Aplenzin

BUPROPION HYDROBROMIDE

Manufacturer: Bausch Health US, LLC

Score: 141.0

Quick Summary

Aplenzin (bupropion hydrobromide) is an antidepressant used for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). It works by increasing the levels of certain neurotransmitters in the brain. The recommended starting dose for MDD is 174 mg once daily, which can be increased to 348 mg once daily after 4 days. For SAD, the starting dose is 174 mg once daily, which can be increased to 348 mg once daily after 7 days. Aplenzin should not be used in patients with a seizure disorder, current or prior diagnosis of bulimia or anorexia nervosa, or abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs. Common adverse reactions include dry mouth, nausea, insomnia, dizziness, and tremors.

Key Clinical Findings and Indications

Treatment of major depressive disorder (MDD)
Treatment of seasonal affective disorder (SAD)
Mechanism of action: increases levels of certain neurotransmitters in the brain

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults

Contraindications

Seizure disorder
Current or prior diagnosis of bulimia or anorexia nervosa
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
Monoamine Oxidase Inhibitors (MAOIs)
Known hypersensitivity to bupropion or other ingredients of Aplenzin

Adverse Reactions

Dry mouth
Nausea
Insomnia
Dizziness
Tremors

Dosing Recommendations

General Guidance

Dose adjustments may be necessary in patients with hepatic or renal impairment

Major Depressive Disorder (MDD)

Adult Dose

174 mg once daily, increased to 348 mg once daily after 4 days

Pediatric Dose

Not established

Seasonal Affective Disorder (SAD)

Adult Dose

174 mg once daily, increased to 348 mg once daily after 7 days

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Pregnancy exposure registry available
No increased risk of congenital malformations overall, but potential risks to the mother associated with untreated depression

Nursing Mothers

Caution advised, as bupropion is excreted in human milk

Pediatric Use

Safety and effectiveness not established in pediatric patients
Balance potential risks with clinical need

Geriatric Use

No overall differences in safety or effectiveness observed between elderly and younger patients
Greater sensitivity of some older individuals cannot be ruled out
Dose adjustments may be necessary in patients with impaired renal function

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