Nucynta

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

What is Nucynta?

Nucynta (tapentadol) belongs to a group of drugs called opioid pain relievers. It is similar to morphine. An opioid is sometimes called a narcotic.

Nucynta is used to treat moderate to severe chronic pain. Nucynta ER is used to treat moderate to severe chronic pain, and to treat pain caused by nerve damage in people with diabetes (diabetic peripheral neuropathy).

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

Important information about Nucynta

You should not use Nucynta if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus.

Do not use Nucynta if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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Nucynta may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are taking Nucynta. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take Nucynta in larger amounts, or for longer than recommended by your doctor. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Nucynta may impair your thinking or reactions. Avoid driving or operating machinery until you know how Nucynta will affect you. Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tapentadol.

Before taking Nucynta

You should not use Nucynta if you are allergic to tapentadol, or if you have severe liver or kidney disease, if you are having an asthma attack, or if you have a bowel obstruction called paralytic ileus. Do not use Nucynta if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take Nucynta, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver or kidney disease;

• curvature of the spine;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• gallbladder disease or pancreas problems;

• mental illness; or

• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether Nucynta is harmful to an unborn baby. Nucynta may cause breathing problems and addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tapentadol can pass into breast milk and may harm a nursing baby. Do not breast-feed while taking this medication.

See also: Nucynta pregnancy and breastfeeding warnings (in more detail)

Nucynta may be habit forming and should be used only by the person it was prescribed for. 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.

Older adults may be more sensitive to the effects of this medicine. Do not give this medicine to a child.

How should I take Nucynta?

Take Nucynta exactly as prescribed. Never take Nucynta in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Your doctor may occasionally change the timing of your dose to make sure you get the best results.

Take this medicine with a full glass of water.

Nucynta can be taken with or without food.

Do not crush, chew, or break an extended-release Nucynta tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Always measure Nucynta oral solution with the oral syringe supplied to ensure an accurate dose.

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

Do not stop using Nucynta suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Nucynta.

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.

Ask a pharmacist about how to dispose of any unused pills after you have stopped taking Nucynta.

Never crush a tablet or other pill to mix into a liquid for snorting or injecting the drug into your vein. This practice has resulted in death with the misuse of narcotic pain medicines and similar prescription drugs.

What happens if I miss a dose?

Since Nucynta is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose 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 the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Nucynta can be fatal.

Overdose symptoms may include extreme drowsiness, blurred vision, confusion, vomiting, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Nucynta?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Nucynta will affect you. Do not drink alcohol while you are using Nucynta. Dangerous side effects or death can occur when alcohol is combined with Nucynta. Check your food and medicine labels to be sure these products do not contain alcohol.

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 a serious side effect such as:

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

• seizure (convulsions);

• severe drowsiness or dizziness;

• confusion, problems with speech or balance; or

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious Nucynta side effects may include:

• mild nausea or vomiting;

• constipation;

• mild dizziness, drowsiness;

• dry mouth;

• itching; or

• increased sweating.

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: Nucynta side effects (in more detail)

What other drugs will affect Nucynta?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by Nucynta. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicines.

There may be other drugs that can interact with Nucynta. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Nucynta.