Nucynta ER

What is Nucynta ER?

Nucynta ER is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Also used to manage pain from damaged nerves (neuropathic pain) that happens with diabetes and is severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Not used to treat pain that is not around-the-clock pain.

Description

NUCYNTA ER (tapentadol) is an opioid 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. Additionally, yellow iron oxide is used in 150 mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths black iron oxide (50, 100, 150, and 200 mg tablets) or titanium dioxide (250 mg tablets).

Mechanism of Action

Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties.

What is the most important information I should know about Nucynta ER?

• Get emergency help right away if you take too much Nucynta ER (overdose). When you first start taking Nucynta ER, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur.
• Taking Nucynta ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your Nucynta ER. They could die from taking it. Selling or giving away Nucynta ER is against the law.
• Store Nucynta ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Who should not take Nucynta ER?

Do not take Nucynta ER if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking Nucynta ER?

Before taking Nucynta ER, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Nucynta ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended during treatment with Nucynta ER. It may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Nucynta ER with certain other medicines can cause serious side effects.

How should I take Nucynta ER?

When taking Nucynta ER:

• Do not change your dose. Take Nucynta ER exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.
• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
• Swallow Nucynta ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject Nucynta ER because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Nucynta ER without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Nucynta ER by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

What should I avoid while taking Nucynta ER?

While taking Nucynta ER DO NOT:

• Drive or operate heavy machinery until you know how Nucynta ER affects you. Nucynta ER can make you sleepy, dizzy, or lightheaded.
• Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Nucynta ER may cause you to overdose and die.

What are the ingredients in Nucynta ER?

Active ingredients: tapentadol hydrochloride

Inactive ingredients: unspecified polyethylene glycol, unspecified hypromellose, alpha.-tocopherol, unspecified polyvinyl alcohol, titanium dioxide, talc, shellac, propylene glycol, ferrosoferric oxide.