Brand Name
Nucynta
Generic Name
Tapentadol
View Brand Information FDA approval date: April 01, 2019
Classification: Opioid Agonist
Form: Tablet
What is Nucynta (Tapentadol)?
NUCYNTA ER is indicated for the management of: Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. severe and persistent neuropathic pain associated with diabetic peripheral neuropathy in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve NUCYNTA ER for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. NUCYNTA ER is not indicated as an as-needed analgesic. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions.
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Brand Information
Nucynta (tapentadol hydrochloride)
1INDICATIONS AND USAGE
NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg.
2DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 75 mg, 100 mg.
50 mg: round, biconvex and film-coated yellow tablets with "O-M" on one side and "50" on the other side.
75 mg: round, biconvex and film-coated yellow-orange tablets with "O-M" on one side and "75" on the other side.
100 mg: round, biconvex and film-coated orange tablets with "O-M" on one side and "100" on the other side.
3CONTRAINDICATIONS
NUCYNTA tablets are contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including suspected paralytic ileus
- Hypersensitivity to tapentadol (e.g., anaphylaxis, angioedema) or to any other ingredients of the product
- Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
4ADVERSE REACTIONS
The following adverse reactions are discussed, or described in greater detail, in other sections:
- Addiction, Abuse, and Misuse
- Life-Threatening Respiratory Depression
- Interactions with Benzodiazepine or Other CNS Depressants
- Neonatal Opioid Withdrawal Syndrome
- Opioid-Induced Hyperalgesia and Allodynia
- Serotonin Syndrome
- Adrenal Insufficiency
- Severe Hypotension
- Gastrointestinal Adverse Reactions [
- Seizures
- Withdrawal
4.1POST-MARKETING EXPERIENCE
The following additional adverse reactions have been identified during post approval use of tapentadol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: diarrhea
Nervous system disorders: headache
Psychiatric disorders: hallucination, suicidal ideation, panic attack
Cardiac disorders: palpitations
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in NUCYNTA tablets.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids for an extended period of time [see .
Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see
Hypoglycemia: Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).
5DRUG INTERACTIONS
Table 2 includes clinically significant drug interactions with NUCYNTA tablets.
6DESCRIPTION
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-[(1
The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C
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.
7HOW SUPPLIED/STORAGE AND HANDLING
NUCYNTA Tablets are available in the following strengths and packages. All tablets are round and biconvex-shaped.
50 mg tablets are yellow and debossed with "O-M" on one side and "50" on the other side, and are available in bottles of 100 (NDC 24510-050-10) and hospital unit dose blister packs of 10 (NDC 24510-050-01).
75 mg tablets are yellow-orange and debossed with "O-M" on one side and "75" on the other side, and are available in bottles of 100 (NDC 24510-075-10) and hospital unit dose blister packs of 10 (NDC 24510-075-01).
100 mg tablets are orange and debossed with "O-M" on one side and "100" on the other side, and are available in bottles of 100 (NDC 24510-100-10) and hospital unit dose blister packs of 10 (NDC 24510-100-01).
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
9PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC 24510-050-10
NUCYNTA
50 mg
CII
Each tablet contains:
Caution: Federal law prohibits the transfer
Dispense the accompanying Medication Guide
Rev Dec 2018
10PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label
NDC 24510-075-10
NUCYNTA
75 mg
CII
Each tablet contains:
Caution: Federal law prohibits the transfer
Dispense the accompanying Medication Guide
Rev Dec 2018
11PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC 24510-100-10
NUCYNTA
100 mg
CII
Each tablet contains:
Caution: Federal law prohibits the transfer
Dispense the accompanying Medication Guide
Rev Dec 2018
