tapentadol

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Related to Nucynta ER: Tapentadol

tapentadol

(ta-pen-ta-dol) ,

Nucynta

(trade name),

Nucynta ER

(trade name)

Classification

Therapeutic: analgesics
Pharmacologic: opioid agonists
Pregnancy Category: C

Indications

Management of moderate to severe pain; extended release product should be used for patients requiring around-the-clock management of chronic pain.Diabetic pain associated with diabetic peripheral neuropathy in patients requiring around-the-clock opioid analgesia for an extended time

Action

Acts as μ-opioid receptor agonist.
Also inhibits the reuptake of norepinephrine.

Therapeutic effects

Decrease in pain severity.

Pharmacokinetics

Absorption: 32% absorbed following oral administration.
Distribution: Widely distributed.
Metabolism and Excretion: Undergoes extensive first-pass hepatic metabolism (97%); metabolites have no analgesic activity; metabolized drug is 99% renally excreted.
Half-life: 4 hr.

Time/action profile (analgesic effect)

ROUTEONSETPEAKDURATION
POunknown1 hr4–6 hr

Contraindications/Precautions

Contraindicated in: HypersensitivitySignificant respiratory depression in unmonitored settings or where resuscitative equipment is not readily available;Paralytic ileus;Severe hepatic or renal impairment;Concurrent MAO inhibitors or use of MAO inhibitors in the preceding 2 wk;Acute or severe bronchial asthma;Acute, mild, intermittent, or postoperative pain (extended-release only); Lactation: Lactation; Pediatric: Safety not established.
Use Cautiously in: Conditions associated with hypoxia, hypercapnea, or ↓ respiratory reserve including asthma, chronic obstructive pulmonary disease, cor pulmonale, extreme obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, use of other CNS depressants or coma (↑ risk of further respiratory depression); use smallest effective dose;History of substance abuse or addiction disorder;Seizure disorders;Moderate hepatic impairment Geriatric: Elderly or debilitated patients (↑ risk of respiratory depression); consider age-related ↓ in hepatic, renal, and cardiovascular function, concurrent disease states and drug therapy (initial dose should be ↓); Obstetric: Use only if potential benefit justifies potential risk to the fetus.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • dizziness
  • headache
  • somnolence

Respiratory

  • respiratory depression (life-threatening)

Cardiovascular

  • hypotension

Gastrointestinal

  • diarrhea
  • nausea
  • vomiting

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Concurrent MAO inhibitors or use of MAO inhibitors in the preceding 2 wk can result in potentially life-threatening adverse cardiovascular reactions due to additive effects on norepinephrine levels.Concurrent use of other CNS depressants including sedative/hypnotics, alcohol, antihistamines, antidepressants, phenothiazines, and other opioids ↑ risk of further CNS depression; consider dose ↓ of one or both agents.↑ risk of serotonin syndrome with SNRIs, SSRIs, triptans, tricyclic antidepressants, and MAO inihibitors.

Route/Dosage

When switching from immediate-release to extended-release product, the same total daily dose can be used.
Oral (Adults) Immediate-release or oral solution—50 mg, 75 mg, or 100 mg initially, then every 4–6 hr as needed and tolerated. If pain control is not achieved within first hour of first dose, additional dose may be given. Doses should not exceed 700 mg on the first day or 600 mg/day thereafter; Extended-release—50 twice daily; titrate dose up to 100–250 mg twice daily (not to exceed dose of 500 mg/day).

Hepatic Impairment

Oral (Adults) Moderate hepatic impairment—Immediate release or oral solution: 50 mg every 8 hr initially, then titrate to maintain analgesia without intolerable side effects; Extended-release: 50 mg once daily; may titrate up to maximum dose of 100 mg once daily, if needed.

Availability

Immediate-release tablets: 50 mg, 75 mg, 100 mg
Extended-release tablets: 50 mg, 100 mg, 150 mg, 200 mg, 250 mg
Oral solution: 20 mg/mL

Nursing implications

Nursing assessment

  • Assess type, location, and intensity of pain before and 1 hr (peak) after administration.
  • Assess BP and respiratory rate before and periodically during administration. Monitor for respiratory depression especially during initial dosing and with patients at increased risk.
  • Assess bowel function routinely. Prevention of constipation should be instituted with increased intake of fluids and bulk and with laxatives to minimize constipating effects. Administer stimulant laxatives routinely if opioid use exceeds 2–3 days, unless contraindicated.
  • Prolonged use may lead to physical and psychological dependence and tolerance, although these may be milder than with opioids. This should not prevent patient from receiving adequate analgesia. Most patients who receive tapentadol for pain do not develop psychological dependence.
  • Monitor patient for seizures. May occur within recommended dose range. Risk is increased in patients with a history of seizures and in patients taking antidepressants (SSRIs, SNRIs, tricyclics) or other drugs that decrease the seizure threshold.
  • Monitor for serotonin syndrome (mental-status changes [agitation, hallucinations, coma]), autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyperreflexia, incoordination] and/or gastrointestinal symptoms [nausea, vomiting, diarrhea] in patients taking SSRIs, SNRIs, triptans, tricyclic antidepressants, or MAO inhibitors concurrently with tapentadol.
  • Overdose may cause respiratory depression. Naloxone (Narcan) may reverse some, but not all, of the symptoms of overdose. Treatment should be symptomatic and supportive. Maintain adequate respiratory exchange.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Initial dose of 50 mg, 75 mg, or 100 mg is individualized based on pain severity, previous experience with similar drugs, and ability to monitor patient. Second dose may be administered as soon as 1 hr after first dose if adequate pain relief is not obtained with first dose.
  • Oral: Tapentadol may be administered without regard to meals.
    • Swallow extended-release tablets whole; do not crush, break or chew.
    • Use calibrated syringe to administer correct dose of oral solution.

Patient/Family Teaching

  • Instruct patient on how and when to ask for and take pain medication and to take tapentadol as directed; do not adjust dose without consulting health care professional. Report breakthrough pain and adverse reactions to health care professional. Do not take tapentadol if pain is mild or can be controlled with other pain medications such as NSAIDs or acetaminophen. Do not stop abruptly; may cause withdrawal symptoms (anxiety, sweating, insomina, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, hallucinations). Decrease dose gradually. Advise patient to read the Medication Guide prior to taking tapentadol and with each Rx refill, in case of new information.
  • Advise patient that tapentadol is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed; may be dangerous.
  • May cause dizziness and drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Inform patient that tapentadol may cause seizures. Stop taking tapentadol and notify health care professional immediately if seizures occur.
  • Advise patient to change positions slowly to minimize orthostatic hypotension.
  • Caution patient to avoid concurrent use of alcohol or other CNS depressants with this medication.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise patient to notify health care professional if signs of serotonin syndrome occur.
  • Encourage patient to turn, cough, and breathe deeply every 2 hr to prevent atelectasis.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in severity of pain without a significant alteration in level of consciousness or respiratory status.
References in periodicals archive ?
Nucynta is indicated to manage moderate-to-severe acute pain in adults, Nucynta ER extended release tablets are indicated to manage pain, including neuropathic pain associated with diabetic peripheral neuropathy, severe enough to require daily, around-the-clock, long-term opioid treatment.
Nucynta ER, an opioid, is already approved for extended use in moderate to severe chronic pain.
The approval of Nucynta ER for DPN pain represents the ongoing commitment of Janssen to bring new and innovative products to patients and physicians for the management of pain," said Paul Chang, vice president of medical affairs at Janssen.
Janssen Pharmaceuticals (JPI) reported on Friday the launch of an agreement to divest its US license rights to NUCYNTA (tapentadol), NUCYNTA ER (tapentadol) extended-release tablets and NUCYNTA (tapentadol) oral solution for USD1.
Currently, JPI licenses the commercialisation rights to NUCYNTA (tapentadol), NUCYNTA ER (tapentadol) extended-release tablets and NUCYNTA (tapentadol) oral solution from Grunenthal GmbH.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed primary care physicians (PCPs) and pain specialists indicate that they have experienced reimbursement restrictions when prescribing Janssen's Nucynta ER for chronic low back pain.
J&JPRD), a subsidiary of US Johnson & Johnson (NYSE:JNJ), said today it had filed a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults.
26 August 2011 - Janssen Pharmaceuticals Inc, part of US Johnson & Johnson (NYSE:JNJ), said on Friday that the US Food and Drug Administration (FDA) has approved NUCYNTA ER (tapentadol extended-release tablets), an oral analgesic taken twice daily, for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
The findings from the Pharmacor topic entitled Fibromyalgia reveal that, through 2020, an expanding drug-treated population and, to a lesser extent, the uptake of Forest Laboratories/Cypress Bioscience's Savella (milnacipran), Johnson & Johnson/Grunenthal's Nucynta ER (tapentadol ER) and Pfizer's controlled-release formulation of Lyrica (pregabalin CR), will help to offset sales lost to the generic erosion of Cymbalta and Lyrica.
The broad label approval of Nucynta ER (extended-release tapentadol; Johnson & Johnson/Grnenthal) will drive market growth, while the launch of novel and topical agents will broaden treatment options.
In addition, the successful launch of certain disease modifying drugs and pain management products such as SMC021 (oral calcitonin) and Nucynta ER (tapentadol) which are currently in the late stage pipeline, may significantly stimulate market growth in the near future.
Nucynta ER is the most clinically and commercially attractive pipeline drug, eclipsing the gold standard OxyContin.