Generic Name: tapentadol (ta-PEN-ta-dol)
Brand Name: Nucynta
Tapentadol is used for:
Relieving moderate to severe acute pain in certain patients.
Tapentadol is a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.
Do NOT use tapentadol if:
- you are allergic to any ingredient in tapentadol
- you have slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma); high levels of carbon dioxide in the blood (hypercapnia or hypercarbia); or you are having an asthma attack
- you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
- you have severe kidney or liver problems
- you are taking mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), sodium oxybate (GHB), tramadol, or another medicine that contains tapentadol
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using tapentadol:
Some medical conditions may interact with tapentadol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to any other narcotic pain medicines (eg, codeine, morphine)
- if you have a history of liver or kidney problems, stomach or bowel problems (eg, blockage, inflammation), gallbladder problems, thyroid problems, a urinary blockage or trouble urinating, stroke or "mini-stroke" (transient ischemic attack [TIA]), or pancreas problems (eg, pancreatitis)
- if you have severe drowsiness, a recent head injury, growths in the brain (eg, lesions, tumors), increased pressure in the brain, or a history of seizures (eg, epilepsy)
- if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a heart problem called cor pulmonale, hypercapnia or hypercarbia, or low levels of oxygen in the blood (hypoxia)
- if you have low blood pressure, constipation, stomach pain, dehydration or low blood volume, or poor health
- if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
- if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
- if you or a member of your family has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
Some MEDICINES MAY INTERACT with tapentadol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticholinergics (eg, scopolamine, oxybutynin) because the risk of constipation and difficulty urinating may be increased
- Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
- Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
- Linezolid, MAOIs (eg, phenelzine), methylene blue, mirtazapine, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), St. John's wort, tramadol, trazodone, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because the risk of developing a severe side effect called serotonin syndrome may be increased
- Other narcotic pain medicines (eg, codeine, hydrocodone) because they may increase the risk of tapentadol's side effects
- Mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or naltrexone because they may decrease tapentadol's effectiveness and withdrawal may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if tapentadol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use tapentadol:
Use tapentadol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tapentadol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get tapentadol refilled.
- Take tapentadol by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Tapentadol must only be taken by mouth. Do not inject tapentadol.
- Swallow tapentadol whole with enough water to be sure that you swallow it completely.
- If you have been taking tapentadol regularly, do not suddenly stop taking it. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop tapentadol, your doctor will gradually lower your dose.
- Tapentadol is usually used as needed. If you forget to take a dose of tapentadol and you still have pain, take it when you remember as directed by your doctor. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use tapentadol.
Important safety information:
- Tapentadol may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use tapentadol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking tapentadol. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking tapentadol; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
- Tapentadol may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
- Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
- Tapentadol may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking tapentadol, talk with your doctor or pharmacist.
- If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
- Tell your doctor or dentist that you take tapentadol before you receive any medical or dental care, emergency care, or surgery.
- Tapentadol may increase the risk of seizures in certain patients, including patients who have a history of seizures. Talk to your doctor to see if you may have a greater risk of seizures while taking tapentadol. Seek immediate medical attention if you have a seizure.
- Serotonin syndrome is a possibly fatal syndrome that can be caused by tapentadol. Your risk may be greater if you take tapentadol with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
- Seek emergency medical care right away if another person swallows tapentadol.
- Use tapentadol with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
- Tapentadol should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking tapentadol while you are pregnant. Long-term use of tapentadol during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. It is not known if tapentadol is found in breast milk. Do not breast-feed while taking tapentadol.
When used for long periods of time or at high doses, tapentadol may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if tapentadol stops working well. Do not take more than prescribed.
Some people who use tapentadol for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as physical DEPENDENCE. If you suddenly stop taking tapentadol, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.
Possible side effects of tapentadol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; dry mouth; headache; mild itching; mild stomach pain; nausea; sweating; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); abnormal sighing; burning, numbness, or tingling; chest pain; cold, clammy skin; confusion; difficult or increased urination; difficult, slow, or shallow breathing; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; loss of coordination; memory problems; mood or mental changes (eg, agitation, depression); seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath; suicidal thoughts or actions; tremor; trouble talking, thinking, or walking; vision changes (eg, blurred vision).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; difficult, slow, or shallow breathing; excessive sweating; fainting; limp muscles; pinpoint or enlarged pupils; seizures; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat; vomiting.Proper storage of tapentadol:
Store tapentadol between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tapentadol out of the reach of children and away from pets.
- If you have any questions about tapentadol, please talk with your doctor, pharmacist, or other health care provider.
- Tapentadol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take tapentadol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tapentadol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tapentadol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tapentadol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.