Escitalopram Oxalate
ESCITALOPRAM OXALATE- escitalopram oxalate tablet, film coated
REMEDYREPACK INC.
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 antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1)]. escitalopram is not approved for use in pediatric patients less than 7 years of age [see Use in Specific Populations ( 8.4)].
1 INDICATIONS AND USAGE
escitalopram is indicated for the treatment of:
- major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
- generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.
2 DOSAGE FORMS AND STRENGTHS
2.1 Major Depressive Disorder
Adults
The recommended dosage of escitalopram in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies ( 14.1)] . Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.
Pediatric Patients 12 years of age and older
The recommended dosage of escitalopram in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks.
2.2 Generalized Anxiety Disorder
Adults
The recommended starting dosage of escitalopram in adults is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.
Pediatric Patients 7 years of age and older
The recommended starting dosage of escitalopram for pediatric patients ages 7 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 2 weeks.
2.3 Administration Information
Administer escitalopram orally once daily, in the morning or evening, with or without food.
2.4 Screen for Bipolar Disorder Prior to Starting escitalopram
Prior to initiating treatment with escitalopram or another antidepressant, screen patients for a personal family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5)] .
2.5 Recommended Dosage for Specific Populations
The recommended dosage for most elderly patients and patients with hepatic impairment is 10 mg once daily [see Use in Specific Populations ( 8.5, 8.6)] .
The recommended dosage for escitalopram in adults with a creatinine clearance less than 20 mL/minute has not been determined. No dosage adjustment is necessary for patients with mild or moderate renal impairment [see Use in Specific Populations ( 8.7)] .
2.6 Discontinuation of Treatment with escitalopram
Symptoms associated with discontinuation of escitalopram and other SSRIs and SNRIs have been reported [see Warnings and Precautions ( 5.3)] . Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.7 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram. Conversely, at least 14 days should be allowed after stopping escitalopram before starting an MAOI intended to treat psychiatric disorders [see Contraindications ( 4)] .
3 DOSAGE FORMS AND STRENGTHS
Escitalopram tablets, USP are available in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base as follows:
The 5 mg tablets: White, film coated, round, biconvex tablets debossed with IG on one side and 249 on other.
4 CONTRAINDICATIONS
Escitalopram is contraindicated in patients:
- taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.7) and Warnings and Precautions ( 5.2)] . Starting escitalopram in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6) and Warnings and Precautions ( 5.2)] .
- taking pimozide [see Drug Interactions ( 7)] .
- with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in escitalopram.
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 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.
Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients
Age Range | Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1000 Patients Treated |
Increases Compared to Placebo | |
<18 years old | 14 additional patients |
18 to 24 years old | 5 additional patients |
Decreases Compared to Placebo | |
25 to 64 years old | fewer patient |
65 years old | 6 fewer patients |
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing escitalopram, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
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