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Nucynta 100 mg Tapentadol oral solution is a mu-opioid receptor agonist, available in a liquid solution for oral administration. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2- methylpropyl]phenolmonohydrochloride
Nucynta 100 mg Tapentadol oral solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.
LIMITATIONS OF USE
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
DOSAGE AND ADMINISTRATION
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Ensure accuracy when prescribing, dispensing, and administering NUCYNTA oral solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. The oral solution contains 20 mg tapentadol per milliliter (mL), when writing prescriptions, include both the total dose in mg and the total dose in volume.
Always use the enclosed calibrated measuring syringe when administering NUCYNTA oral solution to ensure the dose is measured and administered accurately. An oral syringe is supplied with dose marks corresponding directly to 2.5 mL (equals 50 mg) oral solution, 3.75 mL (equals 75 mg) oral solution, and 5 mL (equals 100 mg) oral solution.
Do not use household teaspoons or tablespoons to measure NUCYNTA oral solution, as using a tablespoon instead of a teaspoon could lead to overdosage.
Inform patients of the availability of FDA-approved patient labeling, Instructions for Use, for step-by-step instructions for patients on how to use the medicine bottle and the oral syringe.