Celecoxib/Tramadol

DEA Class; Rx

Common Brand Names; Seglentis

Analgesics, NSAID/Opioid Combos

Oral combination of opioid agonist and nonsteroidal anti-inflammatory drug (NSAID)

Used for the treatment of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

As with other NSAIDs, serious GI and CV adverse events may occur; tramadol associated with risk for seizures and suicidal tendency

Indicated for management of acute pain in adults that requires opioid analgesic and for which alternative treatments are inadequate

Children aged <12 years

Postoperative management in children aged <18 years following tonsillectomy and/or adenoidectomy

Significant respiratory depression

In the setting coronary artery bypass graft (CABG) surgery

Severe or acute bronchial asthma in unmonitored setting or in absence of resuscitative equipment

Known or suspected GI obstruction, including paralytic ileus

Hypersensitivity (eg, anaphylaxis, serious skin reactions) to tramadol, opioids, celecoxib, sulfonamides, or any other component of product

Concurrent use of MAOIs or use within last 14 days

History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

>10%

Nausea (30.1%)

Dizziness (16.9%)

Vomiting (15.8%)

Headache (11.5%)

1-10%

Somnolence (8.2%)

Decreased appetite (3.3%)

Adrenal insufficiency

Androgen deficiency

QT prolongation and/or torsade de pointes

Miosis, mydriasis

Hypoglycemia

Severe hyponatremia

Movement disorder, speech disorder

Delirium

Schedule IV controlled substance (ie, tramadol); exposes users to risks of addiction, abuse, and misuse

Serotonin syndrome may occur; may be life-threatening; may occur with use of tramadol alone, with concomitant use of serotonergic drugs, or with drugs that impair metabolism of serotonin or tramadol

May be subject to the same polymorphic metabolism as codeine, with ultra-rapid metabolizers of CYP2D6 substrates being potentially exposed to life-threatening levels of O-desmethyltramadol (M1)

Opioids can cause sleep-related breathing disorders including central sleep apnea and sleep-related hypoxemia

Prolonged use during pregnancy can result in withdrawal in the neonate

Seizures reported; may occur at recommended tramadol dose; coadministration with other drugs may increase seizure risk; risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures

May increase the risk of suicide; do not prescribe for patients who are suicidal or addiction-prone

Cases of adrenal insufficiency reported with opioid use, more often following >1 month of use; if diagnosed, treat with physiologic replacement doses of corticosteroids

Pregnancy 

There are no available data on use in pregnant females

Tramadol

Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome

Celecoxib

There are no adequate and well-controlled studies on pregnant females; data from observational studies regarding potential embryofetal risks of NSAIDs during the 1st or 2nd trimesters are inconclusive

Lactation; Not recommended for obstetrical preoperative medication or for postdelivery analgesia in lactating women

Adults

224 mg/day PO celecoxib and 176 mg/day PO tramadol.

Geriatric

224 mg/day PO celecoxib and 176 mg/day PO tramadol.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established

Neonates

Safety and efficacy have not been established.

celecoxib/tramadol HCl

Tablets, Schedule IV

• 56mg/44mg
• 44mg tramadol HCl equivalent to 39mg tramadol