Paxil 10mg/5ml Oral Susp
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It is used to treat obsessive-compulsive problems.It is used to treat panic attacks.It is used to treat anxiety.It is used to treat post-traumatic stress. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Selective Serotonin Reuptake Inhibitor (SSRI)
Pregnancy Category
Category D
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Paroxetine is a medication used to treat depression, anxiety disorders, obsessive-compulsive disorder, and post-traumatic stress disorder. It works by helping to restore the balance of a natural substance (serotonin) in the brain, which can improve mood, sleep, appetite, and energy levels, and decrease anxiety and panic attacks.
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. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
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, avoiding bathrooms. Keep all medications in a safe location, out of the 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 want to check if there are 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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. It's essential to continue taking this medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
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, avoiding bathrooms. Keep all medications in a safe location, out of the 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 want to check if there are 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Report any new or worsening symptoms, especially changes in mood, behavior, or thoughts of self-harm, to your doctor immediately.
- Inform your doctor and pharmacist about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg (10 mL) orally once daily, typically in the morning.
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 20 mg (10 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 50 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial: 20 mg (10 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 60 mg/day.
Panic Disorder:
Initial: 10 mg (5 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 60 mg/day.
Social Anxiety Disorder (Social Phobia):
Initial: 20 mg (10 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 50 mg/day.
Generalized Anxiety Disorder (GAD):
Initial: 20 mg (10 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 50 mg/day.
Post-Traumatic Stress Disorder (PTSD):
Initial: 20 mg (10 mL) once daily; Titrate by 10 mg/day increments at weekly intervals, max 50 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for MDD due to increased risk of suicidality. For OCD, 10-20 mg (5-10 mL) once daily, titrate by 10 mg/day increments at weekly intervals, max 50 mg/day (ages 7-17).
Adolescent:
Not recommended for MDD due to increased risk of suicidality. For OCD, 10-20 mg (5-10 mL) once daily, titrate by 10 mg/day increments at weekly intervals, max 50 mg/day (ages 7-17).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
Initial dose 10 mg (5 mL) once daily. Max 40 mg/day.
Severe:
Initial dose 10 mg (5 mL) once daily. Max 40 mg/day.
Dialysis:
Consider lower doses and monitor closely due to potential for accumulation.
Hepatic Impairment:
Mild:
Initial dose 10 mg (5 mL) once daily. Max 40 mg/day.
Moderate:
Initial dose 10 mg (5 mL) once daily. Max 40 mg/day.
Severe:
Initial dose 10 mg (5 mL) once daily. 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). By blocking the reuptake of serotonin into presynaptic neurons, it increases the concentration of serotonin in the synaptic cleft, thereby enhancing serotonergic neurotransmission. This action is believed to be responsible for its antidepressant, anxiolytic, and anti-obsessive effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 50-60% (variable due to first-pass metabolism)
Tmax:
Approximately 5-8 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 (readily crosses the blood-brain barrier)
Elimination:
HalfLife:
Approximately 21 hours (highly variable, can range from 3 to 65 hours)
Clearance:
Approximately 0.3-0.4 L/kg/hr (decreases with higher doses due to saturation of first-pass metabolism)
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug), 36% via feces (1% as unchanged drug)
Unchanged:
Less than 2% in urine, less than 1% in feces
Pharmacodynamics
OnsetOfAction:
Antidepressant effects typically begin within 1-4 weeks; anxiolytic effects may be seen earlier.
PeakEffect:
Full therapeutic effects may take 4-6 weeks or longer.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, allowing once-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine is not approved for use in pediatric patients except for Obsessive Compulsive Disorder (OCD).
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, difficulty 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, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, 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, consult your doctor. Additionally, be aware that this medication can increase the risk of a rare but potentially life-threatening condition called serotonin syndrome, especially when combined with other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or irregular heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, difficulty 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, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, 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, consult your doctor. Additionally, be aware that this medication can increase the risk of a rare but potentially life-threatening condition called serotonin syndrome, especially when combined with other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or irregular heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
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
This is not an exhaustive list of possible side effects. If you have concerns or questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (restlessness), hypomania, and mania.
- New or worsening thoughts of self-harm or suicide.
- Signs of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
- Signs of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, memory problems.
- Unusual bleeding or bruising.
- Allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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, or thioridazine.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Always check with your doctor before starting, stopping, or changing the dose of any medication to confirm that it is safe to do so.
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, or thioridazine.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Always check with your doctor before starting, stopping, or changing the dose of any medication to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, make sure you understand how this medication affects you.
To minimize the risk of side effects, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually taper off the medication.
While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your reactions.
You may need to wait several weeks to experience the full effects of this medication.
Be aware that this medication may increase your risk of fractures. Discuss this potential risk with your doctor.
There is also a potential increased risk of bleeding associated with this medication, which in some cases can be life-threatening. Consult with your doctor to understand this risk.
Some individuals may be more susceptible to eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death. If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. Discuss this potential risk with your doctor.
There is also a potential impact on fertility, and it is unclear whether this effect is reversible.
If you are pregnant, planning to become pregnant, or may be pregnant, inform your doctor, as this medication may pose risks to the unborn baby. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects. Use during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Before operating a vehicle or engaging in any activity that requires your full attention, make sure you understand how this medication affects you.
To minimize the risk of side effects, do not abruptly stop taking this medication without first consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually taper off the medication.
While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult with your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or impair your reactions.
You may need to wait several weeks to experience the full effects of this medication.
Be aware that this medication may increase your risk of fractures. Discuss this potential risk with your doctor.
There is also a potential increased risk of bleeding associated with this medication, which in some cases can be life-threatening. Consult with your doctor to understand this risk.
Some individuals may be more susceptible to eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death. If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.
In some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. Discuss this potential risk with your doctor.
There is also a potential impact on fertility, and it is unclear whether this effect is reversible.
If you are pregnant, planning to become pregnant, or may be pregnant, inform your doctor, as this medication may pose risks to the unborn baby. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects. Use during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea
- Vomiting
- Tachycardia (fast heart rate)
- Tremor
- Dilated pupils
- Agitation
- Serotonin syndrome (severe cases)
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
- Pimozide (risk of QT prolongation)
- Thioridazine (risk of QT prolongation and 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)
- Tricyclic Antidepressants (TCAs) (e.g., imipramine, desipramine) (paroxetine inhibits CYP2D6, increasing TCA levels)
- Antiarrhythmics (e.g., flecainide, propafenone) (paroxetine inhibits CYP2D6, increasing antiarrhythmic levels)
- Warfarin (increased risk of bleeding)
- NSAIDs/Aspirin (increased risk of bleeding)
- Other serotonergic drugs (e.g., fentanyl, tramadol, St. John's Wort, lithium, buspirone) (risk of serotonin syndrome)
- Tamoxifen (paroxetine inhibits CYP2D6, potentially reducing tamoxifen's active metabolite, endoxifen, and efficacy)
- Metoprolol (paroxetine inhibits CYP2D6, increasing metoprolol levels)
Moderate Interactions
- Cimetidine (increases paroxetine levels)
- Phenobarbital, Phenytoin (may decrease paroxetine levels)
- Digoxin (paroxetine may increase digoxin levels)
- Theophylline (paroxetine may increase theophylline levels)
- Risperidone (paroxetine inhibits CYP2D6, increasing risperidone levels)
- Atomoxetine (paroxetine inhibits CYP2D6, increasing atomoxetine levels)
Minor Interactions
- Alcohol (avoid, though no direct pharmacokinetic interaction, can worsen CNS depression)
- Benzodiazepines (additive CNS depression)
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, ALT, AST)
Rationale: To guide initial dosing adjustments in patients with impairment.
Timing: Prior to initiation of therapy.
Electrolytes (especially sodium)
Rationale: To establish baseline, particularly in elderly or those at risk for hyponatremia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and symptom severity
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.
Target: Reduction in target symptoms (e.g., HAM-D, GAD-7 scores).
Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.
Emergence of suicidal ideation or behavior
Frequency: Especially during initial treatment and dose changes (first few months).
Target: Absence of new or worsening suicidal thoughts/behaviors.
Action Threshold: Immediate clinical assessment and intervention if observed.
Adverse effects (e.g., nausea, insomnia, sexual dysfunction, agitation)
Frequency: Regularly, especially during dose titration.
Target: Tolerable side effect profile.
Action Threshold: Severe or intolerable side effects may require dose reduction or discontinuation.
Weight
Frequency: Periodically, especially in long-term therapy.
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: Normal serum sodium levels (135-145 mEq/L).
Action Threshold: Hyponatremia (Na < 135 mEq/L) requires investigation and management.
Bleeding/Bruising
Frequency: Monitor, especially if co-administered with anticoagulants, antiplatelets, or NSAIDs.
Target: Absence of abnormal bleeding.
Action Threshold: Any signs of unusual bleeding require immediate evaluation.
Symptom Monitoring
- Worsening depression or anxiety
- New or worsening suicidal thoughts or behavior
- Agitation, restlessness, panic attacks
- Insomnia, irritability
- Aggressiveness, impulsivity
- Mania or hypomania
- Serotonin syndrome (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
- Hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls)
- Abnormal bleeding or bruising
- Withdrawal symptoms upon discontinuation (dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor, confusion)
Special Patient Groups
Pregnancy
Paroxetine is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is evidence of increased risk of congenital malformations, particularly cardiovascular malformations (e.g., atrial and ventricular septal defects), with first-trimester exposure. Exposure in late pregnancy has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome.
Trimester-Specific Risks:
First Trimester:
Increased risk of cardiovascular malformations (e.g., VSD, ASD).
Second Trimester:
Potential for continued fetal exposure and accumulation.
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, seizures).
Lactation
Paroxetine is excreted into breast milk. While levels in breast milk are generally low, potential for adverse effects in the infant exists. Use with caution, and monitor the infant for drowsiness, poor feeding, and weight gain. Other SSRIs with lower milk transfer (e.g., sertraline) may be preferred.
Infant Risk:
L3 (Moderately Safe) - Monitor for sedation, irritability, poor feeding, and weight gain. Risk of adverse effects is generally low but possible.
Pediatric Use
Not approved for Major Depressive Disorder (MDD) in pediatric patients due to increased risk of suicidality. Approved for Obsessive-Compulsive Disorder (OCD) in children and adolescents (ages 7-17). Close monitoring for suicidality and behavioral changes is crucial. Lower starting doses and careful titration are recommended.
Geriatric Use
Elderly patients may be more sensitive to the effects of paroxetine, particularly side effects such as hyponatremia (SIADH), dizziness, and falls. Lower starting doses (e.g., 10 mg/day) and slower titration are recommended. Monitor renal function and electrolytes closely.
Clinical Information
Clinical Pearls
- Paroxetine is a potent CYP2D6 inhibitor, which can lead to significant drug interactions with substrates of this enzyme (e.g., tamoxifen, TCAs, antiarrhythmics).
- It has a relatively short half-life compared to other SSRIs, making withdrawal symptoms (discontinuation syndrome) more pronounced and common if discontinued abruptly. Tapering is essential.
- Among SSRIs, paroxetine is often associated with a higher incidence of sexual dysfunction and weight gain.
- It can be activating for some patients, so taking it in the morning is generally recommended to avoid insomnia.
- The oral suspension form is useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
- Due to its pregnancy category D, it is generally avoided in women who are pregnant or planning to become pregnant, with alternative SSRIs often preferred if medication is necessary.
Alternative Therapies
- Other SSRIs (e.g., Sertraline, Fluoxetine, Citalopram, Escitalopram, Fluvoxamine)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., Venlafaxine, Duloxetine)
- Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Trazodone)
- Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine)
- Cognitive Behavioral Therapy (CBT)
- Psychotherapy
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 100 mL (200 mg total)
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.