Indications And Usage

Major Depressive Disorder (MDD)

Seasonal Affective Disorder (SAD)

Administration

General Instructions for Use:

To minimize the risk of seizure, increase the dose gradually.

Buproxir should be swallowed whole and not crushed, divided, or chewed. Buproxir should be administered in the morning and may be taken with or without food.

Initial dose: 100 mg orally twice a day, increase if necessary after 3 days to 100 mg orally three times a day.

Maintenance dose: 100 mg orally three times a day

Maximum dose: 450 mg/day in up to 4 divided doses; single doses should not exceed 150 mg

Contraindications

Buproxir are contraindicated in patients with seizure disorder.

    Buproxir 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 Buproxir.

    Buproxir are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic

    The use of MAOIs (intended to treat psychiatric disorders) concomitantly with Buproxir or within 14 days of discontinuing treatment with Buproxir is contraindicated. There is an increased risk of hypertensive reactions when Buproxir are used concomitantly with MAOIs. The use of Buproxir within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting Buproxir in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.

    Buproxir are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of Buproxir. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported.

Precautions

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults, Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment, Seizure, Hypertension, Activation of Mania/Hypomania, Psychosis and Other Neuropsychiatric Reactions, Angle-Closure Glaucoma, Hypersensitivity Reactions

Adverse Reactions

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults, Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment, Seizure, Hypertension, Activation of Mania/Hypomania, Psychosis and Other Neuropsychiatric Reactions, Angle-Closure Glaucoma, Hypersensitivity Reactions

Pregnancy and lactation

C

Renal and liver Impairment

Hepatic Impairment:

Consider reducing the dose and/or frequency of bupropion in patients with renal impairment.

Renal Impairment:

There is limited information on the pharmacokinetics of bupropion in patients with renal impairment.

Laboratory Tests