Paxil 10mg 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 a natural substance in the brain called serotonin. This helps to improve mood, reduce anxiety, and decrease panic attacks. It's used to treat depression, anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder.
How to Use This Medicine
Taking Your Medication
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 better.
Some brands of this medication may need to be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand. 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 place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, or look into 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 one.
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 better.
Some brands of this medication may need to be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand. 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 place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, or look into 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 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 help you gradually reduce the dose when it's time to stop.
- Avoid alcohol while taking this medication, as it can worsen side effects like drowsiness.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, as serious interactions can occur.
- Report any unusual bleeding or bruising to your doctor.
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:
Initial 20 mg once daily; usual range 20-50 mg/day. Max 50 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial 20 mg once daily; usual range 40-60 mg/day. Max 60 mg/day.
Panic Disorder:
Initial 10 mg once daily; usual range 40-60 mg/day. Max 60 mg/day.
Generalized Anxiety Disorder (GAD):
Initial 20 mg once daily; usual range 20-50 mg/day. Max 50 mg/day.
Social Anxiety Disorder (SAD):
Initial 20 mg once daily; usual range 20-60 mg/day. Max 60 mg/day.
Post-Traumatic Stress Disorder (PTSD):
Initial 20 mg once daily; usual range 20-50 mg/day. Max 50 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for most indications; limited use for OCD (7-17 years) and GAD (8-17 years) with specific dosing.
Adolescent:
OCD (7-17 years): Initial 10 mg once daily, may increase by 10 mg/day weekly to 30-50 mg/day. GAD (8-17 years): Initial 10 mg once daily, may increase by 10 mg/day weekly to 20-30 mg/day. Black Box Warning for suicidality applies.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
Initial 10 mg once daily; maximum 40 mg/day.
Severe:
Initial 10 mg once daily; maximum 40 mg/day.
Dialysis:
Consider initial 10 mg once daily; maximum 40 mg/day. Paroxetine is highly protein-bound and not significantly removed by dialysis.
Hepatic Impairment:
Mild:
Initial 10 mg once daily; maximum 40 mg/day.
Moderate:
Initial 10 mg once daily; maximum 40 mg/day.
Severe:
Initial 10 mg once daily; maximum 40 mg/day.
Pharmacology
Mechanism of Action
Paroxetine selectively inhibits the reuptake of serotonin (5-HT) into presynaptic neurons in the central nervous system, thereby potentiating serotonergic activity in the brain. It has weak effects on norepinephrine and dopamine neuronal reuptake. Its antidepressant, anti-obsessive, and anti-panic actions are presumed to be linked to this potentiation of serotonergic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50% (variable due to first-pass metabolism)
Tmax:
Approximately 5.2 hours (for immediate-release tablets)
FoodEffect:
Food does not significantly affect the absorption of paroxetine, but it may decrease the rate of absorption. Can be taken with or without food.
Distribution:
Vd:
Approximately 9.8 L/kg
ProteinBinding:
Approximately 95%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours (range 7-65 hours, due to saturable metabolism)
Clearance:
Dose-dependent due to saturable metabolism
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 symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect may take 4-6 weeks or longer.
PeakEffect:
Not directly quantifiable for clinical effect; steady-state plasma concentrations are typically achieved within 7-14 days.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, requiring once-daily dosing. Withdrawal symptoms can occur rapidly upon discontinuation due to its relatively short half-life.
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. Paroxetine is not approved for use in pediatric patients except for pediatric patients with Obsessive Compulsive Disorder (OCD) and Generalized Anxiety Disorder (GAD).
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 bruising that worsens, 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 achieving orgasm, ejaculation issues, or erectile dysfunction
If you experience any of these symptoms, do not hesitate to contact 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
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following possible side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating
If you experience any of these side effects or have concerns, contact your doctor for guidance. Remember, this is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
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 bruising that worsens, 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 achieving orgasm, ejaculation issues, or erectile dysfunction
If you experience any of these symptoms, do not hesitate to contact 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
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following possible side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating
If you experience any of these side effects or have concerns, contact your doctor for guidance. Remember, this is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- New or worsening depression or anxiety
- Thoughts of harming yourself or others
- Extreme agitation, restlessness, or panic attacks
- Unusual changes in behavior or mood
- Symptoms of serotonin syndrome: confusion, hallucinations, rapid heart rate, sweating, muscle stiffness or twitching, fever, nausea, vomiting, diarrhea
- 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 hyponatremia: headache, confusion, weakness, unsteadiness, falls
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 conditions and situations to ensure safe treatment:
Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A diagnosis of narrow-angle glaucoma.
Current or recent use of specific medications, including:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
Use of certain depression or Parkinson's disease medications within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of 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. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A diagnosis of narrow-angle glaucoma.
Current or recent use of specific medications, including:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
Use of certain depression or Parkinson's disease medications within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: this may increase the risk of 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. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication without 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 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 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: Some 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 teens: 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: If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, and taking it during the first trimester may increase the risk of birth defects (mainly heart defects). Taking it during the third trimester may increase the risk of bleeding after delivery and lead to health problems in the newborn. Discuss the benefits and risks with your doctor.
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 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 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: Some 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 teens: 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: If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, and taking it during the first trimester may increase the risk of birth defects (mainly heart defects). Taking it during the third trimester may increase the risk of bleeding after delivery and lead to health problems in the newborn. Discuss the benefits and risks with your doctor.
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
- Agitation
- Dilated pupils
- Serotonin syndrome (severe cases)
- Seizures
- Coma
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is generally supportive and symptomatic. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Thioridazine (risk of QT prolongation and ventricular arrhythmias)
- Pimozide (risk of QT prolongation and ventricular arrhythmias)
Major Interactions
- Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort, tryptophan) (increased risk of serotonin syndrome)
- Warfarin (increased risk of bleeding due to altered INR)
- NSAIDs/Aspirin (increased risk of bleeding)
- Drugs metabolized by CYP2D6 (e.g., metoprolol, propafenone, flecainide, atomoxetine, risperidone, desipramine) (increased plasma concentrations of these drugs)
- Linezolid (MAOI activity, risk of serotonin syndrome)
- Methylene blue (MAOI activity, risk of serotonin syndrome)
Moderate Interactions
- Cimetidine (increases paroxetine levels)
- Phenobarbital, Phenytoin (may decrease paroxetine levels)
- Fosamprenavir/Ritonavir (may decrease paroxetine levels)
- Tamoxifen (paroxetine may reduce tamoxifen efficacy due to CYP2D6 inhibition)
- Digoxin (paroxetine may increase digoxin levels)
- Theophylline (paroxetine may increase theophylline levels)
Minor Interactions
- Alcohol (avoid due to additive CNS depressant effects, though no pharmacokinetic interaction)
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline mental status and guide treatment.
Timing: Prior to initiation of therapy.
Renal and Hepatic function tests (e.g., BUN, creatinine, AST, ALT)
Rationale: To assess organ function for appropriate dosing adjustments.
Timing: Prior to initiation of therapy.
Electrolytes (especially sodium)
Rationale: To identify baseline hyponatremia risk, particularly in elderly or those on diuretics.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and symptom severity (e.g., HAM-D, GAD-7, Y-BOCS scores)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Reduction in symptom scores, improvement in daily functioning.
Action Threshold: Lack of improvement after adequate trial, worsening symptoms, or emergence of new symptoms.
Emergence of suicidal ideation or behavioral changes
Frequency: Especially during initial treatment and dose changes; monitor closely.
Target: Absence of suicidal thoughts or behaviors.
Action Threshold: Any new or worsening suicidal ideation, agitation, or unusual behavior; requires immediate clinical assessment.
Adverse effects (e.g., nausea, insomnia, sexual dysfunction, weight changes)
Frequency: Regularly, especially during dose titration.
Target: Tolerable side effect profile.
Action Threshold: Intolerable side effects, requiring dose adjustment or discontinuation.
Blood pressure and heart rate
Frequency: Periodically, especially in patients with cardiovascular risk factors.
Target: Within normal limits.
Action Threshold: Significant changes or symptoms of orthostatic hypotension.
Electrolytes (sodium)
Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia.
Target: 135-145 mEq/L.
Action Threshold: Sodium < 130 mEq/L or symptomatic hyponatremia.
Symptom Monitoring
- Worsening depression or anxiety
- New or worsening suicidal thoughts or behavior
- Agitation, restlessness, panic attacks
- Insomnia or new sleep disturbances
- Irritability, hostility, aggressiveness
- Impulsivity
- Mania or hypomania
- Unusual changes in behavior
- Serotonin syndrome symptoms (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, muscle rigidity, tremor, nausea, vomiting, diarrhea)
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
Special Patient Groups
Pregnancy
Paroxetine is classified as Pregnancy Category D due to evidence of fetal risk. It should only be used during pregnancy 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, atrial septal defects) has been observed in some studies with first-trimester exposure.
Second Trimester:
Not specifically associated with unique risks in the second trimester beyond general SSRI exposure risks.
Third Trimester:
Exposure in late pregnancy (third trimester) has been associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, jitteriness, hypotonia, seizures).
Lactation
Paroxetine is excreted into breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother's clinical need for paroxetine, and any potential adverse effects on the breastfed infant from paroxetine or from the underlying maternal condition.
Infant Risk:
L3 (Moderately Safe). Monitor breastfed infants for sedation, poor feeding, poor weight gain, and irritability. Some studies suggest low levels in milk and low infant exposure, but caution is advised, especially in neonates or infants with underlying health issues.
Pediatric Use
Use in pediatric patients is generally not recommended for major depressive disorder due to the Black Box Warning regarding increased risk of suicidality. It is approved for OCD (ages 7-17) and GAD (ages 8-17) in specific circumstances, with careful monitoring for suicidality and behavioral changes. Not established for use in children younger than 7-8 years depending on indication.
Geriatric Use
Elderly patients may be more sensitive to the effects of paroxetine, particularly side effects such as hyponatremia (low sodium levels), falls, and CNS effects (e.g., dizziness, sedation). Lower initial doses and slower titration are recommended. Monitor closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine has the shortest half-life among commonly used SSRIs, which can lead to more pronounced and rapid onset of discontinuation (withdrawal) symptoms if stopped abruptly.
- It is a potent inhibitor of CYP2D6, which can lead to significant drug interactions with medications metabolized by this enzyme (e.g., tamoxifen, metoprolol, some antipsychotics).
- Paroxetine is often associated with a higher incidence of sexual dysfunction and weight gain compared to other SSRIs.
- Consider the controlled-release (CR) formulation for patients who experience significant nausea or other GI side effects with the immediate-release form, or for those who prefer once-daily dosing with potentially smoother plasma levels.
- Due to its potential for withdrawal symptoms, always taper paroxetine slowly when discontinuing, typically over several weeks to months, depending on dose and duration of therapy.
Alternative Therapies
- Other SSRIs (e.g., Fluoxetine, Sertraline, Citalopram, Escitalopram, Fluvoxamine)
- SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
- Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Trazodone, Vilazodone, Vortioxetine)
- Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
- MAOIs (Monoamine Oxidase Inhibitors) (e.g., Phenelzine, Tranylcypromine, Selegiline)
- Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic 10mg)
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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.