Paroxetine 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 used to treat depression, anxiety disorders, obsessive-compulsive disorder, and panic attacks. It works by helping to restore the balance of a natural substance (serotonin) in the brain, which can improve mood, sleep, appetite, and energy levels, and decrease nervousness.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. Some brands of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand.
Unless your doctor advises otherwise, take your medication in the morning. It's essential to take your medication as prescribed by your doctor or healthcare provider to ensure its effectiveness.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location and out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
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 make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. Some brands of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand.
Unless your doctor advises otherwise, take your medication in the morning. It's essential to take your medication as prescribed by your doctor or healthcare provider to ensure its effectiveness.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location and out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
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 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 paroxetine, as it can worsen side effects like drowsiness and dizziness.
- Be cautious when driving or operating machinery until you know how paroxetine affects you, as it can cause dizziness or drowsiness.
- 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:
- Paroxetine 20mg Tablets
- Paroxetine 10mg Tablets
- Paroxetine 40mg Tablets
- Paroxetine 30mg Tablets
- Paroxetine 7.5mg Capsules
- Paroxetine ER 25mg Tablets
- Paroxetine ER 25mg Tablets
- Paroxetine ER 37.5mg Tablets
- Paroxetine ER 12.5mg Tablets
- Paroxetine 10mg/5ml Oral Suspension
- Paroxetine ER 12.5mg Tablets
- Paroxetine ER 25mg Tablets
- Paroxetine ER 37.5mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg once daily, typically in the morning
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial 20 mg/day, target 20-50 mg/day. Max 50 mg/day.
Obsessive-Compulsive Disorder (OCD):
Initial 20 mg/day, target 40 mg/day. Max 60 mg/day.
Panic Disorder:
Initial 10 mg/day, target 40 mg/day. Max 60 mg/day.
Social Anxiety Disorder (SAD):
Initial 20 mg/day, target 20-50 mg/day. Max 50 mg/day.
Generalized Anxiety Disorder (GAD):
Initial 20 mg/day, target 20-50 mg/day. Max 50 mg/day.
Post-Traumatic Stress Disorder (PTSD):
Initial 20 mg/day, target 20-50 mg/day. Max 50 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for most indications. Approved for OCD in children 7-17 years: Initial 10 mg/day, target 20-30 mg/day. Max 50 mg/day.
Adolescent:
Approved for OCD in adolescents 7-17 years: Initial 10 mg/day, target 20-30 mg/day. Max 50 mg/day. Approved for MDD in adolescents 12-17 years: Initial 20 mg/day, target 20-50 mg/day. Max 50 mg/day. (Use with caution due to Black Box Warning).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
Initial 10 mg/day, max 40 mg/day (CrCl <30 mL/min)
Severe:
Initial 10 mg/day, max 40 mg/day (CrCl <30 mL/min)
Dialysis:
Initial 10 mg/day, max 40 mg/day. No supplemental dose after dialysis.
Hepatic Impairment:
Mild:
Initial 10 mg/day, max 40 mg/day
Moderate:
Initial 10 mg/day, max 40 mg/day
Severe:
Initial 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). 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 5.2 hours (range 3-8 hours)
FoodEffect:
Food does not significantly affect absorption, but may decrease Cmax and increase Tmax slightly.
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 chronic dosing due to auto-inhibition of CYP2D6
Clearance:
Variable, non-linear kinetics at higher doses due to saturable first-pass metabolism
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug), 36% via feces (primarily as metabolites)
Unchanged:
Less than 2% in urine
Pharmacodynamics
OnsetOfAction:
Initial symptomatic improvement may be seen within 1-2 weeks; full antidepressant effect typically takes 4-6 weeks.
PeakEffect:
4-6 weeks for full therapeutic effect.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, requiring once-daily dosing.
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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 get bigger, or uncontrollable bleeding
Severe dizziness or fainting
Bone pain
Seizures
Significant weight loss
Abnormal burning, numbness, or tingling sensations
Painful or prolonged erections (lasting more than 4 hours)
Sexual problems, including decreased libido, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection
If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. If you experience any of the following symptoms, seek medical help right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Gas
Dry mouth
Trouble sleeping
Shakiness
Yawning
Back pain
* Sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 or seek medical attention immediately:
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 get bigger, or uncontrollable bleeding
Severe dizziness or fainting
Bone pain
Seizures
Significant weight loss
Abnormal burning, numbness, or tingling sensations
Painful or prolonged erections (lasting more than 4 hours)
Sexual problems, including decreased libido, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection
If you experience any of these symptoms, contact your doctor immediately. Additionally, be aware of the risk of serotonin syndrome, a potentially life-threatening condition that may occur, especially when taking certain other medications. If you experience any of the following symptoms, seek medical help right away:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Gas
Dry mouth
Trouble sleeping
Shakiness
Yawning
Back pain
* Sweating
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
- Allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- New or worsening suicidal thoughts or behaviors.
- Unusual bleeding or bruising.
- Seizures.
- Eye pain, vision changes, or swelling around the eye (signs of angle-closure glaucoma).
- Severe skin reactions (e.g., Stevens-Johnson syndrome).
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 between this medication and other substances. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 between this medication and other substances. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require 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 to minimize potential risks.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Potential Risks
This medication may increase your risk of:
Broken bones: Discuss this risk with your doctor.
Bleeding: This can be life-threatening in some cases. Talk to your doctor about this risk.
* Eye problems: 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
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Effects on Children and Teens
This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.
Reproductive Considerations
This medication may affect fertility in males, although it is unclear if this effect is reversible.
Pregnancy and Breastfeeding
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. 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) or the third trimester (which may increase the risk of bleeding after delivery and lead to health problems in the newborn). If you are breastfeeding, discuss the potential risks to your baby with your doctor. You will need to weigh the benefits and risks of taking this medication while pregnant or breastfeeding.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require 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 to minimize potential risks.
Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions.
Delayed Effects
It may take several weeks to experience the full effects of this medication.
Potential Risks
This medication may increase your risk of:
Broken bones: Discuss this risk with your doctor.
Bleeding: This can be life-threatening in some cases. Talk to your doctor about this risk.
* Eye problems: 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
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Effects on Children and Teens
This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this with your doctor.
Reproductive Considerations
This medication may affect fertility in males, although it is unclear if this effect is reversible.
Pregnancy and Breastfeeding
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. 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) or the third trimester (which may increase the risk of bleeding after delivery and lead to health problems in the newborn). If you are breastfeeding, discuss the potential risks to your baby with your doctor. You will need to weigh the benefits and risks of taking this medication while pregnant or breastfeeding.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea
- Vomiting
- Tachycardia (rapid heart rate)
- Tremor
- Agitation
- Dizziness
- Dilated pupils
- Serotonin syndrome (severe cases)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including maintaining an open airway, monitoring vital signs, and managing specific symptoms (e.g., benzodiazepines for agitation/seizures, cyproheptadine for serotonin syndrome).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
- Pimozide - risk of QTc prolongation
- Thioridazine - risk of QTc prolongation and ventricular arrhythmias
- Linezolid (reversible MAOI) - risk of serotonin syndrome
- Methylene blue (IV) - risk of serotonin syndrome
Major Interactions
- Other serotonergic drugs (e.g., triptans, fentanyl, lithium, tramadol, St. John's Wort, other SSRIs/SNRIs, tricyclic antidepressants) - increased risk of serotonin syndrome
- Drugs metabolized by CYP2D6 (e.g., metoprolol, flecainide, propafenone, atomoxetine, risperidone, clozapine, desipramine) - increased plasma concentrations of these drugs
- Warfarin - increased bleeding risk
- NSAIDs/Aspirin - increased bleeding risk
- Tamoxifen - reduced efficacy of tamoxifen (paroxetine is a strong CYP2D6 inhibitor)
Moderate Interactions
- Cimetidine - increases paroxetine levels
- Phenobarbital/Phenytoin - decreases paroxetine levels
- Fosamprenavir/Ritonavir - decreases paroxetine levels
- Digoxin - increased digoxin levels (minor effect)
- Theophylline - increased theophylline levels (minor effect)
Minor Interactions
- Alcohol - may potentiate CNS effects, generally advised to avoid
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline and guide treatment.
Timing: Prior to initiation
Suicidal ideation/behavior assessment
Rationale: Due to Black Box Warning, especially in young adults.
Timing: Prior to initiation
Renal and hepatic function tests (e.g., SCr, ALT/AST)
Rationale: To guide dosing adjustments in impaired patients.
Timing: Prior to initiation
Electrolytes (especially sodium)
Rationale: To assess baseline for hyponatremia risk.
Timing: Prior to initiation, especially in elderly or those on diuretics
Medication reconciliation (especially for CYP2D6 substrates, serotonergic drugs)
Rationale: To identify potential drug interactions.
Timing: Prior to initiation
Routine Monitoring
Clinical response and symptom severity
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Reduction in target symptoms (e.g., HAM-D, GAD-7 scores)
Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or change in therapy.
Adverse effects (e.g., GI upset, sexual dysfunction, insomnia, anxiety, weight changes)
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects may require dose reduction, change in timing, or switch to another agent.
Suicidal ideation/behavior
Frequency: Weekly for first few weeks, especially in pediatric/young adult patients, then regularly
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Any emergence or worsening of suicidal thoughts/behaviors requires immediate clinical assessment and intervention.
Electrolytes (sodium)
Frequency: Periodically, especially in elderly, volume-depleted, or those on diuretics
Target: Na+ 135-145 mEq/L
Action Threshold: Hyponatremia (<135 mEq/L) requires investigation and potential discontinuation.
Weight
Frequency: Periodically
Target: Stable weight or within healthy range
Action Threshold: Significant weight gain or loss may require intervention.
Symptom Monitoring
- Serotonin syndrome (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
- Withdrawal symptoms (dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor, confusion, headache, flu-like symptoms) - especially with abrupt discontinuation
- Worsening depression or anxiety
- New or worsening suicidal thoughts or behaviors
- Unusual bleeding or bruising
- Allergic reactions (rash, hives, swelling)
- Seizures
- Mania/hypomania (in patients with bipolar disorder)
Special Patient Groups
Pregnancy
Paroxetine is Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is an increased risk of congenital cardiac malformations (e.g., ventricular septal defects) when paroxetine is taken during the first trimester. Use in late pregnancy has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital cardiac malformations (e.g., VSD, ASD).
Second Trimester:
Less data, but continued exposure may contribute to PPHN risk.
Third Trimester:
Risk of PPHN and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulty, irritability, tremor, hypotonia, constant crying).
Lactation
Paroxetine is excreted into breast milk in low amounts. While generally considered to have a low risk of adverse effects in breastfed infants, caution is advised. Monitor infants for drowsiness, poor feeding, and weight gain. Other SSRIs with lower milk transfer (e.g., sertraline) may be preferred.
Infant Risk:
L3 (Moderate risk). Low levels in milk, but potential for mild sedation or irritability in infant. Monitor infant for adverse effects.
Pediatric Use
Use in children and adolescents requires careful consideration due to the Black Box Warning regarding increased risk of suicidal thoughts and behavior. Approved for OCD in children 7-17 years and MDD in adolescents 12-17 years, but benefits must outweigh risks. Close monitoring is essential.
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 and falls. Monitor closely for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine has a relatively short half-life among SSRIs, making withdrawal symptoms (discontinuation syndrome) more pronounced and common if discontinued abruptly. Tapering is crucial.
- It is a potent inhibitor of CYP2D6, which is a significant consideration for drug interactions, especially with tamoxifen (reduced efficacy) and certain beta-blockers or antipsychotics.
- Paroxetine is often associated with more weight gain and sexual dysfunction compared to other SSRIs.
- It can be activating for some patients, so taking it in the morning is generally recommended to avoid insomnia.
- Due to its sedating properties, it can be beneficial for anxiety disorders or insomnia when taken at night, but morning dosing is standard for depression.
- Consider alternative SSRIs in pregnant women or those planning pregnancy due to the Category D classification and cardiac malformation risk.
Alternative Therapies
- Other SSRIs (e.g., Sertraline, Fluoxetine, Citalopram, Escitalopram, Fluvoxamine)
- SNRIs (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
- Atypical antidepressants (e.g., Bupropion, Mirtazapine, Trazodone)
- Tricyclic Antidepressants (TCAs)
- MAOIs (less common due to side effects and interactions)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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 is a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call the poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.