Bupropion XL 450 mg

FORFIVO XL

Open Bupropion XL 450 mg in the interactive console ↗

What it isBupropion HCl 450 mg single-tablet XL (FORFIVO XL, 2011) — one tablet replaces 3x150 XL at the top dose.

Why this oneSame molecule and receptor pharmacology as the parent card — the formulation (and its label) is the difference.

What limits itClass warnings of the parent molecule apply unchanged.

FDA-approved for

depression (2011)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Suicidal thoughts and behaviors — antidepressants increased the risk in children, adolescents, and young adults; monitor closely. FORFIVO XL is not approved for use in pediatric patients.

FDA dosing	Population	Start	Target	Max
Major depressive disorder (MDD)	Adults	Do not initiate with FORFIVO XL; use another bupropion formulation to titrate. Use in patients on 300 mg/day of another bupropion formulation ≥2 weeks who require 450 mg/day	450 mg QD	450 mg/day

Renal Not recommended (no lower dose strength available)

Hepatic Not recommended (no lower dose strength available)

450 mg is the only available strength; do not exceed 450 mg/day and do not initiate therapy with FORFIVO XL.

Instructions

Take one 450 mg tablet once daily, with or without food
Swallow whole; do not chew, divide, or crush
Do not initiate therapy with FORFIVO XL; use another bupropion formulation for titration and for tapering before discontinuation
Allow at least 14 days between MAOI and FORFIVO XL in either direction

Contraindications

Seizure disorder
Current use of other bupropion products
Current or prior diagnosis of bulimia or anorexia nervosa
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
Use of MAOIs (intended to treat psychiatric disorders) concomitantly or within 14 days of discontinuing FORFIVO XL, or starting FORFIVO XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue

Cautions

Neuropsychiatric adverse events (in smoking cessation use)
Seizure risk — dose-dependent; discontinue if seizure occurs
Hypertension — assess and monitor blood pressure
Activation of mania/hypomania — screen for bipolar disorder
Psychosis and other neuropsychiatric reactions
Angle-closure glaucoma
Hypersensitivity reactions (including anaphylactoid reactions, Stevens-Johnson syndrome)

Adverse reactions

Dry mouth, nausea
Insomnia, dizziness
Pharyngitis, abdominal pain
Agitation, anxiety, tremor, palpitation
Sweating, tinnitus, myalgia, anorexia, urinary frequency, rash

Pregnancy First-trimester epidemiologic data have not identified an increased overall risk of congenital malformations; weigh against risks of untreated depression.

Lactation Bupropion and metabolites present in human milk (~2% of maternal weight-adjusted dose); seizures reported in breastfed infants.

⚠ BOXED WARNING