Treats moderate or severe pain. This medicine is a narcotic pain reliever.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to tapentadol, or if you have used an MAO inhibitor (MAOI) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. You should not use this medicine if you have serious breathing problems (such as severe asthma) or a serious blockage in the bowels called paralytic ileus.
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
- You may take this medicine with or without food.
- Drink plenty of fluids to help avoid constipation.
- This medicine is not for long-term use.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using a phenothiazine medicine (such as chlorpromazine, prochlorperazine, promethazine, thioridazine, Compazine®, Phenergan®, or Thorazine®) or a severe pain medicine (such as tramadol, Ultram®). Tell your doctor if you are using medicine for depression (such as amitriptyline, doxepin, fluoxetine, nortriptyline, paroxetine, Celexa®, Effexor®, Elavil®, Lexapro?, Pamelor®, Paxil®, Sinequan®, or Zoloft®) or medicine to treat migraine headaches (such as rizatriptan, sumatriptan, zolmitriptan, Imitrex®, Maxalt®, or Zomig®).
- Do not drink alcohol while you are using this medicine.
- Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung disease or breathing problems (such as chronic obstructive pulmonary disease [COPD] or sleep apnea), an underactive thyroid, gallbladder problems, pancreas problems, or severe curvature of the spine. Tell your doctor if you have a history of a head injury, brain tumor, depression, seizures, or alcohol or drug abuse.
- This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
- This medicine may make you dizzy, lightheaded, faint, drowsy, or less alert than normal. Avoid driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert. Getting up slowly from a lying or sitting position may also help.
- This medicine may cause a serious condition called serotonin syndrome when it is taken with certain medicines that are used for depression, severe pain, or migraines. Check with your doctor first before taking any other medicines.
- Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
- This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Change in how much or how often you urinate.
- Confusion, shortness of breath, or numbness or tingling in your hands, feet, or lips.
- Extreme weakness, shallow breathing, irregular heartbeat, sweating, or cold or clammy skin.
- Fast, slow, or irregular heartbeat.
- Fever, chills, cough, sore throat, and body aches.
- Lightheadedness, dizziness, or fainting.
- Tremors or seizures.
If you notice these less serious side effects, talk with your doctor:
- Anxiety or abnormal dreams.
- Back or muscle pain.
- Blurred vision or other changes in vision.
- Dry mouth.
- Itching skin or rash.
- Nausea, vomiting, constipation, diarrhea, indigestion, decreased appetite, or stomach pain.
- Runny or stuffy nose.
- Sleepiness or unusual drowsiness.
- Trouble with sleeping.
- Warmth or redness in your face, neck, arms, or upper chest.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04