Tapentadol

Tapentadol may be habit-forming. This may occur at recommended doses or if it is misused or abused. Take tapentadol exactly as directed. Do not take more of it, take it more often, stop taking it suddenly, or take it differently than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.

Tapentadol may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain other medications, drinking alcohol, or using street drugs with tapentadol may increase the risk of serious, life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Swallow the extended-release tablets whole. Do not chew, break, divide, crush, or dissolve them as you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

Be sure that you know the dose in milliliters that your doctor has prescribed if you are taking a liquid product. Use the oral syringe and adapter provided with your medication to carefully measure the number of milliliters of solution that your doctor prescribed. Ask your doctor or pharmacist if you have any questions about how to measure your dose or how much medication you should take. You may experience serious or life-threatening side effects if you take a different amount of medication than prescribed by your doctor.

Tell your doctor if you are pregnant or plan to become pregnant. If you take tapentadol regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Tapentadol is used for acute severe pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) and severe persistent neuropathic pain (pain caused by nerve damage) caused by diabetes. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Tapentadol comes as an oral solution (liquid), immediate-release tablet, and an extended-release (long acting) tablet to take by mouth.  

Take the oral solution or the immediate-release tablet with or without food every 4 to 6 hours as needed. Your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment. 

Take the extended-release tablet with or without food every 12 hours. Swallow one whole tablet at a time, right after you put it in your mouth, with plenty of water. Take the medication at around the same times every day.

Your doctor may adjust your dose of tapentadol during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Tell your doctor if you feel that your pain is not controlled or if your pain becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with tapentadol. Do not take more of it, take it more often, or for a longer period of time than prescribed by your doctor.

Do not stop taking tapentadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tapentadol, you may experience withdrawal symptoms such as restlessness; anxiety; irritability; teary eyes; yawning; chills; sweating; difficulty falling asleep or staying asleep; shivering, uncontrollable shaking of a part of your body; muscle, back, or joint pain; weakness; nausea; vomiting; diarrhea; stomach cramps; loss of appetite; runny nose, sneezing, or coughing; hair on your skin standing on end; fast breathing; fast heartbeat; widening of the pupils (black circles in the middle of the eyes); or hallucinations (seeing things or hearing voices that do not exist).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking tapentadol,

• tell your doctor and pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid, linezolid, methylene blue, phenelzine, rasagiline, selegiline, and tranylcypromine.
• you should know the following nonprescription or herbal products may interact with tapentadol: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking tapentadol. Do not start any of these medications while taking tapentadol without discussing with your healthcare provider.
• tell your doctor if you have or have ever had a blockage or narrowing of your stomach or intestines or paralytic ileus (condition in which digested food does not move through the intestines), severe asthma, trouble breathing or other lung problems. Your doctor may tell you not to take tapentadol.
• tell your doctor if you have or have ever had a brain tumor, head injury, or history of seizures; an infection in your brain or spine; difficulty urinating;  diabetes; or pancreas, gallbladder, kidney, thyroid, or liver disease.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking tapentadol without discussing it with your healthcare provider.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking tapentadol.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tapentadol.
• you should know that tapentadol may make you drowsy and may affect your coordination. Do not drive a car, operate machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
• you should know that tapentadol may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that tapentadol may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation.

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

If your doctor has told you to take tapentadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Tapentadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• heartburn
• stomach pain
• dry mouth
• excessive tiredness
• anxiety
• drowsiness
• difficulty falling asleep or staying asleep
• abnormal dreams
• irritability
• sudden feeling of warmth

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS or IMPORTANT WARNING sections, call your doctor immediately or get emergency medical treatment:

• seizures
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire
• rash
• itching
• hives
• swelling of the eyes, face, lips, tongue, or throat
• hoarseness
• difficulty breathing or swallowing
• chest pain
• feeling lightheaded when you change positions
• feeling faint
• loss of consciousness
• feeling overheated
• heavy sweating
• worsening pain, increased sensitivity to pain, or new pain, especially after taking tapentadol

Tapentadol may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

Store tapentadol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or how much solution (liquid), you have left so you will know if any is missing.

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. You can also visit the FDA website (https://www.fda.gov/drugdisposal) to obtain more information about how to dispose of unused or outdated medication.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Talk to your doctor or pharmacist about having a rescue medication called naloxone or nalmefene. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program, over the counter, or with a prescription.  Make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use the medication. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• narrowing or widening of the pupils (dark circles in the eyes)
• sleepiness
• unable to respond or wake up
• muscle weakness
• cold, clammy skin
• slow or shallow breathing
• difficulty breathing
• slowed heartbeat

Keep all appointments with your doctor and laboratory.

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.   Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication or if you continue to have pain after you finish the medication, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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