Paroxetine 20mg 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
D
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Paroxetine is a medication called an antidepressant that works by increasing a natural substance in the brain called serotonin. It helps improve mood, reduce anxiety, and decrease panic attacks. It's used to treat depression, anxiety disorders, obsessive-compulsive disorder, and other related conditions.
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 with or without food, as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Some formulations of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand. Unless your doctor advises otherwise, take your medication in the morning.
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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Some formulations of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand. Unless your doctor advises otherwise, take your medication in the morning.
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're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take paroxetine exactly as prescribed, usually once daily in the morning, 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 drowsiness or dizziness.
- Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
- Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.
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:
20 mg once daily, typically in the morning
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 20 mg once daily; Maintenance: 20-50 mg once daily
Obsessive-Compulsive Disorder (OCD):
Initial: 20 mg once daily; Maintenance: 20-60 mg once daily
Panic Disorder:
Initial: 10 mg once daily; Maintenance: 20-60 mg once daily
Social Anxiety Disorder (Social Phobia):
Initial: 20 mg once daily; Maintenance: 20-50 mg once daily
Generalized Anxiety Disorder (GAD):
Initial: 20 mg once daily; Maintenance: 20-50 mg once daily
Post-Traumatic Stress Disorder (PTSD):
Initial: 20 mg once daily; Maintenance: 20-50 mg once daily
Premenstrual Dysphoric Disorder (PMDD):
Continuous: 12.5 mg/day (CR) or 20 mg/day (IR); Luteal Phase: 12.5 mg/day (CR) or 20 mg/day (IR) for 14 days prior to menstruation
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended due to increased risk of suicidality)
Adolescent:
Not established (generally not recommended due to increased risk of suicidality)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
Initial: 10 mg once daily; Max: 40 mg once daily
Severe:
Initial: 10 mg once daily; Max: 40 mg once daily
Dialysis:
Consider lower doses and monitor closely due to increased plasma levels
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Initial: 10 mg once daily; Max: 40 mg once daily
Severe:
Initial: 10 mg once daily; Max: 40 mg once daily
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 serotonin transporter (SERT), blocking the reuptake of serotonin into the presynaptic neuron, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission. It has weak effects on norepinephrine and dopamine neuronal reuptake.
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 3-65 hours, dose-dependent)
Clearance:
Approximately 0.3 L/min (variable)
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug), 36% via feces (1% as unchanged drug)
Unchanged:
Approximately 2% (urine), 1% (feces)
Pharmacodynamics
OnsetOfAction:
Initial effects (e.g., improved sleep, appetite) within 1-2 weeks; full antidepressant effects may take 4-6 weeks or longer.
PeakEffect:
Clinical peak effect typically seen after 4-6 weeks of consistent dosing.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, requiring 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 or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ 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 achieving orgasm, ejaculation issues, or erectile dysfunction
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. If you experience any of the following symptoms, seek medical help immediately:
Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or stiffness
Seizures or shivering/shaking
Excessive sweating or severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have mild symptoms, it is essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas or bloating
Dry mouth
Sleep disturbances
Shakiness or tremors
Yawning
Back pain
* Sweating
If you are concerned about any side effects or if they persist or worsen, consult your doctor for guidance. 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 or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ 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 achieving orgasm, ejaculation issues, or erectile dysfunction
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. If you experience any of the following symptoms, seek medical help immediately:
Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or stiffness
Seizures or shivering/shaking
Excessive sweating or severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have mild symptoms, it is essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas or bloating
Dry mouth
Sleep disturbances
Shakiness or tremors
Yawning
Back pain
* Sweating
If you are concerned about any side effects or if they persist or worsen, consult your doctor for guidance. 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:
- Worsening depression or anxiety
- New or increased thoughts of self-harm or suicide
- Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, severe restlessness, mania/hypomania)
- Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea
- Symptoms of an allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing
- Unexplained bleeding or bruising
- Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, seizures
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. Be sure to describe the allergic reaction you experienced.
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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting 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. Be sure to describe the allergic reaction you experienced.
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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 tasks that require alertness.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
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.
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: Discuss this risk with your doctor.
Bleeding: This medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this risk.
Eye problems: 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 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. Consult your doctor about this risk.
Fertility: This medication may affect fertility in males, but it is unclear if this effect is reversible.
Pregnancy: Taking this medication during pregnancy may harm the unborn baby. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. Discuss the benefits and risks of taking this medication during pregnancy with your doctor, as it may increase the risk of birth defects (mainly heart defects) in the first trimester and bleeding after delivery in the third trimester.
Breastfeeding: Inform your doctor if you are breastfeeding, as you will need to discuss any potential risks to your baby.
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 tasks that require alertness.
Stopping the Medication
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will instruct you on how to gradually discontinue it.
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.
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: Discuss this risk with your doctor.
Bleeding: This medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this risk.
Eye problems: 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 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. Consult your doctor about this risk.
Fertility: This medication may affect fertility in males, but it is unclear if this effect is reversible.
Pregnancy: Taking this medication during pregnancy may harm the unborn baby. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. Discuss the benefits and risks of taking this medication during pregnancy with your doctor, as it may increase the risk of birth defects (mainly heart defects) in the first trimester and bleeding after delivery in the third trimester.
Breastfeeding: Inform your doctor if you are breastfeeding, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea
- Vomiting
- Tremor
- Tachycardia (fast heart rate)
- Agitation
- Dizziness
- Dilated pupils
- Serotonin syndrome (severe cases)
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive, focusing on maintaining vital functions and managing symptoms. Activated charcoal may be considered if ingested recently.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Thioridazine (risk of QT prolongation, ventricular arrhythmias, sudden death)
- Pimozide (risk of QT prolongation, ventricular arrhythmias)
- Linezolid (MAOI activity, risk of serotonin syndrome)
- Methylene blue (MAOI activity, risk of serotonin syndrome)
Major Interactions
- Triptans (e.g., sumatriptan, zolmitriptan) (risk of serotonin syndrome)
- Other serotonergic drugs (e.g., fentanyl, tramadol, St. John's Wort, tryptophan, buspirone, lithium) (risk of serotonin syndrome)
- Warfarin (increased bleeding risk due to effects on platelet aggregation)
- NSAIDs/Aspirin (increased bleeding risk)
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) (paroxetine inhibits CYP2D6, increasing TCA levels)
- Type 1C antiarrhythmics (e.g., flecainide, propafenone) (paroxetine inhibits CYP2D6, increasing antiarrhythmic levels)
- Metoprolol (paroxetine inhibits CYP2D6, increasing metoprolol levels)
- Atomoxetine (paroxetine inhibits CYP2D6, increasing atomoxetine levels)
- Tamoxifen (paroxetine inhibits CYP2D6, reducing active tamoxifen metabolite formation, potentially reducing efficacy)
Moderate Interactions
- Cimetidine (increases paroxetine levels)
- Phenobarbital, Phenytoin (may decrease paroxetine levels)
- Fosamprenavir/Ritonavir (may decrease paroxetine levels)
- Digoxin (paroxetine may increase digoxin levels)
- Theophylline (paroxetine may increase theophylline levels)
- Alcohol (additive CNS depressant effects, generally advised to avoid)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline and guide treatment decisions.
Timing: Prior to initiation
Renal and hepatic function tests (e.g., BUN, creatinine, ALT, AST)
Rationale: To assess organ function and guide dose adjustments in impaired patients.
Timing: Prior to initiation
Electrolytes (especially sodium)
Rationale: To establish baseline, particularly in elderly or those on diuretics, due to hyponatremia risk.
Timing: Prior to initiation
Routine Monitoring
Clinical response (symptom improvement)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Reduction in symptom severity scores (e.g., HAM-D, GAD-7)
Action Threshold: Lack of improvement after adequate trial, or worsening symptoms
Adverse effects (e.g., nausea, insomnia, sexual dysfunction, agitation)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects, requiring dose adjustment or discontinuation
Suicidality (especially in young adults)
Frequency: Weekly for first few weeks, then regularly during treatment, especially with dose changes
Target: Absence of suicidal ideation or behavior
Action Threshold: Emergence or worsening of suicidal thoughts/behavior, requiring immediate intervention
Weight
Frequency: Periodically (e.g., every 3-6 months)
Target: Stable weight or within healthy range
Action Threshold: Significant weight gain or loss
Electrolytes (sodium)
Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics
Target: Sodium within normal limits (135-145 mEq/L)
Action Threshold: Hyponatremia (<135 mEq/L)
Bleeding/bruising
Frequency: Regularly, especially if co-administered with anticoagulants/antiplatelets
Target: Absence of abnormal bleeding
Action Threshold: Unexplained bruising, petechiae, or bleeding
Symptom Monitoring
- Worsening depression or anxiety
- Emergence of suicidal thoughts or behavior (especially in young adults)
- Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity, mania/hypomania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, nausea, vomiting, diarrhea)
- Symptoms of withdrawal (e.g., dizziness, sensory disturbances, anxiety, agitation, tremor, sweating, confusion, headache, nausea, vomiting) upon abrupt discontinuation
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
Special Patient Groups
Pregnancy
Paroxetine is classified as Pregnancy Category D. Studies have shown an increased risk of congenital cardiac malformations (e.g., ventricular septal defects) in infants exposed to paroxetine during the first trimester. Exposure late in the third trimester has been associated with persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability) in neonates. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital cardiac malformations (e.g., ventricular septal defects).
Second Trimester:
Limited data, but generally considered lower risk than first trimester for cardiac defects. Potential for other adverse outcomes not fully excluded.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, jitteriness, seizures).
Lactation
Paroxetine is excreted into breast milk. The amount transferred to the infant is relatively low, but potential for adverse effects exists. The American Academy of Pediatrics considers paroxetine to be a drug for which the effect on a nursing infant is unknown but may be of concern. Monitor infants for drowsiness, poor feeding, and weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
L3 (Moderate risk) - Monitor infant for sedation, irritability, poor feeding, and weight gain. Consider alternative SSRIs with lower milk transfer if possible.
Pediatric Use
Paroxetine is generally not recommended for use in children and adolescents under 18 years of age for major depressive disorder or other psychiatric disorders due to an increased risk of suicidal thoughts and behavior compared to placebo. Its use in this population should be carefully considered and closely monitored, typically only when other options are ineffective or contraindicated, and under specialist supervision.
Geriatric Use
Elderly patients may be more sensitive to the effects of paroxetine and may have an increased risk of adverse reactions, particularly hyponatremia (low sodium levels) and falls. A lower starting dose (e.g., 10 mg/day) and slower titration are recommended. Maximum dose typically 40 mg/day. Monitor closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine has a relatively short half-life compared to other SSRIs, making withdrawal symptoms (discontinuation syndrome) more pronounced and common upon abrupt cessation or rapid dose reduction. Taper slowly over several weeks to months.
- It is a potent inhibitor of CYP2D6, which can lead to significant drug interactions with other medications metabolized by this enzyme (e.g., tamoxifen, TCAs, metoprolol).
- Paroxetine is often associated with a higher incidence of sexual dysfunction (e.g., decreased libido, delayed ejaculation, anorgasmia) compared to other SSRIs.
- Weight gain is a common side effect with long-term use.
- Due to its activating properties, it is generally recommended to take paroxetine in the morning to avoid insomnia.
- Consider the controlled-release (CR) formulation for patients experiencing significant gastrointestinal side effects or for once-daily dosing convenience.
Alternative Therapies
- Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline (Zoloft), Fluoxetine (Prozac), Citalopram (Celexa), Escitalopram (Lexapro), Fluvoxamine (Luvox)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine (Effexor), Duloxetine (Cymbalta), Desvenlafaxine (Pristiq)
- Atypical Antidepressants: Bupropion (Wellbutrin), Mirtazapine (Remeron), Trazodone
- Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
- Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine (used less commonly due to significant drug and food interactions)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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.