Generic
Sulfasalazine
8 brands available in the market
At a glance
Sulfasalazine is a DMARD used for rheumatoid arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. It suppresses immune system overactivity and blocks inflammatory mediators.
Description
The mechanism of action of Sulfasalazine is not fully understood. It exhibits direct anti-inflammatory action in the colon and systemically interferes with prostaglandin synthesis. Its main active component, 5-aminosalicylic acid (5-ASA), reduces intestinal inflammation, while the sulfapyridine moiety provides systemic immunomodulatory effects.
Indications
- Rheumatoid arthritis
- Juvenile idiopathic arthritis
- Ulcerative colitis
- Crohn's disease (especially with colonic involvement)
- Ankylosing spondylitis
Therapeutic class
Drugs for IBS, Rheumatoid Arthritis & Ulcerative Colitis
Pharmacological class
DMARD (Disease Modifying Anti-Rheumatic Drug)
Pharmacology
Sulfasalazine is broken down in the intestine into 5-aminosalicylic acid (5-ASA) and sulfapyridine. 5-ASA provides local anti-inflammatory action by inhibiting leukotriene and prostaglandin synthesis; sulfapyridine provides systemic immunomodulatory effects. It inhibits both cyclooxygenase and lipoxygenase pathways, reducing production of inflammatory mediators.
Mechanism of action
Suppresses immune system overactivity and blocks inflammatory mediators.
Dosage
Adult Dose (Oral):
- Ulcerative colitis/Crohn's: Start 1-2 g 4 times daily (until remission); Maintenance 2 g/day (divided)
- Rheumatoid arthritis: Start 500 mg/day (week 1), increase by 500 mg weekly; max 3 g/day in 2-4 divided doses
- Ankylosing spondylitis: 2 g/day in 2 divided doses
Pediatric Dose (Oral):
- Ulcerative colitis (>2 years): 40-60 mg/kg/day (divided); Maintenance 20-30 mg/kg/day
- Juvenile RA (>6 years): 30-50 mg/kg/day in 2 divided doses; max 2 g/day
Administration
- Take with food (to reduce stomach upset)
- Swallow tablet whole; do not chew, crush, or break
- Take with plenty of water (to avoid kidney stones)
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Headache, loss of appetite
- GI discomfort, weight loss
- Oligospermia (reversible reduction in sperm count)
Precautions & warnings
- Do not use in hypersensitivity to sulfonamides or salicylates
- Do not use in porphyria, intestinal or urinary obstruction
- Do not use in children <2 years
- Caution in G6PD deficiency, hepatic/renal impairment
- Regular blood tests (liver, kidney function, blood counts) required
Contraindications
- Hypersensitivity to sulfonamides or salicylates
- Porphyria
- Children <2 years
- Intestinal or urinary obstruction
- Blood dyscrasias
Drug interactions
- Rifampicin, ethambutol: Decreased plasma levels
- Folic acid: Interferes with absorption
- Gold therapy: Additive leukopenia
- Azathioprine: Increased hematologic toxicity
- Digoxin: Decreased serum levels
Food interactions
Alcohol is unsafe with Sulfasalazine (increased liver risk).
Use in pregnancy
Use in Pregnancy: Generally safe; animal studies show low or no adverse effects; limited human data; consult your doctor.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited data suggests drug may pass into breast milk and harm the baby; consult your doctor.
Pediatric use
Contraindicated in children <2 years; indicated for children ≥6 years
Geriatric use
Caution required in elderly patients
Renal / hepatic impairment
Renal Impairment: CrCl 10-30: Twice daily; CrCl <10: Once daily; consult your doctor.
Hepatic Impairment: Probably unsafe in liver disease; avoid; consult your doctor.
Overdose effects
No overdose information available; excessive doses may cause nausea, abdominal pain, diarrhea; provide symptomatic treatment.
Storage conditions
Store in a cool and dry place, protected from light; keep out of reach of children.
Chemical structure
Sulfasalazine