Escitalopram 5mg 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, Anxiolytic
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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
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 in the brain called serotonin, which can improve mood and reduce feelings of anxiety. It's important to take it regularly as prescribed and not to stop suddenly.
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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 medication 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 place, avoiding the bathroom. Keep all medications in a secure location, out of the 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 with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs for a safe and environmentally friendly way to dispose of your medications.

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

  • Take the medication at the same time each day, with or without food.
  • 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 like drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
  • Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg once daily, may increase to 20 mg once daily after at least one week
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial 10 mg once daily, target 10-20 mg/day
Generalized Anxiety Disorder (GAD): Initial 10 mg once daily, target 10-20 mg/day
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (approved for adolescents 12-17 years for MDD)
Adolescent: MDD (12-17 years): Initial 10 mg once daily, may increase to 20 mg once daily after at least 3 weeks
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally needed
Moderate: No dose adjustment generally needed
Severe: Caution advised, consider lower dose (e.g., 5 mg/day) or avoid if possible
Dialysis: Not well studied, caution advised

Hepatic Impairment:

Mild: Max 10 mg/day
Moderate: Max 10 mg/day
Severe: Not recommended due to lack of data and potential for increased exposure

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 in the central nervous system.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80%
Tmax: 4-5 hours
FoodEffect: Minimal effect on absorption, can be taken with or without 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 (approximately 8% unchanged) and hepatic (via metabolites)
Unchanged: Approximately 8%
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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 provides sustained 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 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 get bigger
+ Uncontrollable bleeding
Seizures
Fever or chills
Painful erection (priapism) or an erection that lasts longer than 4 hours
Sex problems, including:
+ Decreased interest in sex
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection

Some people 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
Fast 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

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or if they bother you or do not go away, contact your doctor:

Feeling dizzy, sleepy, tired, or weak
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:

  • Worsening depression or anxiety
  • Thoughts of harming yourself or others
  • Panic attacks
  • Agitation, restlessness, or irritability
  • Aggressive or violent behavior
  • Unusual excitement or euphoria (mania/hypomania)
  • Severe restlessness or inability to sit still (akathisia)
  • New or worsening insomnia
  • Serotonin Syndrome symptoms: agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, seizures.
  • Unusual bleeding or bruising.
  • Eye pain, vision changes, or swelling or redness in or around the eye (signs of 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 interactions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor to determine if it is safe to take this medication.
* Never start, stop, or change the dose 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 any activity that requires your full attention, wait until you understand how this medication affects you.

Do not abruptly discontinue use of this medication without first consulting your doctor, as this may increase your risk of experiencing side effects. If you need to stop taking this medication, your doctor will provide guidance on how to gradually taper off the dosage.

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 reaction time.

In the treatment of depression, you may notice improvements in sleep and appetite shortly after initiating this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.

This medication may increase your risk of bleeding, which in some cases can be life-threatening. It is crucial to discuss this risk with your doctor.

Furthermore, this medication can cause low sodium levels in the blood, a condition known as hyponatremia. Severe hyponatremia can be life-threatening and may lead to seizures, loss of consciousness, respiratory distress, or even death.

If you are 65 years or older, exercise caution when taking this medication, 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 it is essential to discuss this with your doctor.

If you are pregnant, planning to become pregnant, or suspect you may be pregnant, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of taking this medication during pregnancy. Taking this medication during the third trimester may increase your risk of postpartum bleeding and may also lead to health complications 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

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Ensure adequate airway, breathing, and circulation. Activated charcoal may be considered if ingested recently. ECG monitoring is recommended due to risk of QT prolongation.

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, other SSRIs, SNRIs, TCAs, 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) - increased risk of QT prolongation and Torsade de Pointes
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding
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Moderate Interactions

  • CYP2C19 inhibitors (e.g., omeprazole, cimetidine, fluoxetine, fluvoxamine, ticlopidine) - may increase escitalopram exposure
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) - may increase escitalopram exposure
  • Alcohol - may potentiate CNS depressant effects
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Mood and anxiety symptoms

Rationale: To establish baseline severity and track treatment response.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: SSRIs carry a Black Box Warning for increased risk in young adults.

Timing: Prior to initiation

Personal and family history of bipolar disorder or mania

Rationale: To assess risk of mood switching.

Timing: Prior to initiation

Electrolytes (especially sodium)

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

Timing: Prior to initiation (if risk factors present)

ECG

Rationale: To assess baseline QT interval, especially if cardiac risk factors or concomitant QT-prolonging drugs.

Timing: Prior to initiation (if indicated)

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Routine Monitoring

Mood and anxiety symptoms

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

Target: Symptom remission or significant improvement

Action Threshold: Lack of improvement, worsening symptoms, or emergence of new symptoms

Suicidal ideation/behavior

Frequency: Weekly for first 4-6 weeks, especially during dose changes, then monthly or as clinically indicated

Target: Absence of suicidal thoughts or plans

Action Threshold: Emergence or worsening of suicidal ideation, agitation, or unusual changes in behavior

Adverse effects (e.g., GI upset, insomnia, sexual dysfunction)

Frequency: Regularly, especially during initial weeks and dose changes

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects, requiring dose adjustment or discontinuation

Weight

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

Target: Stable weight or within healthy range

Action Threshold: Significant weight gain or loss

Blood pressure and heart rate

Frequency: Periodically

Target: Within normal limits

Action Threshold: Significant changes

Electrolytes (sodium)

Frequency: Periodically (e.g., every 3-6 months) in at-risk patients (elderly, diuretic use)

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L)

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, akathisia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
  • Abnormal bleeding or bruising

Special Patient Groups

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Pregnancy

Use during pregnancy should be carefully considered, balancing potential risks to the fetus with the benefits of treating maternal depression/anxiety. Escitalopram is generally considered Category C (older classification).

Trimester-Specific Risks:

First Trimester: Limited data on major congenital malformations. Some studies suggest a small increased risk of cardiac defects, but overall risk is low and inconsistent across studies.
Second Trimester: Not available
Third Trimester: Use in late pregnancy (especially third trimester) has been associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying). These symptoms are usually self-limiting.
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Lactation

Escitalopram is excreted into 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.

Infant Risk: L3 (Moderately Safe). Monitor infants for sedation, poor feeding, weight loss, and irritability. Some infants may experience no adverse effects. Higher doses in the mother may lead to higher infant exposure.
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Pediatric Use

Approved for Major Depressive Disorder in adolescents aged 12-17 years. Close monitoring for suicidal ideation and behavior is crucial, especially at treatment initiation and during dose changes, due to the Black Box Warning. Not approved for Generalized Anxiety Disorder in pediatric patients.

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Geriatric Use

Lower starting dose (5 mg/day) is recommended due to potential for increased exposure and increased risk of adverse effects, particularly hyponatremia and falls. Elderly patients may be more sensitive to the effects of SSRIs.

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 fewer drug interactions compared to racemic citalopram.
  • Gradual dose titration is recommended to minimize side effects, especially at initiation and when increasing the dose.
  • Abrupt discontinuation can lead to withdrawal symptoms (SSRI discontinuation syndrome), including dizziness, nausea, headache, sensory disturbances (e.g., 'electric shock' sensations), anxiety, and insomnia. Tapering over several weeks is advised.
  • Sexual dysfunction (e.g., decreased libido, delayed ejaculation, anorgasmia) is a common and often bothersome side effect that can impact adherence. Discuss this with patients proactively.
  • Monitor for signs of serotonin syndrome, especially if co-administered with other serotonergic agents. This is a medical emergency.
  • Be vigilant for signs of activation or mood switching to mania/hypomania in patients with undiagnosed bipolar disorder.
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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 - CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed to someone else. This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication, the amount taken, and the time it was ingested.