Budeprion SR (Bupropion Hydrochloride) Drug Information
- Other Uses
- Special Dietary
- Side Effects
- Storage Conditions
- Other Information
- Brand Names
Why is this medication prescribed?
BUDEPRION SR® is indicated for the treatment of major depressive disorder. The efficacy of bupropion in the treatment of major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).
How should this medicine be used?
Dose: At doses of BUDEPRION SR® up to a dose of 300 mg/day, the incidenceof seizure is approximately 0.1% (1/1000) and increases to approximately 0.4%(4/1000) at the maximum recommended dose of 400 mg/day.Data for the immediate-release formulation of bupropion revealed a seizure incidenceof approximately 0.4% (i.e., 13 of 3200 patients followed prospectively) inpatients treated at doses in a range of 300 to 450 mg/day. The 450 mg/day upperlimit of this dose range is close to the currently recommended maximum dose of400 mg/day for BUDEPRION SR®. This seizure incidence (0.4%) may exceed thatof other marketed antidepressants and BUDEPRION SR® up to 300 mg/day by asmuch as 4-fold. This relative risk is only an approximate estimate because nodirect comparative studies have been conducted.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using BUDEPRION SR®:
- Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
- The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
What special dietary instructions should I follow?
Be sure to follow all dietary recommendations made by your doctor or dietitian.
What side effects can this medication cause?
BUDEPRION SR® may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor and the laboratory.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
- Budeprion SR