Citalopram 10mg/5ml Solution

Manufacturer HIKMA Active Ingredient Citalopram Solution(sye TAL oh pram) Pronunciation 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 children. However, the doctor may decide the benefits of taking this drug outweigh the risks. If your child has been given this drug, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving this drug to your child. @ COMMON USES: It is used to treat depression.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
C
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FDA Approved
Mar 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Citalopram is a medication used to treat depression. It belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). It works by helping to restore the balance of a natural substance (serotonin) in the brain, which can improve mood and feelings of well-being.
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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. You can take this medication with or without food. Continue taking it as directed by your doctor or healthcare provider, even if you're feeling well.

When taking the liquid form, measure your dose carefully using the device that comes with the medication. If no device is provided, ask your pharmacist for a measuring tool to ensure accurate dosing.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of 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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to 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 exactly as prescribed, usually once daily, with or without food.
  • Do not stop taking citalopram suddenly without talking to your doctor, as this can cause withdrawal symptoms.
  • Avoid alcohol while taking citalopram, 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.
  • Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
  • Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg (10 mL) orally once daily
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

Major Depressive Disorder: Initial: 20 mg (10 mL) orally once daily; may increase to 40 mg (20 mL) once daily after at least one week. Max: 40 mg/day. Doses above 20 mg/day are not recommended for patients over 60 years of age or those with hepatic impairment due to QT prolongation risk.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for major depressive disorder; off-label use for other conditions may occur, but generally not recommended due to suicidality risk.
Adolescent: Not established for major depressive disorder; off-label use for other conditions may occur, but generally not recommended due to suicidality risk.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Use with caution; consider lower doses or alternative agents. Data are limited.
Dialysis: Not available; use with caution.

Hepatic Impairment:

Mild: Max dose 20 mg (10 mL) orally once daily
Moderate: Max dose 20 mg (10 mL) orally once daily
Severe: Max dose 20 mg (10 mL) orally once daily

Pharmacology

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Mechanism of Action

Citalopram is a selective serotonin reuptake inhibitor (SSRI). It potently blocks the reuptake of serotonin (5-HT) into presynaptic neurons in the central nervous system, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission. It has minimal effects on norepinephrine and dopamine reuptake.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80%
Tmax: 2-4 hours
FoodEffect: Absorption is not affected by food.

Distribution:

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

Elimination:

HalfLife: Approximately 35 hours (parent drug)
Clearance: Approximately 330 mL/min
ExcretionRoute: Primarily urine (12-23% unchanged), feces (10-12% unchanged), and metabolites.
Unchanged: Approximately 12-23% (urine), 10-12% (feces)
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Pharmacodynamics

OnsetOfAction: Clinical effects may begin within 1-2 weeks, but full antidepressant effects may take 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 citalopram 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. Citalopram is not approved for use in pediatric patients.
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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 immediate 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
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Shortness of breath
Dizziness or fainting
Seizures
Unintentional weight changes
Prolonged or painful erections (lasting more than 4 hours)
Changes in menstrual cycle
Sexual problems, including:
+ Decreased libido
+ Difficulty having an orgasm
+ Ejaculation problems
+ Trouble getting or maintaining an erection
Serotonin syndrome, a potentially life-threatening condition, which may be more likely if you take certain other medications. Symptoms include:
+ Agitation
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ 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 experience few or no side effects while taking this medication. However, 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
Dry mouth
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Difficulty sleeping
Shakiness
Excessive sweating
Yawning
* Symptoms of a common cold

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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 worsening thoughts of self-harm or suicide
  • Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, insomnia, impulsivity, severe restlessness, or mania)
  • Symptoms of serotonin syndrome (e.g., fever, sweating, confusion, severe muscle stiffness or twitching, shivering, diarrhea, fast heartbeat, severe headache)
  • Symptoms of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing)
  • Unusual bleeding or bruising
  • Seizures
  • Symptoms of hyponatremia (low sodium) such as headache, confusion, weakness, unsteadiness, or seizures
  • Prolonged or painful erection (priapism)
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Abnormal heartbeat or Long QTc on an electrocardiogram (ECG)
+ Slow heartbeat
+ Low potassium or magnesium levels
+ Heart failure (weak heart) or a recent heart attack
Medications you are currently taking, including:
+ Linezolid or methylene blue
+ Escitalopram or pimozide
+ Any medications that can cause a prolonged QT interval, a type of abnormal heartbeat (your doctor or pharmacist can help you identify these medications)
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking these medications with this drug can lead to very high blood pressure)

This is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor needs to verify that it is safe for you to take this medication with all your current medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. This will help prevent accidents and ensure your safety.

Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.

Cardiac Risks
This medication has been associated with an abnormal heartbeat (long QT on ECG), which can increase the risk of sudden death. Discuss this risk with your doctor to understand the potential consequences.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication, as it may interact with the drug and increase the risk of side effects. Additionally, consult your doctor before using marijuana, cannabis, or prescription/over-the-counter medications that may cause drowsiness or slow your reactions.

Depression and Treatment Response
When treating depression, you may experience improvements in sleep and appetite soon after starting this medication. However, other symptoms of depression may take up to 4 weeks to show significant improvement.

Bleeding Risks
This medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor to understand the potential consequences and necessary precautions.

Eye Problems
Some patients may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling/redness in or around the eye, contact your doctor immediately.

Low Sodium Levels
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 60 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. Taking this medication in the third trimester of pregnancy may increase the risk of bleeding after delivery and potentially cause health problems in the newborn. Your doctor will discuss the benefits and risks of the medication with you to make an informed decision.

Pediatric Patients
This medication may affect growth in children and adolescents. Regular growth checks may be necessary to monitor potential effects. Discuss this risk with your doctor to understand the necessary precautions and monitoring requirements.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Sweating
  • Nausea
  • Vomiting
  • Tremor
  • Somnolence
  • Sinus tachycardia
  • QT prolongation
  • Arrhythmias (e.g., Torsade de Pointes)
  • Seizures
  • Coma
  • Hyperventilation
  • Cyanosis
  • Rhabdomyolysis

What to Do:

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

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, buspirone, St. John's Wort) (risk of serotonin syndrome)
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics) (additive QT prolongation risk)
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, NSAIDs) (increased risk of bleeding)
  • Linezolid (MAOI activity, risk of serotonin syndrome)
  • Methylene blue (MAOI activity, risk of serotonin syndrome)
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Moderate Interactions

  • CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, ticlopidine) (may increase citalopram levels)
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) (may increase citalopram levels)
  • Alcohol (additive CNS depression, not recommended)
  • Diuretics (increased risk of hyponatremia)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Depression symptom severity (e.g., HAM-D, PHQ-9)

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.

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

ECG (Electrocardiogram)

Rationale: To assess baseline QTc interval, especially in patients with cardiac disease, electrolyte abnormalities, or on other QT-prolonging drugs. Recommended for doses >20 mg/day.

Timing: Prior to initiation

Renal and Hepatic function tests

Rationale: To guide dosing adjustments in impaired patients.

Timing: Prior to initiation

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Routine Monitoring

Depression symptom severity

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

Target: Reduction in symptom scores

Action Threshold: Lack of improvement or worsening symptoms

Suicidal ideation/behavior

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

Target: Absence of new or worsening ideation

Action Threshold: Any new or worsening suicidal thoughts or behaviors

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

Frequency: Regularly, especially during dose titration

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects or emergence of serotonin syndrome symptoms

Electrolytes (sodium)

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

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

Action Threshold: Hyponatremia (<135 mEq/L)

ECG (QTc interval)

Frequency: Periodically, especially if dose increased to 40 mg/day, or if new risk factors for QT prolongation emerge.

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

Action Threshold: QTc >500 ms or increase of >60 ms from baseline

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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 (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, seizures)

Special Patient Groups

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Pregnancy

Generally avoided if possible, especially in the third trimester, due to potential risks to the neonate. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations. Some studies suggest a small increased risk of cardiac defects, but overall risk is low.
Second Trimester: Not well-studied for specific risks.
Third Trimester: Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, seizures) if exposed late in pregnancy.
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Lactation

Citalopram is excreted into breast milk. While generally considered moderately safe (L3), monitor infants for sedation, poor feeding, and weight gain. Alternative SSRIs with lower milk levels may be preferred.

Infant Risk: Low to moderate risk. Monitor for drowsiness, irritability, poor feeding, and weight loss. Consider alternative agents if infant is premature or has underlying health issues.
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Pediatric Use

Not approved for major depressive disorder in pediatric patients due to increased risk of suicidal thoughts and behaviors. Use in this population should be carefully considered and monitored by a specialist.

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Geriatric Use

Lower starting dose (10 mg/day) and maximum dose (20 mg/day) are recommended due to increased risk of QT prolongation and hyponatremia. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Citalopram has a dose-dependent risk of QT prolongation; doses above 40 mg/day are not recommended, and doses above 20 mg/day are not recommended for patients over 60 years of age or with hepatic impairment.
  • Patients should be advised about the risk of serotonin syndrome, especially when combining with other serotonergic agents.
  • Discontinuation syndrome (withdrawal symptoms) can occur if citalopram is stopped abruptly; taper dose gradually over several weeks.
  • Onset of therapeutic effect may take several weeks; patients should be encouraged to continue treatment even if immediate improvement is not seen.
  • Monitor for hyponatremia, especially in elderly patients, those on diuretics, or those who are volume-depleted.
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Alternative Therapies

  • Other SSRIs (e.g., escitalopram, fluoxetine, sertraline, paroxetine, 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)
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Cost & Coverage

Average Cost: Price range varies widely by pharmacy and dosage form per 150 mL (10mg/5mL) bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.