tapentadol hydrochloride

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Related to Nucynta: Nucynta ER

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 ?
Pharmaceutical company The GrAaAaAeA nenthal Group stated on Tuesday th it plans to commercialise Nucynta (tapentadol) in the US territory via an agreement with Collegium Pharmaceutical Inc for the pain management opioid market, with effect from 2018.
In June Depomed trained and deployed 275 sales specialists to sell NUCYNTA on behalf of the company and resumed significant marketing and medical support for the brand.
With the deal, NUCYNTA will become the flagship asset in Depomed's expanding portfolio of pain and neurology specialty pharmaceuticals.
Depomed, an international pharmaceutical company, has completed the acquisition of the US licence rights to the Nucynta franchise from Belgium-based Janssen Pharmaceuticals, it was reported on Monday.
Depomed recently re-launched its flagship product, Nucynta, which is expected to significantly increase Depomed's product revenue, cash flow, EBITDA and adjusted earnings per share beginning in 2015 and continuing through the mid-2020s.
M2 PHARMA-January 19, 2015-Janssen Pharmaceuticals to sell US license rights to NUCYNTA, NUCYNTA ER and NUCYNTA Oral Solution for USD1.
As part of the agreement, Depomed will receive an upfront payment of USD10m, a low single digit royalty on net sales of NUCYNTA ER (tapentadol extended-release tablets) in the US, Canada and Japan from and after 2 July 2012 through 31 December 2021 and a one-time sales milestone on specified quarterly net sales.
said last month it received regulatory approval for a wider use of its Nucynta ER painkiller, for pain from nerve damage that is brought on by diabetes.
M2 PHARMA-October 31, 2011-Johnson & Johnson files sNDA for NUCYNTA ER extended-release tablets for diabetic peripheral neuropathic pain(C)2011 M2 COMMUNICATIONS