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Uses
Escitalopram oxalate 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 (14.1)].
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 retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Escitalopram oxalate is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].
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.
History
There is currently no drug history available for this drug.
Other Information
Escitalopram oxalate is an orally administered 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-(dimethylamino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:
The molecular formula is C20H21FN2O • C2H2O4 and the molecular weight is 414.40.
Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.
Escitalopram oxalate is available as an oral solution.
Escitalopram oxalate oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.
Sources
Escitalopram Oxalate Solution Manufacturers
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Actavis Pharma, Inc.
Escitalopram Oxalate Solution | Actavis Pharma, Inc.
Escitalopram oxalate should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive DisorderInitial Treatment
Adolescents
The recommended dose of escitalopram oxalate is 10 mg (10 mL) once daily. A flexible-dose trial of escitalopram oxalate (10 to 20 mg/day) (10 to 20 mL/day) demonstrated the effectiveness of escitalopram oxalate [see Clinical Studies (14.1)]. If the dose is increased to 20 mg (20 mL), this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram oxalate is 10 mg (10 mL) once daily. A fixed-dose trial of escitalopram oxalate demonstrated the effectiveness of both 10 mg (10 mL) and 20 mg (20 mL) of escitalopram oxalate, but failed to demonstrate a greater benefit of 20 mg (20 mL) over 10 mg (10 mL) [see Clinical Studies (14.1)]. If the dose is increased to 20 mg (20 mL), 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 10 or 20 mg/day (10 or 20 mL/day) in adult patients with major depressive disorder who responded while taking escitalopram oxalate 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 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.
2.2 Generalized Anxiety DisorderInitial Treatment
Adults
The recommended starting dose of escitalopram oxalate is 10 mg (10 mL) once daily. If the dose is increased to 20 mg (20 mL), 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 in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram oxalate for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations10 mg/day (10 mL/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 should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram OxalateSymptoms associated with discontinuation of escitalopram oxalate 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 DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram oxalate. Conversely, at least 14 days should be allowed after stopping escitalopram oxalate before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Oxalate with Other MAOIs such as Linezolid or Methylene BlueDo not start escitalopram oxalate 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 (4.1)].
In some cases, a patient already receiving escitalopram oxalate 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 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 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 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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Camber Pharmaceuticals, Inc.
Escitalopram Oxalate Solution | Camber Pharmaceuticals, Inc.
Escitalopram oxalate oral solution 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 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.
Adults
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. 2.2 Generalized Anxiety Disorder
Initial Treatment
Adults
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. 2.3 Special Populations
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. 2.4 Discontinuation of Treatment with Escitalopram oxalate oral solution
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 Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of escitalopram oxalate oral solution therapy. Similarly, at least 14 days should be allowed after stopping escitalopram oxalate oral solution before starting an MAOI [ see Contraindications (4.1) and Warnings and Precautions (5.10)]. -
Taro Pharmaceuticals U.s.a., Inc.
Escitalopram Oxalate Solution | Pharmacia And Upjohn Company
CONTRACEPTION AND ENDOMETRIOSIS INDICATIONS Route of Administrationdepo-subQ provera 104 must be given by subcutaneous injection into the anterior thigh or abdomen, once every 3 months (12 to 14 weeks). depo-subQ provera 104 is not formulated for intramuscular injection. Dosage does not need to be adjusted for body weight. The pre-filled syringe of depo-subQ provera 104 must be vigorously shaken just before use to create a uniform suspension.
First InjectionEnsure that the patient is not pregnant at the time of the first injection. For women who are sexually active and having regular menses, the first injection should be given only during the first 5 days of a normal menstrual period. Women who are breast-feeding may have their first injection during or after their sixth postpartum week.
Second and Subsequent InjectionsDosing is every 12 to 14 weeks. If more than 14 weeks elapse between injections, pregnancy should be ruled out before the next injection.
IF USING FOR CONTRACEPTION AND SWITCHING FROM ANOTHER METHODWhen switching from other contraceptive methods, depo-subQ provera 104 should be given in a manner that ensures continuous contraceptive coverage. For example, patients switching from combined (estrogen plus progestin) contraceptives should have their first injection of depo-subQ provera 104 within 7 days after the last day of using that method (7 days after taking the last active pill, removing the patch or ring). Similarly, contraceptive coverage will be maintained in switching from Depo-Provera CI (150 mg) to depo-subQ provera 104, provided the next injection is given within the prescribed dosing period for Depo-Provera CI (150 mg).
IF USING FOR TREATMENT OF ENDOMETRIOSISTreatment for longer than two years is not recommended, due to the impact of long-term depo-subQ provera 104 on bone mineral density. If symptoms return after discontinuation of treatment, bone mineral density should be evaluated prior to retreatment.
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Silarx Pharmaceuticals, Inc
Escitalopram Oxalate Solution | Silarx Pharmaceuticals, Inc
Escitalopram Oxalate should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive DisorderInitial Treatment Adolescents
The recommended dose of escitalopram oxalate is 10 mg once daily. A flexible-dose trial of escitalopram oxalate (10 to 20 mg/day) demonstrated the effectiveness of escitalopram oxalate [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram oxalate is 10 mg once daily. A fixed-dose trial of escitalopram oxalate demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram oxalate, 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
2.2 Generalized Anxiety Disorder Initial Treatment Adults
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 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram oxalate 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 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 is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
2.3 Special Populations
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram oxalate in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram oxalate for extended periods should periodically reevaluate 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 should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram OxalateSymptoms associated with discontinuation of escitalopram oxalate 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 DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram oxalate. Conversely, at least 14 days should be allowed after stopping escitalopram oxalate before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Oxalate with Other MAOIs such as Linezolid or Methylene BlueDo not start escitalopram oxalate 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 (4.1)].
In some cases, a patient already receiving escitalopram oxalate 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 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 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 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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Citron Pharma Llc
Escitalopram Oxalate Solution | Unit Dose Services
2.1 Dosage in AdultsThe dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets for most non-elderly adults is 2 mg immediately before bedtime. Dosing can be initiated at or raised to 3 mg if clinically indicated, since 3 mg is more effective for sleep maintenance . The recommended starting dose of eszopiclone tablets for elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime . The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients. The starting dose of eszopiclone tablets should not exceed 1 mg in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg. Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [ Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency . [see Warnings and Precautions ( )] 5
Use in Geriatric Patients
[see Warnings and Precautions: Special Populations ( )] 5.7
Use in Patients with Hepatic Impairment
Use with CYP3A4 Inhibitors
Use with CNS depressants
see Warnings and Precautions ( )]. 5.5
Administration with Food
[see Clinical Pharmacology: Pharmacokinetics ( )] 12.3 -
Aurobindo Pharma Limited
Escitalopram Oxalate Solution | Aurobindo Pharma Limited
Escitalopram oral solution should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive DisorderInitial Treatment
2.2 Generalized Anxiety Disorder
Adolescents
The recommended dose of
escitalopram oral solution is 10 mg once daily. A flexible-dose trial of escitalopram oral solution (10 to 20 mg/day) demonstrated the effectiveness of escitalopram oral solution [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.
Adults
The recommended dose of escitalopram oral solution is 10 mg once daily. A fixed-dose trial of escitalopram oral solution demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram 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 oral solution 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram 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 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.Initial Treatment
2.3 Special Populations
Adults
The recommended starting dose of escitalopram 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 oral solution in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram 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.
2.4 Discontinuation of Treatment with Escitalopram Oral Solution
No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram oral solution should be used with caution in patients with severe renal impairment.Symptoms associated with discontinuation of escitalopram 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 DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram oral solution. Conversely, at least 14 days should be allowed after stopping escitalopram oral solution before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Oral Solution with Other MAOIs such as Linezolid or Methylene BlueDo not start escitalopram 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 (4.1)].
In some cases, a patient already receiving escitalopram 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 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 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 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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