Bupropion Hydrochloride (XL)

BUPROPION HYDROCHLORIDE

Manufacturer: Bryant Ranch Prepack

Score: 145.0

Quick Summary

Bupropion Hydrochloride Extended-release (SR) tablets are used for the treatment of major depressive disorder (MDD). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD. The tablets should be swallowed whole and not crushed, divided, or chewed, and may be taken with or without food. The usual adult target dose is 300 mg per day, given as 150 mg twice daily, with a maximum dose of 400 mg per day. Bupropion Hydrochloride Extended-release (SR) tablets are contraindicated in patients with a seizure disorder, current or prior diagnosis of bulimia or anorexia nervosa, and undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.

Key Clinical Findings and Indications

Treatment of major depressive disorder (MDD)
Efficacy established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD
Maintenance treatment for up to 44 weeks following 8 weeks of acute treatment

Important Safety Information

Warning

Suicidal thoughts and behaviors in adolescents and young adults

Contraindications

Seizure disorder
Current or prior diagnosis of bulimia or anorexia nervosa
Undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs
Known hypersensitivity to bupropion or other ingredients of Bupropion Hydrochloride Extended-release (SR) tablets
Monoamine Oxidase Inhibitors (MAOIs)

Adverse Reactions

Headache
Dry mouth
Nausea
Insomnia
Dizziness
Pharyngitis
Constipation
Agitation
Anxiety
Abdominal pain
Tinnitus
Tremor
Palpitation
Myalgia
Sweating
Rash
Anorexia

Dosing Recommendations

General Guidance

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

Major depressive disorder (MDD)

Adult Dose

150 mg per day, given as a single daily dose in the morning, with a target dose of 300 mg per day, given as 150 mg twice daily

Pediatric Dose

Not recommended for pediatric use

Special Population Considerations

Pregnancy

Pregnancy Category C
Data from epidemiological studies indicate no increased risk of congenital malformations overall
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

Bupropion and its metabolites are present in human milk
Exercise caution when Bupropion Hydrochloride Extended-release (SR) tablets are administered to a nursing woman

Pediatric Use

Safety and effectiveness in the pediatric population have not been established
Not recommended for pediatric use

Geriatric Use

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