Saturday, April 14, 2012

Tapentadol


Generic Name: tapentadol (ta PEN ta dol)

Brand Names: Nucynta, Nucynta ER


What is tapentadol?

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


Tapentadol is used to treat moderate to severe chronic pain.


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


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


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 use tapentadol 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. Tapentadol 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 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 tapentadol 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.


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tapentadol.

What should I discuss with my healthcare provider before taking tapentadol?


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 use tapentadol 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 tapentadol, 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 this medication is harmful to an unborn baby. Tapentadol 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.

Older adults may be more sensitive to the effects of this medicine.


Tapentadol may be habit forming and should be used only by the person it was prescribed for. Never share tapentadol 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. Do not give tapentadol to a child.

How should I take tapentadol?


Take exactly as prescribed. Never take tapentadol 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.

You may take tapentadol with or without food.


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

Tapentadol 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 tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using tapentadol. 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.


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


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.


See also: Tapentadol dosage (in more detail)

What happens if I miss a dose?


Since tapentadol 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 tapentadol 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 tapentadol?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not drink alcohol while you are using tapentadol. 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.

Tapentadol side effects


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


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?


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 tapentadol. 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 tapentadol. 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.



More tapentadol resources


  • Tapentadol Side Effects (in more detail)
  • Tapentadol Dosage
  • Tapentadol Use in Pregnancy & Breastfeeding
  • Tapentadol Drug Interactions
  • Tapentadol Support Group
  • 105 Reviews for Tapentadol - Add your own review/rating


  • tapentadol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Tapentadol Professional Patient Advice (Wolters Kluwer)

  • Tapentadol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Nucynta Prescribing Information (FDA)

  • Nucynta Monograph (AHFS DI)

  • Nucynta Consumer Overview

  • Nucynta ER Prescribing Information (FDA)

  • Nucynta ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)



Compare tapentadol with other medications


  • Diabetic Nerve Damage
  • Pain


Where can I get more information?


  • Your pharmacist can provide more information about tapentadol.

See also: tapentadol side effects (in more detail)



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