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*
- BOXED WARNING
- 1 INDICATIONS & USAGE
- 2 DOSAGE & ADMINISTRATION
- 2.1 Major Depressive Disorder
- 2.2 Generalized Anxiety Disorder
- 2.3 Special Populations
- 2.4 Discontinuation of Treatment with Escitalopram oxalate
- 2.5 Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
- 2.6 Use of Escitalopram tablets with Other MAOIs such as Linezolid or Methylene Blue
- 3 DOSAGE FORMS & STRENGTHS
- 4 ESCITALOPRAM OXALATE CONTRAINDICATIONS
- 5 WARNINGS AND PRECAUTIONS
- 6 ESCITALOPRAM OXALATE ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- 7.1 Monoamine Oxidase Inhibitors (MAOIs)
- 7.2 Serotonergic Drugs
- 7.3 Triptans
- 7.4 CNS Drugs
- 7.5 Alcohol
- 7.6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
- 7.7 Cimetidine
- 7.8 Digoxin
- 7.9 Lithium
- 7.10 Pimozide and Celexa
- 7.11 Sumatriptan
- 7.12 Theophylline
- 7.13 Warfarin
- 7.14 Carbamazepine
- 7.15 Triazolam
- 7.16 Ketoconazole
- 7.17 Ritonavir
- 7.18 CYP3A4 and -2C19 Inhibitors
- 7.19 Drugs Metabolized by Cytochrome P4502D6
- 7.20 Metoprolol
- 8 USE IN SPECIFIC POPULATIONS
- 9 DRUG ABUSE AND DEPENDENCE
- 10 OVERDOSAGE
- 11 ESCITALOPRAM OXALATE DESCRIPTION
- 12 CLINICAL PHARMACOLOGY
- 13 NONCLINICAL TOXICOLOGY
- 14 CLINICAL STUDIES
- 16 HOW SUPPLIED/STORAGE AND HANDLING
- 17 PATIENT COUNSELING INFORMATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
5.32.5 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 Disorder |
9% |
<1% |
Impotence |
3% |
<1% |
Anorgasmia |
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 Disorder |
14% |
2% |
Anorgasmia |
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 (5.27.2 Serotonergic Drugs
Dosage and Administration (2.5and 2.6),Contraindications (4.1)Warnings and Precautions (5.27.3 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
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 OxalateEscitalopram Oxalate TABLET, FILM COATED
|
Escitalopram OxalateEscitalopram Oxalate TABLET, FILM COATED
|
Escitalopram OxalateEscitalopram Oxalate TABLET, FILM COATED
|