Citalopram 40mg 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
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 (serotonin) in the brain. It's important to take it regularly as prescribed, even if you start to feel better, and not to stop suddenly without talking to your doctor.
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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, and continue taking it even if you start to feel better. It's essential to follow your doctor's or healthcare provider's advice and take the medication as prescribed.

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. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs 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

  • Avoid alcohol, as it can worsen side effects like drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
  • Maintain regular follow-up appointments with your doctor to monitor your progress and side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg orally once daily, may be increased to 40 mg once daily after at least one week.
Dose Range: 20 - 40 mg

Condition-Specific Dosing:

Major Depressive Disorder: Initial 20 mg once daily, target 20-40 mg once daily. Max 40 mg/day due to dose-dependent QT prolongation risk.
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Pediatric Dosing

Neonatal: Not established (contraindicated in neonates due to potential for persistent pulmonary hypertension of the newborn (PPHN) if exposed late in pregnancy).
Infant: Not established
Child: Not established for major depressive disorder; use generally not recommended due to Black Box Warning for suicidality.
Adolescent: Not established for major depressive disorder; use generally not recommended due to Black Box Warning for suicidality. If used, initiate at 10 mg/day, titrate cautiously to 20 mg/day max.
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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. Not well studied.
Dialysis: Not available

Hepatic Impairment:

Mild: Max dose 20 mg/day.
Moderate: Max dose 20 mg/day.
Severe: Max dose 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 presynaptic neurons, 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: Minimal effect on absorption

Distribution:

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

Elimination:

HalfLife: Approximately 35 hours (citalopram), 27 hours (DCT)
Clearance: Approximately 330 mL/min
ExcretionRoute: Primarily hepatic (biliary) and renal (approximately 10% unchanged in urine)
Unchanged: Approximately 10%
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Pharmacodynamics

OnsetOfAction: Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect may take 4-6 weeks or longer.
PeakEffect: Not applicable for antidepressant effect (gradual onset).
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. Citalopram is not approved for use in pediatric patients. Citalopram causes dose-dependent QT interval prolongation, which can lead to Torsade de Pointes (TdP), ventricular tachycardia, and sudden death. The maximum recommended dose is 40 mg/day. For patients >60 years of age, patients with hepatic impairment, or patients who are CYP2C19 poor metabolizers or who are taking concomitant cimetidine or another CYP2C19 inhibitor, the maximum recommended dose is 20 mg/day.
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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 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, or uncontrollable bleeding
Chest pain or pressure
Fast, slow, or irregular heartbeat
Shortness of breath
Dizziness or fainting
Seizures
Unintentional weight changes
Painful or prolonged erections (lasting more than 4 hours)
Changes in menstrual periods
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation problems, or erectile dysfunction

If you experience any of these symptoms, consult your doctor. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. Seek immediate medical attention 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, nausea, or vomiting
Severe headache

Other Possible Side Effects

Most people taking this medication do not experience severe side effects, but some may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor if they bother you or persist:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Sleep disturbances
Shakiness
Excessive sweating
Yawning
* Common cold symptoms

This is not an exhaustive list of potential side effects. If you have concerns or questions, 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 suicidal thoughts
  • New or worsening anxiety, panic attacks, agitation, restlessness, irritability, aggression, or unusual excitement
  • Difficulty sleeping (insomnia)
  • Impulsivity or other unusual changes in behavior
  • Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe diarrhea, shivering, agitation, hallucinations
  • Symptoms of QT prolongation: dizziness, fainting, irregular heartbeat, seizures
  • Unusual bleeding or bruising
  • Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, memory problems
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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 patterns, including a prolonged QTc interval on an electrocardiogram (ECG), slow heartbeat, or low potassium or magnesium levels.
+ Heart failure (a weakened heart) or a recent heart attack.
Medications you are currently taking, including:
+ Linezolid or methylene blue.
+ Escitalopram or pimozide.
+ Any medications that can cause abnormal heartbeat patterns (prolonged QT interval). There are many medications that can have this effect, so be sure to ask your doctor or pharmacist if you are unsure.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.

Please note that this is not an exhaustive list of all potential interactions. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 operating a vehicle or engaging in activities that require alertness until you understand how this medication affects you.
Do not abruptly stop taking this medication without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue treatment, your doctor will guide you on how to gradually stop taking the medication.

Cardiac Risks

This medication has been associated with an abnormal and potentially life-threatening heartbeat (long QT on ECG), which has rarely resulted in sudden death. Discuss this risk with your doctor.

Interactions and Substances to Avoid

Refrain from consuming alcohol while taking this medication.
Consult your doctor before using marijuana, cannabis, or prescription/over-the-counter medications that may cause drowsiness or impaired reaction time.

Depression Treatment and Response

While taking this medication for depression, you may experience improvements in sleep and appetite soon after starting treatment. 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.

Ocular Risks

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

Hyponatremia (Low Sodium Levels)

This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, respiratory distress, 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, 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 may increase the risk of postpartum bleeding and potentially cause health problems in the newborn.

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 of treatment.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Sweating
  • Nausea
  • Vomiting
  • Tremor
  • Somnolence
  • Sinus tachycardia
  • QT prolongation
  • Arrhythmias (including Torsade de Pointes)
  • Seizures
  • Coma
  • Hypotension
  • Rhabdomyolysis

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
  • Pimozide (risk of QT prolongation and Torsade de Pointes)
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Major Interactions

  • Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, 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, certain antihistamines) (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, cimetidine, fluoxetine, fluvoxamine) (may increase citalopram levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) (may increase citalopram levels)
  • Drugs that cause hyponatremia (e.g., diuretics) (increased risk of SIADH/hyponatremia)
  • Alcohol (additive CNS depression, though specific interaction not well studied)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

ECG

Rationale: To assess baseline QT interval, especially in patients with cardiac disease, electrolyte disturbances, or on other QT-prolonging medications.

Timing: Prior to initiation

Electrolytes (Potassium, Magnesium)

Rationale: To correct any abnormalities that could predispose to QT prolongation or Torsade de Pointes.

Timing: Prior to initiation

Renal and Hepatic Function Tests

Rationale: To guide dosing adjustments in patients with impaired organ function.

Timing: Prior to initiation

Mental Status Examination (including suicidality assessment)

Rationale: To establish baseline mood, anxiety, and suicidal ideation.

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 quarterly) or as clinically indicated.

Target: Improvement in depressive symptoms, tolerability of side effects.

Action Threshold: Lack of response, worsening symptoms, intolerable side effects, emergence of suicidal ideation.

Suicidality Assessment

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

Target: Absence of suicidal thoughts or behaviors.

Action Threshold: Emergence or worsening of suicidal ideation or behavior.

ECG

Frequency: Consider if dose exceeds 20 mg/day, in patients with cardiac risk factors, or if new cardiac symptoms develop.

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

Action Threshold: QTc > 500 ms or increase of >60 ms from baseline; consider dose reduction or discontinuation.

Electrolytes (Sodium)

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

Target: 135-145 mEq/L

Action Threshold: Sodium < 130 mEq/L or symptomatic hyponatremia.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, 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 QT prolongation/Torsade de Pointes (e.g., dizziness, palpitations, fainting, seizures)
  • Symptoms of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, seizures)
  • Unusual bleeding or bruising
  • Sexual dysfunction

Special Patient Groups

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Pregnancy

Generally avoided, 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 some studies suggest a possible small increased risk of certain birth defects (e.g., cardiac septal defects), though findings are inconsistent.
Second Trimester: Not well studied for specific risks, but continued exposure carries risks similar to 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, seizures).
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Lactation

Citalopram is excreted into breast milk. Use with caution; monitor the infant for adverse effects.

Infant Risk: Moderate risk (L3). Potential for drowsiness, poor feeding, weight loss, and irritability in breastfed infants. Monitor infant for these symptoms.
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Pediatric Use

Not approved for major depressive disorder in pediatric patients. Black Box Warning regarding increased risk of suicidal thoughts and behavior. Use generally not recommended.

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Geriatric Use

Maximum recommended dose is 20 mg/day due to increased risk of QT prolongation. Increased risk of hyponatremia (SIADH) and falls. Initiate at lower doses and titrate slowly.

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. For patients over 60, with hepatic impairment, or on CYP2C19 inhibitors, the maximum dose is 20 mg/day.
  • Serotonin syndrome is a rare but potentially life-threatening condition. Educate patients on symptoms and advise immediate medical attention if they occur.
  • Discontinuation syndrome can occur if citalopram is stopped abruptly. Taper dose gradually over several weeks to minimize withdrawal symptoms.
  • Monitor for suicidal ideation, especially at the beginning of treatment and with dose changes, particularly in young adults.
  • Hyponatremia (low sodium) can occur, especially in elderly patients, those taking diuretics, or those who are volume-depleted. Monitor sodium levels if risk factors are present or symptoms develop.
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Alternative Therapies

  • Other SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Fluvoxamine)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., Venlafaxine, Duloxetine)
  • Atypical Antidepressants (e.g., Bupropion, Mirtazapine)
  • Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 40mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 and the effectiveness of your treatment, 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 whenever you receive a refill of your medication. 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, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.