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naldemedine (Symproic)
Indications:
- opiate-induced constipation in adults with chronic non-cancer pain
* may be less effective if receiving opiates for < 4 weeks
Contraindications:
- intestinal obstruction
Dosage:
- 0.2 mg PO QD with or without food
Pharmacokinetics:
- metabolized by CYP3A4
Drug interactions:
- concurrent use of CSP3A4 inhibitor(s) may reduce effectiveness of naldemedine
Mechanism of action:
- opioid receptor antagonist
General
opioid receptor antagonist or narcotic antagonist
laxative
Database Correlations
PUBCHEM cid=54732242
References
- Windle ML.
FDA New Drug and Biologic Approvals -- 2017 Year-in-Review
Medscape - Jan 11, 2018.
https://reference.medscape.com/viewarticle/890871
- U.S. Food and Drug Administration.
Novel Drug Approvals for 2017.
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
- Hale M, Wild J, Reddy J et al.
Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2):
two multicentre, phase 3, double-blind, randomised, parallel-group trials.
Lancet Gastroenterol Hepatol. 2017;2(8):555-564
PMID: 28576452
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(17)30105-X/fulltext
- Symproic. HIGHLIGHTS OF PRESCRIBING INFORMATION
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf