General Information
Revision date
2017-04-04
Product name
Paroxetine Extended-Release Tablets, USP
Manufacturer Name
Lupin Limited
Icons in SDS
Company Information
company name
Lupin Limited
Section 2
2.1 Classification of the substance or mixture
Exempt from requirements - product regulated as a medicinal product
2.2 Label elements
Exempt from requirements - product regulated as a medicinal product Health The use of MAOIs intended to treat psychiatric disorders with paroxetine extended-release tablets or within 14 days of stopping treatment with paroxetine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine extended- release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting paroxetine extended-release tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. Concomitant use with thioridazine is contraindicated. Concomitant use in patients taking pimozide is contraindicated. Paroxetine extended-release tablets are contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in paroxetine extended-release tablets.
Environmental hazards
No information is available about the potential of this product to produce adverse environmental effects.