Bupropion Hydrobromide (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- APLENZIN
- BUPROPION HYDROBROMIDE
Boxed Warning
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)] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communicationwith the prescriber [see Warnings and Precautions (5.1)].
Contraindications
Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a seizure disorder. Bupropion Hydrobromide Extended-Release Tablets are 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 bupropion hydrobromide extended-release tablets [see Warnings and Precautions (5.3)]. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3)and Drug Interactions (7.3)]. The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrobromide extended-release tablets or within 14 days of discontinuing treatment with bupropion hydrobromide extended-release tablets is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrobromide extended-release tablets are used concomitantly with MAOIs. The use of bupropion hydrobromide extended-release tablets within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrobromide extended-release tablets in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.5, 2.6, 2.9), Warnings and Precautions (5.4), and Drug Interactions (7.6)]. Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8)].
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)]
Mechanism of Action
The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.