ESCITALOPRAM - escitalopram oxalate tablet, film coated
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use escitalopram oxalate safely and effectively. See full prescribing information for escitalopram tablets USP.
Escitalopram Tablets USP Initial U.S. Approval: 2002 WARNINGS: Suicidality and Antidepressant Drugs See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Escitalopram oxalate is not approved for use in pediatric patients less than 12 years of age (5.1). RECENT MAJOR CHANGESINDICATIONS AND USAGEDOSAGE AND ADMINISTRATIONEscitalopram tablets should generally be administered once daily, morning or evening with or without food (2.1, 2.2).
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONSPregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1). Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3). Pediatric Use: Safety and effectiveness of escitalopram oxalate has not been established in pediatric MDD patients less than 12 years of age (8.4). See 17 for PATIENT COUNSELING INFORMATION, and Medication Guide. Revised: 01/2013 |
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
Do not start escitalopram tablets 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 tablets 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 tablets 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 tablets 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 tablets 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)].
The use of MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets are contraindicated because of an increased risk of serotonin syndrome. The use of escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders are also contraindicated [see Dosage and Administration (2.5), and Warnings and Precautions (5.2)].
Starting escitalopram tablets 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)].
Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
---|---|
| Increases Compared to Placebo |
<18 | 14 additional cases |
18-24 | 5 additional cases |
| Decreases Compared to Placebo |
25-64 | 1 fewer case |
≥ 65 | 6 fewer cases |
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including escitalopram oxalate, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination) seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of escitalopram oxalate with MAOIs intended to treat psychiatric disorders is contraindicated. Escitalopram oxalate should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking escitalopram oxalate. Escitalopram oxalate should be discontinued before initiating treatment with the MAOI [see Contraindications (4.1) and Dosage and Administration (2.5 and 2.6)].
If concomitant use of escitalopram oxalate with other serotonergic drugs including, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with escitalopram oxalate and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Adverse Reaction | Escitalopram oxalate | Placebo |
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(N=715) % | (N=592) % |
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1Primarily ejaculatory delay. 2Denominator used was for males only (N=225 escitalopram oxalate; N=188 placebo). 3Denominator used was for females only (N=490 escitalopram oxalate; N=404 placebo). |
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Autonomic Nervous System Disorders
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Dry Mouth
| 6%
| 5%
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Sweating Increased
| 5%
| 2%
|
Central & Peripheral Nervous System Disorders
|
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Dizziness
| 5% | 3% |
Gastrointestinal Disorders
|
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Nausea | 15% | 7% |
Diarrhea
| 8% | 5% |
Constipation
| 3% | 1% |
Indigestion
| 3% | 1% |
Abdominal Pain
| 2% | 1% |
General
|
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Influenza-like Symptoms
| 5% | 4% |
Fatigue
| 5% | 2% |
Psychiatric Disorders
|
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Insomnia
| 9% | 4% |
Somnolence | 6% | 2% |
Appetite Decreased | 3% | 1% |
Libido Decreased | 3% | 1% |
Respiratory System Disorders
|
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Rhinitis | 5% | 4% |
Sinusitis | 3% | 2% |
Urogenital
|
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Ejaculation Disorder1,2
| 9% | <1% |
Impotence2
| 3% | <1% |
Anorgasmia3
| 2% | <1% |
Adverse Reactions | Escitalopram oxalate | Placebo |
---|---|---|
(N=429) % | (N=427) % |
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1Primarily ejaculatory delay. 2Denominator used was for males only (N=182 escitalopram oxalate; N=195 placebo). 3Denominator used was for females only (N=247 escitalopram oxalate; N=232 placebo). |
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Autonomic Nervous System Disorders
|
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Dry Mouth | 9% | 5% |
Sweating Increased | 4% | 1% |
Central & Peripheral Nervous System Disorders
|
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Headache | 24% | 17% |
Paresthesia | 2% | 1% |
Gastrointestinal Disorders
|
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Nausea | 18% | 8% |
Diarrhea | 8% | 6% |
Constipation | 5% | 4% |
Indigestion | 3% | 2% |
Vomiting | 3% | 1% |
Abdominal Pain | 2% | 1% |
Flatulence | 2% | 1% |
Toothache | 2% | 0% |
General
|
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Fatigue | 8% | 2% |
Influenza-like Symptoms | 5% | 4% |
Musculoskeletal System Disorder
|
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Neck/Shoulder Pain | 3% | 1% |
Psychiatric Disorders
|
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Somnolence | 13% | 7% |
Insomnia | 12% | 6% |
Libido Decreased | 7% | 2% |
Dreaming Abnormal | 3% | 2% |
Appetite Decreased | 3% | 1% |
Lethargy | 3% | 1% |
Respiratory System Disorders
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Yawning | 2% | 1% |
Urogenital
|
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Ejaculation Disorder1,2
| 14% | 2% |
Anorgasmia3
| 6% | <1% |
Menstrual Disorder | 2% | 1% |
Adverse Reaction | Placebo | 10 mg/day | 20 mg/day |
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Escitalopram oxalate | Escitalopram oxalate | ||
(N=311) | (N=310) | (N=125) | |
Insomnia
| 4% | 7% | 14% |
Diarrhea
| 5% | 6% | 14% |
Dry Mouth
| 3% | 4% | 9% |
Somnolence
| 1% | 4% | 9% |
Dizziness
| 2% | 4% | 7% |
Sweating Increased
| <1% | 3% | 8% |
Constipation
| 1% | 3% | 6% |
Fatigue
| 2% | 2% | 6% |
Indigestion
| 1% | 2% | 6% |
Adverse Event
| Escitalopram oxalate
| Placebo
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| In Males Only |
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(N=407) | (N=383) |
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Ejaculation Disorder (primarily ejaculatory delay) | 12% | 1% |
Libido Decreased | 6% | 2% |
Impotence | 2% | <1% |
| In Females Only |
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(N=737) | (N=636) |
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Libido Decreased | 3% | 1% |
Anorgasmia | 3% | <1% |
[See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)].
[See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)].
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of escitalopram oxalate with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions (5.2)].
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
Revised: 01/2013
3. Severe allergic reactions:
Do not stop escitalopram tablets without first talking to your healthcare provider. Stopping escitalopram tablets too quickly may cause serious symptoms including:
People who take escitalopram tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
If you take escitalopram tablets, you should not take any other medicines that contain escitalopram oxalate or citalopram hydrobromide including: Celexa. |
Other side effects in children and adolescents include:
Coumadin® is a registered trademark of Bristol Myers Squibb.
Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.
Orap® is a registered trademark of Teva Pharmaceuticals USA.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
ESCITALOPRAM
escitalopram oxalate tablet, film coated |
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ESCITALOPRAM
escitalopram oxalate tablet, film coated |
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ESCITALOPRAM
escitalopram oxalate tablet, film coated |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 918917642 | ANALYSIS(65862-373, 65862-374, 65862-375), MANUFACTURE(65862-373, 65862-374, 65862-375) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 918917647 | API MANUFACTURE(65862-373, 65862-374, 65862-375) |