Tapentadol

Tapentadol is a strong, prescription, opioid (narcotic) pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Tapentadol comes in three forms, and they are not interchangeable.

• Immediate-release tapentadol tablets (Nucynta) are used to manage short-term (acute) pain in adults and children 6 years of age and older who weigh at least 88 pounds (40 kg), when other pain treatments such as non-opioid pain medicines do not treat the pain well enough, or cannot be tolerated.
• Tapentadol oral solution is used to manage short-term (acute) pain in adults that is severe enough to need an opioid pain medicine, and for which other treatments are not enough. The oral solution may suit people who cannot swallow tablets. Nucynta oral solution has been discontinued but generic tapentadol oral solution is still available.
• Extended-release tapentadol tablets (Nucynta ER) are used to manage severe and persistent pain in adults that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat the pain well enough, or cannot be tolerated. They are also used for severe and persistent pain from damaged nerves (neuropathic pain) that happens with diabetes. Extended-release tablets are not taken on an "as needed" basis, and are not approved for use in children.

Tapentadol is a Schedule II (CII) controlled substance. These are substances with a high potential for abuse but also a currently accepted medical use in treatment in the United States, sometimes with strict limitations. Misuse of these drugs may lead to severe psychological or physical dependence.

• Get emergency help or call 911 right away if you take too much tapentadol (overdose). When you first start taking tapentadol, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
• Taking tapentadol with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Accidental ingestion of even one dose of tapentadol, especially by children, can result in a fatal overdose.
• With the oral solution, measure every dose with the syringe supplied. Mixing up milligrams (mg) and millilitres (mL) has caused accidental overdose and death. Never measure a dose with a household teaspoon or tablespoon.
• Never give anyone else your tapentadol. They could die from taking it. Selling or giving away tapentadol is against the law.
• Store tapentadol securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take tapentadol if you have:

• severe asthma, trouble breathing, or other lung problems
• a bowel blockage or a narrowing of your stomach or intestines
• taken a monoamine oxidase inhibitor (MAOI) in the last 14 days.

Before taking tapentadol, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
• liver, kidney, thyroid problems
• pancreas or gallbladder problems.

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take tapentadol, do not take more tapentadol without first talking to your healthcare provider. Tell your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking tapentadol
• pregnant or planning to become pregnant. Prolonged use of tapentadol during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated
• breastfeeding. Breastfeeding is not recommended during treatment with extended-release tapentadol. Immediate-release tapentadol and the oral solution pass into breast milk and may harm your baby, so carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness, and seek immediate medical care if you notice these signs
• living in a household where there are small children or someone who has abused street or prescription drugs
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking tapentadol with certain other medicines can cause serious side effects that could lead to death.

The possible side effects of tapentadol are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

In children 6 years of age and older taking immediate-release tablets, the most common side effects are vomiting, constipation, nausea, itching, and fever.

Get emergency medical help or call 911 right away if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
• agitation, hallucinations, coma, feeling overheated, or heavy sweating.

These are not all the possible side effects of tapentadol. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take tapentadol exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Do not change your dose.

Immediate-release tablets:

• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Immediate-release tablets can be taken with or without food.
• For acute (short-term) pain, you may only need to take tapentadol for a few days. You may have some tablets left over that you did not use. See the disposal instructions below.

Oral solution:

• The oral solution contains 20 mg of tapentadol in each millilitre (mL). Your prescription will give the dose in both milligrams and millilitres.
• Measure every dose with the graduated oral syringe supplied with the bottle. Never use a household teaspoon or tablespoon. Ask your pharmacist if you need a replacement syringe or are unsure how to use it.
• The usual adult dose is 50 mg (2.5 mL) to 100 mg (5 mL) every 4 to 6 hours as needed for pain. On the first day, a second dose may be taken as early as one hour after the first if the pain is not controlled.
• The oral solution can be taken with or without food.
• Store the bottle upright once it has been opened.

Extended-release tablets:

• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
• Swallow extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject them because this may cause you to overdose and die.

For all forms:

• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking tapentadol regularly, do not stop taking it without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused tapentadol by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Avoid driving or operating heavy machinery until you know how tapentadol affects you. Tapentadol can make you sleepy, dizzy, or lightheaded.

Do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with tapentadol may cause you to overdose and die.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child who takes it by accident, or in a 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 or nalmefene (medicines that reverse an opioid overdose) and keep one with you at all times. A person caring for you can give the medicine 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 it and how to use it.

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

• medicine for allergies, cough, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicine;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• gabapentin or pregabalin;
• sleep medicine, muscle relaxers, or other drugs that make you drowsy;
• water pills (diuretics); or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

Do not take tapentadol if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the past 14 days. MAOIs include phenelzine, tranylcypromine, and linezolid.

Some opioids, including butorphanol, nalbuphine, pentazocine, and buprenorphine, can reduce the pain relief you get from tapentadol or bring on withdrawal symptoms, and should be avoided.

Taking tapentadol with other opioid medicines, benzodiazepines, gabapentinoids, alcohol, or other medicines that slow the central nervous system can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

This list is not complete, and many other drugs may affect tapentadol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: tapentadol HCl

Inactive ingredients vary between products. The lists below are for the products described here. Check the label or ask your pharmacist about the product you have been given.

Immediate-release tablets (Nucynta): croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake. The film coating for the 50 mg and 75 mg tablets also contains the colorant D&C Yellow #10 aluminum lake.

Oral solution (ANI Pharmaceuticals): citric acid anhydrous, purified water, artificial raspberry flavor (flavoring ingredients, propylene glycol), sodium hydroxide, and sucralose.

Extended-release tablets (Nucynta ER): alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating contains polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths, and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150, and 200 mg tablets) or titanium dioxide (250 mg tablets).

Nucynta and Nucynta ER are distributed by Collegium Pharmaceutical, Inc., 100 Technology Center Drive Suite 300, Stoughton, MA, 02072, www.collegiumpharma.com, or call 1-855-331-5615.

Tapentadol hydrochloride oral solution is distributed by ANI Pharmaceuticals, Inc. To report side effects, call 1-855-204-1431. Other generic versions of tapentadol may be made by other companies.