Citalopram 10mg Tablets

Manufacturer TORRENT PHARMACEUTICALS 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
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 belongs to a class of drugs called SSRIs, which work by helping to restore the balance of a natural substance (serotonin) in the brain. This can help improve mood, sleep, appetite, and energy level, and decrease nervousness.
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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 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 have questions about disposal, consult your pharmacist. You may also want to check if there are 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 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 abruptly; withdrawal symptoms can occur. Taper off slowly under medical supervision.
  • Avoid alcohol, as it can worsen side effects like drowsiness.
  • Be aware of potential for increased anxiety or agitation, especially at the start of treatment.
  • Report any new or worsening symptoms, especially suicidal thoughts, to your doctor immediately.
  • Avoid driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
  • Inform all healthcare providers that you are taking citalopram, especially before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg once daily, may increase to a maximum of 40 mg once daily after at least one week.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

depression: Initial: 20 mg once daily; target: 20-40 mg once daily.
panic_disorder_off_label: Initial: 10 mg once daily for 1 week, then 20 mg once daily; max 40 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not FDA approved for depression; off-label use requires careful consideration and monitoring for suicidality.
Adolescent: Not FDA approved for depression; off-label use requires careful consideration and monitoring for suicidality.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: Use with caution; consider lower doses or alternative agents. No specific guidelines for severe impairment.
Dialysis: Not well studied; use with caution. Citalopram is not significantly removed by dialysis.

Hepatic Impairment:

Mild: Initial: 10 mg once daily; maximum: 20 mg once daily.
Moderate: Initial: 10 mg once daily; maximum: 20 mg once daily.
Severe: Initial: 10 mg once daily; maximum: 20 mg 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, leading to an increased concentration of serotonin in the synaptic cleft and enhanced 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 (range 27-42 hours)
Clearance: Approximately 330 mL/min
ExcretionRoute: Approximately 20% renal, 80% fecal (biliary excretion)
Unchanged: Approximately 12-15% (renal)
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Pharmacodynamics

OnsetOfAction: Initial antidepressant effects may be seen within 1-2 weeks, but full therapeutic effects may take 4-6 weeks.
PeakEffect: 4-6 weeks for full antidepressant effect.
DurationOfAction: Due to its long half-life, effects persist for several days after discontinuation, requiring a gradual taper.

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.
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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
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Signs of bleeding, such as:
+ 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
+ Bruises without a cause or that get bigger
+ Uncontrollable bleeding
Chest pain or pressure
Fast, slow, or abnormal heartbeat
Shortness of breath
Dizziness or fainting
Seizures
Unexplained weight changes
Painful erection (hard penis) or an erection that lasts longer than 4 hours
Changes in menstrual period
Sex problems, including:
+ Decreased interest in sex
+ Trouble having an orgasm
+ Ejaculation problems
+ Difficulty getting or maintaining an erection

If you experience any of these symptoms, consult your doctor. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition. If you take certain other medications, your risk may be higher. Seek medical help immediately if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal 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 medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach upset
Vomiting
Decreased appetite
Trouble sleeping
Shakiness
Excessive sweating
Yawning
Signs of a common cold

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

  • New or worsening suicidal thoughts or behaviors
  • Severe agitation, restlessness, panic attacks
  • Unusual changes in behavior or mood (e.g., mania, hypomania)
  • Symptoms of serotonin syndrome (e.g., fever, sweating, confusion, severe muscle stiffness or twitching, shivering, diarrhea, rapid heart rate)
  • Symptoms of QTc prolongation (e.g., fainting, fast/irregular heartbeat, severe dizziness)
  • Unusual bleeding or bruising
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, seizures)
  • Eye pain, vision changes, swelling or redness around the eye (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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain heart conditions, including:
+ A prolonged QTc interval on an electrocardiogram (ECG) or other abnormal heart rhythms
+ A slow heartbeat
+ Low potassium or magnesium levels
A history of heart failure (a weakened heart) or a recent heart attack
Current or recent use of specific medications, such as:
+ 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 determine if any of your medications have this potential)
Use of certain medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note that taking these medications with this drug can lead to very high blood pressure)

This list is not exhaustive, and 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 and pharmacist will help you determine if it is safe to take this medication with your existing 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.
Refrain from consuming alcohol while taking this medication.
Before using marijuana, cannabis, or prescription/over-the-counter medications that may cause drowsiness, consult your doctor.

Depression and Treatment Response

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 improve.

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.

Pregnancy, Breastfeeding, and Pediatric Considerations

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding.
Taking this medication during the third trimester of pregnancy may increase the risk of bleeding after delivery and cause health problems in the newborn.
* In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this with your doctor.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Dizziness
  • Nausea
  • Vomiting
  • Tremor
  • Tachycardia (fast heart rate)
  • Somnolence
  • Sweating
  • Cyanosis
  • Hyperventilation
  • QTc prolongation
  • Arrhythmias (including Torsade de Pointes)
  • Seizures
  • Coma

What to Do:

Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome (allow 14 days washout)
  • Pimozide - risk of QTc prolongation and ventricular arrhythmias
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Major Interactions

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

  • CYP2C19 inhibitors (e.g., omeprazole, esomeprazole, fluoxetine, fluvoxamine) - may increase citalopram levels
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) - may increase citalopram levels
  • Alcohol - may potentiate CNS depressant effects, though no pharmacokinetic interaction.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Psychiatric evaluation (mood, anxiety, suicidal ideation)

Rationale: To establish baseline severity of symptoms and assess risk of suicidality.

Timing: Prior to initiation.

ECG

Rationale: To assess baseline QTc interval, especially in patients with cardiac risk factors, bradycardia, hypokalemia, hypomagnesemia, or concomitant use of other QTc-prolonging drugs.

Timing: Prior to initiation, if risk factors present.

Electrolytes (Potassium, Magnesium)

Rationale: To identify and correct hypokalemia or hypomagnesemia, which can increase risk of QTc prolongation.

Timing: Prior to initiation, if risk factors present.

Liver and Renal Function Tests

Rationale: To assess organ function and guide dosing adjustments if impairment is present.

Timing: Prior to initiation.

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Routine Monitoring

Clinical response and adverse effects

Frequency: Weekly for first 4 weeks, then bi-weekly for next 4 weeks, then periodically (e.g., monthly or every 3 months) or as clinically indicated.

Target: Improvement in target symptoms with tolerable side effects.

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

Suicidal ideation and behavior

Frequency: Especially during initial treatment and dose changes.

Target: Absence of new or worsening suicidal thoughts/behaviors.

Action Threshold: Any emergence or worsening requires immediate clinical assessment and intervention.

QTc interval

Frequency: Periodically, especially if dose is increased to 40 mg/day, or if new cardiac risk factors or QTc-prolonging drugs are added.

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

Action Threshold: Significant QTc prolongation (>500 ms or increase >60 ms from baseline) requires dose reduction or discontinuation.

Weight

Frequency: Periodically

Target: Stable weight or healthy weight management.

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

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behaviors
  • Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, akathisia, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
  • Symptoms of QTc prolongation (e.g., palpitations, dizziness, syncope)
  • Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures, hallucinations, syncope)

Special Patient Groups

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Pregnancy

Generally avoided in the third trimester due to potential for neonatal complications (e.g., persistent pulmonary hypertension of the newborn, withdrawal symptoms). Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Some studies suggest a small increased risk of cardiovascular malformations, but overall data are conflicting and not conclusive.
Second Trimester: Generally considered safer than first or third trimester, but still requires careful risk-benefit assessment.
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) requiring prolonged hospitalization.
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Lactation

Citalopram is excreted into breast milk. While generally considered compatible with breastfeeding (Lactation Risk Category L2), monitor the infant for adverse effects such as sedation, poor feeding, and weight gain. Consult with a healthcare provider.

Infant Risk: Low to moderate risk. Monitor for drowsiness, irritability, poor feeding, and weight changes. Alternative SSRIs with lower milk transfer (e.g., sertraline) may be preferred.
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Pediatric Use

Not FDA approved for pediatric depression. Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Use in this population should be carefully considered and closely monitored by a specialist.

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Geriatric Use

Lower starting dose (10 mg/day) and lower maximum dose (20 mg/day) are recommended due to increased risk of QTc prolongation and hyponatremia. Elderly patients may be more sensitive to 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, those with hepatic impairment, or those taking CYP2C19 inhibitors.
  • Patients should be advised about the potential for serotonin syndrome, especially if combining with other serotonergic agents.
  • Gradual tapering is crucial upon discontinuation to avoid withdrawal symptoms (e.g., dizziness, paresthesias, anxiety, agitation, nausea, tremor).
  • Onset of antidepressant effect is typically 2-4 weeks, with full effect taking 4-6 weeks. Patients should be encouraged to continue treatment even if immediate improvement is not seen.
  • Monitor for hyponatremia, especially in elderly patients or those on diuretics, due to the risk of SIADH.
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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, Selegiline (reserved for refractory cases)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it 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. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.