Escitalopram 20mg Tablets

Manufacturer CADISTA Active Ingredient Escitalopram Tablets(es sye TAL oh pram) Pronunciation es sye TAL oh pram
WARNING: For all patients taking this drug:Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.Children:This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child. @ COMMON USES: It is used to treat depression.It is used to treat anxiety.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antidepressant
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Pharmacologic Class
Selective Serotonin Reuptake Inhibitor (SSRI)
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Pregnancy Category
Not available
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FDA Approved
Mar 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Escitalopram is a medication used to treat depression and anxiety. It works by helping to restore the balance of a natural substance (serotonin) in the brain. It's important to take it regularly as prescribed, even if you start to feel better, and not to stop suddenly without talking to your doctor.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you start feeling well. It's essential to follow your doctor's or healthcare provider's advice on dosage and duration.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. You may also want to explore drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take once daily, with or without food, preferably at the same time each day.
  • Do not stop taking escitalopram suddenly, as this can cause withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
  • Avoid alcohol while taking this medication, as it can worsen side effects.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
  • Regular exercise, a balanced diet, and good sleep hygiene can complement treatment.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally once daily
Dose Range: 10 - 20 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 10 mg once daily; may increase to 20 mg once daily after at least one week. Max: 20 mg/day.
Generalized Anxiety Disorder (GAD): Initial: 10 mg once daily; may increase to 20 mg once daily after at least one week. Max: 20 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: For Major Depressive Disorder (MDD) in patients 12-17 years: Initial 10 mg orally once daily; may increase to 20 mg once daily after at least 3 weeks. Max: 20 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: Use with caution; no specific dosage recommendations available. Consider lower doses.
Dialysis: Not well studied; use with caution. Escitalopram is not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment, but use with caution.
Moderate: Initial 10 mg once daily for the first two weeks, then consider increasing to 20 mg once daily if tolerated. Max: 20 mg/day.
Severe: Use with caution; consider lower doses and monitor closely.

Pharmacology

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Mechanism of Action

Escitalopram is a selective serotonin reuptake inhibitor (SSRI). It potently and selectively inhibits the reuptake of serotonin (5-hydroxytryptamine, 5-HT) into the presynaptic neuron in the central nervous system (CNS). This inhibition leads to an increase in the concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. Escitalopram has minimal effects on norepinephrine and dopamine neuronal reuptake.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80%
Tmax: Approximately 5 hours
FoodEffect: Absorption is not affected by food.

Distribution:

Vd: Approximately 12 L/kg
ProteinBinding: Approximately 56% to plasma proteins
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 27-32 hours
Clearance: Approximately 600 mL/min (oral clearance)
ExcretionRoute: Renal (approximately 8% as unchanged drug, 10% as S-DCT, 27% as S-DDCT) and hepatic (biliary).
Unchanged: Approximately 8%
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Pharmacodynamics

OnsetOfAction: Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect typically takes 2-4 weeks or longer.
PeakEffect: Peak therapeutic effect typically observed after 4-6 weeks of consistent dosing.
DurationOfAction: Due to its long half-life, effects persist for approximately 2-3 days after discontinuation, but withdrawal symptoms can occur.

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of escitalopram or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults older than 24 years; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Escitalopram is not approved for use in pediatric patients less than 12 years of age.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of bleeding, such as:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine
+ Black, red, or tarry stools
+ Bleeding from the gums
+ Abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ Uncontrollable bleeding
Seizures
Fever or chills
Painful erection (priapism) or an erection lasting longer than 4 hours
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection

Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess this risk. If you experience any of the following eye-related symptoms, contact your doctor immediately:

Eye pain
Changes in vision
Swelling or redness in or around the eye

A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help right away if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, drowsiness, fatigue, or weakness
Upset stomach
Diarrhea or constipation
Dry mouth
Difficulty sleeping
Excessive sweating
Flu-like symptoms
Runny nose
Headache
* Yawning

This is not an exhaustive list of potential side effects. If you have concerns or questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • New or increased thoughts about self-harm or suicide
  • Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe restlessness, extreme excitement, or mania)
  • Symptoms of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, fever, sweating, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
  • Unexplained bruising or bleeding
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, seizures)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
If you are taking citalopram or pimozide, as concomitant use with this medication is not recommended.
If you have taken any medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.

Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication. Therefore, it is crucial to:

Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems with your doctor to ensure it is safe to take this medication.
* Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or adverse effects.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.

To minimize the risk of side effects, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually taper off the medication.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your reactions.

In patients with depression, improvements in sleep and appetite may be noticeable soon after starting treatment. However, other symptoms of depression may take up to 4 weeks to show significant improvement.

This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.

Furthermore, this medication can cause low sodium levels in the blood, which can be life-threatening and lead to seizures, loss of consciousness, respiratory difficulties, or even death.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so it is crucial to discuss this with your doctor.

If you are pregnant, planning to become pregnant, or may be pregnant, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication during pregnancy, as well as the potential risks to the baby. Taking this medication during the third trimester may increase the risk of bleeding after delivery and may cause health problems in the newborn.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Sweating
  • Nausea
  • Vomiting
  • Tremor
  • Somnolence
  • Tachycardia
  • Hypotension
  • Arrhythmias (including QT prolongation, Torsade de Pointes)
  • Seizures
  • Coma
  • Serotonin syndrome

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered if ingested recently. Monitor cardiac rhythm and vital signs.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, linezolid, methylene blue) - risk of serotonin syndrome.
  • Pimozide - risk of QT prolongation and cardiac arrhythmias.
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Major Interactions

  • Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, St. John's Wort) - increased risk of serotonin syndrome.
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, certain antihistamines) - increased risk of QT prolongation.
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding.
  • Alcohol - may potentiate CNS depressant effects.
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Moderate Interactions

  • CYP2C19 inhibitors (e.g., omeprazole, cimetidine, fluoxetine, fluvoxamine) - may increase escitalopram plasma concentrations.
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - may increase escitalopram plasma concentrations.
  • Drugs metabolized by CYP2D6 (e.g., metoprolol, desipramine, risperidone, flecainide, propafenone) - escitalopram is a weak inhibitor of CYP2D6, potentially increasing concentrations of these drugs.
  • Diuretics - increased risk of hyponatremia.
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Minor Interactions

  • Not specifically categorized as minor, but general caution with other CNS depressants.

Monitoring

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Baseline Monitoring

Diagnosis and symptom severity (e.g., HAM-D, GAD-7)

Rationale: To establish baseline and monitor treatment response.

Timing: Prior to initiation

Suicidal ideation/behavior assessment

Rationale: To assess baseline risk, especially in young adults and adolescents, due to Black Box Warning.

Timing: Prior to initiation

Electrolytes (Sodium)

Rationale: To assess baseline for hyponatremia risk, especially in elderly or those on diuretics.

Timing: Prior to initiation

Renal and Hepatic function tests

Rationale: To guide dosing adjustments in patients with impairment.

Timing: Prior to initiation

ECG

Rationale: Consider if patient has pre-existing cardiac conditions or is on other QT-prolonging medications.

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Clinical response and adverse effects

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.

Target: Symptom improvement, tolerability.

Action Threshold: Lack of response, intolerable side effects, or worsening symptoms may require dose adjustment or change in therapy.

Suicidal ideation/behavior

Frequency: Closely monitor during the initial few months of treatment and during dose changes.

Target: Absence of new or worsening suicidal thoughts/behaviors.

Action Threshold: Immediate clinical assessment and intervention if observed.

Electrolytes (Sodium)

Frequency: Periodically, especially in elderly, volume-depleted patients, or those on diuretics.

Target: Normal serum sodium levels (135-145 mEq/L).

Action Threshold: Hyponatremia (<135 mEq/L) may require dose reduction or discontinuation.

Weight

Frequency: Periodically

Target: Stable weight or clinically acceptable changes.

Action Threshold: Significant weight gain or loss may require intervention.

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Symptom Monitoring

  • Worsening depression
  • New or worsening anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Impulsivity
  • Akathisia (psychomotor restlessness)
  • Hypomania/mania
  • New or worsening suicidal ideation/behavior
  • Symptoms of serotonin syndrome (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more acute manifestations include hallucinations, syncope, seizure, coma, respiratory arrest)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. There are risks associated with exposure to SSRIs during pregnancy, including neonatal withdrawal syndrome and persistent pulmonary hypertension of the newborn (PPHN).

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible small increased risk of certain birth defects (e.g., cardiac) with SSRI exposure, though overall risk is low and inconsistent across studies.
Second Trimester: Risk of PPHN (Persistent Pulmonary Hypertension of the Newborn) if exposed late in pregnancy (after 20 weeks gestation), particularly in the third trimester.
Third Trimester: Risk of neonatal withdrawal syndrome (poor feeding, irritability, tremor, respiratory distress, seizures) and PPHN. Monitor neonates for these symptoms.
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Lactation

Escitalopram is excreted into human breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for escitalopram, and any potential adverse effects on the breastfed infant from escitalopram or from the underlying maternal condition. Monitor infants for sedation, poor feeding, and poor weight gain.

Infant Risk: L3 (Moderately Safe) - Monitor infant for adverse effects.
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Pediatric Use

Approved for Major Depressive Disorder (MDD) in adolescents aged 12-17 years. Not approved for use in pediatric patients less than 12 years of age. Black Box Warning regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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Geriatric Use

Elderly patients (β‰₯65 years) may be more sensitive to the effects of escitalopram and may have reduced clearance. A lower initial dose (e.g., 10 mg/day maximum) is recommended. Increased risk of hyponatremia and falls in this population.

Clinical Information

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Clinical Pearls

  • Escitalopram is the S-enantiomer of citalopram and is considered more potent and selective for serotonin reuptake inhibition.
  • Patients should be advised that it may take several weeks to experience the full therapeutic effects.
  • Abrupt discontinuation can lead to withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, anxiety, agitation, sleep disturbances); gradual tapering is recommended.
  • Sexual dysfunction (e.g., decreased libido, delayed ejaculation, anorgasmia) is a common side effect of SSRIs, including escitalopram, and can be a reason for non-adherence.
  • Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Consider genetic testing for CYP2C19 poor metabolizers, as they may have higher escitalopram levels and require lower doses, though routine testing is not universally recommended.
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Alternative Therapies

  • Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline, Fluoxetine, Paroxetine, Citalopram, Fluvoxamine
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine
  • Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone, Vilazodone, Vortioxetine
  • Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
  • Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine (reserved for refractory cases)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
  • Electroconvulsive Therapy (ECT) for severe or refractory depression
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 or 4 (Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.