tapentadol hydrochloride

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tapentadol hydrochloride

Nucynta, Nucynta ER

Pharmacologic class: Opioid agonist

Therapeutic class: Opioid analgesic

Controlled substance schedule II

Pregnancy risk category C

FDA Box Warning

Know that Nucynta ER is an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit. Assess each patient's risk of opioid abuse or addiction before prescribing Nucynta ER. Risk of opioid abuse increases in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (such as major depressive disorder). Routinely monitor all patients receiving Nucynta ER for signs and symptoms of misuse, abuse, and addiction during treatment.

Respiratory depression, including fatal cases, may occur with Nucynta ER, even when drug has been used as recommended and not misused or abused. Proper dosing and titration are essential; Nucynta ER should only be prescribed by health care professionals knowledgeable in the use of potent opioids for management of chronic pain. Monitor patients for respiratory depression, especially during initiation of Nucynta ER or after a dosage increase. Instruct patients to swallow tablets whole. Crushing, dissolving, or chewing extended-release tablets can cause rapid release and absorption of a potentially fatal tapentadol dose.

Accidental ingestion of Nucynta ER, especially in children, can result in a fatal tapentadol overdose.

Consuming alcohol with Nucynta ER may result in increased tapentadol plasma level and potentially fatal overdose. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products that contain alcohol while taking Nucynta ER.


Exact mechanism unknown. Analgesic effect may be due to mu-opioid agonist activity and inhibition of norepinephrine reuptake.


Tablets: 50 mg, 75 mg, 100 mg

Tablets (extended-release): 50 mg, 100 mg, 150 mg, 200 mg, 250 mg

Indications and dosages

Relief of moderate to severe acute pain

Adults ages 18 and older: 50 mg, 75 mg, or 100 mg (immediate-release) P.O. q 4 to 6 hours depending on pain intensity. On day 1, may give second dose as early as 1 hour after initial dose, if needed. Maximum daily dosage on day 1 is 700 mg and on subsequent days, 600 mg. Higher dosages not recommended.

Management of moderate to severe chronic pain and neuropathic pain associated with diabetic peripheral neuropathy when continuous, around-the-clock opioid analgesic is needed for an extended period

Adult: Individualize dosing regimen according to pain severity and previous experience with similar drugs. Initially in patient not currently taking opioid analgesics, 50 mg (extended-release tablets) P.O. b.i.d. q 12 hours. Dosage range is 100 to 250 mg (extended-release tablets) P.O. b.i.d. q 12 hours. Patients receiving immediate-release form may be converted to extended-release by administering same total daily dose at half the total daily immediate-release dose q 12 hours. Maximum daily extended release dosage is 500 mg.

Dosage adjustment

• Moderate hepatic impairment

• Elderly patients


• Hypersensitivity to drug or its components (extended-release form)

• Significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or in absence of resuscitative equipment

• Paralytic ileus

• Monoamine oxidase (MAO) inhibitor use within last 14 days


Use cautiously in:

• severe hepatic or renal impairment (use not recommended)

• moderate hepatic impairment

• respiratory depression, hypoxia, hypercapnia, upper airway obstruction, decreased respiratory reserve (such as asthma, chronic obstructive pulmonary disease, or cor pulmonale), severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, coma, hypotension

• biliary tract disease, including pancreatitis

• head injury, other intracranial injuries, increased intracranial pressure, seizures

• impaired consciousness or coma susceptible to intracranial effects of carbon dioxide retention (avoid extended-release use)

• concurrent use of other CNS depressants or serotonergic agents

• elderly or debilitated patients

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).


• Administer with or without food. Give extended-release tablets whole.

Don't give concurrently or within 14 days of MAO inhibitor.

• Be aware that extended-release tablets aren't for use as an as-needed analgesic, for pain that is mild or not expected to persist for an extended time, for acute pain, or for postoperative pain unless patient is already receiving long-term opioid therapy.

• Be aware that withdrawal symptoms may occur if extended-release form is discontinued abruptly. Taper dosage to reduce withdrawal symptoms.

Adverse reactions

CNS: dizziness, somnolence, headache, fatigue, tremor, lethargy, insomnia, confusion, abnormal dreams, anxiety, seizures

EENT: nasopharyngitis

GI: nausea, vomiting, constipation, dry mouth, dyspepsia, decreased appetite

GU: urinary tract infection

Musculoskeletal: arthralgia

Respiratory: upper respiratory tract infection, respiratory depression

Skin: rash, pruritus, excessive sweating

Other: hot flushing, physical or psychological drug dependence, drug tolerance, hypersensitivity


Drug-drug. Antidepressants, antihistamines, general anesthetics, sedative-hypnotics, other CNS depressants: additive CNS depression leading to potentially life-threatening reactions MAO inhibitors (such as isocarboxazid, phenelzine, tranylcypromine): increased risk of potentially fatal reactions (hyperthermia, myoclonus, autonomic instability)

Mixed agonist or antagonist opioids (such as butorphanol, nalbuphine, pentazocine): reduced analgesic effect; precipitated withdrawal symptoms

Serotonergics (such as MOA inhibitors and triptans, selective norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, tricyclic antidepressants, other drugs that impair metabolism of serotonin): risk of potentially life-threatening serotonin syndrome

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

Stay alert for overdose signs and symptoms, such as CNS and respiratory depression, GI cramping, and constipation; provide supportive measures as appropriate.

• Monitor vital signs and CNS and respiratory status.

• Assess pain level and efficacy of pain relief.

• Monitor patient for signs and symptoms of drug dependence or tolerance.

• Monitor patient for hypotension during dosage initiation and titration.

Patient teaching

• Instruct patient to take drug with or without food.

• Tell patient to take one extendedrelease tablet at a time with a sufficient amount of water to ensure complete swallowing immediately after placing tablet in the mouth. Tell patient that these tablets must be swallowed whole and must not be split, broken, chewed, dissolved, or crushed.

Instruct patient to stop taking drug and immediately tell prescriber if a seizure occurs.

Caution patient not to stop taking drug suddenly and that drug must be tapered.

• Advise patient to avoid alcohol use while taking drug.

• Advise patient to consult prescriber before taking other prescription or nonprescription drugs.

• Tell patient to notify prescriber if shortness of breath or difficulty breathing occurs or if nausea, vomiting, or constipation become pronounced.

• Instruct patient to move slowly when sitting up or standing to avoid dizziness or light-headedness from sudden blood pressure decrease.

• Caution patient to avoid driving and other hazardous activities until drug's effects on concentration, alertness, vision, coordination, and physical dexterity are known.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and behaviors mentioned above.

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.