Bupropion: Difference between revisions
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|genericName=Bupropion | |genericName=Bupropion | ||
|aOrAn=a | |aOrAn=a | ||
|drugClass= | |drugClass=tetracyclics and unicyclics | ||
|indication=[[major depressive disorder|major depressive disorder (MDD)]][[depression]], associated with [[seasonal affective disorder]]; prophylaxis | |indication=[[major depressive disorder|major depressive disorder (MDD)]][[depression]], associated with [[seasonal affective disorder]]; prophylaxis | ||
|hasBlackBoxWarning=Yes | |hasBlackBoxWarning=Yes | ||
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|fdaLIADAdult=<h4>[[Major depressive disorder|Major depressive disorder (MDD)]]</h4> | |fdaLIADAdult=<h4>[[Major depressive disorder|Major depressive disorder (MDD)]]</h4> | ||
* Dosing | * To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions]. Increases in dose should not exceed 100 mg per day in a 3‑day period. Bupropion Tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion may be taken with or without food. | ||
*The recommended starting dose is 200 mg per day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg per day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg per day may be accomplished using the 75- or 100-mg tablets. | |||
*A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. Administer the 100‑mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose. | |||
*It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of [[Bupropion]] needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment. | |||
|offLabelAdultGuideSupport=<b>Condition 1</b> | |offLabelAdultGuideSupport=<b>Condition 1</b> | ||
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|warnings=<b>Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults</b> | |warnings=<b>Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults</b> | ||
* Worsening of their [[depression]] and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior. | |||
Pooled analyses of short‑term placebo‑controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs | *Pooled analyses of short‑term placebo‑controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs *Increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with 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 4,400 subjects. 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 subjects. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects 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 1,000 subjects treated) are provided in Table 1 | |||
{| class="wikitable" | {| class="wikitable" | ||
| align="center" width="450"| [[File: BUPROPION 1.jpg|center|thumb|400px|]] | | align="center" width="450"| [[File: BUPROPION 1.jpg|center|thumb|400px|]] | ||
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No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. | No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. | ||
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. | * It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. | ||
* All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases [see Boxed Warning]. | |||
* The following symptoms, [[anxiety]], [[agitation]], [[panic attacks]], [[insomnia]], [[irritability]], [[hostility]], [[aggressiveness]], [[impulsivity]], [[akathisia]] (psychomotor restlessness), [[hypomania]], and [[mania]], have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. | |||
* Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. | |||
* Families and caregivers of patients being treated with antidepressants for MDD or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Bupropion should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. | |||
<b> Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment<b> | |||
* Bupropion is not approved for smoking cessation treatment; however, bupropion HCl sustained-release is approved for this use. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including [[depression]] and [[mania]]), [[psychosis]], [[hallucinations]], [[paranoia]], [[delusions]], [[homicidal ideation]], [[hostility]], [[agitation]], [[aggression]], [[anxiety]], and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur. | |||
*In many of these cases, a causal relationship to bupropion treatment is not certain, because depressed mood can be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. | |||
<b> Seizure <b> | |||
* Bupropion can cause seizure. The risk of seizure is dose-related. The dose should not exceed 450 mg per day. Increase the dose gradually. Discontinue Bupropion and do not restart treatment if the patient experiences a seizure. | |||
The | * The risk of seizures is also related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold. Consider these risks before initiating treatment with Bupropion. Bupropion is contraindicated in patients with a seizure disorder, current or prior diagnosis of [[anorexia nervosa]] or [[bulimia]], or undergoing abrupt discontinuation of [[alcohol]], [[benzodiazepines]], [[barbiturates]], and [[antiepileptic drugs]] [see Contraindications and Drug Interactions]. The following conditions can also increase the risk of [[seizure]]: severe [[head injury]]; [[arteriovenous malformation]]; [[CNS tumor]] or [[CNS infection]]; severe [[stroke]]; concomitant use of other medications that lower the seizure threshold (e.g., other bupropion products, [[antipsychotics]], [[tricyclic antidepressants]], [[theophylline]], and systemic [[corticosteroids]]); [[metabolic disorders]] (e.g., [[hypoglycemia]], [[hyponatremia]], severe [[hepatic impairment]], and [[hypoxia]]); use of illicit drugs (e.g., [[cocaine]]); or abuse or misuse of prescription drugs such as CNS stimulants. Additional predisposing conditions include diabetes mellitus treated with [[oral hypoglycemic drugs]] or [[insulin]]; use of [[anorectic drugs]]; and excessive use of [[alcohol]], [[benzodiazepines]], [[sedative]]/[[hypnotics]], or [[opiates]]. | ||
* Incidence of Seizure With Bupropion Use: Bupropion is associated with seizures in approximately 0.4% (4/1,000) of patients treated at doses up to 450 mg per day. The estimated seizure incidence for Bupropion increases almost 10-fold between 450 and 600 mg per day. | |||
* The risk of seizure can be reduced if the dose of WELLBUTRIN does not exceed 450 mg per day, given as 150 mg 3 times daily, and the titration rate is gradual | |||
|clinicalTrials=<b>Central Nervous System</b> | |clinicalTrials=<b>Central Nervous System</b> | ||
Revision as of 02:30, 20 May 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Black Box Warning
|
Suicidal thoughts and behaviours; and neuropsychiatry reactions
See full prescribing information for complete Boxed Warning.
*Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
|
Overview
Bupropion is a tetracyclics and unicyclics that is FDA approved for the {{{indicationType}}} of major depressive disorder (MDD)depression, associated with seasonal affective disorder; prophylaxis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include suicidal thoughts and behaviors in adolescents and young adults, neuropsychiatric symptoms and suicide risk in smoking cessation treatment, seizure, hypertension, activation of mania or hypomania, psychosis and other neuropsychiatric reactions, hypersensitivity reactions.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Major depressive disorder (MDD)
- To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions]. Increases in dose should not exceed 100 mg per day in a 3‑day period. Bupropion Tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion may be taken with or without food.
- The recommended starting dose is 200 mg per day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg per day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg per day may be accomplished using the 75- or 100-mg tablets.
- A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. Administer the 100‑mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose.
- It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of Bupropion needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Bupropion in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
- Dosing Information
- (Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organization)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Non–Guideline-Supported Use
Condition 1
- Dosing Information
- There is limited information about Off-Label Non–Guideline-Supported Use of Bupropion in pediatric patients.
Contraindications
- Seizure disorder
- Bulimia or anorexia nervosa
- Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
- Condition 5
Warnings
|
Suicidal thoughts and behaviours; and neuropsychiatry reactions
See full prescribing information for complete Boxed Warning.
*Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
|
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
- Worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior.
- Pooled analyses of short‑term placebo‑controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs *Increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with 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 4,400 subjects. 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 subjects. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects 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 1,000 subjects treated) are provided in Table 1
{
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- Confusion (major depressive disorder, 8% ), dizziness (6% to 11%), headache (25% to 34% ), insomnia (11% to 20% )
Cardiovascular
- Tachycardia (major depressive disorder, 11% )
Respiratory
- Nasopharyngitis (seasonal affective disorder, 13% ), pharyngitis (major depressive disorder, 3% to 11% ), upper respiratory infection (seasonal affective disorder, 9% )
Gastrointestinal
- Abdominal pain (2% to 9%), constipation (5% to 10%), nausea (13% to 18%), xerostomia (17% to 26%)
Endocrine metabolic
- Weight gain (2% to 9% ), weight loss (major depressive disorder, 14% to 19% )
Psychiatric
- Agitation (2% to 9%)
Postmarketing Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
- (list/description of adverse reactions)
Respiratory
- (list/description of adverse reactions)
Gastrointestinal
- (list/description of adverse reactions)
Hypersensitive Reactions
- (list/description of adverse reactions)
Miscellaneous
- (list/description of adverse reactions)
Drug Interactions
- (Drug 1)
- (Description)
- (Drug 2)
- (Description)
- (Drug 3)
- (Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Bupropion in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bupropion in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Bupropion during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Bupropion in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Bupropion in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Bupropion in geriatric settings.
Gender
There is no FDA guidance on the use of Bupropion with respect to specific gender populations.
Race
There is no FDA guidance on the use of Bupropion with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Bupropion in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Bupropion in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Bupropion in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Bupropion in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Bupropion Administration in the drug label.
Monitoring
There is limited information regarding Bupropion Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Bupropion and IV administrations.
Overdosage
There is limited information regarding Bupropion overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Bupropion Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Bupropion Mechanism of Action in the drug label.
Structure
There is limited information regarding Bupropion Structure in the drug label.
Pharmacodynamics
There is limited information regarding Bupropion Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Bupropion Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Bupropion Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Bupropion Clinical Studies in the drug label.
How Supplied
There is limited information regarding Bupropion How Supplied in the drug label.
Storage
There is limited information regarding Bupropion Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Bupropion |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Bupropion |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
For patient information, please click here.
Precautions with Alcohol
Alcohol-Bupropion interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Bupropion Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Bupropion Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.