Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of tapentadol. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the extended-release tablet whole, one tablet at a time, with enough water. Do not crush, break, dissolve, or chew it.

Measure the oral liquid with the marked dosing syringe that comes with the package. Your dose needs to be measured and given accurately to avoid an overdose.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For severe pain:
      • Patients switching from Nucynta® to Nucynta® ER:
        • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular tapentadol that is taken per day. The total amount per day will be divided and given as 2 divided doses during the day. However, the dose is usually not more than 500 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • Patients who are not taking narcotic medicines:
        • Adults—At first, 50 milligrams (mg) two times a day (every 12 hours). Your doctor may adjust your dose as needed. However, the dose is usually not more than 500 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • Patients switching from other narcotic medicines:
        • Adults—The tablet is given every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which narcotic you were using. The total amount per day will be divided and given as 2 divided doses during the day. However, the dose is usually not more than 500 mg per day.
        • Children—Use and dose must be determined by your doctor.
    • For nerve pain caused by diabetes:
      • Adults—At first, 50 milligrams (mg) two times a day (every 12 hours). Your doctor may adjust your dose as needed. However, the dose is usually not more than 500 mg per day.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (immediate-release tablets):
    • For moderate to severe pain:
      • Adults—At first, 50 to 100 milligrams (mg) every 4 to 6 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (solution):
    • For moderate to severe pain:
      • Adults—At first, 2.5 milliliters (mL) (50 milligrams [mg]), 3.75 mL (75 mg), or 5 mL (100 mg) every 4 to 6 hours. On the first day of dosing, the second dose may be given as soon as 1 hour after the first dose, if pain is not relieved with the first dose. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For moderate to severe pain:
      • Adults—At first, 50 to 100 milligrams (mg) every 4 to 6 hours. On the first day of dosing, the second dose may be given as soon as 1 hour after the first dose, if pain is not relieved with the first dose. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the oral liquid bottle upright after opening.

Tapentadol can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush any unused medicine down the toilet.