Nucynta ER

Name: Nucynta ER

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Patient information

NUCYNTA® ER
(new-SINN-tah E-R)
(tapentadol) Extended Release Oral Tablets

NUCYNTA® ER is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
  • Also used to manage pain from damaged nerves (neuropathic pain) that happens with diabetes and is severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
  • Not used to treat pain that is not around-the-clock pain.

Important information about NUCYNTA® ER:

  • Get emergency help right away if you take too much NUCYNTAR® ER (overdose). When you first start taking NUCYNTA® ER, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur.
  • Never give anyone your NUCYNTA® ER. They could die from taking it. Store NUCYNTA® ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA® ER is against the law.

Do not take NUCYNTA® ER if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking NUCYNTA® ER, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • liver, kidney, thyroid problems
  • problems urinating
  • pancreas or gallbladder problems
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of NUCYNTA® ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be lifethreatening if not recognized and treated.
  • breastfeeding. NUCYNTA® ER passes into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA® ER with certain other medicines can cause serious side effects.

When taking NUCYNTA® ER:

  • Do not change your dose. Take NUCYNTA® ER exactly as prescribed by your healthcare provider.
  • Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
  • Swallow NUCYNTA® ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject NUCYNTA® ER because this may cause you to overdose and die.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking NUCYNTA® ER without talking to your healthcare provider.
    • After you stop taking NUCYNTA® ER, flush any unused tablets down the toilet.

While taking NUCYNTA® ER DO NOT:

  • Drive or operate heavy machinery until you know how NUCYNTAR® ER affects you. NUCYNTA® ER can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with NUCYNTA® ER may cause you to overdose and die.

The possible side effects of NUCYNTA® ER are:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.
  • agitation, hallucinations, coma, feeling overheated, or heavy sweating.

These are not all the possible side effects of NUCYNTAR® ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

  • Lortab 10
  • Lortab 2.5
  • Lortab 5
  • Lortab 7.5
  • Lortab Elixir
  • OxyContin
  • Reprexain
  • Ultracet
  • Ultram
  • Ultram ER
  • Vicodin
  • Vicodin ES
  • Vicodin HP
  • Vicoprofen

© Nucynta ER Patient Information is supplied by Cerner Multum, Inc. and Nucynta ER Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Nucynta ER Overdose

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

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 constipation and age-related lung, liver, or kidney problems, which may require caution and 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.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nalmefene
  • Naltrexone
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • 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
  • Alfentanil
  • Almotriptan
  • Alprazolam
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amobarbital
  • Amoxapine
  • Amphetamine
  • Anileridine
  • Aripiprazole
  • Asenapine
  • Baclofen
  • Benperidol
  • Benzphetamine
  • Bromazepam
  • Bromopride
  • Brompheniramine
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carphenazine
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorzoxazone
  • Citalopram
  • Clobazam
  • Clomipramine
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Cocaine
  • Codeine
  • Cyclobenzaprine
  • Desipramine
  • Desmopressin
  • Desvenlafaxine
  • Dexmedetomidine
  • Dextroamphetamine
  • Dextromethorphan
  • Dezocine
  • Diazepam
  • Dibenzepin
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Dolasetron
  • Donepezil
  • Doxepin
  • Doxylamine
  • Droperidol
  • Duloxetine
  • Eletriptan
  • Enflurane
  • Escitalopram
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Flibanserin
  • Fluoxetine
  • Flurazepam
  • Fluspirilene
  • Fluvoxamine
  • Fospropofol
  • Frovatriptan
  • Granisetron
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydrocodone
  • Hydromorphone
  • Hydroxytryptophan
  • Hydroxyzine
  • Imipramine
  • Isoflurane
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Levomilnacipran
  • Levorphanol
  • Lisdexamfetamine
  • Lithium
  • Lofepramine
  • Lorazepam
  • Lorcaserin
  • Loxapine
  • Meclizine
  • Melitracen
  • Melperone
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methamphetamine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Midazolam
  • Milnacipran
  • Mirtazapine
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Naratriptan
  • Nefazodone
  • Nicomorphine
  • Nitrazepam
  • Nitrous Oxide
  • Nortriptyline
  • Olanzapine
  • Ondansetron
  • Opipramol
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Palonosetron
  • Papaveretum
  • Paregoric
  • Paroxetine
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Pimozide
  • Piperacetazine
  • Pipotiazine
  • Piritramide
  • Prazepam
  • Primidone
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propofol
  • Protriptyline
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Remifentanil
  • Remoxipride
  • Rizatriptan
  • Secobarbital
  • Sertindole
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sumatriptan
  • Suvorexant
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioridazine
  • Tianeptine
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Trazodone
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Trimipramine
  • Tryptophan
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Zaleplon
  • Ziprasidone
  • Zolmitriptan
  • Zolpidem
  • Zopiclone
  • Zotepine

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:

  • Adrenal problems or
  • Alcohol abuse, history of or
  • Brain tumor, history of or
  • Breathing or other lung problems (eg, chronic obstructive pulmonary disease or COPD, sleep apnea) or
  • Depression, history of or
  • Drug abuse or dependence, history of or
  • Gallbladder problems or
  • Head injuries, history of 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.
  • Breathing problems (eg, asthma, hypercarbia), severe or
  • Paralytic ileus (intestinal blockage or narrowing) or
  • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.
  • Gallbladder problems or
  • Hypotension (low blood pressure) or
  • Pancreatitis (inflammation or 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 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 or pharmacist 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 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 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 (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. 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, 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.

Keep the oral liquid bottle upright after opening.

Dispose any unneeded tablets or oral liquid by flushing them down the toilet.

Uses of Nucynta ER

  • It is used to ease pain.

What do I need to tell my doctor BEFORE I take Nucynta ER?

  • If you have an allergy to Nucynta ER or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Nucynta ER within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, pentazocine, or tramadol.
  • If you are taking another drug that has the same drug in it.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Nucynta ER with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Nucynta ER) best taken?

Use Nucynta ER as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Take with food if it causes an upset stomach.
  • Take by mouth only.
  • Do not inject or snort this medicine. Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
  • To gain the most benefit, do not miss doses.
  • Do not use for fast pain relief or on an as needed basis.
  • Do not use for pain relief after surgery if you have not been taking drugs like Nucynta ER.
  • Swallow whole. Do not chew, break, or crush.
  • Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
  • If you have trouble swallowing, talk with your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Nucynta ER Description

Nucynta ER (tapentadol) is an opioid agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is:

The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO•HCl. The n- octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets)

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