SALAZOPYRIN EN 500/MG TAB 100/TAB

Indications

Approved Uses

Ulcerative colitis (treatment of active disease and maintenance of remission) and rheumatoid arthritis; Crohn’s disease and juvenile idiopathic arthritis are not consistently approved indications for this product across regulators and are best treated as off‑label unless specifically stated in local labeling.

Off-Label Uses

Common off‑label uses include ankylosing spondylitis, psoriatic arthritis, and (depending on local labeling) Crohn’s disease and juvenile idiopathic arthritis.

Dosage & Administration

Dosing by Condition

Ulcerative colitis (adult, active): Typically 3-4 g/day in divided doses (some references allow up to 6 g/day in severe cases under specialist supervision).
Ulcerative colitis (adult, maintenance): Typically 2 g/day in divided doses (range often 2-3 g/day depending on response/tolerability).
Rheumatoid arthritis (adult): Start 500 mg once daily (or 500 mg twice daily) and increase by 500 mg weekly as tolerated to 2 g/day in divided doses; may increase to 3 g/day if needed and tolerated.
Juvenile idiopathic arthritis (≥6 years, specialist use): 30-50 mg/kg/day in 2 divided doses (max commonly 2 g/day; some specialist protocols may use higher maxima).

Initial Dose

500mg-1g twice daily, increasing gradually over 1-2 weeks

Maintenance Dose

IBD (ulcerative colitis): 2g/day in divided doses; Rheumatoid arthritis: 2g/day in divided doses (range 2-3g/day depending on response/tolerability)

Maximum Dose

Ulcerative Colitis: 4g/day. Rheumatoid Arthritis: 3g/day.

Children's Dosage

Children ≥2 years (IBD): 40-60mg/kg/day in 3-6 divided doses (induction); 20-30mg/kg/day in 4 divided doses (maintenance). Not recommended under 2 years

Dose Adjustment Notes

Start low and titrate upward to improve GI tolerability; use with caution in renal or hepatic impairment (no universally specified dose adjustment, but closer monitoring and dose reduction/avoidance may be needed in significant impairment).

How to Take

Swallow the enteric‑coated tablets whole with a full glass of water; do not crush, chew, or split. Preferably take after meals (or with food) and maintain adequate fluid intake.

Side Effects

Common Side Effects

Common: nausea, vomiting, loss of appetite/dyspepsia/abdominal discomfort, headache, diarrhea, rash; orange‑yellow discoloration of urine/skin may occur; reversible oligospermia (reduced sperm count) can occur.

Side Effect Frequency

Very common (≥10%): nausea/GI upset, headache, anorexia; Common (1-10%): vomiting, abdominal pain/dyspepsia, rash/pruritus, dizziness, reversible oligospermia, orange-yellow discoloration of urine/skin, folate deficiency; Rare/serious (<1%): severe blood dyscrasias (e.g., agranulocytosis/aplastic anemia), severe cutaneous reactions (SJS/TEN), hepatotoxicity, pulmonary toxicity, hemolysis (esp. G6PD deficiency), lupus-like syndrome.

Safety & Warnings

Contraindications

Hypersensitivity to sulfasalazine, sulfonamides, or salicylates; intestinal or urinary obstruction; porphyria.

Warnings & Precautions

Baseline and periodic CBC and LFT monitoring; stop immediately for rash/mucosal lesions, fever/sore throat, bruising/bleeding, or pulmonary symptoms; ensure adequate hydration to reduce crystalluria risk; consider folic acid supplementation; caution in G6PD deficiency and severe allergy/asthma; may cause reversible male infertility (oligospermia) and orange discoloration of body fluids.

Age Restriction

Not recommended/avoid use in children under 2 years of age (safety not established).

Drug Interactions

Drug Interactions

Key interactions: digoxin (reduced absorption), folic acid/folate (reduced absorption/folate deficiency), warfarin (INR effect may be altered-monitor closely), methotrexate (additive hematologic/hepatic toxicity risk), oral hypoglycemics (potentiation reported), iron salts (reduced sulfasalazine absorption).

Food Interaction

Take with food or after meals to reduce gastrointestinal upset.

Special Populations

Children

Children ≥2 years (IBD): 40-60mg/kg/day in 3-6 divided doses (induction); 20-30mg/kg/day in 4 divided doses (maintenance). Not recommended under 2 years

Kidney Impairment

Use with caution in renal impairment; avoid in severe renal impairment and ensure adequate hydration/monitor renal function.

Storage & Patient Advice

Stopping the Medicine

Do not stop without medical advice; stopping may worsen/relapse disease (tapering may be considered based on indication and clinical status).

Patient Counseling

Take after meals/with food and a full glass of water; swallow enteric-coated tablets whole (do not crush/chew); maintain good hydration; harmless orange-yellow discoloration of urine/skin may occur; keep scheduled monitoring (CBC and LFTs) and seek urgent care for sore throat/fever, rash, unusual bruising/bleeding, jaundice, or breathing difficulty; folic acid supplementation may be advised; may cause reversible oligospermia in males; do not stop without prescriber advice.

Monitoring Requirements

Baseline CBC (with differential/platelets), LFTs, and renal function; then CBC/LFTs every 2 weeks for the first 3 months, monthly for the next 3 months, then every 3 months thereafter (or per local protocol); monitor renal function periodically and consider folate status in long‑term therapy.

Pharmacology

Mechanism of Action

Sulfasalazine is cleaved by colonic bacteria into 5‑aminosalicylic acid (5‑ASA) and sulfapyridine; 5‑ASA acts mainly locally in the colon to reduce inflammatory mediator production, while sulfapyridine contributes more to systemic immunomodulatory effects (e.g., in RA).

Onset of Action

IBD (ulcerative colitis): clinical improvement typically within 2-4 weeks; Rheumatoid arthritis: onset in ~4-8 weeks with maximal/near-full effect by ~12 weeks (≈3 months).

Duration of Effect

Not immediate; requires continuous dosing-clinical response in ulcerative colitis is often seen within days to weeks, while rheumatoid arthritis benefit typically begins after ~4-12 weeks (maximal effect may take longer).

Bioavailability

Systemic absorption of parent sulfasalazine is low (generally <15% absorbed intact); most reaches the colon where bacterial cleavage releases sulfapyridine (well absorbed, ~60%) and 5-ASA (limited systemic absorption).

Metabolism

Prodrug is cleaved by colonic bacteria into sulfapyridine and 5-ASA; sulfapyridine undergoes hepatic acetylation (NAT2) with additional hydroxylation and glucuronidation; 5-ASA is largely acetylated to N-acetyl-5-ASA.

Excretion

Elimination is mainly renal as sulfapyridine and its metabolites (and some 5-ASA metabolites), with a portion excreted in feces (notably 5-ASA/acetyl-5-ASA and unabsorbed drug).

Product Information

Available Dosage Forms

For this SFDA-registered product: enteric‑coated oral tablet (SALAZOPYRIN‑EN) 500 mg.

Composition per Dose

Each enteric-coated tablet: 500mg sulfasalazine

Generic Availability

Yes

Gi Condition

Inflammatory Bowel Disease

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