Escitalopram Prescribing Information
5.1 Suicidal Thoughts and Behaviors in Adolescents and Young AdultsIn pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in the antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in
Age Range | Drug-Placebo Difference in Number of Patients of Suicidal Thoughts and Behaviors per 1000 Patients Treated |
Increases Compared to Placebo | |
<18 years old | 14 additional patients |
18 to 24 years old | 5 additional patients |
Decreases Compared to Placebo | |
25 to 64 years old | 1 fewer patient |
≥65 years old | 6 fewer patients |
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors.
Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing escitalopram tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
8.4 Pediatric UseThe safety and effectiveness of escitalopram for the treatment of major depressive disorder have been established in pediatric patients 12 years of age and older. Use of escitalopram for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared escitalopram 10 mg to 20 mg once daily to placebo in pediatric patients 12 to 17 years of age with major depressive disorder [
The safety and effectiveness of escitalopram for the treatment of major depressive disorder have not been established in pediatric patients younger than 12 years of age. In a 24-week, open- label safety study in 118 pediatric patients aged 7 to 11 years who had major depressive disorder, the safety findings were consistent with the known safety and tolerability profile for escitalopram.
The safety and effectiveness of escitalopram for the treatment of generalized anxiety disorder have been established in pediatric patients younger than 7 years of age.
Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [
In a juvenile animal study, male and female rats were administered escitalopram at 5, 40, or 80 mg/ kg/day by oral gavage from postnatal day (PND) 21 to PND 69. A delay in sexual maturation was observed in both males and females at ≥ 40 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 5 mg/kg/day. This NOAEL was associated with plasma AUC levels less than those measured at the maximum recommended dose (MRHD) in pediatrics (20 mg). However, there was no effect on reproductive function. Increased motor activity (both ambulatory and fine movements) was observed in females prior to daily dosing at ≥ 40 mg/kg/day (3.5 times the MRHD based on AUC levels). A reversible disruption of learning and memory function was observed in males at 80 mg/kg/day with a NOAEL of 40 mg/kg/day, which was associated with an AUC level 3.5 times those measured at the MRHD in pediatrics. There was no effect on learning and memory function in treated female rats.
Indications (
1 INDICATIONS AND USAGEEscitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the :
- treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older
- treatment of generalized anxiety disorder (GAD) in adults
Escitalopram is indicated for the treatment of:
• major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
• generalized anxiety disorder (GAD) in adults.
Dosage and Administration (
2.2 Generalized Anxiety DisorderThe recommended starting dosage of escitalopram tablets in adults is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.
2.3 Administration InformationAdminister escitalopram tablets orally once daily, in the morning or evening, with or without food
2.5 Recommended Dosage for Specific PopulationsThe recommended dosage for most elderly patients and patients with hepatic impairment is 10 mg once daily [
The recommended dosage for escitalopram tablets in adults with a creatinine clearance less than 20 mL/ minute has not been determined. No dosage adjustment is necessary for patients with mild or moderate renal impairment [
Dosage and Administration, Use of Escitalopram with Other MAOIs such as Linezolid or Methylene Blue (
2.7 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) AntidepressantAt 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 [
Warnings and Precautions (
5.2 Serotonin SyndromeSSRIs, including escitalopram, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, meperidine, methadone, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [
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).
The concomitant use of escitalopram with MAOIs is contraindicated. In addition, do not initiate escitalopram in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection). If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking escitalopram, discontinue escitalopram before initiating treatment with the MAOI [
Monitor all patients taking escitalopram for the emergence of serotonin syndrome. Discontinue treatment with escitalopram and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of escitalopram with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms.
5.7 Increased Risk of BleedingDrugs that interfere with serotonin reuptake inhibition, including escitalopram, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal antiinflammatory drugs (NSAIDs), other antiplatelet 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.
Based on data from the published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see use in Specific Population (8.1)]. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients about the increased risk of bleeding associated with the concomitant use of escitalopram and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [
Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the :
- treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ()
1 INDICATIONS AND USAGEEscitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the :
- treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older
- treatment of generalized anxiety disorder (GAD) in adults
Escitalopram is indicated for the treatment of:
• major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
• generalized anxiety disorder (GAD) in adults.
Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solutions. However, due to AbbVie Inc’s marketing exclusivity rights, this drug product is not labeled with that information. - treatment of generalized anxiety disorder (GAD) in adults ()
1 INDICATIONS AND USAGEEscitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the :
- treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older
- treatment of generalized anxiety disorder (GAD) in adults
Escitalopram is indicated for the treatment of:
• major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.
• generalized anxiety disorder (GAD) in adults.
Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solutions. However, due to AbbVie Inc’s marketing exclusivity rights, this drug product is not labeled with that information.
Indication and Population | Recommended Dose |
MDD in Adults ( 2.1 Major Depressive DisorderAdults The recommended dosage of escitalopram tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [ see Clinical Studies ]. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.Pediatric Patients 12 years of age and older The recommended dosage of escitalopram tablets in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks. | Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily |
MDD in Pediatric Patients 12 years and older ( 2.1 Major Depressive DisorderAdults The recommended dosage of escitalopram tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [ see Clinical Studies ]. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.Pediatric Patients 12 years of age and older The recommended dosage of escitalopram tablets in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks. | Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily |
GAD in Adults ( 2.2 Generalized Anxiety DisorderAdults The recommended starting dosage of escitalopram tablets in adults is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets and LEXAPRO (escitalopram) oral solutions. However, due to AbbVie Inc’s marketing exclusivity rights, this drug product is not labeled with that information. | Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily |
- No additional benefits were seen at 20 mg once daily ().
2.1 Major Depressive DisorderAdultsThe recommended dosage of escitalopram tablets in adults is 10 mg once daily. A fixed-dose trial of escitalopram demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a greater benefit of 20 mg over 10 mg [
see Clinical Studies]. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.Pediatric Patients 12 years of age and olderThe recommended dosage of escitalopram tablets in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks.
- Administer once daily, morning or evening, with or without food ()
2.3 Administration InformationAdminister escitalopram tablets orally once daily, in the morning or evening, with or without food
- Elderly patients: recommended dosage is 10 mg once daily ()
2.4 Screen for Bipolar Disorder Prior to Starting Escitalopram TabletsPrior to initiating treatment with escitalopram or another antidepressant, screen patients for a personal family history of bipolar disorder, mania, or hypomania [
see Warnings and Precautions] - Hepatic impairment: recommended dosage is 10 mg once daily (,
2.4 Screen for Bipolar Disorder Prior to Starting Escitalopram TabletsPrior to initiating treatment with escitalopram or another antidepressant, screen patients for a personal family history of bipolar disorder, mania, or hypomania [
see Warnings and Precautions])8.6 Hepatic ImpairmentIncreased citalopram exposure occurs in patients with hepatic impairment [
see Clinical Pharmacology]. The recommended dosage of escitalopram in patients with hepatic impairment is 10 mg daily [see Dosage and Administration]. - When discontinuing escitalopram tablets, reduce dose gradually whenever possible ()
2.5 Recommended Dosage for Specific PopulationsThe recommended dosage for most elderly patients and patients with hepatic impairment is 10 mg once daily [
see Use in Specific Populations].The recommended dosage for escitalopram tablets in adults with a creatinine clearance less than 20 mL/ minute has not been determined. No dosage adjustment is necessary for patients with mild or moderate renal impairment [
see Use in Specific Populations].
5 mg: Round, white to off-white, biconvex, film coated tablets, debossed with “P 5” on one side and plain on the other side.
10 mg: Round, white to off-white, biconvex, scored film coated tablets, debossed with “P 10” on the scored side and plain on the other side.
20 mg: Round, white to off-white, biconvex, scored film coated tablets, debossed with “P 20” on the scored side and plain on the other side.
Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate (
8.1 PregnancyBased on data form published observational studies, exposure to SSRIs, particulary in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage
Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage. There are risks of persistent pulmonary hypertension of the newborn (PPHN)
In animal reproduction studies, both escitalopram and racemic citalopram have been shown to have adverse effects on embryo/fetal and postnatal development, including fetal structural abnormalities, when administered at doses greater than human therapeutic doses
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Women who discontinue antidepressants are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of major depression, who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
Maternal Adverse Reactions
Use of escitalopram in the month before delivery may be associated with an increased risk of postpartum hemorrhage
Neonates exposed to SSRIs or SNRIs, including escitalopram, late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [
Exposure to SSRIs, particularly later in pregnancy, may increase the risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general populations and is associated with substantial neonatal morbidity and mortality.
In a rat embryo/fetal development study, oral administration of escitalopram (56, 112, or 150 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased fetal body weight and associated delays in ossification at the two higher doses [approximately ≥ 55 times the maximum recommended human dose (MRHD) of 20 mg/day on a mg/m2basis]. Maternal toxicity (clinical signs and decreased body weight gain and food consumption), mild at 56 mg/kg/day, was present at all dose levels. The developmental no-effect dose of 56 mg/kg/day is approximately 27 times the MRHD of 20 mg on a mg/m2basis. No malformations were observed at any of the doses tested (as high as 73 times the MRHD on a mg/m2basis).
When female rats were treated with escitalopram (6, 12, 24, or 48 mg/kg/day) during pregnancy and through weaning, slightly increased offspring mortality and growth retardation were noted at 48 mg/kg/day which is approximately 23 times the MRHD of 20 mg on a mg/m2basis. Slight maternal toxicity (clinical signs and decreased body weight gain and food consumption) was seen at this dose. Slightly increased offspring mortality was also seen at 24 mg/kg/day. The no-effect dose was 12 mg/kg/day which is approximately 6 times the MRHD of 20 mg on a mg/m2basis.
In two rat embryo/fetal development studies, oral administration of racemic citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of organogenesis resulted in decreased embryo/fetal growth and survival and an increased incidence of fetal abnormalities (including cardiovascular and skeletal defects) at the high dose, which is approximately 18 times the MRHD of 60 mg/day on a mg/m2basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental no-effect dose was 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2basis. In a rabbit study, no adverse effects on embryo/fetal development were observed at doses of racemic citalopram of up to 16 mg/kg/day, or approximately 5 times the MRHD on a mg/m2basis. Thus, developmental effects of racemic citalopram were observed at a maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with racemic citalopram (4.8, 12.8, or 32 mg/kg/day) from late gestation through weaning, increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation were observed at the highest dose, which is approximately 5 times the MRHD of 60 mg on a mg/m2basis. The no-effect dose was 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, approximately 4 times the MRHD on a mg/m2basis. A no-effect dose was not determined in that study.