WELLBUTRIN SR TABLETS 150 MG

GLAXOSMITHKLINE LLC D/B/A GLAXOSMITHKLINE - UNITED STATESGLAXO WELLCOME S.A. (PRIMARY AND SECONDARY PACKAGING) (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Jun 16, 1999
Approval ID: ebccc200a7e3e0b3
Company: GLAXOSMITHKLINE LLC D/B/A GLAXOSMITHKLINE - UNITED STATESGLAXO WELLCOME S.A. (PRIMARY AND SECONDARY PACKAGING) (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: ebccc200a7e3e0b3
Drug Name: WELLBUTRIN SR TABLETS 150 MG
Product Name: WELLBUTRIN SR TABLETS 150 MG
Approval Number: SIN10983P
Approval Date: 1999-06-16
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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 eight 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 eight 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 eight 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 WELLBUTRIN SR 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 hepatic 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).
Route Of Administration: ORAL
Indication Info: Indications WELLBUTRIN SR is indicated for the treatment of major depressive episodes.
Contraindications: 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.
Atc Code: N06AX12
Atc Item Name: bupropion
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/glaxosmithkline-pte-ltd

Active Ingredients

BUPROPION HCl

150 mg

BUPROPION HCl

150 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 16, 1999

Approval ID

ebccc200a7e3e0b3

Type

Therapeutic

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