Citalopram 20mg Tablets

Manufacturer MYLAN Active Ingredient Citalopram Tablets(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
Jul 1998
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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 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 part of a group of medicines called SSRIs.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.

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 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 have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available 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 dose, skip the missed dose and resume your regular 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, as this can cause withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose if needed.
  • Avoid alcohol while taking citalopram, 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 unusual changes in mood or behavior, especially during the first few weeks of treatment or after a dose change.
  • 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: Initial: 20 mg orally once daily. May increase to 40 mg once daily after at least one week. Max: 40 mg/day.
Dose Range: 20 - 40 mg

Condition-Specific Dosing:

Major Depressive Disorder: Initial: 20 mg orally once daily. May increase to 40 mg once daily after at least one week. Max: 40 mg/day.
Panic Disorder (off-label): Initial: 10 mg orally once daily for one week, then increase to 20 mg once daily. Max: 40 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for MDD in pediatric patients. Black Box Warning for increased risk of suicidal thoughts and behavior.)
Adolescent: Not established (Safety and efficacy not established for MDD in pediatric patients. Black Box Warning for increased risk of suicidal thoughts and behavior.)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Use with caution; no specific dose adjustment recommendations, but monitor for adverse effects.
Dialysis: Not well studied; use with caution and monitor closely.

Hepatic Impairment:

Mild: Initial: 10 mg orally once daily. Max: 20 mg/day.
Moderate: Initial: 10 mg orally once daily. Max: 20 mg/day.
Severe: Initial: 10 mg orally once daily. Max: 20 mg/day.

Pharmacology

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Mechanism of Action

Citalopram is a selective serotonin reuptake inhibitor (SSRI). It potently and selectively inhibits the reuptake of serotonin (5-HT) into the presynaptic neuron in the central nervous system (CNS), leading to an increased concentration of serotonin 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: 2-4 hours
FoodEffect: Absorption is not affected by food.

Distribution:

Vd: Approximately 12 L/kg
ProteinBinding: Approximately 80% (to plasma proteins)
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 35 hours
Clearance: Approximately 330 mL/min
ExcretionRoute: Approximately 20% renal, 80% fecal (via hepatic metabolism)
Unchanged: Approximately 12% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Initial therapeutic effects may be seen within 1-2 weeks; full antidepressant effect may take 4-6 weeks or longer.
PeakEffect: Peak plasma concentrations reached in 2-4 hours.
DurationOfAction: Due to its long half-life, once-daily dosing is sufficient to maintain 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 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 immediately or seek emergency medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that looks like 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, or bleeding that won't stop
Chest pain or pressure
Fast, slow, or irregular heartbeat
Shortness of breath
Dizziness or fainting
Seizures
Unexplained weight changes
Painful or prolonged erections (lasting more than 4 hours)
Changes in menstrual periods
Sex problems, including decreased interest in sex, trouble having an orgasm, ejaculation problems, or difficulty getting or maintaining an erection

Additionally, a rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you're taking other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or irregular heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache

Other Possible Side Effects

Most people don't experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor if they bother you or don't go away:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite
Trouble sleeping
Shakiness
Excessive sweating
Yawning
* Symptoms of a common cold

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

  • Worsening depression or anxiety
  • New or worsening thoughts of self-harm or suicide
  • Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe restlessness, hypomania, mania)
  • Symptoms of Serotonin Syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe diarrhea, agitation, hallucinations.
  • Symptoms of Hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, memory problems, seizures.
  • Unusual bleeding or bruising.
  • Allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).
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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 heart conditions, such as:
+ Long QTc on an electrocardiogram (ECG) or other abnormal heart rhythms
+ Slow heartbeat
+ Low potassium or magnesium levels
A history of heart failure (weak heart) or a recent heart attack
Current or recent use of specific medications, including:
+ Linezolid or methylene blue
+ Escitalopram or pimozide
+ Any medications that can cause abnormal heart rhythms (prolonged QT interval). There are many medications that can have this effect, so it's crucial to ask your doctor or pharmacist if you're unsure.
Use of 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 vital 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.

Precautions and Safety Measures

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it.
This medication can cause abnormal heart rhythms (long QT on ECG), which may lead to sudden death. Discuss this risk with your doctor.
Avoid consuming alcohol while taking this medication.
Before using marijuana, cannabis, or prescription/over-the-counter medications that may impair your actions, consult your doctor.

Depression Treatment and 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.

Potential Risks and Side Effects

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

Special Considerations

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding.
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.
Breastfeeding mothers should discuss the potential risks to their baby with their doctor.

Pediatric Considerations

This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Consult your doctor to discuss the potential risks and benefits for your child.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Sweating
  • Nausea
  • Vomiting
  • Tremor
  • Somnolence
  • Sinus tachycardia
  • Bradycardia
  • QTc prolongation
  • Arrhythmias (e.g., Torsade de Pointes)
  • Convulsions
  • Coma
  • Hypotension
  • Rhabdomyolysis

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and symptomatic. Activated charcoal may be considered if ingested recently. Monitor cardiac rhythm (ECG) and vital signs closely.

Drug Interactions

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Contraindicated Interactions

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

  • Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) (risk of serotonin syndrome)
  • Drugs that prolong the QTc interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics) (additive QTc prolongation)
  • Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., NSAIDs, aspirin) (increased risk of bleeding)
  • Linezolid (MAOI activity, risk of serotonin syndrome)
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Moderate Interactions

  • CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine, lansoprazole, ticlopidine) (may increase citalopram levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) (may increase citalopram levels)
  • Alcohol (additive CNS depression, though specific interaction not well-defined)
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Minor Interactions

  • Drugs metabolized by CYP2D6 (e.g., metoprolol, desipramine) (citalopram is a weak inhibitor, potential for minor increase in levels)

Monitoring

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Baseline Monitoring

Psychiatric evaluation (mood, anxiety, suicidal ideation)

Rationale: To establish baseline symptoms and assess severity of depression/anxiety.

Timing: Prior to initiation of therapy.

ECG (Electrocardiogram)

Rationale: To assess baseline QTc interval, especially in patients with pre-existing cardiac conditions, family history of prolonged QT, or on other QTc-prolonging medications.

Timing: Prior to initiation, particularly if risk factors for QTc prolongation are present.

Electrolytes (Sodium)

Rationale: To establish baseline, especially in elderly or those at risk for hyponatremia.

Timing: Prior to initiation.

Renal and Hepatic Function Tests

Rationale: To guide dosing adjustments in patients with impairment.

Timing: Prior to initiation.

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Routine Monitoring

Clinical response and adverse effects

Frequency: Weekly for first 4-6 weeks, then periodically (e.g., monthly) or as clinically indicated.

Target: Improvement in mood, reduction in anxiety, resolution of target symptoms.

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

Suicidal ideation and behavior

Frequency: Especially during initial treatment and dose changes, then periodically.

Target: Absence of suicidal thoughts or behaviors.

Action Threshold: Any emergence or worsening of suicidal thoughts/behaviors requires immediate clinical assessment and intervention.

QTc interval (ECG)

Frequency: Periodically, especially if dose is increased to 40 mg/day, or if new QTc-prolonging medications are added, or if patient develops symptoms of arrhythmia.

Target: < 450 ms (men), < 470 ms (women); avoid if QTc > 500 ms.

Action Threshold: QTc prolongation > 500 ms or increase > 60 ms from baseline warrants dose reduction or discontinuation.

Sodium levels

Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.

Target: 135-145 mEq/L

Action Threshold: Sodium < 135 mEq/L (hyponatremia) requires investigation and potential discontinuation.

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Symptom Monitoring

  • Worsening depression
  • Anxiety
  • Agitation
  • Panic attacks
  • Insomnia
  • Irritability
  • Hostility
  • Impulsivity
  • Akathisia (psychomotor restlessness)
  • Hypomania/mania
  • Suicidal ideation or behavior
  • Symptoms of Serotonin Syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, muscle rigidity, tremor, nausea, vomiting, diarrhea)
  • Symptoms of Hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
  • Unusual bleeding or bruising

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may be associated with complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding (Persistent Pulmonary Hypertension of the Newborn - PPHN).

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: No specific increased risks identified.
Third Trimester: Increased risk of PPHN and neonatal withdrawal syndrome (poor feeding, irritability, tremor, respiratory distress) if exposed in late pregnancy.
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Lactation

Citalopram is excreted into breast milk. The American Academy of Pediatrics considers citalopram to be compatible with breastfeeding. However, monitor the infant for adverse effects such as sedation, poor feeding, and weight gain.

Infant Risk: L2 (Safer - limited data, but probably compatible).
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Pediatric Use

Not approved for use in pediatric patients for Major Depressive Disorder due to increased risk of suicidal thoughts and behavior (Black Box Warning). Safety and efficacy have not been established.

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Geriatric Use

Lower starting dose (10 mg/day) and maximum dose (20 mg/day) are recommended due to decreased clearance and increased risk of adverse effects, particularly QTc prolongation and hyponatremia. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Citalopram has a dose-dependent risk of QTc prolongation. The maximum recommended dose is 40 mg/day for most adults and 20 mg/day for patients over 60 years of age, those with hepatic impairment, or those who are CYP2C19 poor metabolizers.
  • Patients should be advised not to abruptly discontinue citalopram to avoid withdrawal symptoms (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, tremor, sweating). Tapering should be gradual.
  • Monitor for signs and symptoms of serotonin syndrome, especially when co-administered with other serotonergic agents.
  • Hyponatremia (low sodium) can occur, particularly in elderly patients, those taking diuretics, or those who are volume-depleted. Monitor sodium levels if risk factors are present or symptoms develop.
  • Clinical improvement may take several weeks. Patients should be encouraged to continue treatment as prescribed even if immediate effects are not felt.
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Alternative Therapies

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

Average Cost: $10 - $50 per 30 tablets (20mg generic)
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 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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult 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. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred.