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Trulance
plecanatide
Black Box Warnings .
Pediatric Risk
contraindicated in pts <6 yo; deaths occurred due to dehydration w/in 24h in nonclinical studies in young juvenile mice after admin. of a single oral dose; avoid use in pts 6 yo to less than 18 yo; safety and efficacy not established in pts <18 yo
Adult Dosing .
Dosage forms: TAB: 3 mg
chronic idiopathic constipation
- [3 mg PO qd]
IBS, constipation-predominant
- [3 mg PO qd]
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- pts <18 yo
- GI obstruction
Drug Interactions .
Overview
plecanatide
guanylate cyclase-C agonist
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- diarrhea, severe
Common Reactions
- diarrhea
- hypersensitivity rxn
Safety/Monitoring .
Monitoring Parameters
no routine tests recommended
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no human data available, though risk of fetal harm not expected based on insignificant systemic absorption
Lactation
Clinical Summary
may use while breastfeeding; no known risk of infant harm based on limited human data and minimal systemic absorption in breastfeeding pts; no human data available, though risk of adverse effects on milk production not expected based on minimal systemic absorption in breastfeeding pts
Pharmacology .
Metabolism: GI tract; CYP450: none; Info: active metabolite; negligible systemic absorption
Excretion: unknown; Half-life: unknown
Subclass: Constipation: Guanylate Cyclase-C (GC-C) Agonists ; Irritable Bowel Syndrome (IBS)
Mechanism of Action
activates guanylate cyclase-C, stimulating cGMP production and increasing intestinal fluid secretion and motility
Formulary .
No Formulary Selected
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