Nucynta 100 milligrams. Nucynta (Tapentadol): Uses, Risks, and Important Safety Information
What is Nucynta and how does it work. What are the potential side effects and risks of using Nucynta. How should Nucynta be used safely and effectively. What precautions should be taken when using Nucynta during pregnancy. How can the risk of addiction and overdose be minimized when using Nucynta.
Understanding Nucynta: An Overview of Tapentadol
Nucynta, also known by its generic name tapentadol, is a powerful prescription medication used to manage moderate to severe acute pain. It belongs to a class of drugs called opioid analgesics, which work by altering the way the brain perceives and responds to pain signals. As an extended-release (ER) formulation, Nucynta ER provides long-lasting pain relief for patients who require around-the-clock pain management.
Tapentadol’s mechanism of action involves binding to mu-opioid receptors in the central nervous system, similar to other opioids. However, it also inhibits the reuptake of norepinephrine, which may contribute to its analgesic effects. This dual mechanism of action sets tapentadol apart from traditional opioids and may offer some advantages in terms of efficacy and side effect profile.
Key Features of Nucynta
- Available as immediate-release and extended-release formulations
- Classified as a Schedule II controlled substance due to its potential for abuse and addiction
- Typically prescribed for short-term pain management following injuries or surgeries
- May be used for chronic pain in certain cases, under close medical supervision
Indications and Appropriate Use of Nucynta
Nucynta is primarily indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The extended-release formulation, Nucynta ER, is approved for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period.
When considering the use of Nucynta, healthcare providers must carefully weigh the potential benefits against the risks associated with opioid medications. The decision to prescribe Nucynta should be made on an individual basis, taking into account the patient’s pain severity, medical history, and response to other pain management strategies.
Common Scenarios for Nucynta Prescription
- Post-operative pain management
- Severe injury-related pain
- Chronic pain conditions unresponsive to non-opioid analgesics
- Cancer-related pain
Dosage and Administration Guidelines for Nucynta
The appropriate dosage of Nucynta varies depending on the individual patient’s needs, pain severity, and prior opioid exposure. It is crucial to follow the prescriber’s instructions and the information provided in the Medication Guide carefully.
For opioid-naive patients, the typical starting dose of immediate-release Nucynta is 50 to 100 mg every 4 to 6 hours as needed for pain relief. The maximum daily dose should not exceed 600 mg. Nucynta ER is typically initiated at 50 mg twice daily, with dosage adjustments made based on individual patient response and tolerability.
Important Dosing Considerations
- Always take Nucynta exactly as prescribed by your healthcare provider
- Do not crush, chew, or dissolve Nucynta ER tablets, as this can lead to rapid release and absorption of a potentially fatal dose
- Avoid alcohol consumption while taking Nucynta, as it can increase the risk of severe side effects
- Never adjust your dose without consulting your healthcare provider
Potential Side Effects and Risks Associated with Nucynta Use
Like all opioid medications, Nucynta carries a risk of side effects and potential complications. Understanding these risks is essential for patients and caregivers to ensure safe and effective use of the medication.
Common Side Effects
- Nausea and vomiting
- Constipation
- Dizziness
- Headache
- Drowsiness
- Dry mouth
Serious Risks and Warnings
Nucynta carries several serious risks that patients and healthcare providers must be aware of:
- Respiratory depression: Nucynta can slow or stop breathing, especially when starting treatment or increasing the dose.
- Addiction and abuse: As an opioid, Nucynta has a high potential for addiction and misuse.
- Overdose: Taking too much Nucynta can lead to life-threatening overdose symptoms.
- Interactions with other substances: Combining Nucynta with alcohol, benzodiazepines, or other CNS depressants can increase the risk of severe side effects.
- Withdrawal symptoms: Abruptly stopping Nucynta can lead to uncomfortable and potentially dangerous withdrawal symptoms.
Mitigating Risks: Safety Measures and Precautions
To minimize the risks associated with Nucynta use, several safety measures and precautions should be implemented:
Risk Evaluation and Mitigation Strategy (REMS)
The FDA has implemented a REMS program for opioid analgesics, including Nucynta, to ensure that the benefits of these medications outweigh the risks. This program includes education for healthcare providers on safe prescribing practices and patient counseling.
Naloxone Availability
Patients prescribed Nucynta should discuss with their healthcare provider whether they should have naloxone, an opioid overdose reversal medication, available. Family members and caregivers should be educated on recognizing and responding to an opioid overdose.
Safe Storage and Disposal
Proper storage and disposal of Nucynta are crucial to prevent accidental ingestion, misuse, or diversion. Keep the medication in a secure location out of reach of children and pets. Unused or expired medication should be disposed of according to FDA guidelines or through local take-back programs.
Special Considerations for Pregnant Women and Breastfeeding Mothers
The use of Nucynta during pregnancy and breastfeeding requires careful consideration and close medical supervision. While pain management is important during pregnancy, the potential risks to the developing fetus must be weighed against the benefits of treatment.
Pregnancy Risks
Nucynta use during pregnancy may increase the risk of certain birth defects, particularly if used during the first trimester. Additionally, prolonged use of opioids during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS), a potentially life-threatening condition in newborns.
Breastfeeding Considerations
Tapentadol can pass into breast milk and may affect a nursing infant. Women who are breastfeeding should discuss the potential risks and benefits with their healthcare provider before using Nucynta.
Managing Chronic Pain: Nucynta as Part of a Comprehensive Treatment Plan
While Nucynta can be an effective tool for managing chronic pain, it should be used as part of a comprehensive pain management strategy. This approach may include:
- Non-pharmacological interventions (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
- Non-opioid pain medications
- Regular follow-up with healthcare providers to assess pain control and medication efficacy
- Monitoring for signs of tolerance or dependence
- Gradual dose tapering when discontinuing treatment to minimize withdrawal symptoms
By combining various treatment modalities and closely monitoring patient response, healthcare providers can optimize pain management while minimizing the risks associated with long-term opioid use.
Drug Interactions and Contraindications for Nucynta
Understanding potential drug interactions and contraindications is crucial for the safe use of Nucynta. Certain medications and medical conditions can increase the risk of adverse effects or reduce the efficacy of tapentadol.
Important Drug Interactions
- Monoamine oxidase inhibitors (MAOIs): Concurrent use can lead to serotonin syndrome, a potentially life-threatening condition
- Benzodiazepines and other CNS depressants: Increased risk of respiratory depression, profound sedation, and death
- CYP3A4 inducers or inhibitors: May affect tapentadol metabolism, altering its effectiveness or increasing side effects
- Serotonergic drugs: Risk of serotonin syndrome when combined with tapentadol
Contraindications
Nucynta is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
- Known or suspected gastrointestinal obstruction
- Hypersensitivity to tapentadol or any component of the formulation
Patients with these conditions or taking medications that interact with Nucynta should explore alternative pain management options with their healthcare provider.
Nucynta Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing
Warnings:
Tapentadol has a risk for abuse and addiction, which can lead to overdose and death. Tapentadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tapentadol that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.
Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Be sure you know how to take tapentadol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms.
Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn’t stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Warnings:
Tapentadol has a risk for abuse and addiction, which can lead to overdose and death. Tapentadol may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of tapentadol that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.
Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.
The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death.
Be sure you know how to take tapentadol and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time.
Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn’t stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
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Uses
Tapentadol is used to help relieve moderate to severe short-term pain (such as pain from an injury or after surgery). It belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain.
How to use Nucynta
Read the Medication Guide provided by your pharmacist before you start taking tapentadol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food.
Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Properly stop the medication when so directed.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.
When this medication is used for a long time, it may not work as well.
Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your pain does not get better or if it gets worse.
Side Effects
See also Warning section.
Nausea, vomiting, constipation, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.
Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: confusion, interrupted breathing during sleep (sleep apnea), stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Get medical help right away if you have any serious side effects, including: slow/shallow breathing, fainting, seizures, severe drowsiness/difficulty waking up.
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before taking tapentadol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as seizures, head injury, tumor), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), gallbladder disease, kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), disease of the pancreas (pancreatitis), difficulty urinating (such as due to enlarged prostate).
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing, confusion, constipation, dizziness, and drowsiness.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. (See also Warning section.)
It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
Interactions
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist.
Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others.
The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (amylase/lipase levels), possibly causing false test results.
Make sure laboratory personnel and all your doctors know you use this drug.
Does Nucynta interact with other drugs you are taking?
Enter your medication into the WebMD interaction checker
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, seizures, coma.
Do not share this medication with others. Sharing it is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.
If you miss a dose, take it as soon as you remember.
If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.
Images
Nucynta 50 mg tablet
Color: yellowShape: roundImprint: O-M 50
This medicine is a yellow, round, film-coated, tablet imprinted with “O-M” and “50”.
Nucynta 100 mg tablet
Color: orangeShape: roundImprint: O-M 100
This medicine is a yellow, round, film-coated, tablet imprinted with “O-M” and “50”.
Nucynta 75 mg tablet
Color: yellow-orangeShape: roundImprint: O-M 75
This medicine is a yellow, round, film-coated, tablet imprinted with “O-M” and “50”.
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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Nucynta Dosage Guide – Drugs.com
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Generic name: TAPENTADOL HYDROCHLORIDE 50mg
Dosage form: tablet, film coated
Drug class: Opioids (narcotic analgesics)
Medically reviewed by Drugs.com. Last updated on Mar 6, 2023.
Important Dosage and Administration Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with NUCYNTA and adjust the dosage accordingly [see Warnings and Precautions (5.3)]
Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with NUCYNTA tablets [see Warnings and Precautions (5.
3), Patient Counseling Information (17)].
Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program).
Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient [see Warnings and Precautions (5.1, 5.3, 5.5)].
Consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose.
Initial Dosage
Initiating Treatment with NUCYNTA Tablets
Initiate treatment with NUCYNTA tablets in a dosing range of 50 mg to 100 mg every 4 to 6 hours as needed for pain.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
NUCYNTA tablets may be given with or without food [see Clinical Pharmacology (12.3)].
Conversion from NUCYNTA Tablets to NUCYNTA ER
Patients can be converted from NUCYNTA tablets to NUCYNTA ER using the equivalent total daily dose of NUCYNTA tablets and dividing it into two equal doses of NUCYNTA ER separated by approximately 12-hour intervals. As an example, a patient receiving 50 mg of NUCYNTA tablets four times per day (200 mg/day) may be converted to 100 mg NUCYNTA ER twice a day.
Dosage Modifications in Patients with Hepatic Impairment
The safety and efficacy of NUCYNTA tablets has not been studied in patients with severe hepatic impairment (Child-Pugh Score 10-15) and use in this population is not recommended [see Warnings and Precautions (5.
16)].
Initiate treatment of patients with moderate hepatic impairment (Child-Pugh Score 7 to 9) with 50 mg no more frequently than once every 8 hours (maximum of three doses in 24 hours). Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval. Monitor closely for respiratory and central nervous system depression [see Clinical Pharmacology (12.3)].
No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Clinical Pharmacology (12.3)].
Titration and Maintenance of Therapy
Continually reevaluate patients receiving NUCYNTA tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the NUCYNTA tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Safe Reduction or Discontinuation of NUCYNTA Tablets
Do not abruptly discontinue NUCYNTA Tablets in patients who may be physically dependent on opioids. Rapid discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances.
When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking NUCYNTA Tablets, there are a variety of factors that should be considered, including the dose of NUCYNTA Tablets the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient.
It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with co-morbid pain and substance use disorders may benefit from referral to a specialist.
There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on NUCYNTA Tablets who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks.
Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper.
It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose, and then proceed with a slower taper. In addition, monitor patients for any changes in mood, emergence of suicidal thoughts, or use of other substances.
When managing patients taking opioid analgesics, particularly those who have been treated for a long duration and/or with high doses for chronic pain, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper.
A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [see Warnings and Precautions (5.13), Drug Abuse and Dependence (9.3)].
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Nucynta vs. Oxycodone: Differences, Similarities & What’s Best for You – Drug Vs. Friend
Home >> Drug Vs. Friend >> Nucynta vs Oxycodone: Differences, Similarities & Which is Best for You
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Drug Overview and Key Differences | Conditions of treatment | Efficiency | Insurance coverage and cost comparison | Side effects | Drug Interactions | Warnings | FAQ
Nucynta and oxycodone are FDA approved. opioid prescription medications indicated for the treatment of severe, acute pain. They are typically used for pain that cannot be controlled with non-opioid medications or when the patient is intolerant of other alternatives. Both painkillers are classified as narcotic (Appendix II), which means they have a high potential for abuse or addiction.
How Nucynta works is not fully understood. Some studies have shown that Nucynta is a mu-receptor (nociceptor) agonist and norepinephrine reuptake inhibitor, resulting in pain relief.
Oxycodone works by binding to mu receptors in the brain, which dampens or blocks pain signals, resulting in pain relief.
Since both drugs are very strong, they are usually used in situations where pain relief is required when lighter (non-narcotic) pain medications would not be effective or would not be tolerated. Although both drugs are used for severe pain, they have many differences, which we will discuss below.
What are the main differences between Nucynta and oxycodone?
Nucinta (tapentadol) is an opioid or narcotic pain reliever (pain reliever). It is available branded as both immediate-release and extended-release tablets. The extended release tablet is called Nucynta ER. The starting dose is 50 to 100 mg every four to six hours as needed for pain. The dose may be changed by your doctor and the maximum dose is 600 mg per day.
Oxycodone is also a general opioid analgesic (and immediate release oxycodone IR) and is available in branded form as OxyContin, an extended release tablet. Dosage varies, but a typical dose for immediate release oxycodone tablets is 5 to 15 mg every four to six hours depending on the pain.
| Main differences between Nucynta and oxycodone | ||
|---|---|---|
| Nucynta | Oxycodone | |
| Drug class | Opioid (narcotic) analgesic | Opioid (narcotic) analgesic |
| Brand/generic status | Brand | Brand and generic |
| What is generic/brand? | Generic: Tapentadol | Brand: OxyIR (immediate release), Oxycontin (long acting) |
| What form(s) does the drug come in? | Immediate-release tablet Extended-release tablet | Immediate-release tablet Immediate-release capsule Extended-release tablet Oral solution |
| What is the standard dosage? | Initial: 50 to 100 mg every 4 to 6 hours as needed.  If necessary, the dose can be adjusted by the doctor. Maximum 700 mg per day on the first day of treatment, then the maximum dose is 600 mg per day after the first day. | Immediate release tablet: 5-15 mg every 4-6 hours as needed Extended-release tablet: 20 mg every 12 hours |
| How long does a typical treatment last? | Short-term, may be used longer depending on the condition treated (eg chronic pain) and response | Short-term, may be used longer depending on the condition treated (eg chronic pain) and response |
| Who usually takes this medicine? | Adults | Adults |
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Conditions Treated by Nucynta and Oxycodone
Both Nucynta and Oxycodone have the same indication for treatment, which is to treat adult acute pain that is severe enough to require an opioid analgesic, and when alternative therapies are inadequate or intolerable.
| Condition | Nucynta | Oxycodone |
| yes | yes |
Nucynta or oxycodone more effective?
In a study comparing immediate release Nucynta with immediate release oxycodone in patients with moderate to severe acute back pain, both drugs were equally safe and effective in treating back pain as well as associated leg pain. Nucynta patients had fewer stomach-related side effects.
In a study comparing the potential for abuse in patients taking Nucynta or oxycodone, Nucynta was found to have less potential for abuse.
The most effective medicine for you should only be determined by your doctor, who will review your condition(s), medical history, and other medicines you are taking.
Coverage and Cost Comparison of Nucynta and Oxycodone
State law states that if you are taking an opioid pain reliever for the first time, it is likely that you will receive a small amount.
Insurance coverage varies by Nucynta. Because it is more expensive and only available under brand names, your copay may be higher or the drug may need prior authorization from your insurance company. Nucynta is generally not covered by Medicare Part D. Nucynta 50mg, 30 tablets usually cost around $250, but you can get it for as little as $211 with the SingleCare discount.
Oxycodone is usually covered by insurance and Part D. Medicare. The cash price of 30.5mg tablets can be around $100, but you can use a single coupon at participating pharmacies and get it from $36.
| Nucynta | Oxycodone | |
| Usually covered by insurance? | Varies | yes |
| Usually covered by Medicare Part D? | No | yes |
| Standard dosage | 50 mg, #30 tablets | 5 mg #30 tablets |
| Typical Medicare Part D copay | $95-482 | $2-56 |
| SingleCare cost | $211+ | $36-62 |
Common side effects of Nucynta versus oxycodone
Most common side effects The effects of Nucynta are nausea, vomiting, drowsiness, dizziness, constipation, dry mouth and itching.
Severe respiratory depression (slowed breathing, lack of oxygen) may occur, which can be life-threatening or fatal.
The exact percentages of oxycodone are not reported, except that side effects were observed in more than or equal to 3% of patients. The most common side effects are nausea, constipation, vomiting, headache, itching (itching), insomnia, dizziness, weakness, and drowsiness. Serious adverse reactions may include respiratory depression, respiratory arrest (breathing arrest), cardiac arrest (sudden loss of heart, breathing, and consciousness function), low blood pressure, and/or shock.
Because of the serious risks, it is very important that if you are taking Nucynta or oxycodone, you take the drug exactly as prescribed and do not take extra doses. You should also monitor respiratory depression, especially when you start taking one of these drugs or during a dose change.
Other side effects may occur. Check with your healthcare provider for a complete list of side effects.
| Nucynta | Oxycodone | |||
| Side effect | 90 036 Applicable? | Frequency | Applicable? | Frequency |
| 8 | ||||
| Vomiting | yes | 18% 9 | ≥3% | |
| Constipation | yes | 8% | yes | ≥3% |
| Dry mouth | yes | 4% | yes | % not reported |
| Drowsiness | yes | fifteen% | yes | ≥3% |
| Dizziness | yes | 24% | ||
| Itching | yes | 5% | yes | ≥3% |
Source: DailyMed (Nucynta), DailyMed (oxycodone)
Drug interactions of Nucynta with oxycodone
Use of benzodiazepines or other CNS depressants, including other opioids, in combination with Nucynta or oxycodone may result in low blood pressure, respiratory depression, severe sedation, coma and/or death.
Combinations should be avoided. However, if no other option is available, the lowest dose of each drug should be used for the shortest period of time, and the patient should be closely monitored, especially at the start of treatment and any dose changes.
Taking Nucynta or oxycodone with drugs that increase serotonin levels may also increase the risk of serotonin syndrome, a life-threatening condition caused by the accumulation of too much serotonin. These drugs include antidepressants such as serotonin reuptake inhibitors, muscle relaxants, MAO inhibitors (MAO inhibitors should not be used within 14 days of taking Nucynta or oxycodone), and triptans for migraine.
Taking oxycodone with certain drugs that are metabolized by CYP3A4 or CYP2D6 may lead to drug interactions. These drugs are known as enzyme inhibitors and include macrolide antibiotics, azole antifungals, and protease inhibitors. Using them along with oxycodone can lead to high levels of the opioid, which can be very dangerous.
These drugs interact with oxycodone but not with Nucynta.
Other drugs, known as enzyme inducers, work in the opposite way to inhibitors, lowering opioid levels so that they are not as effective or may even cause withdrawal symptoms. Inducers may affect Nucynta or oxycodone.
Consult your healthcare professional for a complete list of drug interactions.
| Drug | Drug class | Nucynta | Oxycodone |
| Alprazolam Clonazepam Diazepam Lorazepam | Benzodiazepines | yes | yes |
| Alcohol | Alcohol | yes | yes |
| Codeine Fentanyl 9001 2 Hydrocodone Hydromorphone Methadone Morphine Tramadol | Opioids | yes | yes |
| Baclofen Carisoprodol Cyclobenzaprine Metaxalone Tizanidine | Muscle relaxants | yes | yes |
| Antidepressants | yes | yes | |
| Phenelzine Rasagiline Selegiline Tranylcypromine | MAO inhibitors | yes | yes |
| Furosemide Hydrochlorothiazide | Diuretics | yes | yes | Benztropine Diphenhydramine Oxybutynin Tolterodine | Anticholinergics | yes | yes |
| Almotriptan 900 12 Eletriptan Rizatriptan Sumatriptan Zolmitriptan | Migraine triptans | yes | yes |
| Clarithromycin Erythromycin Fluconazole Ketoconazole Ritonavir | CYP3A4 or CYP2D6 inhibitors | yes | |
| Carbamazepine Phenytoin | CYP3A4 inducers | yes | yes |
The use of opioids during pregnancy, for both medical and non-medical purposes, can cause physical dependence in the baby and can lead to opioid withdrawal in the newborn shortly after birth.
Nucynta may have a lower abuse potential. Talk to your doctor if Nucynta or oxycodone is right for you, if other pain medications haven’t worked or you can’t tolerate them.