Sulfasalazine
سولفاسالازین
🍽️ Alimentary Tract And MetabolismAminosalicylate / DMARD
Market / country: 🇺🇸 USA
Azulfidine EN-tabs (US)
🧮 Dose calculator
Ulcerative colitis · Regimen source: FDA Sulfasalazine DR · Dosage and Administration
- • Dose intervals ≤8 h, after meals, swallow whole. May start at 1–2 g/day. Maintenance: 2 g/day. FDA Sulfasalazine DR · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to sulfasalazine, sulfonamides or salicylates; intestinal or urinary obstruction; porphyria. FDA Sulfasalazine DR · Contraindications
Formulations
- 500 mg delayed-release tablet — tablet 🇺🇸 USA FDA Sulfasalazine DR · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Sulfasalazine DR · Pregnancy:
“Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Sulfasalazine DR · Nursing Mothers:
“Caution should be exercised when sulfasalazine delayed release tablets are administered to a nursing mother.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Sulfasalazine DR · Pediatric Use:
“The safety and effectiveness of sulfasalazine delayed release tablets in pediatric patients below the age of 2 years with ulcerative colitis have not been established.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA007073
- DailyMed (FDA label)FDA Sulfasalazine DR
- MedlinePlus (NIH)Sulfasalazine
- WHO ATC/DDDA07EC01
- Darooyab (Iran)Sulfasalazine
🇮🇷 Registered in Iran Darooyab · G-2652/Sulfasalazine
Dosage forms with Iranian generic codes, per Darooyab.
- 01184 · SULFASALAZINE 3MG/100ML ENEMA · انما سولفاسالازین ۳ میلیگرم / ۱۰۰ میلیلیتر
- 04150 · SULFASALAZINE 500MG EC TAB · قرص انتریککوتد سولفاسالازین ۵۰۰ میلیگرم
- 01183 · SULFASALAZINE 500MG TAB · قرص سولفاسالازین ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Sulfasalazine DR · How SuppliedFDA Sulfasalazine DR · Dosage and AdministrationFDA Sulfasalazine DR · ContraindicationsFDA Sulfasalazine DR · SPL approval / marketing categoryFDA Sulfasalazine DR · Pregnancy:FDA Sulfasalazine DR · Nursing Mothers:FDA Sulfasalazine DR · Pediatric Use:
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2652/Sulfasalazine
- Clinical review⚠ Unverified