Formulary
Sulfasalazine: Indications, Dosing, Side Effects and Interactions
Sulfasalazine clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 4 min read
Sulfasalazine: Indications, Dosing, Side Effects and Interactions
Sulfasalazine clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Treatment of acute attack of mild to moderate and severe ulcerative colitis,Active Crohn's disease**
- **Adult** (By Mouth): 1-2 g 4 times a day until remission occurs, corticosteroids may also be given, if necessary.
- **Adult** (By Rectum): 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**
- **Adult** (By Mouth): 500 mg 4 times a day.
- **Adult** (By Rectum): 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)**
- **Adult** (By Mouth): 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.
**Treatment of acute attack of mild to moderate and severe ulcerative colitis, Active Crohn's disease for sulfasalazine**
- **Child 2-11 years** (By mouth): 10-15 mg/kg 4-6 times a day (max. per dose 1 g) until remission occurs; increased if necessary up to 60 mg/kg daily in divided doses.
- **Child 12-17 years** (By mouth): 1-2 g 4 times a day until remission occurs.
- **Child 5-7 years** (By rectum): 500 mg twice daily.
- **Child 8-11 years** (By rectum): 500 mg, dose to be administered in the morning and 1 g, dose to be administered at night.
- **Child 12-17 years** (By rectum): 0.5-1 g twice daily.
**Maintenance of remission of mild to moderate and severe ulcerative colitis for sulfasalazine**
- **Child 2-11 years** (By mouth): 5-7.5 mg/kg 4 times a day (max. per dose 500 mg).
- **Child 12-17 years** (By mouth): 500 mg 4 times a day.
- **Child 5-7 years** (By rectum): 500 mg twice daily.
- **Child 8-11 years** (By rectum): 500 mg, dose to be administered in the morning and 1 g, dose to be administered at night.
- **Child 12-17 years** (By rectum): 0.5-1 g twice daily.
**Juvenile idiopathic arthritis for sulfasalazine**
- **Child 2-11 years** (By mouth): Initially 5 mg/kg twice daily for 1 week, then 10 mg/kg twice daily for 1 week, then 20 mg/kg twice daily for 1 week; maintenance 20-25 mg/kg twice daily; maximum 2 g per day.
- **Child 12-17 years** (By mouth): Initially 5 mg/kg twice daily for 1 week, then 10 mg/kg twice daily for 1 week, then 20 mg/kg twice daily for 1 week; maintenance 20-25 mg/kg twice daily; maximum 3 g per day.
Cautions
Acute porphyrias ; G6PD deficiency; history of allergy; history of asthma; maintain adequate fluid intake; risk of haematological toxicity; risk of hepatic toxicity; slow acetylator status
Side effects
Common or very common Arthralgia; cough; diarrhoea; dizziness; fever; gastrointestinal discomfort; headache; leucopenia; myalgia; nausea; proteinuria; skin reactions; vomiting Uncommon Alopecia; depression; dyspnoea; face oedema; pancreatitis; paraesthesia; photosensitivity reaction; tachycardia; thrombocytopenia; vertigo Rare or very rare Agranulocytosis; angioedema; blood disorder; bone marrow disorders; cardiac inflammation; hepatic disorders; interstitial lung disease; lupus-like syndrome; nephritis tubulointerstitial; nephrotic syndrome; neutropenia; peripheral neuropathy; renal impairment; respiratory disorders Frequency not known Cholelithiasis; eosinophilia; haematuria; haemolytic anaemia; oligozoospermia (reversible); severe cutaneous adverse reactions (SCARs); ulcerative colitis aggravated Side-effects, further information A blood count should be performed and the drug stopped immediately if there is suspicion of a blood dyscrasia. Side-effects For sulfasalazine General side-effects: Common or very common Insomnia; stomatitis; taste altered; tinnitus Uncommon Seizure; vasculitis Frequency not known Anaemia; appetite decreased; ataxia; crystalluria; cyanosis; encephalopathy; hallucination; hypoprothrombinaemia; lymphadenopathy; macrocytosis; meningitis aseptic; methaemoglobinaemia; parotitis; periorbital oedema; pseudomembranous enterocolitis; serum sickness; smell disorders; systemic lupus erythematosus (SLE); yellow discolouration of body fluids Specific side-effects: Frequency not known With oral use Urine discolouration 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.
Interactions
**Other interactions (5):**
- Reduced absorption of digoxin, resulting in non-therapeutic serum levels, has been reported when used concomitantly with oral sulfasalazine.
- Patients receiving sulfasalazine and hypoglycaemic agents should be closely monitored.
- Due to inhibition of thiopurine methyltransferase by sulfasalazine, bone marrow suppression and leucopenia have been reported when the thiopurine 6-mercaptopurine or it's prodrug, azathioprine, and...
- Coadministration of oral sulfasalazine and methotrexate to rheumatoid arthritis patients did not alter the pharmacokinetic disposition of the drugs.
- Several reports of possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to...
Pregnancy
Theoretical risk of neonatal haemolysis in third trimester; adequate folate supplements should be given to mother.
Breast feeding
Small amounts in milk (1 report of bloody diarrhoea); theoretical risk of neonatal haemolysis especially in G6PD-deficient infants.
Hepatic impairment
Manufacturer advises caution.
Renal impairment
Use with caution in mild to moderate impairment (risk of toxicity including crystalluria); avoid in severe impairment. M
Medicinal forms
Suspension,Tablet,Tablet,Suspension,Suppository
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
Inside MedNext for this topic
- 411 MedNext-authored chapters
- 80,000+ MCQ bank
- 15 study modes
- Growing visual cheat sheets
Study modes
- Notes
- MCQ
- Audio
- Video
- Visual
- 3D Anatomy
- Trace
- Flashcards
- Mnemonics
- Image Bank
- Clinical
- Microscopy
- Audio QBank
- Cadaver
- Book Match
Continue reading
Subject HubPharmacology Hub
All pharmacology resources in one place.
Drug SchedulesIndian Drug Schedules
Schedule H, H1, X and G classifications.
FormularyBrowse all drugs
Search 1,850+ drug profiles.
Study Sulfasalazine in the MedNext app
Challenge yourself with targeted pharmacology MCQs on this drug class. Every explanation links back to the chapter that teaches the concept.
Start drug challengeExplore the full formulary