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These studies suggest that escitalopram 20 mg tablets are bioequivalent to reference formulations, effective and well-tolerated for treating various conditions, and suitable for long-term use.
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Several studies have investigated the bioavailability and bioequivalence of generic and brand name formulations of escitalopram oxalate 20 mg tablets. A study conducted in a healthy Chinese population under both fasting and fed conditions demonstrated that the generic formulation was bioequivalent to the reference product, Lexapro®, with 90% confidence intervals for the geometric mean ratios of AUC0-t, AUC0-∞, and Cmax falling within the bioequivalence acceptance criteria of 80.00% to 125.00%. Similar findings were reported in a study involving healthy Indian male subjects, where the test and reference formulations showed comparable pharmacokinetic parameters and were well tolerated.
The bioavailability of orodispersible escitalopram tablets (ODT) has also been compared to conventional immediate-release (IR) tablets. Studies have shown that both 2 × 10 mg and 1 × 20 mg ODT formulations are bioequivalent to the conventional 2 × 10 mg IR tablets, with similar serum concentration-time profiles and pharmacokinetic parameters . Subjects reported that the ODT was pleasant and convenient to take, with a similar incidence of mild adverse events across all formulations .
In a randomized, double-blind, placebo-controlled study conducted in Japan, escitalopram 20 mg/day was found to be significantly more effective than placebo in reducing symptoms of social anxiety disorder (SAD). The study reported a significant reduction in the Liebowitz Social Anxiety Scale Japanese version (LSAS-J) total score compared to placebo, with common adverse events including somnolence, nausea, and ejaculation disorder.
Escitalopram has also been evaluated for its efficacy in treating major depressive disorder (MDD). In a fixed-dose trial, escitalopram 20 mg/day demonstrated significant improvement in depressive symptoms compared to placebo, with effects observed as early as one week into treatment. The study also found that escitalopram 10 mg/day was at least as effective as citalopram 40 mg/day, with a similar tolerability profile. Another study in primary care settings confirmed the antidepressant efficacy and excellent tolerability of escitalopram 10-20 mg/day, showing significant therapeutic benefits over placebo.
The safety profile of escitalopram 20 mg has been well-documented across various studies. Common adverse events include somnolence, nausea, and mild gastrointestinal disturbances, with most events being mild and transient . A retrospective chart review of supratherapeutic escitalopram ingestions reported no severe adverse outcomes, even in cases of intentional overdose, indicating a relatively safe profile for the drug.
Escitalopram has also been shown to improve quality of life in specific populations. For instance, a study on midlife women experiencing hot flashes found that escitalopram 10-20 mg/day significantly reduced hot flash interference in daily life, enhancing overall quality of life without significant variation based on demographic or clinical variables.
Escitalopram 20 mg tablets, whether in generic, brand name, or orodispersible formulations, have demonstrated bioequivalence and similar pharmacokinetic profiles. The drug is effective in treating social anxiety disorder and major depressive disorder, with a well-tolerated safety profile. These findings support the use of escitalopram 20 mg as a reliable and effective treatment option for various psychiatric conditions.
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