These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS. ESCITALOPRAM tablets, for oral use Initial U.S. Approval: 2002

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

BOXED WARNING SECTION

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 oxalate is not approved for use in pediatric patients less than 7 years of age [see Use in Specific Populations( 8.4 )].

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

9 DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

The following have been reported with escitalopram oxalate 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 oxalate overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a escitalopram oxalate overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

11 DESCRIPTION

DESCRIPTION SECTION

Escitalopram oxalate contains escitalopram, a selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. 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 C 20 H 21 FN 2O • C 2 H 2 O 4 and the molecular weight is 414.40. Escitalopram oxalate 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 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 following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate and talc. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Escitalopram Tablets, USP 5 mg 5 mg Tablets: White to off-white, round, biconvex, film coated tablets, debossed with “5” on one side and plain on other side. NDC 71335-2058-1: 30 Tablets in a BOTTLE NDC 71335-2058-2: 60 Tablets in a BOTTLE NDC 71335-2058-3: 90 Tablets in a BOTTLE NDC 71335-2058-4: 100 Tablets in a BOTTLE Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

SPL MEDGUIDE SECTION

SPL MEDGUIDE SECTION

MEDICATION GUIDE Escitalopram Tablets (ES-sye-TAL-oh-pram) This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 10/2024 What is the most important information I should know about escitalopram tablets? Escitalopram tablets may cause serious side effects, including: Increased risk of suicidal thoughts or actions. Escitalopram tablets and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your child develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled and call your healthcare provider between visits if you are worried about symptoms. Call your healthcare provider or get emergency medical help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you: attempts to commit suicide acting aggressive, being angry or violent new or worse depression panic attacks new or worse irritability an extreme increase in activity or talking (mania) acting on dangerous impulses thoughts about suicide or dying new or worsening anxiety feeling very agitated or restless trouble sleeping other unusual changes in behavior or mood What are escitalopram tablets? Escitalopram tablet is a prescription medicine used to treat: a certain type of depression called Major Depressive Disorder (MDD) in adults and children 12 years of age and older Generalized Anxiety Disorder (GAD) in adults It is not known if escitalopram tablet is safe and effective for use in children under 12 years of age with MDD or children under 7 years of age with GAD. Do not take escitalopram tablets if you or your child: are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue are taking the antipsychotic medicine pimozide are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets. See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets. Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with escitalopram tablets. Before taking escitalopram tablets, tell your healthcare provider about all your medical conditions, including if you or your child: have or had seizures or convulsions have, or have a family history of bipolar disorder, mania, or hypomania have low blood sodium levels have or had bleeding problems have high pressure in the eye (glaucoma) have heart, liver, or kidney problems are pregnant or plan to become pregnant. Escitalopram tablets may harm the unborn baby. Taking escitalopram tablets during the third trimester of pregnancy may cause the baby to have withdrawal symptoms, or breathing, temperature control, feeding, or other problems after birth. Talk to your healthcare provider about the risks to the baby if you or your child take escitalopram tablets during pregnancy. Tell your healthcare provider right away if you or your child become pregnant or think you may be pregnant during treatment with escitalopram tablets. There is a pregnancy registry for females who are exposed to escitalopram tablets during pregnancy. The purpose of the registry is to collect information about the health of females exposed to escitalopram tablets and their baby. If you or your child become pregnant during treatment with escitalopram tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/ research/pregnancyregistry/antidepressants. are breastfeeding or plan to breastfeed. Escitalopram passes into breast milk and may harm the baby. Talk to your healthcare provider about the best way to feed the baby during treatment with escitalopram tablets. If you or your child breastfeed during treatment with escitalopram tablets, call your healthcare provider if the baby develops sleepiness or fussiness, or is not feeding or gaining weight well. Tell your healthcare provider about all the medicines you or your child take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Escitalopram tablets and some medicines may affect each other and may cause serious side effects. Escitalopram tablets may affect the way other medicines work and other medicines may affect the way escitalopram tablets works. Especially tell your healthcare provider if you take: medicines used to treat migraine headache known as triptans tricyclic antidepressants lithium tramadol, fentanyl, meperidine, methadone, or other opioids tryptophan buspirone amphetamines St. John’s Wort medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) diuretics medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin Ask your healthcare provider if you are not sure if you or your child are taking any of these medicines. Your healthcare provider can tell you if it is safe to take escitalopram tablets with your other medicines. Do not start or stop any other medicines during treatment with escitalopram tablets without talking to your healthcare provider first. Stopping escitalopram tablets suddenly may cause you or your child to have serious side effects. See, “What are the possible side effects of escitalopram tablets?” Know the medicines you or your child take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine. How should I take escitalopram tablets? Take escitalopram tablets exactly as prescribed. Your healthcare provider may need to change the dose of escitalopram tablets until it is the right dose for you or your child. Take escitalopram tablets 1 time each day, in the morning or the evening. Take escitalopram tablets with or without food. If you or your child take too much escitalopram tablets, call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away. What should I avoid while taking escitalopram tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how escitalopram tablets affects you. Escitalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. Do not drink alcohol during treatment with escitalopram tablets. What are the possible side effects of escitalopram tablets? Escitalopram tablets may cause serious side effects, including: See “What is the most important information I should know about escitalopram tablets?” Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when escitalopram tablet is taken with certain other medicines. See “Do not take escitalopram tablets if you?” Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of...

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Escitalopram 5 mg Tablet