Tapentadol is an opioid pain medication. An opioid is sometimes called a narcotic.

Tapentadol is a prescription medicine that is used to treat moderate to severe pain.

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

Do not use tapentadol 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 this medicine 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 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. Keep the medication in a place where others cannot get to it.

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 opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Take tapentadol exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of tapentadol.

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 tablets.

Take tapentadol with a full glass of water at the same times each day, with or without food.

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

Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

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 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.

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

Comments:
-Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
-Monitor closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and with each dose increase.
-Due to risks of addiction, abuse, and misuse, even at recommended doses, reserve use for patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products) have not been tolerated, or are not expected to be tolerated, or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

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 tapentadol 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

Comments:
-For patients with breakthrough pain a rescue medication with an appropriate dose of an immediate-release analgesic may be needed.
-If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing dose.
-Because of the risks of addiction, abuse, and misuse even at recommended doses, use should be limited to patients for whom alternative treatment options (e.g. non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management.
-This medicine is not for use as an as-needed analgesic.

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 taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

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

• breathing problems, sleep apnea (breathing that stops during sleep);

• a head injury, brain tumor, or seizures;

• alcoholism or drug addiction, mental illness;

• urination problems,

• liver or kidney disease; or

• problems with your gallbladder, pancreas, thyroid, or adrenal gland.

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.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Do not give tapentadol to a child.

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 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

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

Get emergency medical help if you have signs of an allergic reaction to tapentadol: 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 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:

• noisy breathing, sighing, shallow breathing, breathing that stops;

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

• agitation, feeling hot;

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

• a seizure;

• serotonin syndrome - agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or

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

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common tapentadol side effects may include:

• constipation, nausea, vomiting, stomach pain;

• 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.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or

• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

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

Keep all appointments with your doctor and laboratory. Your doctor may order certain lab tests to check your body's response to tapentadol.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking tapentadol.

This prescription is not refillable. If you continue to have pain after you finish the medication, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.