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Paroxetine is commercially available in the US as paroxetine hydrochloride e. The US Food and Drug Administration FDA considers paroxetine mesylate Pexeva conventional tablets to be a pharmaceutical alternative as described in section of the Federal Food, Drug, and Cosmetic Act and not a pharmaceutical generic equivalent to paroxetine hydrochloride conventional tablets e. The clinical studies that established efficacy of paroxetine in various conditions have been conducted with paroxetine hydrochloride. Because paroxetine hydrochloride and paroxetine mesylate contain the same active moiety paroxetine, clinical efficacy is expected to be similar between the 2 different salts. Paroxetine hydrochloride conventional tablets and oral suspension are used in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder with or without agoraphobia, social phobia social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. Paroxetine hydrochloride extended-release tablets are used in the treatment of major depressive disorder, panic disorder with or without agoraphobia, social phobia, and premenstrual dysphoric disorder PMDD.
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Common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping, and sexual dysfunction. Paroxetine was approved for medical use in the United States in and initially sold by GlaxoSmithKline. Paroxetine is primarily used to treat major depressive disorder, obsessive-compulsive disorder, post-traumatic stress disorder, social anxiety disorder, panic disorder. It could be used also for agoraphobia, generalized anxiety disorder, premenstrual dysphoric disorder and menopausal hot flashes. A variety of meta analyses have been conducted to evaluate the efficacy of paroxetine in depression. They have variously concluded that paroxetine is superior or equivalent to placebo and that it is equivalent or inferior to other antidepressants.
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