Tapentadol

Pronunciation: ta-PEN-ta-dol
Generic Name: Tapentadol
Brand Name: Nucynta

Tapentadol is used for:

Treating moderate to severe acute pain in certain patients.

Tapentadol is a narcotic pain reliever. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tapentadol if:

• you are allergic to any ingredient in Tapentadol


• you have very slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma, wheezing, shortness of breath); severe hypercapnia (high blood carbon dioxide levels); or you are having an asthma attack


• you have or may have paralytic ileus (bowel paralysis)


• you have severe kidney or liver problems


• you are taking another medicine that contains tapentadol


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) 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 (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of liver or kidney problems; stomach or bowel problems, blockage, or surgery; gallbladder problems; thyroid problems; metabolism problems; adrenal problems (eg, Addison disease); enlarged prostate; trouble urinating; curvature of the spine (scoliosis); or pancreas problems (eg, pancreatitis)


• if you have or have recently had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system


• if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], sleep apnea), a heart problem called cor pulmonale, low blood pressure, or a seizure disorder (eg, epilepsy)


• if you have severe drowsiness, constipation, hypercapnia, hypoxia (low blood oxygen levels), dehydration or low blood volume, poor health, or are severely overweight


• if you have a history of mental or mood problems (eg, depression, anxiety, hallucinations), are going through withdrawal from alcohol or other substances, or if you or a family member have a history of alcohol or other substance abuse

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 they may increase the risk of constipation or difficulty urinating


• MAOIs (eg, phenelzine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because a severe side effect called serotonin syndrome may occur. Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea


• Other opioid pain medicines (eg, codeine, hydrocodone), muscle relaxers (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or medicines used for allergies, mental or mood disorders, nausea, or sleep disorders because the risk of side effects, including severe drowsiness, trouble breathing, or low blood pressure, may be increased


• Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because they may decrease Tapentadol's effectiveness

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 you have been taking Tapentadol regularly, do not suddenly stop taking it. You may have an increased risk of withdrawal symptoms. If you need to stop Tapentadol, your doctor will gradually lower your dose.


• If you miss a dose of Tapentadol and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. 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 or dizziness. 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 while you are using Tapentadol.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tapentadol; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• 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, change your dose, or use for longer than prescribed without checking with your doctor.


• Tapentadol may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you use Tapentadol.


• 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.


• Use Tapentadol with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, constipation, weakness or tiredness, and severe light-headedness.


• Tapentadol should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Tapentadol may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tapentadol while you are pregnant. 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 without a break may develop a physical need to continue taking it. 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:

Constipation; dizziness; drowsiness; dry mouth; itching; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; burning, numbness, or tingling; chest pain; cold, clammy skin; confusion; difficult or increased urination; difficult, slow, or shallow breathing; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; memory problems; mood or mental changes; seizures; severe or persistent dizziness, drowsiness, or light-headedness; trouble talking, thinking, or walking.

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.

See also: Tapentadol side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult, slow, or shallow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; 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.

General information:

• 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 is a summary only. It does not contain all information about Tapentadol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tapentadol resources

• Tapentadol Side Effects (in more detail)
• Tapentadol Dosage
• Tapentadol Use in Pregnancy & Breastfeeding
• Tapentadol Drug Interactions
• Tapentadol Support Group
• 105 Reviews for Tapentadol - Add your own review/rating

• Tapentadol Professional Patient Advice (Wolters Kluwer)


• tapentadol Advanced Consumer (Micromedex) - Includes Dosage Information


• Nucynta Prescribing Information (FDA)


• Nucynta Monograph (AHFS DI)


• Nucynta Consumer Overview


• Nucynta ER Prescribing Information (FDA)

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