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Seglentis FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 4, 2021.

FDA Approved: Yes (First approved October 15, 2021)
Brand name: Seglentis
Generic name: celecoxib and tramadol hydrochloride
Dosage form: Tablets
Company: Esteve Pharmaceuticals, S.A.
Treatment for: Pain

Seglentis (celecoxib and tramadol hydrochloride) is a nonsteroidal anti-inflammatory drug (NSAID) and opioid agonist combination indicated for the management of acute pain in adults.

  • Seglentis tablets contain a co-crystal composed of celecoxib (first approved under the brand name Celebrex) and tramadol hydrochloride (first approved under the brand name Ultram). The co-crystal structure produces a unique pharmacokinetic profile of the two active pharmaceutical ingredients compared to their individual or combined administration.
  • Seglentis is administered orally at an initial dose of two tablets every 12 hours as needed for pain relief. Patients should be monitired closely for signs of respiratory depression, especially within the first 24-72 hours of initiating therapy.
  • The Seglentis product label carries a boxed warning for the risks of addiction, abuse, and misuse; respiratory depression; accidental ingestion leading to overdose; increased risk of serious cardiovascular thrombotic events; and the increased risk of serious gastrointestinal (GI) adverse events.
  • Because Seglentis contains the opioid analgesic tramadol, it is classified as a Schedule IV controlled substance.
  • The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis to ensure that the benefits outweigh the risks of addiction, abuse, and misuse,
  • Common adverse reactions include nausea, vomiting, dizziness, headache, somnolence.

Development timeline for Seglentis

DateArticle
Oct 18, 2021Approval FDA Approves Seglentis (celecoxib and tramadol hydrochloride) for the Management of Acute Pain

Further information

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