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Tapentadol (Oral route)

Pronunciation:

ta-PEN-ta-dol

Brand Names:

  • Nucynta
  • Nucynta ER

Dosage Forms:

  • Tablet
  • Tablet, Extended Release
  • Solution

Warnings:

Oral route(Tablet, Extended Release)

Tapentadol extended-release contains tapentadol, an opioid agonist and Schedule II controlled substance, with risk of misuse, abuse, and diversion similar to other opioid analgesics (legal or illicit). Assess each patient's risk for opioid abuse or addiction prior to initiating therapy, with particular attention to patients with a personal of family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving tapentadol hydrochloride extended-release for signs of misuse, abuse, and addiction during treatment. Potentially fatal respiratory depression may occur, even without misuse or abuse. Proper dosing and titration are essential. Monitor for respiratory depression, especially during initiation of tapentadol hydrochloride extended-release or following a dose increase. 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. Accidental ingestion of tapentadol hydrochloride extended-release, especially in children, can result in a fatal overdose. Co-ingestion of alcohol with tapentadol extended-release may lead to increased plasma levels and a potentially fatal overdose. Patients must not consume alcoholic beverages, or use prescription or nonprescription medications containing alcohol during treatment with tapentadol hydrochloride extended-release .

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. It is also used to treat pain caused by nerve damage from diabetes. 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.

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 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 CategoryExplanation
All TrimestersCAnimal 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.

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
  • Carbinoxamine
  • 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
  • Levomilnacipran
  • Levorphanol
  • Lofepramine
  • Lorazepam
  • Meclizine
  • 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
  • Vortioxetine
  • Zaleplon
  • Zolmitriptan
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

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.
  • Brain tumor or head injury, history of or
  • Breathing or other lung problems (eg, chronic obstructive pulmonary disease or COPD, sleep apnea) or
  • Depression, history of or
  • Gallbladder problems or
  • Kyphoscoliosis (severe curvature of the spine that can cause breathing problems) or
  • Pancreatitis (inflammation or swelling of the pancreas) or
  • Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
  • 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.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine 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 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 moderate to severe pain:
      • Adults—At first, 50 milligrams (mg) two times a day (every 12 hours). Your doctor may adjust your dose as needed.
      • 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.
      • 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits, especially for the first few days you take tapentadol. This is necessary to allow dose adjustments and to check for any unwanted effects.

Do 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.

Call your doctor right away if you have difficult, fast or slow, irregular, shallow, or troubled breathing, pale or blue lips, fingernails, or skin, or shortness of breath. These may be symptoms of a serious breathing problem called respiratory depression.

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. 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.

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 a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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 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, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, 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.

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 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, fever
cough
difficult, burning, or painful urination
difficulty with breathing
headache
loss of voice
lower back or side pain
muscle aches
unusual tiredness or weakness
Rare
Anxiety or nervousness
being forgetful or confused
clumsiness or unsteadiness
convulsions
drowsiness
fast or irregular heartbeat
feeling drunk
irritability or restlessness
itching
joint pain, stiffness, or swelling
pale or blue lips, fingernails, or skin
rash or hives
sensation of heaviness
shakiness or trembling
slurred speech
swelling of the eyelids, face, lips, hands, or feet
tightness in the chest
trouble with speaking or hoarseness
troubled breathing or swallowing
Incidence not known
Changes in behavior
dizziness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seeing, hearing, or feeling things that are not there
thoughts of killing oneself

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
nausea
vomiting
Less common
Abnormal dreams
decreased appetite
difficulty with moving
heartburn or indigestion
increased sweating
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.


Last Updated: 4/4/2014

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