LEXAPRO
Lexapro
(escitalopram oxalate)
TABLETS/ORAL SOLUTION
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
Lexapro
Anyone considering the use of
Lexapro
or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Lexapro
is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use)
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
LEXAPRO™ (escitalopram oxalate) is an orally administered Lexapro selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S(+)-1-[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)- 5-phthalancarbonitrile, with the following structural formula:
The molecular formula is C20H21FN2O • C2H2O4 and the molecular weight is 414.40
Escitalopram oxalate occurs Lexapro as a fine white to slightly yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly
Lexapro
soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.
LEXAPRO (escitalopram oxalate) is available as tablets or as an oral solution.
LEXAPRO tablets are film coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.
LEXAPRO oral solution contains escitalopram oxalate equivalent Lexapro to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, Lexapro sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.
LEXAPRO
LEXAPRO
Lexapro
(escitalopram oxalate)
TABLETS/ORAL SOLUTION
Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.