Seglentis Generic Name & Formulations
Celecoxib, tramadol HCl 56mg/44mg; tabs.
NSAID + opioid.
Management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Use only if alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or otherwise inadequate to provide sufficient management of pain.
Seglentis Dosage and Administration
Use lowest effective dose for shortest duration. Individualize. ≥18yrs: 2 tabs every 12hrs as needed. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks.
<18yrs: not recommended.
Children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. Significant respiratory depression. Coronary artery bypass graft surgery. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs. Sulfonamide, aspirin, or other NSAID allergy.
Seglentis Boxed Warnings
Addiction, abuse, and misuse. Risk evaluation and mitigation strategy (REMS). Life-threatening respiratory depression. Accidental ingestion. Cardiovascular thrombotic events. Gastrointestinal bleeding, ulceration, and perforation. Ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children. Neonatal opioid withdrawal syndrome. Interactions with drugs affecting CYP450 isoenzymes. Risks from concomitant use with benzodiazepines or other CNS depressants.
Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, concomitant use of CNS depressants, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor within 1st 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Increased risk of serious cardiovascular thrombotic events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk for serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of peptic ulcer disease and/or GI bleeding. Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of tramadol (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant use of drugs that cause respiratory depression). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Circulatory shock, impaired consciousness, or coma; avoid. Increased intracranial pressure, brain tumors; monitor. Head injury. Biliary tract disease. Acute pancreatitis. Discontinue at 1st sign of skin rash or any other hypersensitivity. Hypertension; monitor BP closely. Coagulation disorders. May mask signs of infection or fever. Seizure disorders. Avoid in depressed, suicidal, or addiction-prone patients; consider non-narcotic analgesics. Emotional disturbance. Dehydration. Hypovolemia. Hyperkalemia. Preexisting asthma (monitor). Adrenal insufficiency. Hyponatremia. Hypoglycemia. Diabetes. Drug abusers. Ultra-rapid metabolizers (due to CYP2D6 polymorphism), CYP2C9 poor metabolizers, moderate and severe hepatic or severe renal impairment: not recommended. Reevaluate periodically. Avoid abrupt cessation. Elderly (esp. >75yrs). Cachetic. Debilitated. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Potential neonatal opioid withdrawal syndrome with prolonged use. Labor & delivery, nursing mothers: not recommended.
See Contraindications. Concomitant aspirin, salicylates (eg, diflunisal, salsalate), other NSAIDs, other tramadol or celecoxib-containing products: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. Increased risk of respiratory depression, sedation, hypotension with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, antipsychotics, other opioids, alcohol); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Increased risk of seizures with SSRIs, SNRIs, anorectics, TCAs, cyclobenzaprine, promethazine, other opioids, MAOIs, naloxone, neuroleptics, and others that lower seizure threshold. May antagonize, or increase risk of renal failure and hypertension with diuretics (eg, loop or thiazide), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May be affected by CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine, bupropion). Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine). Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Paralytic ileus may occur with anticholinergics.
Seglentis Adverse Reactions
Nausea, vomiting, dizziness, headache, somnolence; respiratory depression, cardiovascular thrombotic events, GI ulcer/bleed, severe hypotension, hypertension, heart failure, edema, hepatotoxicity, renal toxicity, hematologic toxicity, syncope; rare: serious skin reactions or other hypersensitivity; discontinue if occur.
Seglentis Clinical Trials
Seglentis Patient Counseling