Description
Tapentadol oral solution and tablet are used to treat pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. The extended-release tablet is used to treat severe pain, including pain caused by nerve damage from diabetes. It should not be used to treat pain that you only have once in a while or "as needed". Tapentadol belongs to the group of medicines called narcotic analgesics (pain medicines) that act on the central nervous system (CNS) to relieve pain.
When tapentadol is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Tablet, Extended Release
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tapentadol extended-release tablets, immediate-release tablets, and oral liquid in children and tablets in children younger than 6 years of age and weighing less than 40 kilograms (kg). Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tapentadol in the elderly. However, elderly patients are more likely to have constipation and age-related lung, liver, or kidney problems, which may require caution and an adjustment in the dose for patients receiving tapentadol.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
- Linezolid
- Methylene Blue
- Naltrexone
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- Selegiline
- Tranylcypromine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Anileridine
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Atropine
- Baclofen
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzhydrocodone
- Benzphetamine
- Benzthiazide
- Benztropine
- Biperiden
- Bromazepam
- Bromopride
- Brompheniramine
- Bumetanide
- Buprenorphine
- Bupropion
- Buspirone
- Butabarbital
- Butalbital
- Butorphanol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Adrenal problems or
- Alcohol abuse, history of or
- Brain tumor, history of or
- Breathing or other lung problems (eg, COPD, sleep apnea) or
- Depression, history of or
- Drug abuse or dependence, history of or
- Gallbladder problems or
- Head injuries, history of or
- Increased pressure in the head or
- Kyphoscoliosis (severe curvature of the spine that can cause breathing problems) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problems, severe or
- Stomach or bowel blockage (including paralytic ileus)—Should not be used in patients with these conditions.
- Diabetes or
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe—Use is not recommended in patients with these conditions.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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) 2 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.
- Patients switching from Nucynta® to Nucynta® ER:
- For nerve pain caused by diabetes:
- Adults—At first, 50 milligrams (mg) 2 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 severe pain:
- 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 moderate to severe pain:
- 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 moderate to severe pain:
- 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 and tolerated.
- Children 6 years of age and older weighing 80 kilograms (kg) or more—50 mg every 4 hours. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 100 mg per dose.
- Children 6 years of age and older weighing 60 to 79 kg—50 mg every 4 hours. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 75 mg per dose.
- Children 6 years of age and older weighing 40 to 59 kg—50 mg every 4 hours.
- Children younger than 6 years of age and weighing less than 40 kg—Use and dose must be determined by your doctor.
- For moderate to severe pain:
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.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress at regular visits, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that sometimes produces a pink frothy sputum, difficult, fast or slow, irregular, shallow, or trouble breathing, increased sweating, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, skin, sleepiness or unusual drowsiness, swelling in the legs and ankles, or yellow eyes..
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.
This medicine may cause some people to become dizzy, lightheaded, faint, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Getting up slowly from a lying or sitting position may also help.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines. Check with your doctor first before you take any other medicines. Call your doctor right away if you have a fever, confusion, restlessness, loss of coordination, or diarrhea.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.
Do not change the dose or suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, restlessness, fever or chills, joint pain, nausea or vomiting, loss of appetite. runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
For nursing mothers:
- Talk to your doctor if you have any questions about taking tapentadol or about how this medicine may affect your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- chills
- cough
- difficult, burning, or painful urination
- difficulty with breathing
- fever
- headache
- loss of voice
- lower back or side pain
- muscle aches
- unusual tiredness or weakness
Rare
- Anxiety
- being forgetful or confused
- chest tightness
- clumsiness or unsteadiness
- drowsiness
- fast or irregular heartbeat
- feeling drunk
- irritability or restlessness
- joint pain, stiffness, or swelling
- pale or blue lips, fingernails, or skin
- rash, hives, or itching
- seizures
- sensation of heaviness
- shakiness or trembling
- slurred speech
- swelling of the eyelids, face, lips, hands, or feet
- trouble swallowing
- trouble with speaking or hoarseness
Incidence not known
- Agitation
- changes in behavior
- confusion
- darkening of the skin
- diarrhea
- dizziness
- fainting
- increased sensitivity to pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- mental depression
- nausea
- overactive reflexes
- poor coordination
- seeing, hearing, or feeling things that are not there
- shivering
- sweating
- talking or acting with excitement you cannot control
- thoughts of killing oneself
- trembling or shaking
- twitching
- vomiting
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Change in consciousness
- chest pain or discomfort
- cold, clammy skin
- coughing that sometimes produce a pink frothy sputum
- decreased awareness or responsiveness
- difficult or trouble breathing
- increased sweating
- irregular, fast or slow, or shallow breathing
- lightheadedness, dizziness or fainting
- loss of consciousness
- pale or blue lips, fingernails, or skin
- sleepiness or unusual drowsiness
- swelling in the legs and ankles
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
Less common
- Abnormal dreams
- heartburn or indigestion
- muscle pain or stiffness
- redness of the face, neck, arms, and occasionally, upper chest
- stomach discomfort, upset, or pain
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Rare
- Change in vision
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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