"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, ACCIDENTAL EXPOSURE, and INTERACTION WITH ALCOHOL
NUCYNTA® ER contains tapentadol, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see WARNINGS AND PRECAUTIONS]. Assess each patient's risk for opioid abuse or addiction prior to prescribing NUCYNTA® ER. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving NUCYNTA® ER for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence].
Life-threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of NUCYNTA® ER, even when the drug has been used as recommended and not misused or abused [see WARNINGS AND PRECAUTIONS]. Proper dosing and titration are essential and NUCYNTA® ER should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of NUCYNTA® ER or following a dose increase. Instruct patients to swallow NUCYNTA® ER tablets whole. Crushing, dissolving, or chewing NUCYNTA® ER can cause rapid release and absorption of a potentially fatal dose of tapentadol.
Accidental ingestion of NUCYNTA® ER, especially in children, can result in a fatal overdose of tapentadol [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
The co-ingestion of alcohol with NUCYNTA® ER may result in an increase of plasma levels and potentially fatal overdose of tapentadol [see WARNINGS AND PRECAUTIONS]. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while on NUCYNTA® ER.
NUCYNTA® ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2- methylpropyl]phenol monohydrochloride. The structural formula is:
The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO•HCl. The n-octanol: water partition coefficient log P value is 2.89. The pKa values are 9.36 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide. The film coating is comprised of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and the colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths; and additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150 and 200 mg tablets) or titanium dioxide (250 mg tablets).
What are the possible side effects of tapentadol (Nucynta, Nucynta ER)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- weak or shallow breathing, weak pulse, slow heartbeat;
- seizure (convulsions);
- severe drowsiness or dizziness;
- confusion, problems with speech or balance; or
- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination,...
Last reviewed on RxList: 10/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta ER Information
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