Nucynta

What is Nucynta?

Nucynta (tapentadol) is an opioid pain medication. An opioid is sometimes called a narcotic.

Nucynta is used to treat moderate to severe pain.

Nucynta ER is an extended-release form of tapentadol and is used for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Important Information

Do not use Nucynta if you have used a MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

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

Tapentadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take Nucynta 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 if the mother has taken this medicine during pregnancy.

Fatal side effects can occur if you use Nucynta with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before Taking Nucynta

You should not use Nucynta if you are allergic to tapentadol, or if you have:

• severe asthma or breathing problems; or

• a blockage in your digestive tract (stomach or intestines).

Do not use Nucynta 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.

To make sure Nucynta is safe for you, tell your doctor if you have ever had:

• any type of breathing problem or lung disease;

• a head injury, brain tumor, or seizures;

• drug or alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease; or

• problems with your gallbladder, pancreas, or thyroid.

If you use opioid medicine 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 opioids may need medical treatment for several weeks.

You should not breast-feed while using Nucynta.

Do not give this medicine to a child.

How should I take Nucynta?

Take Nucynta exactly as prescribed. Follow the directions on your prescription label and read all medication guides. Never use this medicine 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 abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Take this medicine with a full glass of water. Nucynta can be taken with or without food.

Stop taking all other around-the-clock narcotic pain medications when you start taking Nucynta ER extended-release tablets.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Nucynta 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 Nucynta suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a Nucynta pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tapentadol and similar prescription drugs.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Nucynta dosing information

Usual Adult Dose for Pain:

Individualize therapy taking into consideration severity of pain, response to therapy, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse:

Immediate-Release:
Initial dose: 50 to 100 mg orally every 4 to 6 hours as needed for pain
-Day 1: A second dose may be administered as soon as 1 hour after the first dose if needed
-Subsequent dosing: 50, 75, or 100 mg orally every 4 to 6 hours; adjust dosing to maintain adequate analgesia with acceptable tolerability
Maximum dose: 700 mg on day 1; 600 mg/day on subsequent days

-Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Chronic Pain:

Individualize therapy taking into consideration severity of pain, response to therapy, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse:
-Discontinue all other tapentadol and tramadol products prior to starting Nucynta ER extended-release tablets

EXTENDED RELEASE TABLETS:
Initial dose: 50 mg orally twice a day
-Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; dose increases should not exceed 50 mg twice a day every 3 days
Maintenance dose: 100 mg to 250 mg orally twice a day
Maximum dose: 500 mg/day

CONVERSION from IMMEDIATE-RELEASE to EXTENDED-RELEASE:
-Provide same total daily dose of tapentadol divided into 2 equal doses and administered orally twice a day approximately 12 hours apart

CONVERSION from Other Opioids:
-As there are no established conversion ratios from other opioids, initiate at 50 mg orally every 12 hours
-Close observation and frequent titration are warranted until pain is controlled; monitor for signs and symptom of opioid withdrawal
-Provide rescue medication with an appropriate dose of an immediate-release analgesic as appropriate

Uses:
-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.
-For the management of neuropathic pain associated with diabetic peripheral neuropathy severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Since Nucynta is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

What happens if I overdose of Nucynta?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A tapentadol overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, fainting, or coma.

What should I avoid while taking Nucynta?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Nucynta will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Nucynta side effects

Get emergency medical help if you have signs of an allergic reaction to Nucynta: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should 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:

• weak or shallow breathing, weak pulse, slow heartbeat;

• a light-headed feeling, like you might pass out;

• agitation, feeling hot;

• seizure (convulsions);

• severe drowsiness or dizziness, confusion, problems with speech or balance;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

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.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Nucynta side effects may include:

• constipation, mild nausea, stomach pain;

• headache, tired feeling; or

• mild drowsiness or 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.

What other drugs will affect Nucynta?

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Nucynta only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.