Seroxat® is the commercial brand name of Paroxetine Hydrochloride Enteric‑Coated Sustained‑Release Tablets, an oral selective serotonin reuptake inhibitor (SSRI) antidepressant developed by GSK. It inhibits presynaptic serotonin re‑uptake in the central nervous system and increases synaptic serotonin concentration to produce antidepressant, anti‑anxiety and anti‑obsessive‑compulsive therapeutic effects.
Main Indications
Treatment of major depressive disorder;
Treatment of obsessive‑compulsive disorder;
Treatment of panic disorder with or without agoraphobia;
Treatment of social anxiety disorder;
Treatment of generalized anxiety disorder.
Clinical Research
Global multicenter double‑blind, placebo‑controlled trials demonstrated that Seroxat® can effectively relieve depressive, anxiety and obsessive‑compulsive symptoms;
Compared with immediate‑release paroxetine tablets, this sustained‑release formulation delivers more stable plasma drug concentration and reduces fluctuation‑related gastrointestinal adverse events;
Domestic multicenter clinical trials in China showed consistent efficacy and safety results between Chinese patients and global trial populations.
Common Side Effects
Serious risks: suicidal ideation and behaviours (especially in young adults), serotonin syndrome, hyponatremia, withdrawal symptoms after abrupt drug discontinuation;
Common mild adverse reactions: nausea, somnolence, insomnia, headache, dry mouth, excessive sweating, sexual dysfunction, dizziness and fatigue.
Approval Status in China
Original drug Seroxat® (Paroxetine Hydrochloride Enteric‑Coated Sustained‑Release Tablets) was officially approved for marketing in China in 2000, with the specification of 25 mg. It is currently a prescription drug included in China’s category B medical insurance.
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