NUCYNTA ER Film-coated tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Collegium Pharmaceutical, Inc.

Λέξεις κλειδιά

24510-058 24510-116 24510-174 24510-232 24510-291

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1. Indications and Usage

NUCYNTA ER (tapentadol) is indicated for the management of: pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate ...

2. Dosage and Administration

2.1 Important Dosage and Administration Instructions NUCYNTA ER should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. ...

3. Dosage Forms and Strengths

NUCYNTA ER 50 mg, 100 mg, 150 mg, 200 mg and 250 mg extended-release tablets are available in the following colors and prints: 50 mg extended-release tablets are white oblong-shaped with a black print ...

4. Contraindications

NUCYNTA ER is contraindicated in patients with: Significant respiratory depression Acute or severe bronchial asthma or hypercarbia in an unmonitored setting or in the absence of resuscitative equipment ...

5. Warnings and Precautions

5.1 Addiction, Abuse, and Misuse NUCYNTA ER contains tapentadol, a Schedule II controlled substance. As an opioid, NUCYNTA ER exposes users to the risks of addiction, abuse, and misuse. Because extended-release ...

6. Adverse Reactions

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following 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 ...

7. Drug Interactions

Table 3 includes clinically significant drug interactions with NUCYNTA ER. Table 3: Clinically Significant Drug Interactions with NUCYNTA ER Alcohol Clinical Impact: Concomitant use ...

8. Use in Specific Populations

8.3 Females and Males of Reproductive Potential Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility ...

8.1. Pregnancy

Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with NUCYNTA ER are insufficient ...

8.2. Lactation

Risk Summary There is insufficient/limited information on the excretion of tapentadol in human or animal breast milk. Physicochemical and available pharmacodynamic/toxicological data on tapentadol point ...

8.2. Labor and Delivery

Opioids cross the placenta and may produce respiratory depression and psychophysiological effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory ...

8.4. Pediatric Use

The safety and efficacy of NUCYNTA ER in pediatric patients less than 18 years of age have not been established.

8.5. Geriatric Use

Of the total number of patients in Phase ⅔ double-blind, multiple-dose clinical studies of NUCYNTA ER, 28% (1023/3613) were 65 years and over, while 7% (245/3613) were 75 years and over. No overall differences ...

8.6. Hepatic Impairment

Use of NUCYNTA ER in patients with severe hepatic impairment (Child-Pugh Score 10-15) is not recommended. In patients with moderate hepatic impairment (Child-Pugh Score 7 to 9), dosage reduction of NUCYNTA ...

8.7. Renal Impairment

Use of NUCYNTA ER in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) is not recommended. No dosage adjustment is recommended in patients with mild or moderate renal ...

9.1. Controlled Substance

NUCYNTA ER contains tapentadol, a Schedule II controlled substance.

9.2. Abuse

NUCYNTA ER contains tapentadol, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. NUCYNTA ...

9.3. Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of ...

10. Overdosage

Clinical Presentation Acute overdosage with NUCYNTA ER can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted ...

11. 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 ...

12.1. 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 ...

12.2. Pharmacodynamics

Effects on the Central Nervous System (CNS) Tapentadol produces respiratory depression, by direct action on the brainstem respiratory centers. The respiratory depression involves a reduction in the responsiveness ...

12.3. Pharmacokinetics

Absorption The mean absolute bioavailability after single-dose administration (fasting) of NUCYNTA ER is approximately 32% due to extensive first-pass metabolism. Maximum serum concentrations of tapentadol ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In mice, tapentadol HCl was administered by oral gavage at dosages of 50, 100 and 200 mg/kg/day for 2 years (up to 0.34 times in the male mice and 0.25 times in the female mice the plasma ...

13.2. Animal Toxicology and/or Pharmacology

In toxicological studies with tapentadol, the most common systemic effects of tapentadol were related to the mu-opioid receptor agonist and norepinephrine reuptake inhibition pharmacodynamic properties ...

14. Clinical Studies

14.1 Clinical Trials Summary The efficacy of NUCYNTA ER was studied in five studies in patients with chronic pain and DPN. Efficacy was demonstrated in one randomized, double-blind, placebo- and active-controlled ...

16.1. How Supplied

NUCYNTA ER tablets are available in the following strengths and packages: 50 mg extended-release tablets are white oblong-shaped with a black print OMJ 50 on one side and are available in bottles of 60 ...

16.2. Storage and Handling

Store at 20°C 25°C (68°F 77°F); excursions permitted to 15°C 30°C (59°F 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Store NUCYNTA ER securely and dispose of properly [see ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store ...

BOXED WARNING SECTION

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION ...