Escitalopram Oxalate description, usages, side effects, indications, overdosage, supplying and lots more!

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Escitalopram Oxalate

Macleods Pharmaceuticals Limited

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Escitalopram Tablets, USP safely and effectively. See full prescribing information for Escitalopram Tablets, USP. Escitalopram Tablets, USP  Initial U.S. Approval: 2002 RECENT MAJOR CHANGESBOXED WARNINGWARNING: Suicidality and Antidepressant DrugsSee 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 is not approved for use in pediatric patients less than 12 years of age (5.1). INDICATIONS AND USAGE1.11.2DOSAGE AND ADMINISTRATION2.12.2 Indication Recommended Dose MDD (2.1) Adolescents ( 2.1 )  Initial: 10 mg once daily Recommended: 10 mg once dailyMaximum: 20 mg once daily Adults (2.1) Initial: 10 mg once dailyRecommended: 10 mg once dailyMaximum: 20 mg once daily GAD (2.2)   Adults (2.2) Initial: 10 mg once dailyRecommended: 10 mg once daily 2.12.32.32.4DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1) CONTRAINDICATIONS Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets. Do not use escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue (4.1). Pimozide: Do not use concomitantly (4.2). Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4.3). WARNINGS AND PRECAUTIONS5.15.25.35.45.55.65.75.85.9Side Effects6.1www.fda.gov/medwatchDRUG INTERACTIONS7.17.6USE IN SPECIFIC POPULATIONS8.18.38.4


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


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 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 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 Used in Specific Populations: Pediatric Use (8.4)].

1 INDICATIONS & USAGE

1.1 Major Depressive Disorder


14.1

1.2 Generalized Anxiety Disorder


see Clinical Studies (14.2)

2 DOSAGE & ADMINISTRATION


2.1 Major Depressive Disorder


Initial Treatment

Adolescents
14.1

Adults
14.1

Maintenance Treatment
14.1

2.2 Generalized Anxiety Disorder


Initial Treatment

Adults


Maintenance Treatment

2.3 Special Populations




2.4 Discontinuation of Treatment with Escitalopram oxalate

5.3

2.5 Switching Patients 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 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)].

 

2.6 Use of Escitalopram tablets with Other MAOIs such as Linezolid or Methylene Blue

 

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 )].

 

3 DOSAGE FORMS & STRENGTHS

3.1 Tablets






4 CONTRAINDICATIONS

4.1 Monoamine oxidase inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets is 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 is 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 )].

4.2 Pimozide


[see Drug Interactions (7.10)]

4.3 Hypersensitivity to escitalopram or citalopram


5 WARNINGS AND PRECAUTIONS

5.1 Clinical Worsening and Suicide Risk




Table 1



 Table 1 
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








Dosage and Administration (2.4

Patient Counseling Information (17.1

Screening Patients for Bipolar Disorder



5.2 Serotonin Syndrome


The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including escitalopram tablets, 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 tablets with MAOIs intended to treat psychiatric disorders is contraindicated. Escitalopram tablets 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 tablets. Escitalopram tablets 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 tablets 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 tablets and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

 

5.3 Discontinuation of Treatment with Escitalopram




2.4

5.4 Seizures

Although anticonvulsant effects of racemic citalopram have been observed in animal studies, escitalopram has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product's premarketing testing. In clinical trials of escitalopram, cases of convulsion have been reported in association with escitalopram treatment. Like other drugs effective in the treatment of major depressive disorder, escitalopram should be introduced with care in patients with a history of seizure disorder.

5.5 Activation of Mania/Hypomania

In placebo-controlled trials of escitalopram in major depressive disorder, activation of mania/hypomania was reported in one (0.1%) of 715 patients treated with escitalopram and in none of the 592 patients treated with placebo. One additional case of hypomania has been reported in association with escitalopram treatment. Activation of mania/ hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, escitalopram should be used cautiously in patients with a history of mania.

5.6 Hyponatremia


8.5

5.7 Abnormal Bleeding

SSRIs and SNRIs, including escitalopram, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Patients should be cautioned about the risk of bleeding associated with the concomitant use of escitalopram and NSAIDs, aspirin, or other drugs that affect coagulation.

5.8 Interference with Cognitive and Motor Performance


5.9 Use in Patients with Concomitant Illness






2.3

2.3

 

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience




Clinical Trial Data Sources
Pediatrics (6 -17 years) 


Adults






Adverse Events Associated with Discontinuation of Treatment

Major Depressive Disorder

Pediatrics (6 -17 years)


Adults


Generalized Anxiety Disorder

Adults


Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials

Major Depressive Disorder

Pediatrics (6 -17 years)







 TA BLE 2
Treatment-Emergent Adverse Reactions observed with a frequency of ≥ 2% and greater than placebo for Major Depressive Disorder
Adverse Reaction
 Escitalopram
Placebo
 
(N=715)
%

(N=592)
%

Autonomic Nervous System Disorders
 
 
Dry Mouth
6%
5%
Sweating Increased
5%
2%
Central & Peripheral Nervous System Disorders
 
 
Dizziness
5%
3%
Gastrointestinal Disorders
 
 
Nausea
15%
7%
Diarrhea
8%
5%
Constipation
3%
1%
Indigestion
3%
1%
Abdominal Pain
2%
1%
General
 
 
Influenza-like Symptoms
5%
4%
Fatigue
5%
2%
Psychiatric Disorders
 
 
Insomnia
9%
4%
Somnolence
6%
2%
Appetite Decreased
3%
1%
Libido Decreased
3%
1%
Respiratory System Disorders
 
 
Rhinitis
5%
4%
Sinusitis
3%
2%
Urogenital
 
 
Ejaculation DisorderPrimarily ejaculatory delay. Denominator used was for males only (N=225 escitalopram oxalate; N=188 placebo).
9%
<1%
ImpotenceDenominator used was for males only (N=225 escitalopram oxalate; N=188 placebo).
3%
<1%
AnorgasmiaDenominator used was for females only (N=490 escitalopram oxalate; N=404. placebo).
2%
<1%

Generalized Anxiety Disorder
Adults


Table 3

TABLE 3
Treatment-Emergent Adverse Reactions observed with a frequency of ≥ 2% and greater than placebo for Generalized Anxiety Disorder
Adverse Reactions
 Escitalopram
Placebo
 
(N=429)
%

(N=427)
%

Autonomic Nervous System Disorders
 
 
  Dry Mouth
9%
5%
  Sweating Increased
4%
1%
Central & Peripheral Nervous System Disorders
 
 
   Headache
24%
17%
   Paresthesia
2%
1%
Gastrointestinal Disorders
 
 
   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
 
 
   Fatigue
8%
2%
   Influenza-like Symptoms
5%
4%
Musculoskeletal System Disorder
 
 
   Neck/Shoulder Pain
3%
1%
Psychiatric Disorders
 
 
   Somnolence
13%
7%
   Insomnia
12%
6%
   Libido Decreased
7%
2%
   Dreaming Abnormal
3%
2%
   Appetite Decreased
3%
1%
   Lethargy
3%
1%
Respiratory System Disorders
 
 
   Yawning
2%
1%
Urogenital
 
 
   Ejaculation DisorderPrimarily ejaculatory delay. Denominator used was for males only (N=182 ecitalopram oxalate; N=195 placebo).
14%
2%
   AnorgasmiaDenominator used was for females only (N=247 escitalopram oxalate; N=232 placebo).
6%
<1%
   Menstrual Disorder
2%
1%


Dose Dependency of Adverse Reactions



TABLE 4
Incidence of Common Adverse Reactions in Patients with Major Depressive Disorder
Adverse Reaction
Placebo
10 mg/day
20 mg/day
 
(N=311)
 Escitalopram
 Escitalopram
 
 
(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%


Male and Female Sexual Dysfunction with SSRIs



TABLE 5
Incidence of Sexual Side Effects in Placebo-Controlled Clinical  Trials
Adverse Event
 Escitalopram
Placebo
 
In Males Only
 
(N = 407)
(N = 383)
Ejaculation Disorder (primarily ejaculatory delay)
12%
1%
Libido Decreased
6%
2%
Impotence
2%
<1%
 
In Females Only
 
(N = 737)
(N = 636)
Libido Decreased
3%
1%
Anorgasmia
3%
<1%








Vital Sign Changes


Weight Changes


Laboratory Changes


ECG Changes




Other Reactions Observed During the Premarketing Evaluation of escitalopram
ADVERSE REACTIONSTables 2 & 35
























6.2 Post-Marketing Experience


Adverse Reactions Reported Subsequent to the Marketing of Escitalopram









































7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors (MAOIs)

Dosage and Administration (2.5 and 2.6),Contraindications (4.1)Warnings and Precautions (5.2

7.2 Serotonergic Drugs

Dosage and Administration (2.5and 2.6),Contraindications (4.1)Warnings and Precautions (5.2

7.3 Triptans


5.2

7.4 CNS Drugs


7.5 Alcohol


7.6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when escitalopram is initiated or discontinued.

7.7 Cimetidine


max

7.8 Digoxin


7.9 Lithium

Coadministration of racemic citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of escitalopram, caution should be exercised when escitalopram and lithium are coadministered.

7.10 Pimozide and Celexa


max

7.11 Sumatriptan

There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of an SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is clinically warranted, appropriate observation of the patient is advised.

7.12 Theophylline


7.13 Warfarin


7.14 Carbamazepine

Combined administration of racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escitalopram should be considered if the two drugs are coadministered.

7.15 Triazolam


7.16 Ketoconazole


max

7.17 Ritonavir


7.18 CYP3A4 and -2C19 Inhibitors




7.19 Drugs Metabolized by Cytochrome P4502D6

In vitro studies did not reveal an inhibitory effect of escitalopram on CYP2D6. In addition, steady state levels of racemic citalopram were not significantly different in poor metabolizers and extensive CYP2D6 metabolizers after multiple-dose administration of citalopram, suggesting that coadministration, with escitalopram, of a drug that inhibits CYP2D6, is unlikely to have clinically significant effects on escitalopram metabolism. However, there are limited in vivo data suggesting a modest CYP2D6 inhibitory effect for escitalopram, i.e., coadministration of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single dose of 50 mg), a substrate for CYP2D6, resulted in a 40% increase in Cmax and a 100% increase in AUC of desipramine. The clinical significance of this finding is unknown. Nevertheless, caution is indicated in the coadministration of escitalopram and drugs metabolized by CYP2D6.

7.20 Metoprolol


max

7.21 Electroconvulsive Therapy (ECT)


8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy




222

22











Warnings and Precautions (5.2





Dosage and Administration (2.1.)

8.2 Labor & Delivery


8.3 Nursing Mothers


8.4 Pediatric Use







 

8.5 Geriatric Use




5.6

12.32.3


9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse and Dependence




10 OVERDOSAGE

10.1 Human Experience





10.2 Management of Overdose





11 DESCRIPTION




Escitalopram Oxalate
20212224





12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action


12.2 Pharmacodynamics


In vitroin vivo1-71-51-31-5++-++

12.3 Pharmacokinetics














1-71-51-31-5++-++
In vitro


Age
max

Elderlymax2.3

Gender

Reduced hepatic function2.3

Reduced renal function

Drug-Drug Interactions
In vitroin vitroin vivoin vivo7.18

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility







in vitroin vitro
in vitroin vitroin vivoin vitroin vivo




13.2 Animal Pharmacology & OR Toxicology











14 CLINICAL STUDIES

14.1 Major Depressive Disorder


Adolescents








Adults










14.2 Generalized Anxiety Disorder





16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Tablets



























17 PATIENT COUNSELING INFORMATION


17.1 Information for Patients




General Information about Medication Guide



Clinical Worsening and Suicide Risk
Warnings and Precautions (5.1

Serotonin Syndrome

Warnings and Precautions (5.2)

Abnormal Bleeding
Warnings and Precautions (5.7

Concomitant Medications



Continuing the Therapy Prescribed



Interference with Psychomotor Performance




Alcohol



Pregnancy and Breast Feeding





Need for Comprehensive Treatment Program

17.2 FDA-Approved Medication Guide


Medication Guide

Escitalopram Tablets, USP



What is the most important information I should know about Escitalopram Tablets?


1. Suicidal thoughts or actions:









Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:













Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency.  Escitalopram Tablets may be associated with these serious side effects:


2. Serotonin Syndrome. This condition can be life-threatening and may include:









3. Severe allergic reactions:





4. Abnormal bleeding: 

5. Seizures or convulsions

6. Manic episodes:









7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:






Do not stop Escitalopram Tablets without first talking to your healthcare provider.






What is Escitalopram Tablet?







Who should not take Escitalopram Tablets?








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:









• take the antipsychotic medicine pimozide (Orap®) because taking this drug with  Escitalopram Tablets can cause serious heart problems.

What should I tell my healthcare provider before taking Escitalopram Tablets? Ask if you are not sure.






















Tell your healthcare provider about all the medicines that you take,






How should I take Escitalopram Tablets?






What should I avoid while taking Escitalopram Tablets?



What are the possible side effects of Escitalopram Tablets?
Escitalopram Tablets may cause serious side effects, including all




























CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store Escitalopram Tablets?



Keep Escitalopram Tablets and all medicines out of the reach of children.

General information about  Escitalopram Tablets



For more information, call 1-888-943-3210.


What are the ingredients in Escitalopram Tablets?

Active ingredient: escitalopram oxalate USP


• Tablets:





Manufactured for:
Macleods Pharma USA, INC,.
Plainsboro, NJ 08536

Manufactured by:
Macleods Pharmaceutical Ltd.
Baddi, Himachal Pradesh, India.

Revised  JANUARY 2013 
This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL











Escitalopram Oxalate










Escitalopram Oxalate










Escitalopram Oxalate

Escitalopram Oxalate

Escitalopram Oxalate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-036
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE ESCITALOPRAM 5 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CARBOXYMETHYLCELLULOSE SODIUM
PROPYL GALLATE
ISOPROPYL ALCOHOL
talc
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400

Product Characteristics

Color Size Imprint Code Shape
WHITE 6 mm ML59 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-036-11 100 in 1 BOTTLE
2 NDC:33342-036-12 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202210 2012-09-11


Escitalopram Oxalate

Escitalopram Oxalate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-037
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE ESCITALOPRAM 10 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CARBOXYMETHYLCELLULOSE SODIUM
PROPYL GALLATE
ISOPROPYL ALCOHOL
talc
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400

Product Characteristics

Color Size Imprint Code Shape
WHITE 7 mm ML60 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-037-11 100 in 1 BOTTLE
2 NDC:33342-037-12 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202210 2012-09-11


Escitalopram Oxalate

Escitalopram Oxalate TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33342-038
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ESCITALOPRAM OXALATE ESCITALOPRAM 20 mg

Inactive Ingredients

Ingredient Name Strength
lactose monohydrate
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CARBOXYMETHYLCELLULOSE SODIUM
PROPYL GALLATE
ISOPROPYL ALCOHOL
talc
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
titanium dioxide
polyethylene glycol 400

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm ML61 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33342-038-11 100 in 1 BOTTLE
2 NDC:33342-038-12 100 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202210 2012-09-11


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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