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Mesalamine (mesalazine)
مزالازین
🍽️ Alimentary Tract And MetabolismAminosalicylate
🤰 Pregnancy:Use with caution🤱 Breastfeeding:Use with caution👶 Children:Safety not established👴 Older adults:Use with caution 🇮🇷 Registered in Iran⛔ 2 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA203286ATC A07EC02
Market / country: 🇺🇸 USA
Asacol HD (US)
🧮 Dose calculator
Ulcerative colitis · Regimen source: FDA Mesalamine DR · 2.2
- • Do not substitute one 800 mg tablet for two 400 mg products. Check renal function first. FDA Mesalamine DR · 2.1FDA Mesalamine DR · 2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to salicylates or aminosalicylates. FDA Mesalamine DR · 4
- ⛔ This product not established in children. FDA Mesalamine DR · 8.4
Formulations
- 800 mg tablet — tablet 🇺🇸 USA FDA Mesalamine DR · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Mesalamine DR · 8.1
“Risk Summary Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Mesalamine DR · 8.2
“Risk Summary Mesalamine and its N-acetyl metabolite are present in human milk in undetectable to small amounts [ see Data ].”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Mesalamine DR · 8.4
“Safety and effectiveness of mesalamine in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Mesalamine DR · 8.5
“Monitor complete blood cell counts and platelet counts in elderly patients during therapy with mesalamine delayed-release tablets.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA203286
- DailyMed (FDA label)FDA Mesalamine DR
- MedlinePlus (NIH)MesalamineMesalamine Rectal
- WHO ATC/DDDA07EC02
- Darooyab (Iran)Mesalazine
🇮🇷 Registered in Iran Darooyab · G-2613/Mesalazine
Dosage forms with Iranian generic codes, per Darooyab.
- 06168 · MESALASINE 1000MG ENEMA · انما مسالاسین ۱۰۰۰ میلی‌گرم
- 11655 · MESALAZINE 1000MG SUPP · شیاف مزالازین ۱۰۰۰ میلی‌گرم
- 02443 · MESALAZINE 1G/SACHET GRANULE · ساشه مزالازین ۱ گرم
- 01728 · MESALAZINE 250MG EC TAB · قرص انتریک‌کوتد مزالازین ۲۵۰ میلی‌گرم
- 00812 · MESALAZINE 400MG TAB · قرص مزالازین ۴۰۰ میلی‌گرم
- 00785 · MESALAZINE 4G ENEMA · انما مزالازین ۴ گرم
- 02246 · MESALAZINE 500MG SUPP · شیاف مزالازین ۵۰۰ میلی‌گرم
- 00813 · MESALAZINE 500MG TAB · قرص مزالازین ۵۰۰ میلی‌گرم
- 01867 · MESALAZINE 50MG SUPP · شیاف مزالازین ۵۰ میلی‌گرم
- 09916 · MESALAZINE 800MG TAB · قرص مزالازین ۸۰۰ میلی‌گرم
- 02155 · MESALAZINE SR 250MG TAB · قرص آهسته‌رهش مزالازین ۲۵۰ میلی‌گرم
- 02156 · MESALAZINE SR 500MG TAB · قرص آهسته‌رهش مزالازین ۵۰۰ میلی‌گرم
- 50426 · MESALAZINE CAPSULE, EXTENDED RELEASE ORAL 500 mg · کپسول آهسته‌رهش مزالازین ۵۰۰ میلی‌گرم
- 50022 · MESALAZINE GRANULE, EXTENDED RELEASE ORAL 2 g · گرانول آهسته‌رهش مزالازین ۲ گرم
- 52302 · MESALAZINE TABLET, EXTENDED RELEASE ORAL 1 g · قرص آهسته‌رهش مزالازین ۱ گرم
- 52146 · MESALAZINE ENEMA RECTAL 1 g/100mL · انما مزالازین ۱ گرم / ۱۰۰ میلی‌لیتر
- 52236 · MESALAZINE GRANULE, EXTENDED RELEASE ORAL 4 g · گرانول آهسته‌رهش مزالازین ۴ گرم
- 52672 · MESALAZINE TABLET, EXTENDED RELEASE ORAL 1200 mg · قرص آهسته‌رهش مزالازین ۱۲۰۰ میلی‌گرم
- 52885 · MESALAZINE TABLET, EXTENDED RELEASE ORAL 1600 mg · قرص آهسته‌رهش مزالازین ۱۶۰۰ میلی‌گرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Mesalamine DR · 3FDA Mesalamine DR · 2.2FDA Mesalamine DR · 2.1FDA Mesalamine DR · 2FDA Mesalamine DR · 4FDA Mesalamine DR · 8.4FDA Mesalamine DR · 8.1FDA Mesalamine DR · 8.2FDA Mesalamine DR · 8.5FDA Mesalamine DR · SPL approval / marketing category
- 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-2613/Mesalazine
- Clinical review⚠ Unverified