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Budeprion XL

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Budeprion XL

Budeprion XL

PATIENT INFORMATION

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) and should counsel them in its appropriate use. A patient Medication Guide About “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions” and a Patient Information Leaflet are available for BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) . The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and Patient Information Leaflet and should assist them in understanding the contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and Patient Information Leaflet and to obtain answers to any questions they may have. Medication Guides and Patient Information Leaflets are available upon request.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) .

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Patients should be made aware that BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) contains the same active ingredient found in ZYBAN® or a sustained-release formulation of bupropion, used as an aid to smoking cessation treatment, and that BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) should not be used in combination with ZYBAN® or a sustained-release formulation of bupropion, or any other medications that contain bupropion hydrochloride (such as other sustained-release formulation of bupropion, and immediate-release formulation of bupropion).

Patients should be told that BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) should be discontinued and not restarted if they experience a seizure while on treatment.

Patients should be told that any CNS-active drug like BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Consequently, until they are reasonably certain that BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery.

Patients should be told that the excessive use or abrupt discontinuation of alcohol or sedatives (including benzodiazepines) may alter the seizure threshold. Some patients have reported lower alcohol tolerance during treatment with BUDEPRION XL™. Patients should be advised that the consumption of alcohol should be minimized or avoided.

Patients should be advised to inform their physicians if they are taking or plan to take any prescription or over-the-counter drugs. Concern is warranted because BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) and other drugs may affect each other's metabolism.

Patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy.

Patients should be advised to swallow BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) whole so that the release rate is not altered. Do not chew, divide, or crush tablets.

Patients should be advised that they may notice in their stool something that looks like a tablet. This is normal. The medication in BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is contained in a non-absorbable shell that has been specially designed to slowly release drug in the body. When this process is completed, the empty shell is eliminated from the body.

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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