Plecanatide
پلکاناتاید
🍽️ Alimentary Tract And MetabolismGuanylate cyclase-C agonist
Market / country: 🇺🇸 USA
Trulance (US)
🧮 Dose calculator
Chronic idiopathic constipation · Regimen source: FDA Trulance · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Children under 6 years (serious dehydration); mechanical GI obstruction. FDA Trulance · 4
Warnings
- • Boxed warning: serious dehydration in children — contraindicated under 6 y, avoid 6–<18 y. Severe diarrhoea. FDA Trulance · Boxed WarningFDA Trulance · 5
Formulations
- 3 mg tablet — tablet 🇺🇸 USA FDA Trulance · 3
👥 Special populations
- 🤰 PregnancyNo specific problem stated
Label: minimal systemic absorption; fetal exposure not expected. FDA Trulance · 8.1
“Risk Summary Plecanatide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology (12.3) ] and maternal use is not expected to result in fetal exposure to the drug.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Trulance · 8.2
“Risk Summary After administration of multiple doses of TRULANCE 3 mg once daily for 2 weeks to nursing mothers, plecanatide and its active metabolite were not measurable in breast milk collected at 2 hours, 6 hours, and 12 hours post-dosing.”
- 👶 ChildrenContraindicated
Label: contraindicated in children below a stated age. FDA Trulance · 4
“TRULANCE is contraindicated in: Patients less than 6 years of age due to the risk of serious dehydration [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] .”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Trulance · 8.5
“Chronic Idiopathic Constipation (CIC) Of 2,601 subjects in placebo-controlled clinical trials of TRULANCE, 273 (10%) were 65 years of age and over, and 47 (2%) were 75 years and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA208745
- DailyMed (FDA label)FDA Trulance
- MedlinePlus (NIH)Plecanatide
- WHO ATC/DDDA06AX07
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
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 Trulance · 3FDA Trulance · 2.1FDA Trulance · 4FDA Trulance · Boxed WarningFDA Trulance · 5FDA Trulance · SPL approval / marketing categoryFDA Trulance · 8.1FDA Trulance · 8.2FDA Trulance · 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 · search
- Clinical review⚠ Unverified