Nucynta

DRUG DESCRIPTION

NUCYNTA® (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-l-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is:

NUCYNTA®
  (tapentadol) Structural Formula Illustration

The molecular weight of tapentadol HC1 is 257.80, and the molecular formula is C14H23NO·HCl. The n-octanol:water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HC1, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.

What are the possible side effects of tapentadol (Nucynta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • 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,...

Read All Potential Side Effects and See Pictures of Nucynta »


Nucynta Patient Information Including Side Effects

Brand Names: Nucynta

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

  • What is tapentadol (Nucynta)?
  • What are the possible side effects of tapentadol (Nucynta)?
  • What is the most important information I should know about tapentadol (Nucynta)?
  • What should I discuss with my healthcare provider before taking tapentadol (Nucynta)?
  • How should I take tapentadol (Nucynta)?
  • What happens if I miss a dose (Nucynta)?
  • What happens if I overdose (Nucynta)?
  • What should I avoid while taking tapentadol (Nucynta)?
  • What other drugs will affect tapentadol (Nucynta)?
  • Where can I get more information?

What is tapentadol (Nucynta)?

Tapentadol is in a group of drugs called narcotic pain relievers. It is similar to morphine.

Tapentadol is used to treat moderate to severe pain.

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

What are the possible side effects of tapentadol (Nucynta)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • 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 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.

What is the most important information I should know about tapentadol (Nucynta)?

You should not use this medication 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 tapentadol if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take tapentadol before the MAO inhibitor has cleared from your body.

Tapentadol may be habit-forming and should be used only by the person it was prescribed for. Tapentadol 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 tapentadol. 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 tapentadol than is prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tapentadol 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 tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

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