Paxil 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
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 the amount of a natural substance called serotonin in the brain. Serotonin helps to improve mood, sleep, and other functions. It is used to treat depression, anxiety disorders, obsessive-compulsive disorder, and panic disorder. It can take several weeks to feel the full benefits of this medication.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
Continue taking your medication as prescribed 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 about your specific brand, consult with your doctor or pharmacist.
Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure 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 by your pharmacist.
If you have questions about disposing of your medication, consult with your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 ensure you get the most benefit from your medication, follow these guidelines:
Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
Continue taking your medication as prescribed 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 about your specific brand, consult with your doctor or pharmacist.
Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure 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 by your pharmacist.
If you have questions about disposing of your medication, consult with your pharmacist. You may also have access to drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
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 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 this medication, as it can worsen side effects like drowsiness or dizziness.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, as serious interactions can occur.
- Regular exercise and a balanced diet can complement the treatment.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
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/day; Titrate: 10 mg/week increments, max 50 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial: 20 mg/day; Titrate: 10 mg/week increments, max 60 mg/day.
Panic Disorder:
Initial: 10 mg/day; Titrate: 10 mg/week increments, max 60 mg/day.
Social Anxiety Disorder (Social Phobia):
Initial: 20 mg/day; Titrate: 10 mg/week increments, max 50 mg/day.
Generalized Anxiety Disorder (GAD):
Initial: 20 mg/day; Titrate: 10 mg/week increments, max 50 mg/day.
Post-Traumatic Stress Disorder (PTSD):
Initial: 20 mg/day; Titrate: 10 mg/week increments, max 50 mg/day.
Vasomotor Symptoms of Menopause (Brisdelle):
7.5 mg once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not generally recommended for MDD due to increased risk of suicidality. Approved for OCD in children 7-17 years: Initial 10 mg/day, max 50 mg/day.
Adolescent:
Not generally recommended for MDD due to increased risk of suicidality. Approved for OCD in adolescents 7-17 years: Initial 10 mg/day, max 50 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
Initial dose 10 mg/day, max 40 mg/day.
Severe:
Initial dose 10 mg/day, max 40 mg/day.
Dialysis:
Consider initial dose 10 mg/day, max 40 mg/day. Paroxetine is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment, but monitor closely.
Moderate:
Initial dose 10 mg/day, max 40 mg/day.
Severe:
Initial dose 10 mg/day, max 40 mg/day.
Pharmacology
Mechanism of Action
Paroxetine is a potent and highly selective inhibitor of serotonin (5-HT) reuptake in the central nervous system (CNS). It weakly inhibits norepinephrine and dopamine reuptake. This inhibition leads to an increase in the concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. Chronic administration may lead to downregulation of postsynaptic 5-HT2 receptors and desensitization of presynaptic 5-HT1A autoreceptors, contributing to its therapeutic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70% (variable due to first-pass metabolism)
Tmax:
Approximately 5.2 hours (range 3-8 hours)
FoodEffect:
Food does not significantly affect absorption, but may decrease Cmax and increase Tmax slightly. Can be taken with or without food.
Distribution:
Vd:
Approximately 9.8 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours (range 10-24 hours), can be longer with higher doses due to saturable metabolism.
Clearance:
Variable, decreases with increasing dose due to saturable metabolism.
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug, 62% as metabolites); approximately 36% via feces (primarily as metabolites).
Unchanged:
Less than 2% (urine)
Pharmacodynamics
OnsetOfAction:
Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect typically takes 4-6 weeks.
PeakEffect:
Peak therapeutic effect typically observed after 4-6 weeks of consistent dosing.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, requiring once-daily dosing. Withdrawal symptoms can occur rapidly if discontinued abruptly.
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 24 years of age; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years 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. Paroxetine is not approved for use in pediatric patients less than 7 years of age.
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 discolored sputum, 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, gum bleeding, 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, such as 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 medical help immediately 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
Most people taking this medication may not experience significant side effects or may only have mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
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 discolored sputum, 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, gum bleeding, 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, such as 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 medical help immediately 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
Most people taking this medication may not experience significant side effects or may only have mild ones. However, if you notice any of the following side effects or if they persist or bother you, contact your doctor:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
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:
- Worsening depression or thoughts of harming yourself (especially in young adults)
- Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, irritability, aggression, impulsivity, severe insomnia, mania)
- Symptoms of serotonin syndrome: fast heartbeat, sweating, muscle stiffness or spasms, fever, confusion, hallucinations, severe nausea/vomiting/diarrhea.
- Symptoms of an allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing.
- Unusual bleeding or bruising.
- Symptoms of hyponatremia: headache, confusion, weakness, unsteadiness, memory problems, 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 inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Any health problems you are experiencing
To ensure your safety, always verify with your doctor that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without 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 inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Any health problems you are experiencing
To ensure your safety, always verify with your doctor that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This will help prevent accidents and ensure your safety.
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually taper off the dosage to minimize potential risks.
While taking this medication, it is recommended that you avoid consuming alcohol, as it may interact with the medication and increase the risk of side effects.
Before using marijuana, cannabis products, or other prescription or over-the-counter medications that may cause drowsiness, consult your doctor to discuss potential risks and interactions.
It may take several weeks to experience the full effects of this medication. Be patient and follow your doctor's instructions for taking the medication as directed.
This medication may increase your risk of fractures. Discuss this potential risk with your doctor, who can assess your individual situation and provide guidance on minimizing this risk.
Additionally, this medication may increase your risk of bleeding, which can be life-threatening in some cases. Talk to your doctor about this potential risk and report any signs of bleeding, such as bruising, bleeding gums, or nosebleeds, immediately.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk and monitor your eye health. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
This medication can cause low sodium levels, which can be life-threatening if left untreated. Very low sodium levels can lead to seizures, loss of consciousness, breathing difficulties, or even death. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth and development. Regular growth checks may be necessary to monitor any potential effects. Discuss this potential risk with your doctor, who can provide guidance on minimizing any adverse effects.
This medication may also affect fertility in some individuals, making it more difficult to father a child. It is unclear whether this effect is reversible.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, particularly if taken during the first trimester, which may increase the risk of birth defects, mainly heart defects. Taking this medication during the third trimester may increase the risk of bleeding after delivery and lead to health problems in the newborn.
If you are breastfeeding or plan to breastfeed, inform your doctor, as they will need to discuss the potential risks and benefits of taking this medication while nursing.
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This will help prevent accidents and ensure your safety.
Do not suddenly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually taper off the dosage to minimize potential risks.
While taking this medication, it is recommended that you avoid consuming alcohol, as it may interact with the medication and increase the risk of side effects.
Before using marijuana, cannabis products, or other prescription or over-the-counter medications that may cause drowsiness, consult your doctor to discuss potential risks and interactions.
It may take several weeks to experience the full effects of this medication. Be patient and follow your doctor's instructions for taking the medication as directed.
This medication may increase your risk of fractures. Discuss this potential risk with your doctor, who can assess your individual situation and provide guidance on minimizing this risk.
Additionally, this medication may increase your risk of bleeding, which can be life-threatening in some cases. Talk to your doctor about this potential risk and report any signs of bleeding, such as bruising, bleeding gums, or nosebleeds, immediately.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk and monitor your eye health. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
This medication can cause low sodium levels, which can be life-threatening if left untreated. Very low sodium levels can lead to seizures, loss of consciousness, breathing difficulties, or even death. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth and development. Regular growth checks may be necessary to monitor any potential effects. Discuss this potential risk with your doctor, who can provide guidance on minimizing any adverse effects.
This medication may also affect fertility in some individuals, making it more difficult to father a child. It is unclear whether this effect is reversible.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, particularly if taken during the first trimester, which may increase the risk of birth defects, mainly heart defects. Taking this medication during the third trimester may increase the risk of bleeding after delivery and lead to health problems in the newborn.
If you are breastfeeding or plan to breastfeed, inform your doctor, as they will need to discuss the potential risks and benefits of taking this medication while nursing.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea and vomiting
- Tachycardia (fast heart rate)
- Tremor
- Agitation
- Dizziness
- Dilated pupils
- Serotonin syndrome (severe cases)
- Seizures
- Coma
What to Do:
Seek immediate medical attention or call 911. Call 1-800-222-1222 (Poison Control Center) for advice. Do not induce vomiting. Be prepared to provide information about the amount taken and any other medications involved.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Pimozide (risk of QT prolongation)
- Thioridazine (risk of QT prolongation and sudden death)
- Linezolid (MAOI activity)
- Methylene Blue (MAOI activity)
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) - increased risk of arrhythmias.
- Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding.
- Drugs metabolized by CYP2D6 (e.g., metoprolol, propafenone, flecainide, desipramine, nortriptyline, risperidone) - paroxetine is a strong CYP2D6 inhibitor, leading to increased levels of these drugs.
- Tamoxifen (paroxetine can reduce tamoxifen's efficacy by inhibiting its conversion to active metabolites via CYP2D6).
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 (mood, anxiety, suicidal ideation)
Rationale: To establish baseline severity of symptoms and assess risk of suicidality.
Timing: Prior to initiation of therapy.
Renal and Hepatic function tests (BUN, creatinine, LFTs)
Rationale: To guide initial dosing and identify patients at risk for altered drug clearance.
Timing: Prior to initiation of therapy.
Electrolytes (Sodium)
Rationale: To establish baseline, especially in elderly or those on diuretics, due to risk of hyponatremia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and symptom severity (e.g., HAM-D, HAM-A scales)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Reduction in symptom scores, improved mood/anxiety.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.
Suicidal ideation/behavior
Frequency: Weekly for first 4-6 weeks, especially in children, adolescents, and young adults; then monthly or as clinically indicated.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Emergence or worsening of suicidal thoughts/behaviors requires immediate clinical assessment and intervention.
Adverse effects (e.g., GI upset, sexual dysfunction, insomnia, agitation, serotonin syndrome symptoms)
Frequency: Regularly, especially during dose titration and initial weeks.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects may require dose reduction or change in therapy. Serotonin syndrome symptoms require immediate medical attention.
Weight
Frequency: Periodically (e.g., every 3-6 months).
Target: Stable weight or within healthy range.
Action Threshold: Significant weight gain or loss may require intervention.
Electrolytes (Sodium)
Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.
Target: 135-145 mEq/L.
Action Threshold: Sodium < 135 mEq/L requires investigation and potential intervention.
Symptom Monitoring
- Worsening depression or anxiety
- Emergence of suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, hostility, 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 withdrawal (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor, confusion, headache, fatigue, emotional lability, irritability, hypomania, seizures) upon discontinuation
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, hallucinations, syncope, seizures, coma)
- Abnormal bleeding or bruising
Special Patient Groups
Pregnancy
Paroxetine is generally not recommended during pregnancy, especially in the first trimester, due to potential risks. It is classified as Pregnancy Category D. The decision to use paroxetine during pregnancy should be made after careful consideration of the risks versus benefits, particularly if alternative treatments are not effective.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations, particularly cardiovascular defects (e.g., ventricular septal defects, atrial septal defects), though absolute risk is low.
Second Trimester:
Potential for persistent pulmonary hypertension of the newborn (PPHN) if exposed late in pregnancy, though data are conflicting and absolute risk is low.
Third Trimester:
Risk of neonatal withdrawal syndrome (poor feeding, irritability, tremor, respiratory distress, seizures) and other adverse effects (e.g., respiratory distress, temperature instability, hypoglycemia) if exposed late in the third trimester.
Lactation
Paroxetine is excreted into breast milk. While levels in breast milk and infant plasma are generally low, potential for adverse effects in the infant exists. It is rated L3 (Moderately Safe) by Hale's Lactation Risk Category. Monitor breastfed infants for drowsiness, poor feeding, and weight gain. Consider alternatives or lower doses if possible.
Infant Risk:
Low to moderate risk. Monitor for irritability, poor feeding, drowsiness, and changes in sleep patterns. Some studies suggest minimal adverse effects, while others report mild symptoms in a small percentage of infants.
Pediatric Use
Use in pediatric patients (under 18 years) for Major Depressive Disorder and other psychiatric disorders (except OCD in 7-17 years) carries a Black Box Warning due to increased risk of suicidal thoughts and behavior. Close monitoring is essential if used. Not approved for use in patients under 7 years of age.
Geriatric Use
Lower starting doses (e.g., 10 mg/day) and slower titration are recommended due to increased sensitivity to side effects and potential for reduced clearance. Increased risk of hyponatremia (low sodium levels) and falls in this population. Monitor closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine has a relatively short half-life compared to other SSRIs, making it more prone to withdrawal symptoms if discontinued abruptly. Tapering is crucial.
- It is a potent inhibitor of CYP2D6, which can lead to significant drug interactions, especially with other medications metabolized by this enzyme (e.g., tamoxifen, tricyclic antidepressants, some beta-blockers).
- Paroxetine is often associated with a higher incidence of sexual dysfunction and weight gain compared to other SSRIs.
- The controlled-release (CR) formulation may help reduce some GI side effects and provide smoother plasma levels.
- Brisdelle (low-dose paroxetine) is specifically approved for vasomotor symptoms of menopause and should not be used for psychiatric indications due to its lower dose.
- Monitor for signs of serotonin syndrome, especially when co-administered with other serotonergic agents.
Alternative Therapies
- Other SSRIs (e.g., Fluoxetine, Sertraline, Citalopram, Escitalopram, Fluvoxamine)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
- Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
- Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine, Selegiline)
- Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
- Electroconvulsive Therapy (ECT) for severe depression
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 and effective treatment, 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, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.