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Tapentadol, marketed as Nucynta, is a medication associated with significant risks, including potential for misuse and addiction, which can lead to overdose and death. It is critical to follow your healthcare provider’s instructions precisely to minimize these risks. Below are important safety precautions and warnings that you should be aware of:

• Risk of Addiction and Misuse: Tapentadol is a controlled substance with a high potential for addiction. Misuse can result in serious side effects, including dangerously slow breathing, inability to stay awake, and overdose. Individuals with a history of substance use disorder or mental health issues should exercise extra caution.

• Respiratory Depression: Tapentadol can cause significantly slowed breathing, which can be life-threatening. This risk is heightened when starting treatment, increasing the dose, or when combined with alcohol or other sedative medications.

• Opioid Overdose: Strictly adhere to the prescribed dosage to avoid life-threatening overdose. Keep the medication out of reach of children and pets to prevent accidental ingestion. Always have naloxone available as an emergency treatment for opioid overdose. Educate family members on recognizing overdose symptoms like extreme drowsiness, slow breathing, or unresponsiveness.

• Interactions with Alcohol and Other Medications: Avoid alcohol and other sedatives (e.g., benzodiazepines, muscle relaxants) while using tapentadol, as these can increase sedative effects and risk of severe side effects.

• Pregnancy and Newborn Risks: Use during pregnancy should be avoided unless absolutely necessary due to risks of neonatal opioid withdrawal syndrome and potential birth defects. Long-term use can lead to newborns experiencing withdrawal symptoms, which can be life-threatening if untreated.

• Physical Dependence and Withdrawal: Regular use may lead to physical dependence. Do not abruptly stop the medication without consulting your healthcare provider to avoid withdrawal symptoms such as anxiety, restlessness, and irritability.

• Low Blood Pressure and Adrenal Hormone Levels: Tapentadol can cause low blood pressure and low adrenal hormone levels, leading to dizziness or fainting. Rise slowly from sitting or lying positions to avoid falls, and consult your healthcare provider if symptoms persist.

• Seizure Risk: Individuals with a history of seizures should be cautious, as tapentadol may increase seizure frequency. Seek immediate medical attention if seizures occur.

Contraindications: Tapentadol should not be used in cases of severe respiratory depression, severe asthma, gastrointestinal blockages, or if taking MAO inhibitors in the last 14 days due to the risk of serious health complications.

Always discuss any concerns or questions with your healthcare provider to ensure safe use of tapentadol.

When using Nucynta (tapentadol), it's important to be aware of potential drug interactions. Certain medications and substances can affect how Nucynta works or increase the risk of serious side effects.

Drugs to Avoid:

• MAO Inhibitors: Combining Nucynta with MAO inhibitors like isocarboxazid, Linezolid, and Selegiline can lead to dangerous interactions. It's advised to stop MAO inhibitors at least two weeks before starting Nucynta. Always consult your doctor on when to start or stop these medications.

Increased Risk of Serotonin Syndrome:

• Taking drugs that increase serotonin levels, such as SSRIs (e.g., Fluoxetine, paroxetine) and SNRIs (e.g., Duloxetine, Venlafaxine), alongside Nucynta can heighten the risk of serotonin syndrome, especially when starting or increasing doses.

Increased Risk of Drowsiness and Breathing Problems:

• Using Nucynta with other medications that cause drowsiness or breathing issues, like opioids (codeine, hydrocodone), alcohol, or benzodiazepines (Alprazolam, Lorazepam), can increase these risks. It’s crucial to inform your healthcare provider about all medications you are taking, including over-the-counter drugs and supplements.

Potential Lab Test Interference:

• Nucynta might affect certain lab tests, potentially leading to inaccurate results. Ensure that all healthcare providers and lab personnel are aware you are taking this medication.

Always check medication labels to avoid unintended interactions and consult your pharmacist or doctor for guidance on using these products safely.