Nucynta ER (Page 9 of 10)
16 HOW SUPPLIED/STORAGE AND HANDLING
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 with child-resistant closure
100 mg extended-release tablets are light-blue oblong-shaped with a black print “OMJ 100” on one side and are available in bottles of 60 with child-resistant closure
150 mg extended-release tablets are blue-green oblong-shaped with a black print “OMJ 150” on one side and are available in bottles of 60 with child-resistant closure
200 mg extended-release tablets are blue oblong-shaped with a depression in the middle running lengthwise on each side and with a black print “OMJ 200” on one side, and are available in bottles of 60 with child- resistant closure
250 mg extended-release tablets are dark blue oblong-shaped with a depression in the middle running lengthwise on each side and with a white print “OMJ 250” on one side, and are available in bottles of 60 with child-resistant closure
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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Addiction, Abuse, and Misuse
Inform patients that the use of NUCYNTA ER, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1)]. Instruct patients not to share NUCYNTA ER with others and to take steps to protect NUCYNTA ER from theft or misuse.
Life-threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting NUCYNTA ER or when the dosage is increased, and that it can occur even at recommended dosages [see Warnings and Precautions (5.3)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3)]. Instruct patients to take steps to store NUCYNTA ER securely and to dispose of unused NUCYNTA ER by flushing the tablets down the toilet.
Interactions with Benzodiazepines and other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if NUCYNTA ER is used with benzodiazepines or other CNS depressants, including and not to use these concomitantly unless supervised by a health care provider [see Warnings and Precautions (5.5), Drug Interactions (7)].
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications [see Warnings and Precautions [5.7], Drug Interactions (7).
Inform patients not to take NUCYNTA ER while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking NUCYNTA ER [see Warnings and Precautions (5.7)].
Inform patients that opioids could cause adrenal insufficiency, a potentially life- threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.8)].
Inform patients that NUCYNTA ER could cause seizures if they are at risk for seizures or have epilepsy. Patients should be advised to stop taking NUCYNTA ER if they have a seizure while taking NUCYNTA ER and call their healthcare provider right away [see Warnings and Precautions (5.12)].
Important Administration Instructions
Instruct patients how to properly take NUCYNTA ER, including the following:
- Using NUCYNTA ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression) [see Dosage and Administration (2)]
- Swallowing NUCYNTA ER tablets whole [see Dosage and Administration (2.1)]
- To take each tablet with enough water to ensure complete swallowing immediately after placing in mouth [see Dosage and Administration (2.1)]
- Not cutting, crushing, chewing, or dissolving the tablets [see Dosage and Administration (2.1)]
- Not discontinuing NUCYNTA ER without first discussing the need for a tapering regimen with the prescriber [see Dosage and Administration (2.5)]
Inform patients that NUCYNTA ER may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see Warnings and Precautions (5.9)].
Inform patients that anaphylaxis has been reported with ingredients contained in NUCYNTA ER. Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6.2)].
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of NUCYNTA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].
Advise female patients that NUCYNTA ER can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant [see Use in Specific Populations (8.1)].
Advise patients that breastfeeding is not recommended during treatment with NUCYNTA ER [see Use in Specific Populations (8.2)]
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3)].
Driving or Operating Heavy Machinery
Inform patients that NUCYNTA ER may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication.
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.
Disposal of Unused NUCYNTA ER
Advise patients to flush the unused tablets down the toilet when NUCYNTA ER is no longer needed.
Distributed by: Collegium Pharmaceutical, Inc., Stoughton, MA 02072
U.S. Patent Nos. 6071970, 7994364, 8075872, 8114383, 8309060, 8420056, 8536130, and RE39593.
Revised: November 2018
|Medication Guide |
NUCYNTA® ER (new-SINN-tah E-R) (tapentadol) extended-release oral tablets, CII
|This Medication Guide has been approved by the U.S. Food and Drug Administration||NUCX-012-C.1 Revised: 12/2016|
| NUCYNTA ER is: |
| Important information about NUCYNTA ER: |
|Do not take NUCYNTA ER if you have:|
|Before taking NUCYNTA ER, tell your healthcare provider if you have a history of:|
| || |
| Tell your healthcare provider if you are: |
| When taking NUCYNTA ER: |
| While taking NUCYNTA ER DO NOT: |
| The possible side effects of NUCYNTA ER are: |
|Get emergency medical help if you have: |
Distributed by: Collegium Pharmaceutical, Inc., 100 Technology Center Drive Suite 300, Stoughton, MA, 02072, www.collegiumpharma.com or call 1-855-331-5615.
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