Tapentadol

If you are taking tapentadol tablets, your doctor will probably tell you to take the medication as needed. If your doctor has told you to take the tablets regularly, take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

If you are taking tapentadol extended-release capsules, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Nucynta is the brand name for tapentadol, a prescription painkiller used to treat both acute and chronic pain, including lower back pain. It is also used for controlling diabetic neuropathy pain as needed.

Nucynta is an opioid (or narcotic) pain medication that works by changing the levels of neurotransmitters in the brain.

Developed by Grunenthal in partnership with Johnson & Johnson Pharmaceutical Research and Development, Nucynta was approved by the Food and Drug Administration (FDA) in August 2008. It is the first new pain killer of its type approved in the United States in more than 25 years.

Nucynta Warnings

It's important to know that Nucynta is habit forming. Misuse can cause addiction, overdose, or death. Nucynta should only be taken exactly as prescribed. Nucynta should not be taken in conjunction with alcohol, or illicit drugs.

Seek emergency medical attention if you have trouble breathing, feel faint, dizzy, confused, or have a seizure or hallucinations. Improper use can result in central nervous system depression, hypotension, respiratory depression, coma, and even death.

Nucynta should be avoided by pregnant and nursing mothers, because of the danger posed to the fetus or breastfeeding infant.

It's important to discuss with your doctor the potential for Nucynta to cause physical dependence, and whether you are at risk of abuse or addiction based on previous drug use, or a family history of drug or alcohol abuse.

Elderly patients may have a lower tolerance for Nucynta, and should be monitored. Respiratory depression may result in patients who have chronic obstructive pulmonary disease (COPD).

Nucynta may result in severe hypotension (low blood pressure), and should be avoided in patients with circulatory shock. Nucynta may also aggravate seizures.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using tapentadol with other medicines can cause serious side effects. The doses of some other medicines may need to be changed. Your doctor can tell you what medicines can be safely taken with tapentadol. 

Especially tell your doctor if you take:

• Monoamine Oxidase Inhibitors (MAOIs)
• Any medicine that makes you sleepy. Tapentadol can make you sleepy and affect your breathing. Taking these medicines together can be dangerous.

Tapentadol can cause serious side effects including:

• Life-threatening breathing problems. Call your doctor right away or get emergency medical help if you:
  • have trouble breathing, or have slow or shallow breathing 
  • have a slow heartbeat 
  • have severe sleepiness 
  • have cold, clammy skin 
  • feel faint, dizzy, confused, or can not think, walk or talk normally 
  • have a seizure 
  • have hallucinations
• Physical Dependence. Tapentadol can cause physical dependence. Talk to your doctor about slowly stopping tapentadol to avoid getting sick with withdrawal symptoms. You could become sick with uncomfortable symptoms because your body has become used to the medicine. Tell your doctor if you have any of these symptoms of withdrawal: feeling anxious, sweating, sleep problems, shivering, pain, nausea, tremors, diarrhea, upper respiratory symptoms, hallucinations, hair "standing on end." Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. 
• Serotonin syndrome. Serotonin syndrome is a rare, life-threatening problem that could happen if you take tapentadol with Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Monoamine Oxidase Inhibitors (MAOIs), triptans or certain other medicines. Call your doctor or get medical help right away if you have any one or more of the these symptoms: you feel agitated, have hallucinations, coma, rapid heart beat, feel overheated, loss of coordination, over active reflexes, nausea, vomiting, or diarrhea. 
• Seizures. Tapentadol can cause seizures in people who are at risk for seizures or who have epilepsy. Tell your doctor right away if you have a seizure and stop taking tapentadol. 
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

Do not drive, operate machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. Tapentadol can make you sleepy. 

Do not take tapentadol if you:

• have severe asthma, trouble breathing, or other lung problems
• a bowel blockage or have narrowing of the stomach or intestines.
• taken a monoamine oxidase inhibitor (MAOI) medicine or have taken a MAOI medicine within the last 14 days.

You should not drink alcohol while using tapentadol. Alcohol increases your chance of having dangerous side effects.

Tapentadol is an opioid pain medication. An opioid is sometimes called a narcotic.

Tapentadol is used to treat moderate to severe pain.

The extended-release form of this medicine (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Tapentadol may also be used for purposes not listed in this medication guide.

Since tapentadol is used for pain, you are not likely to miss a dose. If you do miss a dose, take the medicine as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

Immediate release:

>10%:

Central nervous system: Dizziness (24%), drowsiness (15%)

Gastrointestinal: Nausea (30%), vomiting (18%)

1% to 10%:

Central nervous system: Fatigue (3%), insomnia (2%), abnormal dreams (1%), anxiety (1%), confusion (1%), lethargy (1%)

Dermatologic: Pruritus (3% to 5%), hyperhidrosis (3%), skin rash (1%)

Endocrine & metabolic: Hot flash (1%)

Gastrointestinal: Constipation (8%), xerostomia (4%), decreased appetite (2%), dyspepsia (2%)

Genitourinary: Urinary tract infection (1%)

Neuromuscular & skeletal: Arthralgia (1%), tremor (1%)

Respiratory: Nasopharyngitis (1%), upper respiratory tract infection (1%)

Extended release:

>10%:

Central nervous system: Dizziness (17% to 18%), headache (10% to 15%), drowsiness (12% to 14%)

Gastrointestinal: Nausea (21% to 27%), constipation (13% to 17%), vomiting (8% to 12%)

1% to 10%:

Cardiovascular: Hypotension (1%)

Central nervous system: Fatigue (9%), anxiety (2% to 5%), insomnia (4%), irritability (2%), lethargy (2%), abnormal dreams (1% to 2%), vertigo (1% to 2%), chills (1%), depression (1%), hypoesthesia (1%), lack of concentration (1%), nervousness (1%), sedation (1%), withdrawal syndrome (1%)

Dermatologic: Pruritus (1% to 8%), hyperhidrosis (3% to 5%), skin rash (1%)

Endocrine & metabolic: Hot flash (2% to 3%)

Gastrointestinal: Diarrhea (7%), xerostomia (7%), decreased appetite (2% to 6%), dyspepsia (1% to 3%), abdominal distress (1%)

Genitourinary: Erectile dysfunction (1%)

Neuromuscular & skeletal: Tremor (1% to 3%), weakness (2%)

Ophthalmic: Blurred vision (1%)

Respiratory: Dyspnea (1%)

Immediate and/or extended release: <1% (Limited to important or life-threatening): Abnormality in thinking, altered mental status, anaphylaxis, angioedema, ataxia, decreased blood pressure, delayed gastric emptying, disorientation, drug withdrawal, dysarthria, euphoria, hallucination, hypersensitivity, hypogonadism (Brennan, 2013; Debono, 2011), impaired consciousness, intoxicated feeling, memory impairment, panic attack, pollakiuria, presyncope, respiratory depression, seizure, syncope, urinary hesitation, visual disturbance

Do not use tapentadol if you have used a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use this medicine if you have severe breathing problems, or a bowel obstruction called paralytic ileus.

Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take this medicine in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Tapentadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Tapentadol may cause life-threatening withdrawal symptoms in a newborn if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Mild liver dysfunction (Child-Pugh 5-6): No adjustment recommended.

Moderate liver dysfunction (Child-Pugh 7 to 9):
-Immediate release tablets and solution: Initial dose 50 mg orally no more than every 8 hours (maximum of 3 doses in 24 hours)
-Extended release tablets: Initial dose 50 mg orally once a day (maximum of 100 mg/day)

Severe liver dysfunction (Child-Pugh 10-15): Not recommended.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. It includes a medication guide, elements to assure safe use, and an implementation system. For additional information: www.fda.gov/REMS

US BOXED WARNINGS (Extended release tablets):
-ADDICTION, ABUSE, AND MISUSE: Addiction to, abuse, or misuse of this drug can lead to overdose and death. Assess each patient's risk before prescribing and monitor regularly for these behaviors or conditions.
-LIFE-THREATENING RESPIRATORY DEPRESSION: Respiratory depression with fatal outcome can occur. Monitor closely upon initiation or following a dose increase. Instruct patients to swallow the tablets whole; crushing, chewing, or dissolving the tablets can cause rapid release and absorption of a potentially fatal dose.
-ACCIDENTAL INGESTION: Accidental ingestion, especially in children, can be fatal.
-NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use during pregnancy can result in this life-threatening syndrome if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk and ensure appropriate treatment will be available.
-INTERACTION WITH ALCOHOL: Instruct patients not to consume alcoholic beverages or use products that contain alcohol while taking this drug. Ingestion with alcohol can result in fatal plasma tapentadol levels.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II