADVISORY LABELS 14 ▶Salazopyrin (Pfizer Ltd) Sulfasalazine 500 mg Salazopyrin 500mg suppositories | 10 suppository P £3.30 DT = £3.30 CORTICOSTEROIDS eiiii F 709

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Clinical care

Patient And Carer Advice

Contact lenses Some soft contact lenses may be stained.

PDF page 70

Dose text by age group

Adult

1–2 g 4 times a day until remission occurs,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

0.5–1 g twice daily, administered alone or in

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

500 mg 4 times a day

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

0.5–1 g twice daily, administered alone or in

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

Initially 500 mg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Sulfasalazine

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 69, 70

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 69

Cautions

Acute porphyrias p. 1120. G6PD deﬁciency. history of allergy. history of asthma. maintain adequate ﬂuid intake. risk of haematological toxicity. risk of hepatic toxicity. slow acetylator status

PDF page 69

Safety

Important Safety Information

SAFE PRACTICE Sulfasalazine has been confused with sulfadiazine; care must be taken to ensure the correct drug is prescribed and dispensed.

PDF page 69

Interactions

→Appendix 1: sulfasalazine

PDF page 69

Side Effects

PDF pages 69, 70

Pregnancy

Theoretical risk of neonatal haemolysis in third trimester; adequate folate supplements should be given to mother.

PDF page 70

Breast Feeding

Small amounts in milk (1 report of bloody diarrhoea); theoretical risk of neonatal haemolysis especially in G6PD-deﬁcient infants.

PDF page 70

Hepatic Impairment

Manufacturer advises caution.

PDF page 70

Renal Impairment

Risk of toxicity, including crystalluria, in moderate impairment—ensure high ﬂuid intake. Avoid in severe impairment.

PDF page 70

Monitoring Requirements

PDF page 70

Dose and formulations

Medicinal Forms

PDF page 70

Clinical care

Patient And Carer Advice

Contact lenses Some soft contact lenses may be stained.

PDF page 70

Dose text by age group

Adult

1–2 g 4 times a day until remission occurs,

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

0.5–1 g twice daily, administered alone or in

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

500 mg 4 times a day

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

0.5–1 g twice daily, administered alone or in

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Adult

Initially 500 mg daily, increased in steps of

First-line fragment. Read the complete Indications and Dose section above.

PDF page 69

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.