What is Nucynta?
Nucynta (tapentadol) is an opioid pain medication. An opioid is sometimes called a narcotic.
Tapentadol is used for the treatment of moderate to severe pain for both acute (following injury, surgery, etc.) and chronic musculoskeletal pain in adults. . It is also specifically indicated for controlling the pain of diabetic neuropathy when around-the-clock opioid medication is required.
Its general potency is somewhere between that of tramadol and morphine, with an analgesic efficacy comparable to that of oxycodone despite a lower incidence of side effects.
The extended-release form of tapentadol (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. It is not for use on an as-needed basis for pain.
Nucynta may also be used for purposes not listed in this medication guide.
You should not use Nucynta if you have severe breathing problems, or a bowel obstruction called paralytic ileus.
Do not use Nucynta 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.
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. Nucynta may cause life-threatening withdrawal symptoms in a newborn.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.
Before taking this medicine
You should not use Nucynta if you are allergic to tapentadol, or if you have:
severe asthma or breathing problems; or
a bowel obstruction called paralytic ileus.
Do not use Nucynta if you have taken 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, and tranylcypromine.
Tapentadol may be habit forming. Never share Nucynta with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away Nucynta to any other person is against the law
Some medicines can interact with tapentadol and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
To make sure this medicine is safe for you, tell your doctor if you have:
any type of breathing problem or lung disease;
a history of head injury, brain tumor, or seizures;
a history of drug abuse, alcohol addiction, or mental illness;
liver or kidney disease; or
problems with your gallbladder, pancreas, or thyroid.
Nucynta is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
It is not known whether Nucynta will harm an unborn baby. If you use tapentadol while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether tapentadol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Do not give Nucynta to a child.
Nucynta information: Dosage Forms and Strengths
Initiation of Therapy
Usual Adult Dose of Nucynta for Pain in Immediate release tablets:
50 mg, 75 mg, or 100 mg orally every 4 to 6 hours depending upon pain intensity, with or without food.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability. Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are, therefore, not recommended. Nucynta may be given with or without food.
Opioid naive: Initial: 50 mg twice daily (recommended interval: 12 hours); titrate in increments of 50 mg no more frequently than twice daily every 3 days to effective dose (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day)
Opioid experienced: Initial: 50 mg titrated to an effective dose; titrate in increments of 50 mg no more frequently than twice daily every 3 days (therapeutic range: 100 to 250 mg twice daily) (maximum dose: 500 mg/day). Note: No adequate data on converting patients from other opioids to Nucynta ER extended release.
Conversion from immediate release to extended release: Convert using same total daily dose but divide into two equal doses and administer twice daily (recommended interval: 12 hours) (maximum dose: 500 mg/day).
Individualization of Dosage
As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of tapentadol, give attention to the following:
The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving tapentadol is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy.
During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family. Monitor the patient for signs of respiratory or central nervous system depression.
What other drugs will affect Nucynta?
Some medicines can cause unwanted or dangerous effects when used with tapentadol. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.
Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Nucynta with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Use of Nucynta in patients with severe renal impairment is not recommended.
No dosage adjustment is recommended in patients with mild or moderate renal impairment.
The safety and efficacy of Nucynta® has not been studied in patients with severe hepatic impairment (Child-Pugh Score 10–15) and use in this population is not recommended.
Initiate treatment of patients with moderate hepatic impairment (Child-Pugh Score 7 to 9) with 50 mg no more frequently than once every 8 hours (maximum of three doses in 24 hours). Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval.
In general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
Cessation of Therapy
When the patient no longer requires therapy with tapentadol, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.
Nucynta® is contraindicated in:
How should I take Nucynta?
Take Nucynta exactly as prescribed. Follow all directions on your prescription label. Nucynta can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Nucynta in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Tapentadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.
Take this medicine with a full glass of water. Nucynta can be taken with or without food.
Stop taking all other around-the-clock narcotic pain medications when you start taking Nucynta ER extended-release tablets.
Do not crush, break, or open an extended-release tablet. Swallow the tablet whole to avoid exposure to a potentially fatal dose.
Nucynta can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.
While using Nucynta, you may need frequent blood tests.
Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using tapentadol.
Never crush or break a Nucynta tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Nucynta is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover Nucynta tablets. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused tablets down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.
What happens if I miss a dose?
Since Nucynta 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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.
What should I avoid?
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol. Check your food and medicine labels to be sure these products do not contain alcohol.
This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Nucynta will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Nucynta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Nucynta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Warnings and Precautions
Nucynta® contains tapentadol, an opioid agonist and a Schedule II controlled substance. Tapentadol can be abused in a manner similar to other opioid agonists legal or illicit. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Nucynta® in situations where there is concern about increased risks of misuse, abuse, or diversion. Concerns about abuse, addiction, and diversion should not, however, prevent the proper management of pain.
Assess each patient's risk for opioid abuse or addiction prior to prescribing Nucynta®. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with opioids; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving opioids for signs of misuse, abuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use.
Misuse or abuse of Nucynta® by crushing, chewing, snorting or injecting will pose a significant risk that could result in overdose and death.
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Life Threatening Respiratory Depression
Respiratory depression is the chief hazard of opioid agonists, including Nucynta®. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a "sighing" pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status.
Instruct patients against use by individuals other than the patient for whom Nucynta® was prescribed and to keep Nucynta® out of the reach of children, as such inappropriate use may result in fatal respiratory depression.
Patients with conditions accompanied by hypoxia, hypercarbia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, central nervous system (CNS) depression, or coma may be at increased risk for increased airway resistance and decreased respiratory drive to the point of apnea even with usual therapeutic doses of Nucynta®. Consider the use of alternative non-mu-opioid agonist analgesics and use Nucynta® only under careful medical supervision at the lowest effective dose in such patients. If respiratory depression occurs, treat the patient for mu-opioid agonist-induced respiratory depression. To reduce the risk of respiratory depression, proper dosing of Nucynta® is essential .
Accidental ingestion of Nucynta®, especially in children, can result in a fatal overdose of tapentadol.
Interactions with Alcohol, Other Opioids, and Drugs of Abuse
Due to its mu-opioid agonist activity, Nucynta® may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression, respiratory depression, hypotension, and profound sedation, coma or death. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol, other opioids, or drugs of abuse while on Nucynta® therapy.
Elderly, Cachectic, and Debilitated Patients
Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Therefore, closely monitor such patients, particularly when Nucynta® is given concomitantly with other drugs that depress respiration.
Use in Patients with Chronic Pulmonary Disease
Monitor for respiratory depression those patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercarbia, or pre-existing respiratory depression, as in these patients, even usual therapeutic doses of Nucynta® may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible.
Interactions with CNS Depressants and Illicit Drugs
Hypotension, and profound sedation, coma or respiratory depression may result if Nucynta® is used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids and illicit drugs). When considering the use of Nucynta® in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient's response, including the degree of tolerance that has developed to CNS depression. Additionally, consider the patient's use, if any, of alcohol and/or illicit drugs that can cause CNS depression. If Nucynta® therapy is to be initiated in a patient taking a CNS depressant, start with a lower Nucynta® dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant
Nucynta® may cause severe hypotension. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after the dose of Nucynta®. In patients with circulatory shock, Nucynta® may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Nucynta® in patients with circulatory shock.
Use in Patients with Head Injury or Increased Intracranial Pressure
Monitor patients taking Nucynta® who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression. Nucynta® may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.
Avoid the use of Nucynta® in patients with impaired consciousness or coma.
Call your doctor at once if you have:
weak or shallow breathing, weak pulse, slow heartbeat;
a light-headed feeling, like you might pass out;
severe drowsiness or dizziness, confusion, problems with speech or balance;
infertility, missed menstrual periods;
impotence, sexual problems, loss of interest in sex; or
low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Morphine and naltrexone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Common Nucynta side effects may include:
constipation, mild nausea, stomach pain;
headache, tired feeling; or
mild drowsiness or dizziness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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