Paroxetine 40mg Tablets
WARNING: 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.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It is used to treat obsessive-compulsive problems.It is used to treat panic attacks.It is used to treat anxiety.It is used to treat post-traumatic stress. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Selective Serotonin Reuptake Inhibitor (SSRI)
Pregnancy Category
Category D
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Paroxetine is a medication used to treat depression, anxiety disorders, obsessive-compulsive disorder (OCD), panic disorder, and post-traumatic stress disorder (PTSD). It works by helping to restore the balance of a natural substance (serotonin) in the brain, which can improve mood, sleep, appetite, and energy levels, and decrease nervousness.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Some formulations of this medication may need to be swallowed whole. If you're unsure whether your specific brand should be taken whole, consult with your doctor or pharmacist. Unless your doctor advises otherwise, take this medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of any unused or expired medication. Do not flush medication down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about the proper disposal of your medication, consult with your pharmacist. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel well.
Some formulations of this medication may need to be swallowed whole. If you're unsure whether your specific brand should be taken whole, consult with your doctor or pharmacist. Unless your doctor advises otherwise, take this medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of any unused or expired medication. Do not flush medication down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about the proper disposal of your medication, consult with your pharmacist. You may also want to explore local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily in the morning or evening, with or without food.
- Do not stop taking paroxetine 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 paroxetine, as it can worsen side effects like drowsiness and dizziness.
- Be cautious when driving or operating machinery until you know how paroxetine affects you, as it can cause dizziness or drowsiness.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, triptans, blood thinners, and other antidepressants.
- Report any unusual bleeding or bruising to your doctor.
- Monitor for changes in mood, behavior, or thoughts, especially suicidal thoughts, and report them immediately to your doctor or a healthcare professional.
Available Forms & Alternatives
Available Strengths:
- Paroxetine 20mg Tablets
- Paroxetine 10mg Tablets
- Paroxetine 40mg Tablets
- Paroxetine 30mg Tablets
- Paroxetine 7.5mg Capsules
- Paroxetine ER 25mg Tablets
- Paroxetine ER 25mg Tablets
- Paroxetine ER 37.5mg Tablets
- Paroxetine ER 12.5mg Tablets
- Paroxetine 10mg/5ml Oral Suspension
- Paroxetine ER 12.5mg Tablets
- Paroxetine ER 25mg Tablets
- Paroxetine ER 37.5mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For major depressive disorder, typical maintenance is 20 mg once daily. For panic disorder, 40 mg once daily. For OCD, 40 mg once daily. For PTSD, 20 mg once daily. For PMDD, 12.5 mg/day (CR) or 25 mg/day (IR). 40 mg is often a maximum or higher dose for some indications.
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
Major Depressive Disorder:
Initial 20 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 50 mg/day (IR) or 62.5 mg/day (CR).
Obsessive-Compulsive Disorder (OCD):
Initial 20 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 60 mg/day (IR).
Panic Disorder:
Initial 10 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 60 mg/day (IR).
Generalized Anxiety Disorder (GAD):
Initial 20 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 50 mg/day (IR).
Social Anxiety Disorder (SAD):
Initial 20 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 60 mg/day (IR).
Post-Traumatic Stress Disorder (PTSD):
Initial 20 mg once daily, may increase by 10 mg/day at weekly intervals to a maximum of 50 mg/day (IR).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Generally not recommended for depression/anxiety due to increased risk of suicidality. For OCD: 10-20 mg once daily, max 50 mg/day (IR) for ages 7-17.
Adolescent:
Generally not recommended for depression/anxiety due to increased risk of suicidality. For OCD: 10-20 mg once daily, max 50 mg/day (IR) for ages 7-17.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
Initial 10 mg once daily, maximum 40 mg/day (IR).
Severe:
Initial 10 mg once daily, maximum 40 mg/day (IR).
Dialysis:
No specific recommendations, but use with caution and monitor closely due to potential for accumulation.
Hepatic Impairment:
Mild:
Initial 10 mg once daily, maximum 40 mg/day (IR).
Moderate:
Initial 10 mg once daily, maximum 40 mg/day (IR).
Severe:
Initial 10 mg once daily, maximum 40 mg/day (IR).
Pharmacology
Mechanism of Action
Paroxetine is a potent and highly selective inhibitor of serotonin (5-HT) reuptake in the central nervous system (CNS). It binds to the presynaptic serotonin transporter, blocking the reuptake of serotonin into the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70% (variable due to first-pass metabolism)
Tmax:
Approximately 5.2 hours (IR tablets)
FoodEffect:
Food does not significantly affect absorption, but may decrease Cmax and increase Tmax slightly.
Distribution:
Vd:
Approximately 2.8 L/kg
ProteinBinding:
Approximately 95%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours (range 7-65 hours)
Clearance:
Approximately 0.3 L/kg/hr
ExcretionRoute:
Approximately 64% in urine (2% as unchanged drug), 36% in feces (1% as unchanged drug).
Unchanged:
Approximately 2% (urine), 1% (feces)
Pharmacodynamics
OnsetOfAction:
Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect may take 4-6 weeks.
PeakEffect:
4-6 weeks for full therapeutic effect.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, allowing once-daily dosing.
Safety & Warnings
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 paroxetine 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.
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, difficulty 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, confusion, weakness, seizures, or changes in balance.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding.
Severe dizziness or fainting.
Bone pain.
Seizures.
Significant weight loss.
Abnormal burning, numbness, or tingling sensations.
Painful or prolonged erections (lasting more than 4 hours).
Sexual problems, including decreased libido, difficulty having an orgasm, ejaculation problems, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes 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
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Feeling nervous or excitable
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Difficulty sleeping
Shakiness
Yawning
Back pain
* Sweating
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
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, difficulty 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, confusion, weakness, seizures, or changes in balance.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrollable bleeding.
Severe dizziness or fainting.
Bone pain.
Seizures.
Significant weight loss.
Abnormal burning, numbness, or tingling sensations.
Painful or prolonged erections (lasting more than 4 hours).
Sexual problems, including decreased libido, difficulty having an orgasm, ejaculation problems, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes 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
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Feeling nervous or excitable
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Difficulty sleeping
Shakiness
Yawning
Back pain
* Sweating
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression, anxiety, or panic attacks
- Thoughts about self-harm or suicide
- Unusual changes in behavior (e.g., agitation, restlessness, aggression, irritability, impulsivity, severe insomnia, mania)
- Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, severe diarrhea, shivering, overactive reflexes
- Symptoms of an allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing
- Unusual bleeding or bruising
- Seizures
- Symptoms of low sodium (hyponatremia): headache, confusion, weakness, unsteadiness, memory problems
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.
If you have been diagnosed with narrow-angle glaucoma.
If you are currently taking or have recently taken any of the following medications:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
If you have taken any medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. This includes:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor needs to assess the safety of taking this medication with all your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
If you have been diagnosed with narrow-angle glaucoma.
If you are currently taking or have recently taken any of the following medications:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
If you have taken any medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to very high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications, health problems, and concerns with your doctor and pharmacist. This includes:
Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins
Your doctor needs to assess the safety of taking this medication with all your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert.
Stopping the Medication
Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it to minimize potential risks.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Potential Risks
This medication may increase your risk of:
Broken bones: Consult your doctor about this potential risk.
Bleeding: This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Eye problems: Certain individuals may be more susceptible 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 and 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.
Special Considerations
Older adults (65 and older): Use this medication with caution, as you may be more susceptible to side effects.
Children and adolescents: This medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this risk with your doctor.
Male fertility: This medication may affect fertility, but it is unclear if this effect is reversible.
* Pregnancy and breastfeeding:
+ If you are pregnant or become pregnant while taking this medication, contact your doctor immediately.
+ Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding.
+ Taking this medication during the first trimester of pregnancy may increase the risk of birth defects (mainly heart defects) in the unborn baby.
+ Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and may lead to health problems in the newborn.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert.
Stopping the Medication
Do not stop taking this medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it to minimize potential risks.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Potential Risks
This medication may increase your risk of:
Broken bones: Consult your doctor about this potential risk.
Bleeding: This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
Eye problems: Certain individuals may be more susceptible 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 and 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.
Special Considerations
Older adults (65 and older): Use this medication with caution, as you may be more susceptible to side effects.
Children and adolescents: This medication may affect growth in some cases. Regular growth checks may be necessary. Discuss this risk with your doctor.
Male fertility: This medication may affect fertility, but it is unclear if this effect is reversible.
* Pregnancy and breastfeeding:
+ If you are pregnant or become pregnant while taking this medication, contact your doctor immediately.
+ Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding.
+ Taking this medication during the first trimester of pregnancy may increase the risk of birth defects (mainly heart defects) in the unborn baby.
+ Taking this medication during the third trimester of pregnancy may increase your risk of bleeding after delivery and may lead to health problems in the newborn.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea and vomiting
- Tremor
- Tachycardia (fast heart rate)
- Dilated pupils
- Agitation
- Dizziness
- Serotonin syndrome symptoms (severe cases)
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Bring the medication bottle with you.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
- Pimozide - risk of QT prolongation and arrhythmias
- Thioridazine - risk of QT prolongation and arrhythmias
Major Interactions
- Serotonergic drugs (e.g., triptans, fentanyl, lithium, tramadol, St. John's Wort, other SSRIs/SNRIs, tricyclic antidepressants) - increased risk of serotonin syndrome
- Warfarin - increased risk of bleeding due to inhibition of CYP2D6 and potential effects on platelet aggregation
- NSAIDs/Aspirin - increased risk of bleeding
- Drugs metabolized by CYP2D6 (e.g., metoprolol, propafenone, flecainide, atomoxetine, risperidone, venlafaxine, tricyclic antidepressants) - increased plasma concentrations of these drugs
- Tamoxifen - reduced efficacy of tamoxifen (prodrug activated by CYP2D6)
Moderate Interactions
- Cimetidine - increases paroxetine levels
- Phenobarbital, Phenytoin - may decrease paroxetine levels
- Fosamprenavir/Ritonavir - may decrease paroxetine levels
- Theophylline - paroxetine may increase theophylline levels
- Digoxin - paroxetine may increase digoxin levels
Minor Interactions
- Alcohol - generally advised to avoid due to potential for additive CNS depressant effects, though no direct pharmacokinetic interaction.
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline and guide treatment.
Timing: Prior to initiation
Renal and hepatic function tests (BUN, creatinine, ALT, AST)
Rationale: To guide initial dosing and identify patients at risk for accumulation.
Timing: Prior to initiation
Electrolytes (Sodium)
Rationale: To identify baseline hyponatremia risk, especially in elderly or those on diuretics.
Timing: Prior to initiation
Weight and Height (especially in pediatric patients)
Rationale: To monitor for growth effects and weight changes.
Timing: Prior to initiation
Routine Monitoring
Clinical response and symptom severity
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Reduction in target symptoms (e.g., HAM-D, GAD-7 scores)
Action Threshold: Lack of improvement after adequate trial, worsening symptoms, or emergence of new symptoms.
Emergence of suicidal ideation or behavior
Frequency: Especially during initial treatment and dose changes; monitor closely.
Target: Absence of suicidal thoughts/behaviors.
Action Threshold: Any new or worsening suicidal thoughts/behaviors; requires immediate clinical assessment and intervention.
Side effects (e.g., nausea, insomnia, sexual dysfunction, anxiety, agitation)
Frequency: Regularly, especially during dose titration.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects; consider dose adjustment or alternative.
Weight
Frequency: Periodically (e.g., every 3-6 months).
Target: Stable weight or within healthy range.
Action Threshold: Significant weight gain or loss.
Blood pressure and heart rate
Frequency: Periodically, especially in patients with cardiovascular risk factors.
Target: Within normal limits.
Action Threshold: Significant changes.
Serum Sodium
Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.
Target: 135-145 mEq/L
Action Threshold: <135 mEq/L or symptomatic hyponatremia.
Symptom Monitoring
- Worsening depression or anxiety
- New or worsening suicidal thoughts or behavior
- Unusual changes in behavior or mood (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, hallucinations, syncope, seizures, coma)
- Symptoms of withdrawal (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor, confusion, headache, flu-like symptoms) upon discontinuation.
Special Patient Groups
Pregnancy
Category D. Paroxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid, especially in the first trimester, if possible.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital cardiac malformations (e.g., atrial and ventricular septal defects) compared to other SSRIs. Consider alternative SSRIs if possible.
Second Trimester:
Not specifically associated with major malformations, but continued exposure carries risks.
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) if exposed late in pregnancy.
Lactation
Excreted into breast milk. Use with caution. Monitor infant for adverse effects.
Infant Risk:
L3 (Moderately Safe). Potential for infant drowsiness, poor feeding, weight loss, and irritability. Monitor for these effects. Consider alternatives with lower milk levels (e.g., sertraline).
Pediatric Use
Generally not recommended for depression or anxiety in children and adolescents due to increased risk of suicidal thoughts and behavior (Black Box Warning). May be used for OCD in children aged 7-17, but with careful monitoring for suicidality.
Geriatric Use
Start with lower doses (e.g., 10 mg/day) and titrate slowly. Increased risk of hyponatremia (SIADH) and falls. Monitor closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine has a relatively short half-life compared to other SSRIs, which can lead to more pronounced and rapid onset of withdrawal symptoms if discontinued abruptly. Taper slowly over several weeks to months.
- It is a potent inhibitor of CYP2D6, which can lead to significant drug interactions with medications metabolized by this enzyme (e.g., tamoxifen, metoprolol, TCAs).
- Among SSRIs, paroxetine is often associated with a higher incidence of sexual dysfunction and weight gain.
- Consider taking paroxetine in the morning to avoid insomnia, or in the evening if sedation is a desired effect.
- The controlled-release (CR) formulation may be associated with a lower incidence of nausea and withdrawal symptoms compared to the immediate-release (IR) formulation.
Alternative Therapies
- Other SSRIs (e.g., Sertraline, Fluoxetine, Escitalopram, Citalopram, Fluvoxamine)
- SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
- Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Trazodone)
- Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine, Selegiline)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.