"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Instruct patients to take NUCYNTA® only as prescribed.
Inform patients that NUCYNTA® contains tapentadol, a Schedule II controlled substance that is subject to abuse. Instruct patients not to share NUCYNTA® with others and to take steps to protect NUCYNTA® from theft or misuse.
Life-threatening Respiratory Depression
Discuss the risk of respiratory depression with patients, explaining that the risk is greatest when starting NUCYNTA® or when the dose is increased. Advise patients how to recognize respiratory depression and to seek medical attention if they are experiencing breathing difficulties.
Instruct patients to take steps to store NUCYNTA® securely. Accidental exposure, especially in children, may results in serious harm or death. Advise patients to dispose of unused NUCYNTA® by flushing the tablets down the toilet.
Important Administration Instructions
Instruct patients how to properly take NUCYNTA®, including the following:
- Using NUCYNTA® exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression).
- Not discontinuing NUCYNTA® without first discussing the need for a tapering regimen with the prescriber.
Risks from Concomitant Use of Alcohol and other CNS Depressants
Inform patients that the concomitant use of alcohol with NUCYNTA® can increase the risk of life-threatening respiratory depression. Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter drug products that contain alcohol, during treatment with NUCYNTA® .
Inform patients that potentially serious additive effects may occur if NUCYNTA® is used with other CNS depressants, and not to use such drugs unless supervised by a health care provider.
Concurrent use of MAOI
Inform patients not to take NUCYNTA® while using any drugs that inhibit monoamine oxidase. Patients should not start any new medications while taking NUCYNTA® .
Inform patients that NUCYNTA® could cause seizures if they are at risk for seizures or have epilepsy. Patients should be advised to stop taking NUCYNTA® if they have a seizure while taking NUCYNTA® and call their healthcare provider right away.
Inform patients that NUCYNTA® could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs (including Serotonin Reuptake Inhibitors, Serotonin and Norepinephrine Reuptake Inhibitors and tricyclic antidepressants). Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.
Instruct patients to inform their physicians if they are taking or plan to take additional medications, including CNS Depressants, MAO inhibitors, mixed agonists/antagonist opioid analgesics, anticholinergics, SSRIs, SNRIs, or tricyclic antidepressants.
Inform patients that NUCYNTA® 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).
Driving or Operating Heavy Machinery
Inform patients that NUCYNTA® 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.
Inform patients that anaphylaxis has been reported with ingredients contained in NUCYNTA® . Advise patients how to recognize such a reaction and when to seek medical attention.
Advise female patients that NUCYNTA® can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant.
Last reviewed on RxList: 7/24/2013
This monograph has been modified to include the generic and brand name in many instances.
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