Pronunciation:

ta-PEN-ta-dol

Brand Names:

• Nucynta

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Analgesic

Chemical—

Opioid

Uses of This Medicine:

Tapentadol is a narcotic analgesic that acts in the central nervous system to relieve moderate or severe pain. If tapentadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine. Since this medicine is only used for short-term relief of pain, physical dependence will probably not occur.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tapentadol in the pediatric population. Safety and efficacy have not been established.

Older adults—

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 age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving tapentadol.

Pregnancy—

Breast-feeding—

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.

Other medicines—

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.

• Brofaromine
• Clorgyline
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Moclobemide
• Nialamide
• Pargyline
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Toloxatone
• 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.

• Alfentanil
• Almotriptan
• Alprazolam
• Amitriptyline
• Amoxapine
• Anileridine
• Buprenorphine
• Buspirone
• Butabarbital
• Butorphanol
• Chlordiazepoxide
• Chlorpromazine
• Citalopram
• Clomipramine
• Clonazepam
• Clorazepate
• Codeine
• Desipramine
• Desvenlafaxine
• Dexmedetomidine
• Dezocine
• Diazepam
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Dothiepin
• Doxepin
• Doxylamine
• Duloxetine
• Eletriptan
• Escitalopram
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Fentanyl
• Flumazenil
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluvoxamine
• Frovatriptan
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Imipramine
• Levomethadyl
• Levorphanol
• Lofepramine
• Lorazepam
• Meperidine
• Meprobamate
• Methadone
• Midazolam
• Milnacipran
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nortriptyline
• Oxazepam
• Oxycodone
• Oxymorphone
• Paroxetine
• Pentazocine
• Pentobarbital
• Perphenazine
• Phenobarbital
• Prazepam
• Prochlorperazine
• Promethazine
• Propofol
• Propoxyphene
• Protriptyline
• Quazepam
• Ramelteon
• Remifentanil
• Rizatriptan
• Secobarbital
• Sertraline
• Sufentanil
• Sumatriptan
• Temazepam
• Thioridazine
• Tramadol
• Triazolam
• Trifluoperazine
• Trimipramine
• Venlafaxine
• Zaleplon
• Zolmitriptan
• Zolpidem

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:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Physical dependence on tapentadol may be more likely to develop.

• Bowel blockage (e.g., paralytic ileus) or
• Kidney disease, severe or
• Liver disease, severe or
• Lung disease (e.g., asthma or hypercapnia), severe—Should not be used in patients with these conditions.

• Brain tumor or head injury, history of or
• Breathing or other lung problems (e.g., chronic obstructive pulmonary disease [COPD], hypoxia, or sleep apnea) or
• Depression, history of or
• Gallbladder problems or
• Kyphoscoliosis (severe curvature of the spine that can cause breathing problems) or
• Pancreatitis (inflammation of the pancreas) or
• Seizures or epilepsy, history of or
• Underactive thyroid—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal from the body.

Proper Use of This Medicine:

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. To do so may increase the chance of side effects and the chances of abuse.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

• For oral dosage form (tablets):
  • For pain:
    • Adults—50 to 100 milligrams (mg) every 4 to 6 hours. Your doctor may adjust your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

You should not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system and may cause drowsiness. Some examples of CNS depressants are antihistamines or medicines for hay fever or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; barbiturates; medicines for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using tapentadol.

This medicine may cause some people to become dizzy, lightheaded, faint, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do 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.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause a serious condition called serotonin syndrome. This is more likely to occur when it is taken with certain medicines for depression (e.g., amitriptyline, doxepin, fluoxetine, nortriptyline, paroxetine, Celexa®, Effexor®, Elavil®, Lexapro™, Pamelor®, Paxil®, Sinequan®, or Zoloft®), pain (e.g., tramadol [e.g., Ultram®]), or migraine headaches (sumatriptan [e.g., Imitrex®], zolmitriptan [e.g., Zomig®], or rizatriptan [e.g., Maxalt®]). Check with your doctor first before taking any other medicines.

Do not 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 prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

Side Effects of This Medicine:

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 in breathing

ear congestion

fever

frequent urge to urinate

headache

loss of voice

lower back or side pain

muscle aches

nasal congestion

runny nose

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Rare

Anxiety

being forgetful

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in patterns and rhythms of speech

clumsiness or unsteadiness

confusion

confusion about identity, place, and time

convulsions

delusions

dementia

drowsiness

dry mouth

fainting

false or unusual sense of well-being

fast heartbeat

feeling drunk

hives

hoarseness

hyperventilation

irregular heartbeats

irregular, fast, slow, or shallow breathing

irritability

itching

joint pain, stiffness, or swelling

nervousness

pale or blue lips, fingernails, or skin

rash

redness of the skin

relaxed and calm

restlessness

sensation of heaviness

shakiness and unsteady walk

shortness of breath

sleepiness

slurred speech

swelling

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble in speaking

trouble with sleeping

troubled breathing or swallowing

unsteadiness, trembling, or other problems with muscle control or coordination

wheezing

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

dizziness

nausea

sleepiness or unusual drowsiness

vomiting

Less common

Abnormal dreams

acid or sour stomach

belching

decreased appetite

difficulty in moving

feeling hot

feeling of warmth

heartburn

increased sweating

indigestion

muscle pain or stiffness

rash

redness of the face, neck, arms, and occasionally, upper chest

sleeplessness

stomach discomfort, upset, or pain

sudden sweating

unable to sleep

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Rare

Blurred or loss of vision

disturbed color perception

double vision

halos around lights

night blindness

overbright appearance of lights

tunnel 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.