Escitalopram 5mg/5ml Solution

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Escitalopram Solution(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 reduce feelings of anxiety.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions 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 directed by your doctor or healthcare provider, even if you start feeling well.

When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of 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 a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily, 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.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, as serious interactions can occur.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg (10 ml) orally once daily, may increase to 20 mg (20 ml) once daily after at least one week.
Dose Range: 10 - 20 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial 10 mg (10 ml) once daily; target 10-20 mg (10-20 ml) once daily.
Generalized Anxiety Disorder (GAD): Initial 10 mg (10 ml) once daily; target 10-20 mg (10-20 ml) once daily.
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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 (10 ml) orally once daily; may increase to 20 mg (20 ml) once daily after at least 3 weeks.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: Use with caution; no specific recommendations available, but consider lower doses.
Dialysis: Not available; use with caution.

Hepatic Impairment:

Mild: Maximum recommended dose is 10 mg (10 ml) per day.
Moderate: Maximum recommended dose is 10 mg (10 ml) per day.
Severe: Not recommended due to lack of data; use with extreme caution if necessary.

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
FoodEffect: Absorption is not affected by food.

Distribution:

Vd: Approximately 12 L/kg
ProteinBinding: Approximately 80%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 27-32 hours
Clearance: Approximately 0.6 L/min
ExcretionRoute: Renal (approximately 27% as unchanged drug and metabolites), Hepatic (biliary)
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 long half-life, effects persist for several days after discontinuation.

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 when 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 taking this medication do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor 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 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, aggression, impulsivity, or unusual changes in behavior.
  • Thoughts of self-harm or suicide.
  • Symptoms of serotonin syndrome: confusion, hallucinations, rapid heart rate, sweating, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Symptoms of an allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing.
  • Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, seizures.
  • Unusual bleeding or bruising.
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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 or have recently taken certain medications, including:
+ Linezolid or methylene blue
+ Citalopram or pimozide
+ Medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist to ensure safe use.

To guarantee your safety, it is vital to:
Inform your doctor and pharmacist about all your medications and health conditions.
Verify that it is safe to take this medication with your existing medications and health conditions.
Never start, stop, or adjust the dose of any medication without 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.

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, which can be life-threatening and lead to seizures, loss of consciousness, breathing 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 some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure 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 fetus. Taking this medication during the third trimester may increase the risk of bleeding after delivery and may lead to 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)
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center at 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered if ingested recently.

Drug Interactions

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Contraindicated Interactions

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

  • Other serotonergic drugs (e.g., triptans, tramadol, fentanyl, lithium, buspirone, St. John's Wort, other SSRIs, SNRIs, tricyclic antidepressants) - increased risk of serotonin syndrome.
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - additive QT prolongation risk.
  • 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

  • Drugs metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, desipramine, clomipramine, nortriptyline, risperidone, thioridazine) - escitalopram is a weak inhibitor of CYP2D6, potentially increasing concentrations of these drugs.
  • Cimetidine, omeprazole, lansoprazole (CYP2C19 inhibitors) - may increase escitalopram levels.
  • Carbamazepine (CYP3A4 inducer) - may decrease 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

Suicidal ideation/behavior assessment

Rationale: Due to Black Box Warning, especially in young adults.

Timing: Prior to initiation

Electrolytes (Sodium)

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

Timing: Prior to initiation (if risk factors present)

ECG

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

Timing: Prior to initiation (if indicated)

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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 scores (e.g., HAM-D, GAD-7)

Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.

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

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

Target: Tolerable side effect profile.

Action Threshold: Intolerable side effects may require dose reduction or discontinuation.

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: Any new or worsening suicidal ideation requires immediate clinical assessment and intervention.

Weight

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

Target: Stable weight or acceptable changes.

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

Blood Pressure/Heart Rate

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

Target: Within normal limits.

Action Threshold: Significant changes may require investigation.

Serum Sodium

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

Target: 135-145 mEq/L

Action Threshold: <135 mEq/L (hyponatremia) requires investigation and management.

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Symptom Monitoring

  • Worsening depression or anxiety
  • New or worsening suicidal thoughts or behavior
  • Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, hallucinations, fainting)
  • Unexplained bruising or bleeding
  • Allergic reactions (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)

Special Patient Groups

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Pregnancy

Generally avoided unless potential benefits outweigh risks. Category C. Use during the third trimester has been associated with complications in neonates, including persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data, generally considered lower risk than third trimester.
Third Trimester: 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).
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Lactation

Escitalopram is excreted into breast milk. Monitor breastfed infants for adverse effects such as sedation, poor feeding, and poor weight gain. Use with caution, or consider alternative therapies with better safety profiles during lactation.

Infant Risk: L3 (Moderately Safe) - potential for infant adverse effects; monitor closely.
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Pediatric Use

Not approved for use in children under 12 years of age. For adolescents (12-17 years) with MDD, a Black Box Warning exists regarding increased risk of suicidal thoughts and behavior. Close monitoring is essential.

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Geriatric Use

Elderly patients (â‰Ĩ65 years) may be more sensitive to the effects of escitalopram and are at increased risk of hyponatremia. A lower starting dose (5 mg/day) and a maximum recommended dose of 10 mg/day are advised.

Clinical Information

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Clinical Pearls

  • Escitalopram is the S-enantiomer of citalopram, offering similar efficacy with potentially fewer side effects due to its more selective action.
  • Titrate dose slowly to minimize side effects, especially at initiation and when increasing dose.
  • Patients should be advised about the delayed onset of therapeutic effect (several weeks) and to continue medication as prescribed even if immediate improvement is not seen.
  • Do not discontinue abruptly; gradual tapering over several weeks is necessary to avoid discontinuation syndrome (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia).
  • Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Counsel patients on the Black Box Warning regarding suicidality, particularly in younger populations, and the importance of reporting any changes in mood or behavior.
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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)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage form per 150ml bottle (5mg/5ml)
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'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 crucial 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 detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.