naldemedine (Symproic)

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Indications

* may be less effective if receiving opiates for < 4 weeks

Contraindications

Dosage

  • 0.2 mg PO QD with or without food

Pharmacokinetics

Drug interactions

  • concurrent use of CSP3A4 inhibitor(s) may reduce effectiveness of naldemedine

Mechanism of action

More general terms

References

  1. 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
  2. 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: https://www.ncbi.nlm.nih.gov/pubmed/28576452 https://www.thelancet.com/journals/langas/article/PIIS2468-1253(17)30105-X/fulltext
  3. Symproic. HIGHLIGHTS OF PRESCRIBING INFORMATION https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf

Database