WELLBUTRIN SR TABLETS 150 mg

Indications

WELLBUTRIN SR is indicated for the treatment of major depressive episodes.

Contraindications

WELLBUTRIN SR is contraindicated in patients with hypersensitivity to bupropion or any of the other components of the preparation.

WELLBUTRIN SR is contraindicated in patients with a seizure disorder.

WELLBUTRIN SR is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives.

WELLBUTRIN SR tablets contain bupropion and should not be administered to patients currently being treated with any other preparation containing bupropion as the incidence of seizures is dose dependent.

WELLBUTRIN SR is contraindicated in patients with a current or previous diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was seen in this patient population when an immediate release form of bupropion was administered.

Concomitant use of WELLBUTRIN SR and monoamine oxidase inhibitors (MAOIs) is contraindicated. At least 14 days should elapse between discontinuation of MAOIs and initiation of treatment with WELLBUTRIN SR tablets.

Dosage and Administration

Pharmaceutical form: Sustained-release (SR) film-coated tablet.

WELLBUTRIN SR tablets should be swallowed whole. The tablets should not be cut, crushed or chewed as this may lead to an increased risk of adverse effects including seizures.

Studies suggest that exposure to bupropion may be increased when sustained-release bupropion tablets are taken with food (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in adults

The maximum single dose of WELLBUTRIN SR is 150 mg.

WELLBUTRIN SR tablets should be taken twice daily with an interval of at least 8 hours between successive doses.

Insomnia is a very common adverse event which is often transient. Insomnia may be reduced by avoiding dosing at bedtime (provided there is at least 8 hours between doses) or, if clinically indicated, dose reduction may be considered.

Initial treatment

Dosing with WELLBUTRIN SR tablets should begin at 150 mg/day given as a single daily dose in the morning. If the 150 mg initial dose is adequately tolerated, patients who are not responding adequately may benefit from an increase to 300 mg/day, given as 150 mg twice daily, after an interval of at least one week. There should be an interval of at least 8 hours between successive doses.

The maximum daily dose should not exceed 300 mg/day.

Maintenance therapy

It is generally agreed that acute episodes of depression require 6 months or longer of antidepressant drug treatment.

Use in children and adolescents

WELLBUTRIN SR is not indicated for use in children or adolescents aged less than 18 years (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety and efficacy of WELLBUTRIN SR tablets in patients under 18 years of age have not been established.

Use in elderly

Greater sensitivity of some elderly individuals to bupropion cannot be ruled out, hence a reduced frequency and/or dose may be required (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in patients with liver impairment

WELLBUTRIN SR should be used with caution in patients with liver impairment. Because of increased variability in the pharmacokinetics in patients with mild to moderate hepatic cirrhosis, a reduced frequency of dosing should be considered (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

WELLBUTRIN SR should be used with extreme caution in patients with severe hepatic cirrhosis. The dose should not exceed 150 mg on alternate days in these patients (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in patients with renal impairment

Treatment of patients with renal impairment should be initiated at reduced frequency and/or dose, as bupropion and its metabolites may accumulate in such patients to a greater extent than usual (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).