Drug Database - Nucynta

Generic Name: tapentadol (ta-PEN-ta-dol)

Brand Names: Nucynta®

Classification: Narcotic Pain Reliever

Nucynta (tapentadol) is in a group of drugs called narcotic pain relievers. It is similar to morphine. Nucynta is used to treat moderate to severe pain. Nucynta may also be used for other purposes not listed in this medication guide.

Important Facts

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 take Nucynta if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan)
• phenelzine (Nardil)
• rasagiline (Azilect)
• selegiline (Eldepryl, Emsam)
• tranylcypromine (Parnate)

within the past 14 days. Serious, life-threatening side effects can occur if you take Nucynta before the MAO inhibitor has cleared from your body. Nucynta may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to another person, especially someone who has a history of drug abuse or addiction. 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 more Nucynta than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Nucynta can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using Nucynta suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

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 take Nucynta if you have used an MAO inhibitor such as:

• isocarboxazid (Marplan)
• phenelzine (Nardil)
• rasagiline (Azilect)
• selegiline (Eldepryl, Emsam)
• tranylcypromine (Parnate)

within the past 14 days. Serious, life-threatening side effects can occur if you take Nucynta before the MAO inhibitor has cleared from your body.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 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
• a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication 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.

Do not give Nucynta to a child. Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Nucynta should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How To Take Nucynta

Take Nucynta exactly as it was prescribed for you. Never take Nucynta in larger amounts, or use it 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 from this medication.

Take this medicine with a full glass of water.

You may take Nucynta with or without food.

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. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store this medicine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Nucynta is a drug of abuse and you should be aware if any person in the household is using this 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 tapentadol or injecting the drug into your vein. This practice has resulted in death with the misuse of narcotic pain medicines and similar prescription drugs.

In Case of Overdose

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room IMMEDIATELY.

Symptoms may include:

• extreme drowsiness
• blurred vision
• confusion
• vomiting
• cold and clammy skin
• weak pulse
• shallow breathing
• fainting, or breathing that stops

Do not drink alcohol while you are using Nucynta. 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. Nucynta can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• hivess
• difficulty breathing
• swelling of your face
• lips
• tongue
• throat

Seek medical attention right away if any of these SEVERE side effects occur:

• weak or shallow breathing, weak pulse, slow heartbeat
• seizure (convulsions)
• severe drowsiness or dizziness
• confusion, problems with speech or balance
• 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
• 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.

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.

This list is not complete and there may be other drugs that can interact with Nucynta. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.