Nucynta ER

Generic Name: tapentadol (Oral route)

ta-PEN-ta-dol

Oral route(Tablet, Extended Release)

Tapentadol extended-release contains tapentadol, a mu-opioid agonist and Schedule II controlled substance, with risk of misuse, abuse, and diversion similar to other opioid analgesics. Tapentadol extended-release is not intended for use as an as-needed analgesic or for the management of acute or postoperative pain. Tapentadol extended-release tablets should be swallowed whole. Taking split, broken, chewed, dissolved, or crushed tapentadol extended-release tablets could lead to rapid release and absorption of a potentially fatal dose of tapentadol. Patients must not consume alcoholic beverages, prescription or non-prescription medications containing alcohol. Co-ingestion of alcohol with tapentadol extended-release may result in a potentially fatal overdose of tapentadol .

Commonly used brand name(s)

In the U.S.

• Nucynta


• Nucynta ER

Available Dosage Forms:

• Tablet


• Tablet, Extended Release

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Nucynta ER

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 Nucynta ER

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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 tapentadol

This section provides information on the proper use of a number of products that contain tapentadol. It may not be specific to Nucynta ER. Please read with care.

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 Nucynta ER

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.

Nucynta ER 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 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.

See also: Nucynta ER side effects (in more detail)

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More Nucynta ER resources

• Nucynta ER Side Effects (in more detail)
• Nucynta ER Use in Pregnancy & Breastfeeding
• Nucynta ER Drug Interactions
• 3 Reviews for Nucynta ER - Add your own review/rating

• Nucynta ER Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Nucynta ER Prescribing Information (FDA)


• Tapentadol Professional Patient Advice (Wolters Kluwer)


• Nucynta Prescribing Information (FDA)


• Nucynta Monograph (AHFS DI)


• Nucynta MedFacts Consumer Leaflet (Wolters Kluwer)


• Nucynta Consumer Overview

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