Escitalopram 10mg 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
Category C
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FDA Approved
Aug 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 in the brain called serotonin, which can improve mood and feelings of well-being. It's important to take it regularly as prescribed, even if you start feeling better, and not to stop suddenly without talking to your doctor.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.

What to Do If You Miss 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

  • Avoid alcohol, as it can worsen side effects and impair judgment.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.
  • Do not stop taking this medication suddenly, as it can lead to withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg 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 for children under 12 years.
Adolescent: MDD (12-17 years): Initial: 10 mg once daily; may increase to 20 mg once daily after at least three weeks. Max: 20 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally needed.
Moderate: No dose adjustment generally needed.
Severe: Use with caution; consider lower starting dose and slower titration. Max 10 mg/day may be appropriate.
Dialysis: Not well studied; use with caution. Escitalopram is not significantly removed by dialysis.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Initial: 5 mg once daily for the first two weeks; may increase to 10 mg once daily. Max: 10 mg/day.
Severe: Initial: 5 mg once daily for the first two weeks; may increase to 10 mg once daily. Max: 10 mg/day.

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-HT) into the presynaptic neuron, leading to an increase in the concentration of 5-HT in the synaptic cleft and enhanced serotonergic neurotransmission. It has minimal effects on norepinephrine and dopamine neuronal reuptake.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80%
Tmax: Approximately 5 hours (range 2.5-6 hours)
FoodEffect: Absorption is not affected by food.

Distribution:

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

Elimination:

HalfLife: Approximately 27-32 hours
Clearance: Approximately 0.6 L/min
ExcretionRoute: Renal (major), fecal (minor)
Unchanged: Approximately 8% (renal)
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Pharmacodynamics

OnsetOfAction: Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect typically takes 4-6 weeks.
PeakEffect: 4-6 weeks for full therapeutic effect.
DurationOfAction: Due to its long half-life, once-daily dosing maintains therapeutic levels.

Safety & Warnings

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BLACK BOX WARNING

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

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 or if they persist or bother you, contact your doctor:

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 possible side effects. If you have questions or concerns about side effects, 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:

  • New or worsening anxiety, panic attacks, agitation, restlessness, irritability, hostility, aggressiveness, impulsivity, severe restlessness (akathisia), hypomania, or mania.
  • Thoughts about suicide or harming yourself.
  • Symptoms of Serotonin Syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe nausea/vomiting/diarrhea.
  • Unusual bleeding or bruising.
  • Seizures.
  • Symptoms of low sodium (hyponatremia): headache, confusion, weakness, unsteadiness, memory problems.
  • Eye pain, vision changes, or swelling or redness around the eye (may indicate angle-closure glaucoma).
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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 concerns. Therefore, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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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 observed soon after initiating 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, which can be life-threatening and lead to seizures, loss of consciousness, respiratory difficulties, or death.

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

In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary, and you should 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 to both you and your baby. Taking this medication during the third trimester of pregnancy may increase your risk of postpartum bleeding and potentially 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
  • Convulsions
  • Tachycardia
  • Hypotension
  • Arrhythmias (including QT prolongation, Torsade de Pointes)
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, including maintaining an open airway, monitoring cardiac and vital signs, and managing symptoms.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
  • Pimozide (risk of QT prolongation)
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Major Interactions

  • Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, 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 and Torsade de Pointes.
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding.
  • Alcohol (potentiates CNS depressant effects).
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Moderate Interactions

  • CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ticlopidine) - may increase escitalopram levels.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase escitalopram levels.
  • Drugs metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine) - escitalopram is a weak inhibitor of CYP2D6, potentially increasing levels of these drugs.
  • Cimetidine, lansoprazole, omeprazole - may increase escitalopram levels.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Psychiatric evaluation (diagnosis, symptom severity)

Rationale: To establish baseline and guide treatment.

Timing: Prior to initiation

Assessment for suicidal ideation/behavior

Rationale: SSRIs carry a black box warning for increased suicidality risk in certain populations.

Timing: Prior to initiation

Electrolytes (especially sodium)

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

Timing: Prior to initiation (if risk factors present)

ECG

Rationale: To assess baseline QT interval, especially in patients with cardiac disease or on other QT-prolonging drugs.

Timing: Prior to initiation (if risk factors present)

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Routine Monitoring

Clinical response (symptom improvement)

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

Target: Reduction in symptom severity (e.g., HAM-D, GAD-7 scores)

Action Threshold: Lack of improvement after 4-6 weeks, consider dose increase or alternative.

Adverse effects (e.g., nausea, insomnia, sexual dysfunction, anxiety, agitation)

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

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects, consider dose adjustment or alternative.

Suicidal ideation/behavior

Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then at 12 weeks, and as clinically indicated.

Target: Absence of new or worsening suicidal thoughts/behaviors

Action Threshold: Emergence or worsening of suicidality, requires immediate clinical assessment and intervention.

Weight

Frequency: Periodically (e.g., every 3-6 months)

Target: Stable weight or within healthy range

Action Threshold: Significant weight gain or loss.

Electrolytes (especially sodium)

Frequency: Periodically (e.g., every 6-12 months) or if symptoms of hyponatremia develop, especially in elderly or those on diuretics.

Target: Sodium within normal limits (135-145 mEq/L)

Action Threshold: Sodium < 135 mEq/L, investigate and manage.

QTc interval (ECG)

Frequency: Periodically, especially if dose increased, new QT-prolonging drugs added, or new cardiac symptoms develop.

Target: QTc < 450 ms (men), < 470 ms (women)

Action Threshold: QTc > 500 ms or increase > 60 ms from baseline, requires immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Serotonin Syndrome: agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms (nausea, vomiting, diarrhea).
  • Suicidal Ideation/Behavior: new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, or thoughts of self-harm.
  • Hyponatremia: headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe cases: hallucinations, syncope, seizures, coma, respiratory arrest.
  • Withdrawal Symptoms (SSRI Discontinuation Syndrome): dizziness, sensory disturbances (e.g., paresthesias, electric shock sensations), sleep disturbances (insomnia, vivid dreams), agitation, anxiety, nausea, vomiting, tremor, confusion, headache, sweating, fatigue.

Special Patient Groups

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Pregnancy

Use during pregnancy should be carefully considered, balancing potential risks and benefits. Untreated depression can also pose risks to both mother and fetus. Escitalopram is generally considered a Category C drug, meaning animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible small increased risk of cardiovascular malformations, though overall risk is low and inconsistent across studies.
Second Trimester: Not specifically associated with unique risks.
Third Trimester: Use in late pregnancy may lead to complications in the newborn requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can include persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).
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Lactation

Escitalopram is excreted into breast milk. The decision to breastfeed while taking escitalopram should weigh the benefits of breastfeeding against the potential risks of infant exposure. Monitor the infant for adverse effects.

Infant Risk: L3 (Moderate Risk). Infants should be monitored for drowsiness, poor feeding, weight gain, and irritability. Some infants may experience no adverse effects, while others may show mild symptoms. Consult with a healthcare provider.
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Pediatric Use

Escitalopram is approved for Major Depressive Disorder in adolescents aged 12-17 years. A black box warning exists regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (up to age 24) taking antidepressants. Close monitoring is essential.

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Geriatric Use

Lower starting dose (5 mg once daily) and slower titration are recommended due to increased sensitivity to side effects and potential for hyponatremia. Max dose typically 10 mg/day. Elderly patients may have reduced clearance and increased plasma concentrations. Increased risk of falls and hyponatremia.

Clinical Information

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Clinical Pearls

  • Escitalopram is the S-enantiomer of citalopram and is generally considered to have a more favorable side effect profile and less potential for drug interactions compared to racemic citalopram.
  • It is often a first-line choice for MDD and GAD due to its efficacy and relatively good tolerability.
  • Patients should be advised that it may take several weeks to experience the full therapeutic effects.
  • Discontinuation syndrome can occur if escitalopram is stopped abruptly; gradual tapering is crucial.
  • Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Be mindful of the QT prolongation risk, particularly in patients with pre-existing cardiac conditions or those on other QT-prolonging medications.
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Alternative Therapies

  • Other SSRIs (e.g., sertraline, fluoxetine, paroxetine, citalopram, fluvoxamine)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine, desvenlafaxine)
  • Atypical Antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
  • Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
  • Electroconvulsive Therapy (ECT) for severe, refractory depression.
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred 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, which provides crucial information about its use. Please read this guide 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.