Nucynta

What is Nucynta?

Nucynta is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.

An 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.

Description

NUCYNTA (tapentadol) tablets are a mu-opioid receptor agonist, available 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, equivalent to 50, 75, and 100 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]phenol monohydrochloride, and it has the following chemical structure:

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.

The inactive ingredients in NUCYNTA tablets include: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone. 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.

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?

• Get emergency help right away if you take too much Nucynta (overdose) tablets. When you first start taking Nucynta tablets, 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 tablets 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 Tablets. They could die from taking it. Selling or giving away Nucynta Tablets is against the law.
• Store Nucynta tablets 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?

Do not take Nucynta tablets 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?

Before taking Nucynta tablets, 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
• mental health problems

Tell your healthcare provider if you are:

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

How should I take Nucynta?

When taking Nucynta tablets:

• Do not change your dose. Take Nucynta tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 4-6 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Nucynta tablets regularly, do not stop taking Nucynta tablets without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Nucynta Tablets 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?

While taking Nucynta tablets do not:

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

What are the possible side effects of Nucynta?

The possible side effects of Nucynta tablets:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face, tongue, or throat
• extreme drowsiness
• light-headedness when changing positions
• feeling faint
• agitation
• high body temperature
• trouble walking
• stiff muscles
• mental changes such as confusion

These are not all the possible side effects of Nucynta tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Nucynta?

Store at 20ºC-25°C (68°F-77ºF); excursions permitted to 15º – 30ºC (59º – 86ºF). Protect from moisture.

Keep Nucynta tablets in a secure place out of reach of children.

Nucynta tablets that are no longer needed should be destroyed by flushing down the toilet.

Store Nucynta tablets securely and dispose of properly.

What are the ingredients in Nucynta?

Active ingredient: tapentadol hydrochloride

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone unspecified, magnesium stearate, polyvinyl alcohol unspecified, titanium dioxide, polyethylene glycol unspecified, talc, aluminum oxide.

Label

PRINCIPAL DISPLAY PANEL – 50 MG TABLET BOTTLE LABEL

• NDC 24510-050-10
  100 Tablets
• NUCYNTA®
  (tapentadol) Tablets
• 50 mg
• CII
• Each tablet contains:
  tapentadol 50 mg
• Caution: Federal law prohibits the transfer
  of this drug to any person other than the patient
  for whom it was prescribed.
• Dispense the accompanying Medication Guide
  to each patient.
• Rev Dec 2018
  NUC-003-C.4

PRINCIPAL DISPLAY PANEL – 75 MG TABLET BOTTLE LABEL

• NDC 24510-075-10
  100 Tablets
• NUCYNTA®
  (tapentadol) Tablets
• 75 mg
• CII
• Each tablet contains:
  tapentadol 75 mg
• Caution: Federal law prohibits the transfer
  of this drug to any person other than the patient
  for whom it was prescribed.
• Dispense the accompanying Medication Guide
  to each patient.
• Rev Dec 2018
  NUC-006-C.4

PRINCIPAL DISPLAY PANEL – 100 MG TABLET BOTTLE LABEL

• NDC 24510-100-10
  100 Tablets
• NUCYNTA®
  (tapentadol) Tablets
• 100 mg
• CII
• Each tablet contains:
  tapentadol 100 mg
• Caution: Federal law prohibits the transfer
  of this drug to any person other than the patient
  for whom it was prescribed.
• Dispense the accompanying Medication Guide
  to each patient.
• Rev Dec 2018
  NUC-009-C.4