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Description

Generic Name

Tapentadol (as tapentadol hydrochloride)

Active Ingredient

Tapentadol hydrochloride

Chemical Name and Composition

Tapentadol hydrochloride is chemically described as 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol hydrochloride.

Tapentadol hydrochloride is a white to off-white crystalline powder. It is freely soluble in water and has a molecular weight of about 257.80 (as the hydrochloride salt). It is a synthetic, centrally acting compound.

Medication Classification

Tapentadol is a centrally acting opioid analgesic with a dual mechanism of action. It works in two ways:

• Mu-opioid receptor agonism: It binds to opioid receptors in the central nervous system to change how the body senses and responds to pain.
• Norepinephrine reuptake inhibition: It blocks the reuptake of norepinephrine, a nerve signaling chemical, which also contributes to pain relief.

Tapentadol is a Schedule II (CII) controlled substance under U.S. federal law.

Indications

• Immediate-release tablets (Nucynta) are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
• Extended-release tablets (Nucynta ER) are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, and for neuropathic pain associated with diabetic peripheral neuropathy severe enough to require an opioid analgesic, in adults for whom alternative treatments are inadequate. The extended-release form is not for use as an as-needed (PRN) pain reliever.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Immediate-release oral tablets
  • Extended-release oral tablets
• Route of Administration: Oral
• Common Strengths:
• • Immediate-release tablets: 50 mg, 75 mg, and 100 mg
  • Extended-release tablets: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg

Formulations and strengths may vary by manufacturer. Confirm the exact strength on your product label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. Immediate-release tablets may contain microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, lactose, hypromellose, titanium dioxide, polyethylene glycol, talc, and colorants that differ by strength. Extended-release tablets may contain hypromellose, polyethylene oxide, and other release-controlling agents, along with a film coating. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take tapentadol exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your pain, your prior opioid use, and your overall health. Do not change your dose on your own.

How to Take Tapentadol

• Immediate-release tablets: Swallow with water. These are usually taken every 4 to 6 hours as needed for pain, following your provider's directions.
• Extended-release tablets: Swallow the tablet whole, one at a time, with enough water to make sure it goes down right away. Take these on a regular schedule, usually every 12 hours.
• Never crush, chew, break, cut, or dissolve an extended-release tablet. Doing so can release a fatal dose all at once.
• Do not pre-soak, lick, or wet the extended-release tablet before placing it in your mouth.
• Take only one extended-release tablet at a time, and do not lie down for about 10 minutes after taking it, if directed.
• Do not take more than prescribed, and do not take it more often than directed.

General Dosing Principles

• Dosing is individualized based on the severity of pain, your response, and your prior opioid experience.
• The immediate-release and extended-release forms are not interchangeable milligram-for-milligram, and tapentadol is not equivalent to other opioids on a milligram basis.
• Your provider will select the exact dose, strength, and schedule for your situation and may adjust it based on your response and side effects.

Food Considerations

Tapentadol may be taken with or without food. Avoid alcohol entirely while taking tapentadol. Drinking alcohol or taking products that contain alcohol with the extended-release tablet can cause it to release the drug too quickly, leading to a dangerous or fatal overdose.

Missed Dose Instructions

• Immediate-release tablets are usually taken only when you have pain, so a missed dose is often not a concern. Take it when needed, following your provider's directions.
• Extended-release tablets: If you miss a dose, take it as soon as you remember, then take the next dose about 12 hours later. If it is almost time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you are unsure what to do, contact your healthcare provider or pharmacist.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children. Accidental use by a child can be fatal.

Disposal

Because tapentadol is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain opioid products, including tapentadol, down the toilet to prevent accidental exposure. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.

Special Instructions

Children: The safety and effectiveness of tapentadol have not been established in pediatric patients. It is not recommended for use in children. Keep the medication where children cannot reach it. Accidental ingestion by a child can cause fatal respiratory depression. If a child swallows this medication, seek emergency care immediately.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of tapentadol, including sedation, confusion, dizziness, constipation, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.

Patients with Liver Problems: Use with caution. Tapentadol is not recommended for patients with severe liver problems. For patients with moderate liver problems, a lower starting dose and longer time between doses may be needed, since impaired liver function can increase drug levels.

Patients with Kidney Problems: Tapentadol has not been well studied in patients with severe kidney problems, and its use is not recommended in this group. Use with caution in patients with reduced kidney function.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking tapentadol suddenly after prolonged use. Abrupt discontinuation can cause opioid withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose should be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble sleeping, nausea, loss of appetite, vomiting, diarrhea, and a rapid heartbeat.
• Tell your provider if withdrawal symptoms occur so the taper can be adjusted.

Overdose Warning

An overdose of tapentadol can be serious and may be fatal, especially when combined with benzodiazepines, alcohol, or other CNS depressants. Symptoms of overdose may include:

• Slowed, shallow, or stopped breathing
• Extreme drowsiness or difficulty staying awake
• Loss of consciousness or coma
• Limp or weak muscles
• Cold, clammy skin
• Pinpoint pupils
• Slow heartbeat or low blood pressure
• Seizures

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse an opioid overdose. Because the extended-release tablet releases tapentadol over a long period, its effects can last a long time. Repeated doses of naloxone may be needed, and the patient should be watched closely for an extended period, even after the first dose.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking tapentadol and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when starting treatment, after a dose increase, or when combined with other CNS depressants.
• Serotonin syndrome: Agitation, hallucinations, fast heartbeat, fever, excessive sweating, shivering, shaking, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea, especially when taken with certain other medicines. Because tapentadol affects norepinephrine and can interact with serotonergic drugs, this risk deserves special attention.
• Seizures: Tapentadol may increase the risk of seizures, particularly in people with a seizure disorder or other risk factors.
• Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
• Severe allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
• Severe constipation or bowel obstruction: Ongoing constipation, stomach pain, or inability to have a bowel movement.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Nausea
• Dizziness
• Constipation
• Drowsiness or sleepiness (somnolence)
• Headache
• Vomiting
• Dry mouth
• Itching
• Fatigue

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; and Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

• Addiction, abuse, and misuse: Tapentadol exposes users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing and monitor throughout treatment.
• Life-threatening respiratory depression: Serious, life-threatening, or fatal respiratory depression may occur. The risk is greatest during treatment initiation and after a dose increase. Monitor closely, especially when starting treatment and after dose increases.
• Accidental ingestion: Accidental ingestion of even one dose, especially by children, can result in fatal overdose. Store securely and out of reach.
• Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS, which may be life-threatening if not recognized and treated.
• Risks from concomitant use with benzodiazepines or other CNS depressants: Combining tapentadol with these substances may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with no alternative options, and limit the dose and duration.

Conditions to Disclose to Your Healthcare Provider

Before taking tapentadol, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
• Liver or kidney problems
• A head injury, brain tumor, or a condition causing increased pressure in the brain
• Seizures or a seizure disorder
• Adrenal gland problems, such as Addison's disease
• Low blood pressure or fainting spells
• Enlarged prostate or urination problems
• Gallbladder, pancreas, or thyroid problems
• Trouble swallowing, or a narrowing or blockage in your stomach or intestines
• Mental health conditions, including depression
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• Recent use of an MAOI (within the past 14 days)
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take tapentadol if you:

• Have significant respiratory depression
• Have acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
• Have a known or suspected gastrointestinal obstruction, including paralytic ileus
• Are taking, or have taken within the past 14 days, a monoamine oxidase inhibitor (MAOI), because this can cause serious and possibly fatal interactions, including serotonin syndrome and a dangerous rise in blood pressure
• Have a known hypersensitivity to tapentadol or any component of the formulation

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• Monoamine oxidase inhibitors (MAOIs): Combined use, or use within 14 days of an MAOI, may cause serious, possibly fatal reactions, including serotonin syndrome and a dangerous rise in blood pressure. This combination is contraindicated.
• Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics), triptans, or other serotonergic medicines may increase the risk of serotonin syndrome. Because tapentadol also affects norepinephrine, this risk deserves close attention.
• Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, other opioids, and alcohol.
• Alcohol: Drinking alcohol or taking products that contain alcohol can cause the extended-release tablet to release tapentadol too quickly, dangerously raising drug levels and increasing the risk of fatal overdose. Avoid alcohol entirely.
• CYP2D6 and CYP3A4 inducers or inhibitors: Drugs that affect these liver enzymes may change tapentadol levels. Drugs such as rifampin, carbamazepine, and phenytoin may reduce its effectiveness, while some other medicines may increase its levels and the risk of side effects.
• Mixed agonist/antagonist and partial agonist opioids: Drugs such as buprenorphine, nalbuphine, or pentazocine may reduce the pain-relieving effect and may trigger withdrawal.
• Anticholinergic drugs: May increase the risk of severe constipation, urinary retention, or bowel obstruction.

Monitoring Requirements

Your healthcare provider may monitor:

• Signs of respiratory depression and sedation, especially early in treatment and after dose increases
• Signs of serotonin syndrome, particularly when combined with serotonergic medicines
• Your pain relief and overall response to treatment
• Your risk for abuse, misuse, and diversion throughout treatment
• Blood pressure, particularly in patients at risk for low blood pressure
• Bowel function, given the risk of constipation
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Tapentadol is a Schedule II controlled substance.

• Tapentadol is a potent opioid and may be a target for people who abuse prescription medicines or street drugs.
• Physical dependence and tolerance can develop with continued use. Physical dependence is not the same as addiction, but it means you should not stop suddenly.
• Do not increase your dose on your own.
• Do not sell or give away tapentadol. Doing so may harm others and is against the law. Even a single dose can be fatal to someone who is not opioid-tolerant, especially a child.
• Misusing this medication, including crushing, snorting, or injecting it or taking it in ways other than prescribed, can cause overdose and death.

Long-Term Use Considerations

• If long-term treatment is needed, your provider should regularly reassess whether it is still appropriate.
• Physical dependence and tolerance are expected with continued use. Any decision to stop treatment should involve a gradual, supervised taper.
• Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
• Ongoing constipation is common with continued use and may require a management plan from your provider.

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Patient Counseling Information

Safe Medication Use

• Take tapentadol exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Swallow extended-release tablets whole, one at a time. Never crush, chew, break, or dissolve them, as this can release a fatal dose all at once.
• Take extended-release tablets on a regular schedule, usually every 12 hours. The extended-release form is not for as-needed pain relief.
• Do not stop taking tapentadol suddenly after prolonged use. Talk to your healthcare provider about a safe tapering plan.
• Do not share tapentadol with anyone else. Sharing is dangerous and against the law.
• Keep tapentadol in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Benzodiazepines, alcohol, and CNS depressants: Do not use these with tapentadol unless directed by your healthcare provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking tapentadol. Alcohol can cause the extended-release tablet to release the drug too quickly, leading to a fatal overdose.
• Serotonergic medicines and MAOIs: Tell your provider about all antidepressants and other medicines you take. Never take tapentadol within 14 days of an MAOI. Watch for signs of serotonin syndrome, such as agitation, fast heartbeat, fever, or muscle stiffness.
• Driving and machinery: Tapentadol can make you sleepy or dizzy and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
• Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone. Because the extended-release form is long-acting, more than one dose of naloxone may be needed.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant, as prolonged use can cause neonatal opioid withdrawal syndrome in your baby.
• Breastfeeding: Talk to your provider before breastfeeding while taking tapentadol, as it may pass into breast milk and affect a nursing baby.
• Constipation: Ask your provider about ways to prevent or manage constipation while taking tapentadol.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Feel faint, very dizzy, or lightheaded
• Develop signs of serotonin syndrome, such as agitation, hallucinations, fast heartbeat, fever, or muscle stiffness
• Have a seizure
• Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
• Have a severe allergic reaction, such as swelling of the face or throat, hives, or trouble breathing
• Have severe constipation, stomach pain, or are unable to have a bowel movement
• Experience withdrawal symptoms such as restlessness, sweating, muscle aches, nausea, or diarrhea after reducing or stopping the medication
• Have any symptom that concerns you or does not go away