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Escitalopram 10 mg Tablet, Film Coated, 60-count — NDC 80425-0320-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Escitalopram 10 mg Tablet, Film Coated, 60-count — NDC 80425-0320-2 (Billing 80425-0320-02)

by Advanced Rx Pharmacy of Tennessee, LLC · 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Escitalopram 10 mg Tablet, Film Coated from Advanced Rx Pharmacy of Tennessee, LLC, marketed since Apr 2023 and currently FDA-listed.

NDC 80425-0320-02
🏷️ FDA NDC (as labeled) 80425-0320-2 billing pads the package segment with a zero
This package
Contains60-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1381/unit — full pricing hub ↓
Product page 80425-0320-01 Also comes in: 30 tablets 80425-0320-1 60 tablets 80425-0320-3
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80425-0320-2
Product NDC 80425-0320
11-digit billing NDC 80425032002
NCPDP billing unit EA — each (per item)
RxCUI 349332
UNII 5U85DBW7LO
Application # ANDA078032
SPL Set ID f914fec5-4ce7-794d-e053-6294a90a7cc5
Established class (EPC) Serotonin Reuptake Inhibitor
Mechanism of action Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-11
Route ORAL
Dosage form TABLET, FILM COATED
Substance ESCITALOPRAM OXALATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 349332
Why two NDCs? The FDA registers this code as 80425-0320-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0320-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor
Drug family (ATC) Selective serotonin reuptake inhibitors
How it works Serotonin Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Escitalopram is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life and lasts for 6 months or longer). Escitalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats major depressive disorder and generalized anxiety disorder. Age limits depend on the product, so check with me or your prescriber about yours.
  • Take it once a day, morning or evening, with or without food. Capsules should be swallowed whole. Follow your prescriber's directions.
  • Please don't stop suddenly. Stopping can cause withdrawal-type symptoms. Talk to your prescriber about lowering the dose gradually.
  • The most common are nausea, trouble sleeping, sleepiness, tiredness, sweating and sexual side effects such as delayed ejaculation or lower sex drive. Tell us if sexual problems bot...
📖 Read our full Escitalopram guide →
1
Nutrient depletion considerations

Escitalopram may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Escitalopram nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1381 $8.29 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80425-0320-01 80425-0320-1 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2023-04-11 — Active
80425-0320-02 You're viewing this 60 TABLET, FILM COATED in 1 BOTTLE 2023-04-11 — Active
80425-0320-03 80425-0320-3 60 TABLET, FILM COATED in 1 BOTTLE 2023-04-11 — Active

Pack size FAQ

What quantity is in this package?
This is a 60-count package — 60 tablet, film coated in 1 bottle.
How does this package differ from NDC 80425-0320-01?
Both are Escitalopram 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 60-count one, while NDC 80425-0320-01 is the 30 tablets package.
What NDC number is used to bill for this package of Escitalopram 10 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
escitalopram 10 mg 00904-6426-61 Major 100 tablets $0.039 AB Availability likely —
escitalopram 10 mg 13668-0136-01 Torrent 100 tablets $0.039 AB Availability likely —
escitalopram 10 mg 16571-0756-01 Rising 100 tablets $0.039 AB Availability likely —
Escitalopram 10 mg 43547-0281-10 SOLCO 100 tablets $0.039 AB Availability likely —
Escitalopram 10 mg 65862-0374-01 Aurobindo 100 tablets $0.039 AB Availability likely —
Escitalopram 10 mg 68001-0592-00 BluePoint 100 tablets $0.039 AB Availability likely —
Escitalopram 10 mg 68084-0617-01 American 1 tablet $0.039 AB Availability likely —
Escitalopram Oxalate 10 mg 68645-0519-54 Legacy 30 tablets $0.039 AB Availability likely —
Escitalopram Oxalate 10 mg/21 72603-0150-01 NorthStar 1000 tablets $0.039 AB Availability likely —
escitalopram oxalate 10 mg 82009-0036-10 Quallent 1000 tablets $0.039 AB Availability likely —
Escitalopram 10 mg 59746-0280-01 Jubilant 100 tablets $0.046 AB FDA listed —
Escitalopram 10 mg 16729-0169-01 Accord 100 tablets $0.048 AB FDA listed —
Escitalopram Oxalate 10 mg/21 33342-0037-11 Macleods 100 tablets $0.048 AB FDA listed —
Lexapro 10 mg 00456-2010-01 Allergan, 100 tablets $15.413 AB Availability likely —
Escitalopram 10 mg 00615-8476-05 NCS 15 tablets — AB FDA listed —
Escitalopram 10 mg 42708-0077-30 QPharma, 30 tablets — AB FDA listed —
Escitalopram 10 mg 42708-0155-30 QPharma, 30 tablets — AB FDA listed —
escitalopram oxalate 10 mg 43063-0761-01 PD-Rx 100 tablets — AB FDA listed —
Escitalopram Oxalate 10 mg 43602-0474-10 Ascent 1000 tablets — AB FDA listed —
Escitalopram 10 mg 50090-4915-00 A-S 90 tablets — AB FDA listed —
Escitalopram 10 mg 50090-6190-00 A-S 30 tablets — AB FDA listed —
Escitalopram 10 mg 50090-6191-00 A-S 90 tablets — AB FDA listed —
Escitalopram 10 mg 50090-6496-00 A-S 30 tablets — AB FDA listed —
Escitalopram 10 mg 51655-0149-26 Northwind 90 tablets — AB FDA listed —
Escitalopram 10 mg 51655-0277-26 Northwind 90 tablets — AB FDA listed —
Escitalopram 10 mg 51655-0449-52 Northwind 30 tablets — AB FDA listed —
Escitalopram Oxalate 10 mg 53746-0020-05 Amneal 500 tablets — AB FDA listed —
escitalopram 10 mg 55154-6893-00 Cardinal 10 tablets — AB FDA listed —
Escitalopram 10 mg 55700-0847-30 Quality 30 tablets — AB Discontinued —
escitalopram 10 mg 60760-0895-30 St. 30 tablets — AB FDA listed —
Escitalopram Oxalate 10 mg 65162-0020-03 Amneal 30 tablets — AB FDA listed —
Escitalopram 10 mg 67046-0355-03 Coupler 30 tablets — AB FDA listed —
escitalopram oxalate 10 mg 68788-8371-01 Preferred 100 tablets — AB FDA listed —
escitalopram 10 mg 68788-8569-01 Preferred 100 tablets — AB FDA listed —
Escitalopram Oxalate 10 mg 69097-0848-02 Cipla 30 tablets — AB FDA listed —
Escitalopram 10 mg 70518-2472-00 REMEDYREPACK 30 tablets — AB Discontinued —
escitalopram 10 mg 70518-3923-00 REMEDYREPACK 30 tablets — AB FDA listed —
Escitalopram 10 mg 70518-4567-00 REMEDYREPACK 30 tablets — AB FDA listed —
Escitalopram 10 mg 71205-0168-30 Proficient 30 tablets — AB FDA listed —
Escitalopram 10 mg 71205-0344-30 Proficient 30 tablets — AB FDA listed —
Escitalopram 10 mg 71205-0782-30 Proficient 30 tablets — AB FDA listed —
escitalopram oxalate 10 mg 71205-0792-30 Proficient 30 tablets — AB FDA listed —
escitalopram oxalate 10 mg 71335-0322-01 Bryant 30 tablets — AB FDA listed —
Escitalopram 10 mg 71335-1030-01 Bryant 30 tablets — AB Discontinued —
Escitalopram 10 mg 71335-1187-01 Bryant 30 tablets — AB FDA listed —
escitalopram 10 mg 71335-2903-01 Bryant 1000 tablets — AB FDA listed —
escitalopram 10 mg 71335-3094-01 Bryant 30 tablets — AB FDA listed —
escitalopram 10 mg 72162-2241-00 Bryant 1000 tablets — AB FDA listed —
Escitalopram 10 mg 72189-0424-30 Direct_Rx 30 tablets — AB FDA listed —
Escitalopram 10 mg 72789-0194-30 PD-Rx 30 tablets — AB FDA listed —
Escitalopram oxalate 10 mg 76282-0250-01 Exelan 100 tablets — AB FDA listed —
Escitalopram 10 mg 76420-0722-01 Asclemed 100 tablets — AB FDA listed —
Escitalopram 10 mgthis 80425-0320-02 Advanced 60 tablets — AB FDA listed —
Escitalopram 10 mg 80425-0375-01 Advanced 30 tablets — AB FDA listed —
escitalopram oxalate 10 mg 82982-0065-60 Pharmasource 60 tablets — AB Discontinued —
Escitalopram Oxalate 10 mg 70518-4703-00 REMEDYREPACK 30 tablets — AB FDA listed —
Escitalopram oxalate 10 mg 53401-0037-53 Aphena 60 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintP;10
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderPRINSTON PHARMACEUTICAL INC
FDA applicationANDA078032 (ANDA)
Labeler code80425
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 66 words ▾

WARNINGS: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Escitalopram tables are not approved for use in pediatric patients less than 12 years of age [see Use in Specific Populations (8.4)].

🎯 Indications and Usage 200 words ▾

1. Indications and Usage

1.1Major Depressive Disorder Escitalopram 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.

1.2Generalized Anxiety Disorder Escitalopram 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.

⏱️ Dosage and Administration ~3 min read ▾

2. Dosage and Administration Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.

2.1Major Depressive Disorder Initial Treatment Adolescents The recommended dose of Escitalopram tablets is 10 mg once daily. A flexible-dose trial of Escitalopram (10 to 20 mg/day) demonstrated the effectiveness of Escitalopram [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 tablets 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 (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 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking Escitalopram 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 tablets 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.

2.2Generalized Anxiety Disorder Initial Treatment Adults The recommended starting dose of Escitalopram tablets 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 in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use Escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

2.3Screen for Bipolar Disorder Prior to Starting Escitalopram Prior 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 (5.5)].

2.4Special 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 should be used with caution in patients with severe renal impairment.

2.5Discontinuation of Treatment with Escitalopram tablets Symptoms associated with discontinuation of Escitalopram tablets 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.

2.6Switching a Patient 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)].

2.7Use of Escitalopram 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 blu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 53 words ▾

3. Dosage Forms and Strengths Escitalopram Tablets, USP are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with "P" and either "5", “10”, or “20” on same side according to their respective strengths.

⛔ Contraindications 151 words ▾

4. Contraindications

4.1Monoamine 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)].

4.2Pimozide Concomitant use in patients taking pimozide is contraindicated [see Drug Interactions (7.10)].

4.3Hypersensitivity to escitalopram or citalopram Escitalopram tablets are contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Escitalopram tablets.

⚠️ Warnings and Cautions ~3 min read ▾

5. Warnings and Precautions

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In 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 TABLE 1.. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range Drug-Placebo Difference in Number of Cases of Suicidality 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.

5.2Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Escitalopram, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, 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 with MAOIs intended to treat psychiatric disorders is contraindicated.

Escitalopram 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 treatme… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. Adverse Reactions

6.1Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Clinical Trial Data Sources Pediatrics (6 -17 years) Adverse events were collected in 576 pediatric patients (286 Escitalopram, 290 placebo) with major depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of Escitalopram in pediatric patients less than 12 years of age has not been established.

Adults Adverse events information for Escitalopram was collected from 715 patients with major depressive disorder who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials. An additional 284 patients with major depressive disorder were newly exposed to escitalopram in open-label trials. The adverse event information for Escitalopram in patients with GAD was collected from 429 patients exposed to escitalopram and from 427 patients exposed to placebo in double-blind, placebo-controlled trials.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Events Associated with Discontinuation of Treatment Major Depressive Disorder Pediatrics (6 -17 years) Adverse events were associated with discontinuation of 3.5% of 286 patients receiving Escitalopram and 1% of 290 patients receiving placebo.

The most common adverse event (incidence at least 1% for Escitalopram and greater than placebo) associated with discontinuation was insomnia (1% Escitalopram, 0% placebo). Adults Among the 715 depressed patients who received Escitalopram in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies, the rate of discontinuation for adverse events in patients receiving 10 mg/day Escitalopram was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo.

The rate of discontinuation for adverse events in patients assigned to a fixed dose of 20 mg/day Escitalopram was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Escitalopram (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Escitalopram, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients). Generalized Anxiety Disorder Adults Among the 429 GAD patients who received Escitalopram 10-20 mg/day in placebo-controlled trials, 8% discontinued treatment due to an adverse event, as compared to 4% of 427 patients receiving placebo.

Adverse events that were associated with the discontinuation of at least 1% of patients treated with Escitalopram, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and fatigue (1%). Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials Major Depressive Disorder Pediatrics (… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7. Drug Interactions

7.1Monoamine Oxidase Inhibitors (MAOIs) [See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)].

7.2Serotonergic Drugs [See Dosage and Administration (2.5 and 2.6), Contraindications (4.1) and Warnings and Precautions (5.2)].

7.3Triptans There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Escitalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Warnings and Precautions (5.2)].

7.4CNS Drugs Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination with other centrally acting drugs.

7.5Alcohol Although Escitalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by patients taking Escitalopram is not recommended.

7.6Drugs 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.

7.7Cimetidine In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of 400 mg twice a day cimetidine for 8 days resulted in an increase in citalopram AUC and Cmax of 43% and 39%, respectively. The clinical significance of these findings is unknown.

7.8Digoxin In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.

7.9Lithium 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.

7.10Pimozide and Celexa In a controlled study, a single dose of pimozide 2 mg co-administered with racemic citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Racemic citalopram did not alter the mean AUC or Cmax of pimozide. The mechanism of this pharmacodynamic interaction is not known.

7.11Sumatriptan 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.

7.12Theophylline Combined administration of racemic citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.

7.13Warfarin Administration of 40 mg/day racemic citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8. Use in Specific Populations

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at HTTPS://WOMENSMENTALHEALTH.ORG/CLNICAL-AND RESEARCH PROGRAMS/PREGNANCYREGISTRY/ANTIDEPRESSANTS/ Risk Summary 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) (see Data) and poor neonatal adaptation (see Clinical Considerations) with exposure to selective serotonin reuptake inhibitors (SSRIs), including Escitalopram, during pregnancy. There are risks associated with untreated depression in pregnancy (see Clinical Considerations). 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 (see Data).

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.

Clinical Considerations Disease-associated maternal risk and/or embryo/fetal risk 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.

Fetal/Neonatal adverse reactions 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 [see Warnings and Precautions (5.2)]. Data Human Data 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. Animal Data 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/m2 basis]. 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/m2 basis. No malformations were observed at any of the doses tested (as high as 73 times the MRHD on a mg/m2 basis). When female rats were treated with escitalopram… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 120 words ▾

10. Overdosage The following have been reported with Escitalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes.

Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in Escitalopram tablets overdosage ingestions due to the arrhythmia risk.

Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a Escitalopram tablets overdose. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12. Clinical Pharmacology

12.1Mechanism of Action The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

12.2Pharmacodynamics In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. Tolerance to a model of antidepressant effect in rats was not induced by long-term (up to 5 weeks) treatment with escitalopram.

Escitalopram has no or very low affinity for serotonergic (5-HT1-7) or other receptors including alpha- and beta-adrenergic, dopamine (D1-5), histamine (H1-3), muscarinic (M1-5), and benzodiazepine receptors. Escitalopram also does not bind to, or has low affinity for, various ion channels including Na+, K+, Cl-, and Ca++ channels. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular side effects of other psychotropic drugs.

12.3Pharmacokinetics The single- and multiple-dose pharmacokinetics of escitalopram are linear and dose-proportional in a dose range of 10 to 30 mg/day. Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of about 27-32 hours. With once-daily dosing, steady state plasma concentrations are achieved within approximately one week.

At steady state, the extent of accumulation of escitalopram in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose. The tablet and the oral solution dosage forms of escitalopram oxalate are bioequivalent. Absorption and Distribution Following a single oral dose (20 mg tablet or solution) of escitalopram, peak blood levels occur at about 5 hours.

Absorption of escitalopram is not affected by food. The absolute bioavailability of citalopram is about 80% relative to an intravenous dose, and the volume of distribution of citalopram is about 12 L/kg. Data specific on escitalopram are unavailable.

The binding of escitalopram to human plasma proteins is approximately 56%. Metabolism and Elimination Following oral administrations of escitalopram, the fraction of drug recovered in the urine as escitalopram and S-demethylcitalopram (S-DCT) is about 8% and 10%, respectively. The oral clearance of escitalopram is 600 mL/min, with approximately 7% of that due to renal clearance.

Escitalopram is metabolized to S-DCT and S-didemethylcitalopram (S-DDCT). In humans, unchanged escitalopram is the predominant compound in plasma. At steady state, the concentration of the escitalopram metabolite S-DCT in plasma is approximately one-third that of escitalopram.

The level of S-DDCT was not detectable in most subjects. In vitro studies show that escitalopram is at least 7 and 27 times more potent than S-DCT and S-DDCT, respectively, in the inhibition of serotonin reuptake, suggesting that the metabolites of escitalopram do not contribute significantly to the antidepressant actions of escitalopram. S-DCT and S-DDCT also have no or very low affinity for serotonergic (5-HT1-7) or other receptors including alpha- and beta-adrenergic, dopamine (D1-5), histamine (H1-3), muscarinic (M1-5), and benzodiazepine receptors.

S-DCT and S-DDCT also do not bind to various ion channels including Na+, K+, Cl-, and Ca++ channels. In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes involved in the N-demethylation of escitalopram. Population Subgroups Age Adolescents - In a single dose study of 10 mg escitalopram, AUC of escitalopram decreased by 19%, and Cmax increased… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 73 words ▾

16. How Supplied/Storage and Handling Escitalopram Tablets, USP, 10 mg are round, white to off-white, biconvex, film coated tablets, debossed with "P 10" on the scored side and plain on the other side. They are sold in bottles of: Bottles of 30 Tablets NDC: 80425-0320-01 Bottles of 60 Tablets NDC: 80425-0320-02 Bottles of 90 Tablets NDC: 80425-0320-03 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

📋 Description 196 words ▾

11. Description Escitalopram tablets contains escitalopram oxalate, 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(dimethyl-amino)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 , USP 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 is available as tablets for oral administration.

Escitalopram tablets , USP are film-coated, round tablets containing 6.38 mg, 12.75 mg, 25.50 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the follcowing inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, and a film coating agent.

The film coating agent, Opadry II White Y-22-7719, contains the following ingredients: hypromellose; polydextrose; polyethylene glycol; triacetin; and titanium dioxide. Meets USP Dissolution Test 2. Description

💬 Medication Guide ~3 min read ▾

Medication Guide Dispense with Medication Guide available at: WWW.SOLCOHEALTHCARE.COM/MEDGUIDE/ESCITALOPRAM-TABLETS.PDF Read the Medication Guide that comes with Escitalopram tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about Escitalopram tablets? Escitalopram tablets and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: Escitalopram tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Pay particular attention to such changes when Escitalopram tablets are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. 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: attempts to commit suicide acting on dangerous impulses acting aggressive or violent thoughts about suicide or dying new or worse depression new or worse anxiety or panic attacks feeling agitated, restless, angry or irritable trouble sleeping an increase in activity or talking more than what is normal for you other unusual changes in behavior or mood 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: agitation, hallucinations, coma or other changes in mental status coordination problems or muscle twitching (overactive reflexes) racing heartbeat, high or low blood pressure sweating or fever nausea, vomiting, or diarrhea muscle rigidity 3.

Severe allergic reactions: trouble breathing swelling of the face, tongue, eyes or mouth rash, itchy welts (hives) or blisters, alone or with fever or joint pain 4. Abnormal bleeding: Escitalopram tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin 5. Seizures or convulsions 6.

Manic episodes: greatly increased energy severe trouble sleeping racing thoughts reckless behavior unusually grand ideas excessive happiness or irritability talking more or faster than usual 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: headache weakness or feeling unsteady confusion, problems concentrating or thinking or memory problems 9. Visual problems eye pain changes in vision swelling or redness in or around the eye Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

10.Sexual Dysfunction. Taking selective serotonin reuptake inhibitors (SSRIs), including Escitalopram tablets, may cause sexual problems. Symptoms in males may include: Delayed ejaculation or inability to have an ejaculation Decreased sex drive Problems getting or keeping an erect… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14. Clinical Studies

14.1Major Depressive Disorder Adolescents The efficacy of Escitalopram as an acute treatment for major depressive disorder in adolescent patients was established in an 8-week, flexible-dose, placebo-controlled study that compared Escitalopram 10-20 mg/day to placebo in outpatients 12 to 17 years of age inclusive who met DSM-IV criteria for major depressive disorder. The primary outcome was change from baseline to endpoint in the Children’s Depression Rating Scale - Revised (CDRS-R). In this study, Escitalopram showed statistically significant greater mean improvement compared to placebo on the CDRS-R.

The efficacy of Escitalopram in the acute treatment of major depressive disorder in adolescents was established, in part, on the basis of extrapolation from the 8-week, flexible-dose, placebo-controlled study with racemic citalopram 20-40 mg/day. In this outpatient study in children and adolescents 7 to 17 years of age who met DSM-IV criteria for major depressive disorder, citalopram treatment showed statistically significant greater mean improvement from baseline, compared to placebo, on the CDRS-R; the positive results for this trial largely came from the adolescent subgroup.

Two additional flexible-dose, placebo-controlled MDD studies (one Escitalopram study in patients ages 7 to 17 and one citalopram study in adolescents) did not demonstrate efficacy. Although maintenance efficacy in adolescent patients has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic parameters in adults and adolescent patients. Adults The efficacy of Escitalopram as a treatment for major depressive disorder was established in three, 8-week, placebo-controlled studies conducted in outpatients between 18 and 65 years of age who met DSM-IV criteria for major depressive disorder.

The primary outcome in all three studies was change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS). A fixed-dose study compared 10 mg/day Escitalopram and 20 mg/day Escitalopram to placebo and 40 mg/day citalopram. The 10 mg/day and 20 mg/day Escitalopram treatment groups showed statistically significant greater mean improvement compared to placebo on the MADRS.

The 10 mg and 20 mg Escitalopram groups were similar on this outcome measure. In a second fixed-dose study of 10 mg/day Escitalopram and placebo, the 10 mg/day Escitalopram treatment group showed statistically significant greater mean improvement compared to placebo on the MADRS. In a flexible-dose study, comparing Escitalopram, titrated between 10 and 20 mg/day, to placebo and citalopram, titrated between 20 and 40 mg/day, the Escitalopram treatment group showed statistically significant greater mean improvement compared to placebo on the MADRS.

Analyses of the relationship between treatment outcome and age, gender, and race did not suggest any differential responsiveness on the basis of these patient characteristics. In a longer-term trial, 274 patients meeting (DSM-IV) criteria for major depressive disorder, who had responded during an initial 8-week, open-label treatment phase with Escitalopram 10 or 20 mg/day, were randomized to continuation of Escitalopram at their same dose, or to placebo, for up to 36 weeks of observation for relapse. Response during the open-label phase was defined by having a decrease of the MADRS total score to ≤ 12.

Relapse during the double-blind phase was defined as an increase of the MADRS total score to ≥ 22, or discontinuation due to insufficient clinical response. Patients receiving continued Escitalopram experienced a statistically significant longer time to relapse compared to those receiving placebo.

14.2Generalized Anxiety Disorder The efficacy of Escitalopram in the acute treatment of Generalized Anxiety Disorder (GAD) was demonstrated in three, 8-week, multicenter, flexible-dose, placebo-controlled studies that compared Escitalop… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 123 words ▾

9. Drug Abuse and Dependence

9.2Abuse and Dependence Physical and Psychological Dependence Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with Escitalopram did not reveal any drug-seeking behavior.

However, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Escitalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

🧪 Nonclinical Toxicology ~2 min read ▾

13. Non-Clinical Toxicology

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Racemic citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for 18 and 24 months, respectively. There was no evidence for carcinogenicity of racemic citalopram in mice receiving up to 240 mg/kg/day. There was an increased incidence of small intestine carcinoma in rats receiving 8 or 24 mg/kg/day racemic citalopram.

A no-effect dose for this finding was not established. The relevance of these findings to humans is unknown. Mutagenesis Racemic citalopram was mutagenic in the in vitro bacterial reverse mutation assay (Ames test) in 2 of 5 bacterial strains (Salmonella TA98 and TA1537) in the absence of metabolic activation.

It was clastogenic in the in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence and absence of metabolic activation. Racemic citalopram was not mutagenic in the in vitro mammalian forward gene mutation assay (HPRT) in mouse lymphoma cells or in a coupled in vitro/in vivo unscheduled DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the in vitro chromosomal aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays.

Impairment of Fertility When racemic citalopram was administered orally to 16 male and 24 female rats prior to and throughout mating and gestation at doses of 32, 48, and 72 mg/kg/day, mating was decreased at all doses, and fertility was decreased at doses ≥ 32 mg/kg/day. Gestation duration was increased at 48 mg/kg/day.

13.2Animal Toxicology and/or Pharmacology Retinal Changes in Rats Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with racemic citalopram. There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day. Similar findings were not present in rats receiving 24 mg/kg/day of racemic citalopram for two years, in mice receiving up to 240 mg/kg/day of racemic citalopram for 18 months, or in dogs receiving up to 20 mg/kg/day of racemic citalopram for one year.

Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established. Cardiovascular Changes in Dogs In a one-year toxicology study, 5 of 10 beagle dogs receiving oral racemic citalopram doses of 8 mg/kg/day died suddenly between weeks 17 and 31 following initiation of treatment. Sudden deaths were not observed in rats at doses of racemic citalopram up to 120 mg/kg/day, which produced plasma levels of citalopram and its metabolites demethylcitalopram and didemethylcitalopram (DDCT) similar to those observed in dogs at 8 mg/kg/day.

A subsequent intravenous dosing study demonstrated that in beagle dogs, racemic DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs.

📄 Package Label / Principal Display Panel 6 words ▾

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