Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
XET 20 TABLETS SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): XET 20 TABLETS COMPOSITION: Each tablet contains paroxetine hydrochloride equivalent to paroxetine 20 mg free base. PHARMACOLOGICAL CLASSIFICATION: A 1.2 Psychoanaleptics (Antidepressants) PHARMACOLOGICAL ACTION: Paroxetine is a selective serotonin re-uptake inhibitor (SSRI). The antidepressant effect of paroxetine is thought to be related to its effect on serotonergic neurotransmission. Pharmacokinetics: After oral administration, paroxetine is readily absorbed from the gastrointestinal tract. Absorption is not influenced by the presence of food, milk or antacids. Paroxetine is highly protein bound (95%) and undergoes extensive first-pass metabolism in the liver where it is metabolised in part by cytochrome P450 2D6 (CYP2D6). The metabolites appear to be clinically inactive. The elimination half-life is about 24 hours, but there is wide intersubject variability. Steady-state is achieved in 7 to 14 days in most patients. Paroxetine is excreted renally (approximately 64%) and in the faeces (approximately 36%) mainly as inactive metabolites. INDICATIONS: • Depression • Obsessive Compulsive Disorder (OCD) • Social phobia • Panic disorder CONTRA-INDICATIONS: • Hypersensitivity to paroxetine or any of the ingredients of XET 20 TABLETS. • MAO Inhibitors: XET 20 TABLETS should not be used in combination with MAO inhibitors or within 2 weeks of terminating treatment with MAO inhibitors. MAO inhibitors should not be introduced within 2 weeks of cessation of therapy with XET 20 TABLETS. • Children under the age of 18 years (see WARNINGS and SIDE EFFECTS AND SPECIAL PRECAUTIONS). • Co-administration with thioridazine. WARNINGS: Safety and efficacy in children under 18 years have not been established. (See Read the complete document