Nucynta
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
NUCYNTA™ (tapentadol) is indicated for the relief of moderate to severe acute pain in patients 18 years of age or older.
History
There is currently no drug history available for this drug.
Other Information
NUCYNTA™ (tapentadol) Tablets are immediate-release film-coated tablets for oral administration. 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 2.87. 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.
Sources
Nucynta Manufacturers
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Stat Rx Usa
![Nucynta (Tapentadol Hydrochloride) Tablet, Film Coated [Stat Rx Usa]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Nucynta | Stat Rx Usa
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA™ has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA™ has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Lake Erie Medical Dba Quality Care Products Llc
Nucynta | Lake Erie Medical Dba Quality Care Products Llc
2 DOSAGE AND ADMINISTRATIONAs 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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Physicians Total Care, Inc.
Nucynta | Physicians Total Care, Inc.
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
Nucynta | Lake Erie Medical Surgical & Supply Dba Quality Care Products Llc
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Bryant Ranch Prepack
Nucynta | Bryant Ranch Prepack
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Rebel Distributors Corp
Nucynta | Rebel Distributors Corp
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
-
Bryant Ranch Prepack
Nucynta | Bryant Ranch Prepack
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
-
Lake Erie Medical Dba Quality Care Products Llc
Nucynta | Lake Erie Medical Dba Quality Care Products Llc
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 [see Clinical Pharmacology (12.3)].
2.1 Renal ImpairmentNo dosage adjustment is recommended in patients with mild or moderate renal impairment [see Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe renal impairment. The use in this population is not recommended.
2.2 Hepatic ImpairmentNo dosage adjustment is recommended in patients with mild hepatic impairment [see Clinical Pharmacology (12.3)].
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 Clinical Pharmacology (12.3)].
NUCYNTA® has not been studied in patients with severe hepatic impairment and use in this population is not recommended [see Warnings and Precautions (5.10)].
2.3 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
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Janssen Pharmaceuticals, Inc.
Nucynta | Dolgencorp Inc
DISTRIBUTED BY:
DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
MADE IN KOREA
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Janssen Pharmaceuticals, Inc.
Nucynta | Janssen Pharmaceuticals, Inc.
2.1 Individualization of DosageAs with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of tapentadol, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine sulfate dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Continual re-evaluation of the patient receiving tapentadol is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy.
During chronic therapy, especially for non-cancer-related pain, periodically re-assess the continued need for the use of opioid analgesics.
During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family. Monitor the patient for signs of respiratory or central nervous system depression.
2.2 Initiation of TherapyThe 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 [see Clinical Pharmacology (12.3)].
2.3 Renal ImpairmentUse of NUCYNTA® in patients with severe renal impairment is not recommended [see Warnings and Precautions (5.16) and Clinical Pharmacology (12.3)].
No dosage adjustment is recommended in patients with mild or moderate renal impairment.
2.4 Hepatic ImpairmentThe safety and efficacy of NUCYNTA® has not been studied in patients with severe hepatic impairment (Child-Pugh Score 10–15) and use in this population is not recommended [see Warnings and Precautions (5.15)].
Initiate treatment of patients with moderate hepatic impairment (Child-Pugh Score 7 to 9) with 50 mg no more frequently than once 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 Clinical Pharmacology (12.3)].
No dosage adjustment is recommended in patients with mild hepatic impairment (Child-Pugh Score 5 to 6) [see Clinical Pharmacology (12.3)].
2.5 Elderly PatientsIn general, recommended dosing for elderly patients with normal renal and hepatic function is the same as for younger adult patients with normal renal and hepatic function. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.
2.6 Cessation of TherapyWhen the patient no longer requires therapy with tapentadol, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient [see Warnings and Precautions (5.13)].
![Nucynta (Tapentadol) Tablet [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07c33315-90c9-4a73-bf1d-bca70c7e0ff5&name=Nucynta50mg30JanssenOrthoLLC.jpg)
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