Tapentadol

DEA Class; Rx

Common Brand Names; Nucynta, Nucynta ER

Oral opioid mu-receptor agonist and norepinephrine reuptake inhibitor
Used for severe pain
No active metabolites

Indicated for the treatment of severe pain.

Hypersensitivity (eg, anaphylaxis, angioedema)

Significant respiratory depression

Acute or severe asthma

Hypercarbia in unmonitored setting or in absence of resuscitative equipment

Gastrointestinal obstruction, including suspected paralytic ileus

Coadministration with monoamine oxidase inhibitors (MAOIs) or use within 14 days

Conditions with risk for respiratory depression (particularly in patients who are elderly or debilitated or have comorbid conditions with hypoxia, hypercarbia, or airway obstruction)

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

Avoid dosing errors that may result from confusion between mg and mL when prescribing, dispensing, and administering oral solution; ensure the dose is communicated clearly and dispensed accurately; always use the enclosed calibrated syringe when administering drug to ensure the dose is measured and administered accurately; do not use teaspoon or tablespoon to measure a dose; a household teaspoon or tablespoon is not an adequate measuring device; health care providers should recommend a calibrated device that can measure and deliver prescribed dose accurately, and instruct caregivers to use extreme caution in measuring dosage

In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

May cause drowsiness (use with caution when driving or operating machinery)

Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol, other opioids, or drugs of abuse

Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage

Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period