Tapentadol

(ta pen' ta dol)

Brand Name(s): Nucynta^®, Nucynta^® ER

IMPORTANT WARNING:

Tapentadol may be habit forming, especially with prolonged use. Take tapentadol exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking tapentadol, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. 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. There is a greater risk that you will overuse tapentadol if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

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. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take tapentadol. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. 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 during your treatment with tapentadol may increase the risk that you will experience breathing problems or other serious, life threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take tapentadol with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with tapentadol increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment with tapentadol.

Do not allow anyone else to take your medication. Tapentadol may harm or cause death to other people who take your medication, especially children. Keep tapentadol in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep tapentadol out of the reach of children. Keep track of how many tablets or extended-release tablets are left so you will know if any medication is missing. Flush any tablets or extended-release tablets that are outdated or no longer needed down the toilet so that others will not take them.

If you are taking the extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.

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. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of taking tapentadol.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment with tapentadol and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Tapentadol immediate-release tablets are used as short-term treatment to relieve severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in adults and children 6 years of age and older who weigh at least 88 lb (40 kg) who are expected to need an opioid pain medication and whose pain cannot be controlled by the use of alternative pain medications. Tapentadol extended-release tablets are used to relieve severe and persistent (around-the-clock) pain that cannot be controlled by the use of other pain medications. Tapentadol extended-release tablets are also used to relieve severe and persistent (around-the-clock) neuropathic pain (pain caused by nerve damage) that cannot be controlled by the use of other pain medications.in people who have diabetes. Tapentadol extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Tapentadol comes as an immediate-release tablet and an extended-release (long acting) tablet to take by mouth. The immediate-release tablets are usually taken with or without food every 4 to 6 hours as needed to treat acute pain, usually for no more than a few days. If you are taking the immediate-release tablets, 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 and do not ever take extra doses of the extended-release tablets. The extended-release tablets are taken once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tapentadol exactly as directed.

If you are taking the extended-release tablets, swallow them one at a time with plenty of water. Swallow each tablet right after you put it in your mouth.

Your doctor will probably start you on a low dose of tapentadol and gradually increase your dose until your pain is controlled. Your doctor may adjust your dose at any time during your treatment if your pain is not controlled. If you feel that your pain is not controlled or if your pain increases ,becomes worse, or if you have new pain or an increased sensitivity to pain while you are taking tapentadol, call your doctor. Do not change the dose of your medication without talking to your doctor.

After you take tapentadol for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose of medication to control your pain. Talk to your doctor about how you are feeling during your treatment with tapentadol.

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).

What SPECIAL PRECAUTIONS should I follow?

Before taking tapentadol,

• tell your doctor and pharmacist if you are allergic to tapentadol, or any other medications, or any of the ingredients in tapentadol immediate-release tablets or extended-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• 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 (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate). Also tell your doctor if any of these medications are prescribed for you during your treatment with tapentadol. Your doctor will probably tell you not to take tapentadol if you are taking one or more of these medications.

• 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 doses of your medications or monitor you carefully for side effects.

• 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 any of the conditions mentioned in the IMPORTANT WARNING section or a blockage or narrowing of your stomach or intestines or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take tapentadol.

• tell your doctor if you have or have ever had any condition that causes difficulty urinating; seizures; 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 extended-release tablets. If you breastfeed while taking tapentadol, monitor the breastfed infant carefully for increased sleepiness, trouble breathing, or limpness. If you stop taking tapentadol, or if you stop breastfeeding the infant, monitor the infant carefully for signs of withdrawal such as restlessness, teary eyes, runny nose, yawning, sweating, chills, or dilated pupils. Call your doctor immediately if the breastfed infant has any of these symptoms.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking tapentadol.

• you should know that tapentadol may make you drowsy. 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 while you are taking tapentadol.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

If you are taking tapentadol immediate-release or extended-release tablets, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

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.

While taking tapentadol, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should 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, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. 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

What OTHER INFORMATION should I know?

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. 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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: March 15, 2024.