Bupropion Hydrobromide
Generic Name: bupropion hydrobromide
Brand Names:
Aplenzin
11 DESCRIPTION APLENZIN ® (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-butylamino)-3’-chloropropiophenone hydrobromide. The molecular weight is 320.6. The molecular formula is C 13 H 18 ClNO•HBr.
Overview
11 DESCRIPTION APLENZIN ® (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin reuptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-2-(tert-butylamino)-3’-chloropropiophenone hydrobromide. The molecular weight is 320.6. The molecular formula is C 13 H 18 ClNO•HBr.
Uses
1 INDICATIONS AND USAGE APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder APLENZIN ® (bupropion hydrobromide) extended-release tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD.
Dosage
2 DOSAGE AND ADMINISTRATION General • Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Major Depressive Disorder • Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl). ( 2.3 ) • After 4 days, may increase the dose to 348 mg once daily. ( 2.3 ) Seasonal Affective Disorder • Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. ( 2.4 ) • Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl). ( 2.4 ) • After one week, may increase the dose to 348 mg once daily. ( 2.4 ) • Continue treatment through the winter season.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1) ] • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2) ] • Seizure [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Activation of mania or hypomania [see Warnings and Precautions (5.5 )] • Psychosis and other neuropsychiatric events [see Warnings and Precautions (5.6) ] • Angle-closure glaucoma [see Warnings and Precautions (5.7) ] • Hypersensitivity reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× plac...
Interactions
7 DRUG INTERACTIONS • CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin) based on clinical exposure, but should not exceed the maximum dose. ( 7.1 ) • Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion. ( 7.2 ) • Drugs that lower seizure threshold: Dose APLENZIN with caution.
Warnings
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS • Neuropsychiatric Adverse Events During Smoking Cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with APLENZIN for the occurrence of such symptoms and instruct them to discontinue APLENZIN and contact a healthcare provider if they experience such adverse events. ( 5.2 ) • Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 522 mg and gradually increasing the dose. 4 CONTRAINDICATIONS • APLENZIN is contraindicated in patients with a seizure disorder. • APLENZIN is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with APLENZIN [see Warnings and Precautions (5.3) ].
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Bupropion Hydrobromide used for?▼
1 INDICATIONS AND USAGE APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder APLENZIN ® (bupropion hydrobromide) extended-release tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD.
What are the side effects of Bupropion Hydrobromide?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1) ] • Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2) ] • Seizure [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Activation of mania or hypomania [see Warnings and Precautions (5.5 )] • Psychosis and other neuropsychiatric events [see Warnings and Precautions (5.6) ] • Angle-closure glaucoma [see Warnings and Precautions (5.7) ] • Hypersensitivity reactions [see Warnings and Precautions (5.8) ] Most common adverse reactions are (incidence ≥5%; ≥2× plac...
Can I take Bupropion Hydrobromide during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
What are the important warnings for Bupropion Hydrobromide?▼
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS • Neuropsychiatric Adverse Events During Smoking Cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with APLENZIN for the occurrence of such symptoms and instruct them to discontinue APLENZIN and contact a healthcare provider if they experience such adverse events. ( 5.2 ) • Seizure Risk: The risk is dose-related. Can minimize risk by limiting daily dose to 522 mg and gradually increasing the dose. 4 CONTRAINDICATIONS • APLENZIN is contraindicated in patients with a seizure disorder. • APLENZIN is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with APLENZIN [see Warnings and Precautions (5.3) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.