Lubiprostone
لوبیپروستون
🍽️ Alimentary Tract And MetabolismChloride-channel activator (laxative)
Market / country: 🇺🇸 USA
Amitiza (US)
🧮 Dose calculator
Chronic idiopathic constipation · Regimen source: FDA Amitiza · 2.1, Table 1
- • Moderate hepatic impairment: 16 mcg twice daily; severe: 8 mcg twice daily. Swallow whole. FDA Amitiza · 2.1, Table 1FDA Amitiza · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Known or suspected mechanical GI obstruction. FDA Amitiza · 4
Warnings
- • Nausea; diarrhoea; syncope and hypotension; dyspnoea. FDA Amitiza · 5
Formulations
- 24 mcg capsule — capsule 🇺🇸 USA FDA Amitiza · 3
- 8 mcg capsule — capsule 🇺🇸 USA FDA Amitiza · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Amitiza · 8.1
“Risk Summary Following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, M3, has measurable systemic concentrations [see Clinical Pharmacology (12.3) ] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Amitiza · 8.2
“Risk Summary There are no data available on the presence of lubiprostone in human milk or the effect of lubiprostone on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Amitiza · 8.4
“Safety and effectiveness have not been established in pediatric patients with IBS-C, pediatric functional constipation (PFC), and OIC.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Amitiza · 8.5
“Chronic Idiopathic Constipation The efficacy of Amitiza 24 mcg twice daily in the elderly (at least 65 years of age) subpopulation with CIC was consistent with the efficacy in the overall study population.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA021908
- DailyMed (FDA label)FDA Amitiza
- MedlinePlus (NIH)Lubiprostone
- WHO ATC/DDDA06AX03
- Darooyab (Iran)lubiprostone
🇮🇷 Registered in Iran Darooyab · G-5501/lubiprostone
Dosage forms with Iranian generic codes, per Darooyab.
- 51409 · LUBIPROSTONE 8 ug CAPSULE · کپسول لوبیپروستون ۸ میکروگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Amitiza · 3FDA Amitiza · 2.1, Table 1FDA Amitiza · 2.2FDA Amitiza · 4FDA Amitiza · 5FDA Amitiza · SPL approval / marketing categoryFDA Amitiza · 8.1FDA Amitiza · 8.2FDA Amitiza · 8.4FDA Amitiza · 8.5
- 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-5501/lubiprostone
- Clinical review⚠ Unverified