ESCITALOPRAM OXALATE — escitalopram oxalate solution
Camber Pharmaceuticals, Inc.
WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of escitalopram oxalate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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. Escitalopram oxalate is not approved for use in pediatric patients less than 12 years of age. [See Warnings and Precautions: Clinical Worsening and Suicide Risk ( 5.1), Patient Counseling Information: Information for Patients ( 17.1), and Use in Specific Populations: Pediatric Use ( 8.4)].
Escitalopram oxalate oral solution 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 Studies (
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardati on, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Escitalopram oxalate oral solution is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults
[see Clinical Studies (
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
Escitalopram oxalate oral solution should be administered once daily, in the morning or evening, with or without food.
The recommended dose of escitalopram oxalate oral solution is 10 mg once daily. A flexible-dose trial of escitalopram oxalate oral solution (10 to 20 mg/day) demonstrated the effectiveness of escitalopram oxalate oral solution [see Clinical Studies ( 14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
The recommended dose of escitalopram oxalate oral solution is 10 mg once daily. A fixed-dose trial of escitalopram oxalate oral solution demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram oxalate oral solution, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies ( 14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram oxalate oral solution 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram oxalate oral solution during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies ( 14.1)]. Nevertheless, the physician who elects to use escitalopram oxalate oral solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
The recommended starting dose of escitalopram oxalate oral solution is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram oxalate oral solution in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram oxalate oral solution for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment. No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram oxalate oral solution should be used with caution in patients with severe renal impairment.
Symptoms associated with discontinuation of escitalopram oxalate oral solution 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.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram oxalate oral solution. Conversely, at least 14 days should be allowed after stopping escitalopram oxalate oral solution before starting an MAOI intended to treat psychiatric disorders [see Contraindications ( 4.1)].
Do not start escitalopram oxalate oral solution in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered
[see Contraindications (
In some cases, a patient already receiving escitalopram oxalate oral solution therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram oxalate oral solution should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram oxalate oral solution may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions ( 5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram oxalate oral solution is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions ( 5.2)].
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