| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NUCYNTA® safely and effectively. See full prescribing information for NUCYNTA®.
NUCYNTA® (tapentadol) immediate-release oral tablets C-II
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, tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.
| CLINICAL PHARMACOLOGY
Mechanism of Action
Effects on the cardiovascular system: There was no effect of therapeutic and supratherapeutic doses of tapentadol on the QT interval. In a randomized, double-blind, placebo- and positive-controlled crossover study, healthy subjects were administered five consecutive doses of NUCYNTA® 100 mg every 6 hours, NUCYNTA® 150 mg every 6 hours, placebo and a single oral dose of moxifloxacin. Similarly, NUCYNTA® had no relevant effect on other ECG parameters (heart rate, PR interval, QRS duration, T-wave or U-wave morphology).
| INDICATIONS AND USAGE
NUCYNTA® is an opioid analgesic indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
--Impaired pulmonary function (significant respiratory depression, acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment)
| WARNINGS AND PRECAUTIONS
--Respiratory depression: Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction.
--CNS effects: Additive CNS depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs.
--Elevation of intracranial pressure: May be markedly exaggerated in the presence of head injury, other intracranial lesions.
--Abuse potential may occur. Monitor patients closely for signs of abuse and addiction.
--Impaired mental/physical abilities: Caution must be used with potentially hazardous activities.
--Seizures: Use with caution in patients with a history of seizures.
--Serotonin Syndrome: Potentially life-threatening condition could result from concomitant serotonergic administration.
USE IN SPECIFIC POPULATIONS
| ADVERSE REACTIONS
The most common adverse events were nausea, dizziness, vomiting and somnolence.
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
| DOSAGE AND ADMINISTRATION
Immediate release tablets:
As with many centrally-acting analgesic medications, the dosing regimen should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to monitor the patient.
The dose is 50 mg, 75 mg, or 100 mg every 4 to 6 hours depending upon pain intensity.
On the first day of dosing, the second dose may be administered as soon as one hour after the first dose, if adequate pain relief is not attained with the first dose. Subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours and should be adjusted to maintain adequate analgesia with acceptable tolerability.
Daily doses greater than 700 mg on the first day of therapy and 600 mg on subsequent days have not been studied and are not recommended.
NUCYNTA® may be given with or without food.
---As with many centrally acting analgesic medications, the dosing regimen of NUCYNTA® ER should be individualized according to the severity of pain being treated, the previous experience with similar drugs and the ability to follow-up and provide oversight of treatment.
---The recommended NUCYNTA® ER total daily dose is 100 mg to 250 mg twice daily approximately every 12 hours. Patients not currently taking opioid analgesics should begin NUCYNTA® ER therapy with 50 mg twice a day.
---Patients receiving NUCYNTA® (immediate-release formulation) may be converted to NUCYNTA® ER by administering the same total daily dose. Administer half the total daily dose of NUCYNTA® ER approximately every 12 hours. Do not exceed the maximum daily dose of NUCYNTA® ER of 500 mg.
No dosage adjustment is recommended in patients with mild or moderate renal impairment.
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
NUCYNTA® should be used with caution in patients with moderate hepatic impairment. Treatment in these patients should be initiated at 50 mg with the interval between doses no less than every 8 hours (maximum of three doses in 24 hours). Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval [see package insert for Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended.
| DOSAGE FORMS AND STRENGTHS
Immediate release tablets:
Extended release tablets:
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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