Alosetron
آلوسترون
🍽️ Alimentary Tract And Metabolism5-HT3 antagonist
Market / country: 🇺🇸 USA
Lotronex (US)
🧮 Dose calculator
Functional bowel / irritable bowel syndrome · Regimen source: FDA Alosetron · 2.1
- • Stop at once if constipated; after resolution restart at 0.5 mg once daily; stop permanently if it recurs. Stop if not controlled after 4 weeks at 1 mg twice daily. FDA Alosetron · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Current constipation; history of severe constipation or its sequelae, obstruction, stricture, toxic megacolon, perforation or adhesions; ischaemic colitis, impaired intestinal circulation, thrombophlebitis or hypercoagulable state; Crohn disease or ulcerative colitis; diverticulitis; severe hepatic impairment; fluvoxamine. FDA Alosetron · 4
Warnings
- • Boxed warning: serious GI adverse reactions (ischaemic colitis, complications of constipation) sometimes requiring surgery or causing death — only for women with severe refractory IBS-D; stop immediately with constipation or rectal bleeding. FDA Alosetron · Boxed Warning
Formulations
- 0.5 mg tablet — tablet 🇺🇸 USA FDA Alosetron · 3
- 1 mg tablet — tablet 🇺🇸 USA FDA Alosetron · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Alosetron · 8.1
“Risk Summary The available data with alosetron tablets use in pregnant women are insufficient to draw conclusions about any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Alosetron · 8.2
“Risk Summary There are no data regarding the presence of alosetron in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Alosetron · 8.4
“Safety and effectiveness 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 Alosetron · 8.5
“In some studies in healthy men or women, plasma concentrations were elevated by approximately 40% in individuals 65 years and older compared to young adults [see Warnings and Precautions ( 5.1 )] .”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA211621
- DailyMed (FDA label)FDA Alosetron
- MedlinePlus (NIH)Alosetron
- WHO ATC/DDDA03AE01
- Darooyab (Iran)Alosetron
🇮🇷 Not found in Iran list Darooyab · G-2534/Alosetron
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Alosetron · 3FDA Alosetron · 2.1FDA Alosetron · 4FDA Alosetron · Boxed WarningFDA Alosetron · 8.1FDA Alosetron · 8.2FDA Alosetron · 8.4FDA Alosetron · 8.5FDA Alosetron · 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-2534/Alosetron
- Clinical review⚠ Unverified