LEXAPRO Tablet / Oral solution (2020)

Βιβλιογραφική αναφορά

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Allergan, Inc.

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BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all ...

1. Indications and Usage

1.1 Major Depressive Disorder Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical ...

2. Dosage and Administration

Lexapro should be administered once daily, in the morning or evening, with or without food. 2.1 Major Depressive Disorder Initial Treatment Adolescents: The recommended dose of Lexapro is 10 mg ...

3. Dosage Forms and Strengths

Tablets Lexapro tablets are film-coated, round tablets containing escitalopram in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with FL ...

4. Contraindications

4.1 Monoamine O xidase I nhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Lexapro or within 14 days of stopping treatment with Lexapro is contraindicated because of an increased ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately ...

6.1. Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

Adverse Reactions Reported Subsequent to the Marketing of Escitalopram The following adverse reactions have been identified during post-approval use of Lexapro. Because these reactions are reported voluntarily ...

7. Drug Interactions

7.1 Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)]. 7.2 Serotonergic Drugs [See Dosage and Administration ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...

8.2. Lactation

Risk Summary Data from the published literature report the presence of escitalopram and desmethylescitalopram in human milk (see Data). There are reports of excessive sedation, restlessness, agitation, ...

8.4. Pediatric Use

The safety and effectiveness of Lexapro have been established in adolescents (12 to 17 years of age) for the treatment of major depressive disorder [see Clinical Studies (14.1)]. Although maintenance ...

8.5. Geriatric Use

Approximately 6% of the 1144 patients receiving escitalopram in controlled trials of Lexapro in major depressive disorder and GAD were 60 years of age or older; elderly patients in these trials received ...

9.2. Abuse

Physical and Psychological Dependence Animal studies suggest that the abuse liability of racemic citalopram is low. Lexapro has not been systematically studied in humans for its potential for abuse, tolerance, ...

10. Overdosage

10.1 Human Experience In clinical trials of escitalopram, there were reports of escitalopram overdose, including overdoses of up to 600 mg, with no associated fatalities. During the postmarketing evaluation ...

11. Description

Lexapro contains escitalopram, an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. ...

12.1. Mechanism of Action

The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting ...

12.2. Pharmacodynamics

In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal ...

12.3. Pharmacokinetics

The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day. Biotransformation of escitalopram is mainly hepatic, with a mean terminal ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Racemic citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of racemic citalopram ...

13.2. Animal Toxicology and/or Pharmacology

Retinal Changes in Rats Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with racemic citalopram. There was an increase in both ...

14. Clinical Studies

14.1 Major Depressive Disorder Adolescents The efficacy of Lexapro as an acute treatment for major depressive disorder in adolescent patients was established in an 8-week, flexible-dose, placebo-controlled ...

16.1. How Supplied

Tablets 5 mg Tablets: Bottle of 100 NDC # 0456-2005-01 White to off-white, round, non-scored, film-coated. Imprint FL on one side of the tablet and 5 on the other side. 10 mg Tablets: Bottle ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15 to 30°C (59° to 86°F).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients, their families and caregivers to look for the emergence of suicidal ideation ...