SEGLENTIS safety profile

The safety of SEGLENTIS (celecoxib and tramadol hydrochloride) was studied in 550 patients across 7 clinical trials, including both single and multiple administrations.1

In a placebo-controlled post‑bunionectomy with osteotomy acute pain trial, 637 patients received either 200 mg of SEGLENTIS every 12 hours, 50 mg of tramadol hydrochloride every 6 hours, 100 mg of celecoxib every 12 hours, or placebo orally for 48 hours (blinded period) and were followed up to 7 days postdose.1

  • The most common adverse events (reported in >5% and > placebo) were nausea (30%), vomiting (16%), dizziness (17%), headache (12%), and somnolence (8%)
  • Discontinuation due to adverse events occurred in 1.6% of SEGLENTIS-treated patients (3 of 183), 1.6% of tramadol-treated patients (3 of 183), no celecoxib-treated patients, and no placebo-treated patients
  • Nausea (1.1%), and pruritus/rash (0.5%) were the adverse reactions that led to discontinuation in the SEGLENTIS group, whereas vomiting (1.1%) and supraventricular tachycardia (0.5%) led to discontinuation in the tramadol hydrocholoride group

Reported adverse reactions in >5% of patients in any treatment group and greater in SEGLENTIS vs placebo1

The safety of SEGLENTIS was studied in a Phase 3, placebo-controlled, post-bunionectomy acute pain trial (N=637).1,2

Discontinuing SEGLENTIS treatment

Decreasing the dose of or discontinuing SEGLENTIS

If it is deemed appropriate to decrease the dose or discontinue therapy in an opioid-dependent patient taking SEGLENTIS, consider the following1:

  • The total daily dose of opioid (including SEGLENTIS) the patient has been taking
  • The duration of treatment
  • The type of pain being treated
  • The physical and psychological attributes of the patient

To taper the dosage for patients on SEGLENTIS who are physically opioid dependent1:

  • Initiate the taper by reducing the daily opioid dosage by no more than 10%-25% to avoid withdrawal symptoms
  • Proceed by incrementally lowering the dose at intervals of every 2 to 4 weeks
  • Note that patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper
  • Provide your patients with a dose-tapering schedule of SEGLENTIS to help accomplish a successful taper
  • Continually reassess and check in with your patient to help manage pain and withdrawal symptoms

Abuse and dependence

Crucial considerations for prescribers

SEGLENTIS (celecoxib and tramadol hydrochloride) contains tramadol, a Schedule IV controlled substance with a high potential for abuse similar to other opioids, and it can be abused and is subject to misuse, addiction, and criminal diversion. The use of opioid analgesics carries the risk of addiction or abuse even under appropriate medical circumstances. Prescription drug abuse is the intentional use of medication for its physiological or psychological effect. Patients treated with opioids require careful monitoring for signs of addiction and abuse.1

Physical dependence differs from abuse and addiction. Dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug.1

Signs of drug-seeking behavior, such as making calls or visits toward the end of office hours, repeated loss of prescriptions, reluctance to provide medical record or contact information, or doctor shopping, should be closely monitored. All patients should receive thorough assessment, proper prescribing and dispensing of their treatment, guidance on appropriate storing practices, and periodic re-evaluation of therapy to help limit the abuse of SEGLENTIS.1

Because opioids like SEGLENTIS can lead to physical dependence or addiction, withdrawal syndrome may occur if the treatment is abruptly discontinued.1

  • Symptoms of this syndrome may include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis
  • Other symptoms may include irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or 
 increased blood pressure, respiratory rate, or heart rate

Find supportive resources for SEGLENTIS


References: 1. Seglentis [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; October 2021. 2. Viscusi ER, de Leon-Casasola O, Cebrecos J, et al. Celecoxibtramadol co-crystal in patients with moderate-to-severe pain following bunionectomy with osteotomy: a phase 3, randomized, double-blind, factorial, active- and placebo-controlled trial. Pain Pract. 2023;23(1):8-22. doi:10.1111/papr.13136. Epub 2022 Jul 8. PMID: 35686380