Generic Name: tapentadol (ta PEN ta dol)
Brand Names: Nucynta, Nucynta ER

What is Nucynta?

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.

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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 pill. 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 addiction and 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 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:

  • 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;

  • urination problems;

  • 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.

FDA pregnancy category C. It is not known whether Nucynta will harm an unborn baby. Tapentadol may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 pill. Swallow it 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 pill 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.

After you have stopped using this medication, flush any unused pills 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:

  • weak or shallow breathing, weak pulse, slow heartbeat;

  • a light-headed feeling, like you might pass out;

  • seizure (convulsions);

  • severe drowsiness or dizziness, confusion, problems with speech or balance; or

  • signs of too much serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

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.

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.

Where can I get more information?

  • Your pharmacist can provide more information about Nucynta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Nucynta only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 6.03. Revision Date: 2014-01-13, 6:09:17 PM.

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