Nucynta (tapentadol) is an opioid pain medication. An opioid is sometimes called a narcotic.
Nucynta is used to treat moderate to severe pain.
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.
Important information
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 taken an 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 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:
Do not use Nucynta if you have taken an 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
To make sure this medicine is safe for you, tell your doctor if you have:
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any type of breathing problem or lung disease;
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a history of head injury, brain tumor, or seizures;
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a history of drug abuse, alcohol addiction, or mental illness;
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urination problems;
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liver or kidney disease; or
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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.
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.
Call your doctor at once if you have:
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weak or shallow breathing, weak pulse, slow heartbeat;
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a light-headed feeling, like you might pass out;
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seizure (convulsions);
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severe drowsiness or dizziness, confusion, problems with speech or balance; or
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signs of too much serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.
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:
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constipation, mild nausea, stomach pain;
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headache, tired feeling; or
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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.
See also: Side effects (in more detail)
Nucynta dosing information
Usual Adult Dose of Nucynta for Pain:
Immediate release:
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.
Extended release:
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).
What other drugs will affect Nucynta?
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.
