What is Nucynta (Tapentadol)?
Nucynta (tapentadol) is indicated for the management of Pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Prolonged-release tapentadol (Nucynta ER) is for the 24-hour treatment of pain that is not controlled by other medications. This form of tapentadol is not intended for use as needed for pain. Tapentadol may also be used for purposes not listed in this guide.
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What important information should I know about Nucynta (tapentadol)?
If you take opioid medicine during pregnancy, your baby may become addicted to the drug. This can cause life-threatening withdrawal symptoms in the baby after he or she is born. Babies born dependent on opioids may need treatment for several weeks. Ask your doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe sleepiness or slow breathing in your baby. Do not give tapentadol to your baby. You should not use tapentadol if you are allergic to it or if you have: severe asthma or breathing problems; stomach or intestinal obstruction, including paralytic ileus. Tell your doctor if you have ever had: breathing problems, sleep apnea; head injury, brain tumor, or seizures; alcohol or drug abuse; mental illness; urinary problems; liver or kidney disease; or problems with your gallbladder, pancreas, thyroid, or adrenal glands.
If you stop using Tapentadol suddenly, you may experience withdrawal symptoms. Check with your doctor before stopping the medication. Store at room temperature away from moisture and heat. Keep an eye on your medicine. You should know if someone is using it improperly or without a prescription. Do not keep leftover opioid medicine. Just one dose can be fatal to someone who accidentally or improperly uses the medicine. Ask your pharmacist where to find a drug take-back program. If there is no take-back program, flush unused medication down the toilet.
How should I take Nucynta (tapentadol)?
Nucynta (tapentadol) is available in 50 mg, 75 mg, and 100 mg doses. Use the lowest effective dose for the shortest period of time according to your individual treatment goals. Individualize dosage according to pain severity, response, previous experience with pain treatment, and risk factors for addiction, abuse, and misuse.
Use Nucynta (tapentadol) exactly as directed or as prescribed by your doctor. Do not use more or less or for longer than recommended.
Follow the directions on the prescription label and read all medication guides. Do not use tapentadol in larger amounts or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medication.
Never share opioid medications with others, especially those with a history of addiction. misuse can lead to addiction, overdose, or death. Keep your medicine in a place where others can't get to it.
Stop taking any other medications that contain tapentadol or tramadol when you start taking tapentadol extended-release tablets.
Take this medicine by mouth with a full glass of water. Take this medicine with meals.
Do not crush, break, or open the extended-release tablet. Swallow the tablet whole to avoid a potentially fatal dose.
Tapentadol may cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.
Patients may be switched from Nucynta to Nucynta ER by taking the equivalent total daily dose of Nucynta and dividing it into 2 equal doses separated by approximately 12 hour intervals. For example, a patient receiving 50 mg of Nucynta 4 times daily (200 mg/day) could be switched to 100 mg of Nucynta ER every 12 hours.
What side effects may I notice from Nucynta?
Get emergency medical help if you have signs of an allergic reaction: hives chest pain, fast heartbeat, difficulty breathing swelling of your face, lips, tongue, or throat. Opioid medications can slow or stop your breathing, which can lead to death. Your caregiver should give you naloxone and/or get emergency medical help if you have slow breathing with long pauses, blue lips, or if you have difficulty waking up. Call your doctor immediately if you have:
- ragged breathing, sighing, shallow breathing, breathing with pauses
- a slight feeling that you may lose consciousness
- restlessness, feeling hot
- severe drowsiness or dizziness, confusion, problems with speech or balance
- serotonin syndrome - agitation, hallucinations, fever, fast heartbeat, muscle stiffness, twitching, loss of coordination, nausea, diarrhea
- low cortisol - nausea, vomiting, loss of appetite, dizziness, increased tiredness or weakness.
Serious breathing problems may be more likely in the elderly and weakened or in people with debilitating syndrome or chronic breathing problems. Common side effects may include:
- constipation, nausea, vomiting, stomach pain
- headache, fatigue
- drowsiness, dizziness
This is not a complete list of side effects others may occur. Ask your doctor or health care professional about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088.
What medicines and foods should you avoid when taking Nucynta (Tapentadol)?
Do not drink alcohol. Dangerous side effects or death may occur. Do not drive or do any dangerous work until you know how this medicine affects you. Dizziness or drowsiness may cause falls, accidents, or serious injury.
Addiction, Abuse, and Misuse of Tapentadol.
Tapentadol exposes patients and other users at risk for opioid dependence, abuse, and misuse, which can lead to overdose and death. Each patient's risk should be assessed before prescribing tapentadol tablets and all patients should be monitored regularly for the development of these behaviors and conditions.