What is tapentadol?

Tapentadol 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. Nucynta ER is not for use on an as-needed basis for pain.

Important information

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.

Before taking this medicine

You should not use this medication if you are allergic to tapentadol, or if you have:

• severe asthma or breathing problems; or
• a blockage in your digestive tract (stomach or intestines).

Do not use tapentadol 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 this medicine 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 this medicine 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 tapentadol is safe for you, tell your doctor if you have ever had:

• any type of breathing problem or lung disease;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease; or
• problems with your gallbladder, pancreas, or thyroid.

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 this medicine to a child.

How should I take tapentadol?

Take tapentadol exactly as prescribed. Follow all directions on your prescription label. Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take tapentadol 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. Tapentadol can be taken with or without food.

Stop taking all other around-the-clock narcotic pain medications when you start taking tapentadol extended-release tablets.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

While using this medicine, 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 this medicine.

Never crush or break a tapentadol 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. Tapentadol 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 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.

What happens if I overdose?Generic Nucynta (Tapentadol)

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, fainting, or coma.

What should I avoid?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tapentadol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how tapentadol will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Tapentadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tapentadol: hives, chest pain, fast heartbeats, difficult breathing, swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, tapentadol can slow your breathing. Death may occur if breathing becomes too weak.

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;
• agitation, feeling hot;
• seizure (convulsions);
• 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.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common tapentadol 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.

Tapentadol dosing information

Usual Adult Dose 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 tapentadol 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 tapentadol?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications – opioid pain medicine or prescription cough medicine;
• a sedative like Valium – diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
• drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine; or
• drugs that affect serotonin levels in your body – medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use tapentadol only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.