Nucynta ER (tapentadol extended-release) is a prescription opioid analgesic designed for the management of severe and persistent pain in adults requiring continuous, around-the-clock pain relief for an extended period. It is particularly indicated for moderate to severe chronic pain and neuropathic pain associated with diabetic peripheral neuropathy (DPN) when other treatments, such as non-opioid analgesics, are inadequate or not tolerated.
What is Nucynta ER?
Nucynta ER is an extended-release formulation of tapentadol, a centrally acting synthetic analgesic that works through two mechanisms: mu-opioid receptor agonism and norepinephrine reuptake inhibition. This dual mechanism helps manage pain by altering how the brain and body perceive it, making it effective for both chronic pain and neuropathic pain associated with DPN. Nucynta ER is taken twice daily and is available in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths. It is not intended for as-needed (PRN) use or for acute or postoperative pain.
Indications for Use
- Management of Moderate to Severe Chronic Pain: For adults requiring continuous opioid treatment for an extended period when alternative treatments are inadequate.
- Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN): For adults with severe nerve pain due to diabetes, when other pain relief options are ineffective or not tolerated.
How Nucynta ER Works
- Mu-Opioid Receptor Agonism: Binds to opioid receptors in the brain to reduce pain perception.
- Norepinephrine Reuptake Inhibition: Increases norepinephrine levels, which modulates pain signals, particularly for neuropathic pain.
Dosage and Administration
- Starting Dose: 50 mg orally twice daily (every 12 hours) for opioid-naïve patients or those not opioid-tolerant. Higher starting doses may cause fatal respiratory depression in these patients.
- Titration: Adjust dose by no more than 50 mg twice daily every 3 days to balance pain relief and tolerability. Maintenance doses typically range from 100 mg to 250 mg twice daily, with a maximum of 500 mg/day.
- Conversion from Immediate-Release (IR) Nucynta: Use the same total daily dose, divided into two equal doses given every 12 hours. For example, 200 mg/day of Nucynta IR (50 mg four times daily) converts to 100 mg Nucynta ER twice daily.
- Administration Instructions:
- Swallow tablets whole; do not crush, chew, split, or dissolve, as this can lead to rapid release and potentially fatal overdose. Can be taken with or without food.
- Missed Dose: Take the next dose at the usual time; do not double the dose.
Side Effects
Common Side Effects
- Nausea
- Constipation
- Vomiting
- Dizziness
- Headache
- Sleepiness (somnolence)
- Tiredness
- Abdominal pain
Serious Side Effects
- Respiratory Depression: Life-threatening slowing or stopping of breathing, especially in older adults, debilitated patients, or those with chronic lung conditions.
- Serotonin Syndrome: Symptoms include agitation, hallucinations, fever, sweating, fast heart rate, muscle stiffness, nausea, or diarrhea, particularly when combined with other serotonergic drugs.
- Low Blood Pressure (Hypotension): May cause dizziness or fainting, especially when standing up quickly.
- Increased Pain Sensitivity (Hyperalgesia or Allodynia): Pain may worsen or become more sensitive, requiring consultation with a healthcare provider.
- Seizures: Rare but possible, especially in patients with a history of seizures.
- Sphincter of Oddi Spasm: Can cause severe abdominal pain, particularly in patients without a gallbladder.
- Adrenal Insufficiency: Symptoms include nausea, fatigue, muscle pain, or craving salty foods.
Warnings and Precautions
- Addiction, Abuse, and Misuse: As a Schedule II controlled substance, Nucynta ER has a high potential for addiction, even at prescribed doses. Patients with a history of substance abuse or mental illness are at higher risk.
- Life-Threatening Respiratory Depression: Can occur at any time, particularly during dose initiation or increases.
- Accidental Ingestion: A single dose can be fatal, especially in children. Store securely out of reach.
- Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can cause life-threatening withdrawal symptoms in newborns.
- Interaction with Alcohol or CNS Depressants: Combining with alcohol, benzodiazepines, or other central nervous system depressants can lead to severe sedation, respiratory depression, coma, or death.
- Contraindications:
- Severe breathing problems or asthma in unmonitored settings.
- Bowel obstruction (paralytic ileus).
- Use of monoamine oxidase inhibitors (MAOIs) within the past 14 days.
Precautionary Measures:
- Avoid alcohol and inform your doctor about all medications, including over-the-counter drugs, supplements, and herbal products.
- Do not drive or operate heavy machinery until you know how Nucynta ER affects you.
- Consider keeping naloxone (an opioid overdose reversal drug) available, especially if there are risk factors for overdose.
Disposal of Nucynta ER
- Dispose of expired, unwanted, or unused Nucynta ER through a DEA-registered drug take-back program.
- If no take-back program is available, flush the tablets down the toilet or mix with an unappealing substance (e.g., dirt, coffee grounds), seal in a plastic bag, and discard in the trash.
FAQs
1. What is Nucynta ER used for?
Nucynta ER is used for around-the-clock management of moderate to severe chronic pain and neuropathic pain associated with diabetic peripheral neuropathy in adults when other treatments are inadequate. It is not for as-needed use or acute/postoperative pain.
2. Can I drink alcohol while taking Nucynta ER?
No, combining Nucynta ER with alcohol can cause dangerous side effects, including severe sedation, respiratory depression, coma, or death. Avoid alcohol entirely while using this medication.
3. What should I do if I miss a dose?
Take the missed dose as soon as you remember, but skip it if it’s almost time for your next dose. Do not take two doses at once, as this increases the risk of overdose.
4. Is Nucynta ER addictive?
Yes, Nucynta ER is a Schedule II controlled substance with a high potential for addiction, abuse, and misuse, even at prescribed doses. Patients with a history of substance abuse are at higher risk. Follow your doctor’s instructions and never share the medication.
6. Can I stop taking Nucynta ER suddenly?
No, stopping Nucynta ER abruptly can cause withdrawal symptoms such as restlessness, sweating, chills, muscle aches, or anxiety. Your doctor will gradually taper the dose to minimize withdrawal risks.
8. Can Nucynta ER be used during pregnancy?
Nucynta ER should only be used during pregnancy if the benefits outweigh the risks. Prolonged use may cause neonatal opioid withdrawal syndrome. Consult your doctor if you are pregnant or planning to become pregnant.
9. How should I store Nucynta ER?
Store at room temperature (77°F, 25°C) in a secure place out of reach of children and others, as accidental ingestion can be fatal. Protect from moisture and light.