Product Description

Nucynta ER (tapentadol) is a mu-opioid receptor agonist indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

Tapentadol is used to treat moderate to severe pain.

Applies to the following strength(s): 50 mg ; 75 mg ; 100 mg ; 150 mg ; 200 mg ; 250 mg

The information at is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

The extended-release form of this medicine (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.

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

 

Important Information

Do not use tapentadol if you have taken an 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.

You should not use this medicine if you have severe breathing problems, or a bowel obstruction called paralytic ileus.

Nucynta ER (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.

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

 

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 bowel obstruction called paralytic ileus.

Do not use tapentadol if you have taken an 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 tapentadol to any other person is against the law.

To make sure tapentadol is safe for you, tell your doctor if you have:

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

Tapentadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

It is not known whether this medicine will harm an unborn baby. 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.