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Bupropion Hydrochloride Oral tablet, extended release 12 hour [Smoking Cessation]

It is used to help people quit smoking.

Generic Name: buPROPion

Brand Names: Wellbutrin XL, Budeprion XL, Budeprion SR, Wellbutrin SR, BuPROPion Hydrochloride SR, Zyban, Zyban Advantage Pack, Wellbutrin, BuPROPion Hydrochloride XL

There is an FDA Alert for this drug. Click here to view it.

    Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Bupropion is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders under Cautions.)

    Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
  • Serious neuropsychiatric symptoms (e.g., depression, suicidal ideation, suicide attempt, completed suicide) have been reported in patients receiving bupropion for smoking cessation. (See Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment under Cautions.)
  • Symptoms have occurred in patients with and without preexisting psychiatric disease; some patients experienced worsening of their psychiatric illness.
  • Depressed mood may be a symptom of nicotine withdrawal; however, some symptoms occurred in bupropion-treated patients who continued to smoke.
  • Most symptoms occurred during bupropion therapy, but some were reported following discontinuance of drug.
  • Monitor all patients receiving bupropion for smoking cessation for neuropsychiatric symptoms, including changes in behavior, hostility, agitation, depressed mood, and suicide-related events (including ideation, behavior, and attempted suicide).
  • Patients should discontinue bupropion and immediately contact their clinician if agitation, hostility, depressed mood, or changes in thinking or behavior not typical for the patient occur, or if patient develops suicidal ideation or behavior.
  • Symptoms resolved upon drug discontinuance in many cases, but persisted in a few cases. Provide ongoing monitoring and supportive care until symptoms resolve.
  • Weigh risks of bupropion for smoking cessation against benefits. Bupropion shown to increase likelihood of abstinence from smoking for up to 6 months compared with placebo. Health benefits of quitting smoking are immediate and substantial.

REMS:

FDA approved a REMS for bupropion to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bupropion and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

BUPROPION (byoo PROE pee on) is used to help people quit smoking.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • an eating disorder, such as anorexia or bulimia
  • bipolar disorder or psychosis
  • diabetes or high blood sugar, treated with medication
  • head injury or brain tumor
  • heart disease, previous heart attack, or irregular heart beat
  • high blood pressure
  • kidney or liver disease
  • seizures
  • suicidal thoughts or a previous suicide attempt
  • Tourette's syndrome
  • weight loss
  • an unusual or allergic reaction to bupropion, other medicines, foods, dyes, or preservatives
  • breast-feeding
  • pregnant or trying to become pregnant

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. If you take this medicine more than once a day, take your second dose at least 8 hours after you take your first dose. To limit difficulty in sleeping, avoid taking this medicine at bedtime. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, skip the missed dose and take your next tablet at the regular time. There should be at least 8 hours between doses. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • linezolid
  • MAOIs like Azilect, Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • methylene blue (injected into a vein)
  • other medicines that contain bupropion like Wellbutrin

This medicine may also interact with the following medications:

  • alcohol
  • certain medicines for anxiety or sleep
  • certain medicines for blood pressure like metoprolol, propranolol
  • certain medicines for depression or psychotic disturbances
  • certain medicines for HIV or AIDS like efavirenz, lopinavir, nelfinavir, ritonavir
  • certain medicines for irregular heart beat like propafenone, flecainide
  • certain medicines for Parkinson's disease like amantadine, levodopa
  • certain medicines for seizures like carbamazepine, phenytoin, phenobarbital
  • cimetidine
  • clopidogrel
  • cyclophosphamide
  • furazolidone
  • isoniazid
  • nicotine
  • orphenadrine
  • procarbazine
  • steroid medicines like prednisone or cortisone
  • stimulant medicines for attention disorders, weight loss, or to stay awake
  • tamoxifen
  • theophylline
  • thiotepa
  • ticlopidine
  • tramadol
  • warfarin


Last Updated: May 06, 2013
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