"Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
In addition to requiring new labeling on these prescript"...
(tapentadol) Immediate-Release Oral Tablets
NUCYNTA® (tapentadol) is a mu-opioid receptor agonist, supplied in immediate-release film-coated tablets for oral administration, containing 58.24, 87.36 and 116.48 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2methylpropyl]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 2.87. The pKa values are 9.34 and 10.45.
In addition to the active ingredient tapentadol HCl, NUCYNTA® tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate. The film coatings for all tablet strengths contain polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake; the film coatings for the 50 mg and 75 mg tablets also contain the additional colorant D&C Yellow #10 aluminum lake.
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: 7/24/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta Information
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