Nucynta ER (Oral)
Tapentadol is an opioid medicine used to treat short-term pain. Tapentadol tablet can be used as needed in adults and children at least 6 years old that weigh at least 88 pounds (40 kg).
The extended-release form of tapentadol is used only in adults to treat severe to chronic pain that requires longer treatment. This medicine is not to be used for pain on an as needed basis.
The extended-release form of tapentadol may also used to treat severe and chronic nerve pain in adults with diabetes.
Tapentadol is usually given after other treatments did not work or were not tolerated.
Tapentadol may also be used for purposes not listed in this medication guide.
warnings
What is the most important information I should know about Nucynta ER (Oral)?
You should not use tapentadol if you are allergic to it, or if you have:
- severe asthma or breathing problems;
- a stomach or bowel obstruction (including paralytic ileus); or
- if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.
Tell your doctor if you have ever had:
- other breathing problems, sleep apnea (breathing that stops during sleep);
- low blood pressure, other heart or circulation problems;
- a head injury, brain tumor, high pressure inside the skull, or seizures;
- a drug or alcohol addiction, or mental illness;
- urination problems, problems with your gallbladder, pancreas, thyroid, or adrenal gland; or
- liver or kidney disease.
Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with tapentadol could cause a serious condition called serotonin syndrome.
Long-term tapentadol may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.
May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use tapentadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.
Do not breastfeed. Tapentadol in breast milk can cause life-threatening side effects in a nursing baby.
Side Effects
What are the side effects of Nucynta ER (Oral)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
- chest pain, fast or pounding heartbeats;
- extreme drowsiness, feeling like you might pass out;
- a seizure; or
- decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.
Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
- constipation, nausea, vomiting, stomach pain;
- fever, itching;
- headache, feeling tired; or
- drowsiness, dizziness.
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.
Pregnancy & Breastfeeding
Can I take Nucynta ER (Oral) if I’m pregnant or breastfeeding?
May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use tapentadol during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.
Do not breastfeed. Tapentadol in breast milk can cause life-threatening side effects in a nursing baby.
Interactions
What drugs and food should I avoid while taking Nucynta ER (Oral)?
Do not drink alcohol or any products that contain alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Dosage Guidelines & Tips
How to take Nucynta ER (Oral)?
Use Nucynta ER (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.
Stop taking all other medications that contain tapentadol or tramadol when you start taking tapentadol extended-release.
Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.
Never crush a pill to inhale the powder or inject it into your vein. This could result in death.
Take this medicine with a full glass of water with or without food.
Swallow the tablet whole to avoid exposure to a potentially fatal dose. Do not crush, chew, break, or dissolve it.
Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.
You may be given other medications to help prevent or treat certain side effects. Keep taking these medicines for as long as your doctor has prescribed.
Call your doctor if your symptoms do not improve, or if they get worse.
You may have withdrawal symptoms if you stop using tapentadol suddenly. Ask your doctor before stopping the medicine.
Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.
Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.
Since tapentadol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
Overdose Signs
What happens if I overdose on Nucynta ER (Oral)?
Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.
Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.
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OMJ 150
Color: blue
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Form: film coated
Imprint: OMJ 150
OMJ 150
Color: blue
Shape: oblong
Imprint: OMJ 150
OMJ 150
Color: green
Shape: oval
Imprint: OMJ 150