Paxil CR 12.5mg 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 panic attacks.It is used to treat anxiety.It is used to treat mood problems caused by monthly periods.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
Jun 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Paroxetine CR is a medication called an antidepressant, specifically a Selective Serotonin Reuptake Inhibitor (SSRI). It works by helping to restore the balance of a natural substance (serotonin) in the brain. It is used to treat depression, panic attacks, social anxiety, and a severe form of PMS called PMDD. The 'CR' means Controlled-Release, so it releases the medicine slowly over time.
How to Use This Medicine
Taking Your Medication Correctly
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 your medication as directed by your doctor or healthcare provider, even if you start to feel better. Swallow the tablet whole - do not chew, break, or crush it. Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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 have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 your medication as directed by your doctor or healthcare provider, even if you start to feel better. Swallow the tablet whole - do not chew, break, or crush it. Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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 have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is 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 food.
- Do not crush, chew, or break the tablet; swallow it whole.
- Do not stop taking this medication suddenly, as it 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 can 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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
12.5 mg once daily, typically in the morning with food.
Dose Range:
12.5 - 62.5 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 25 mg once daily; Max: 62.5 mg/day
Panic Disorder (PD):
Initial: 12.5 mg once daily; Max: 75 mg/day
Social Anxiety Disorder (SAD):
Initial: 12.5 mg once daily; Max: 37.5 mg/day
Premenstrual Dysphoric Disorder (PMDD):
Initial: 12.5 mg once daily (continuously or luteal phase); Max: 25 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for MDD, OCD, SAD in pediatric patients. Use generally not recommended due to suicidality risk.)
Adolescent:
Not established (Safety and efficacy not established for MDD, OCD, SAD in pediatric patients. Use generally not recommended due to suicidality risk.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
Initial dose 12.5 mg/day, titrate cautiously. Max 50 mg/day for MDD/PD, 25 mg/day for SAD/PMDD.
Severe:
Initial dose 12.5 mg/day, titrate cautiously. Max 50 mg/day for MDD/PD, 25 mg/day for SAD/PMDD.
Dialysis:
Considerations: Paroxetine is highly protein bound and not effectively removed by dialysis. Follow severe impairment guidelines.
Hepatic Impairment:
Mild:
Initial dose 12.5 mg/day, titrate cautiously. Max 50 mg/day for MDD/PD, 25 mg/day for SAD/PMDD.
Moderate:
Initial dose 12.5 mg/day, titrate cautiously. Max 50 mg/day for MDD/PD, 25 mg/day for SAD/PMDD.
Severe:
Initial dose 12.5 mg/day, titrate cautiously. Max 50 mg/day for MDD/PD, 25 mg/day for SAD/PMDD.
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-panic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70% (variable due to first-pass metabolism)
Tmax:
Approximately 6-10 hours for CR formulation
FoodEffect:
Food does not significantly affect the absorption of paroxetine CR, but taking it with food may reduce gastrointestinal side effects.
Distribution:
Vd:
Approximately 9.8 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 15-20 hours (for CR formulation, slightly longer than IR)
Clearance:
Highly variable due to non-linear kinetics and genetic polymorphism of CYP2D6
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug), 36% via feces (1% as unchanged drug)
Unchanged:
Approximately 2% (urine), 1% (feces)
Pharmacodynamics
OnsetOfAction:
Clinical effects typically begin within 1-2 weeks, but full therapeutic effects may take 4-6 weeks.
PeakEffect:
Peak therapeutic effect typically observed after 4-6 weeks of consistent dosing.
DurationOfAction:
Due to its half-life, effects persist for approximately 24 hours, 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.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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, gum bleeding, abnormal vaginal bleeding, unexplained bruising 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, such as decreased libido, difficulty achieving orgasm, ejaculation issues, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek 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, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
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. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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 can also provide medical advice 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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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, gum bleeding, abnormal vaginal bleeding, unexplained bruising 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, such as decreased libido, difficulty achieving orgasm, ejaculation issues, or erectile dysfunction. If you have concerns, discuss them with your doctor.
Serotonin Syndrome: A Potentially Life-Threatening Condition
There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek 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, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:
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. Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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 can also provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or anxiety
- New or worsening thoughts of self-harm or suicide
- Unusual changes in behavior or mood (e.g., agitation, irritability, aggression, panic attacks, impulsivity, restlessness, severe insomnia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness/twitching, loss of coordination, nausea, vomiting, diarrhea)
- Symptoms of hyponatremia (low sodium) (e.g., headache, confusion, weakness, unsteadiness, memory problems, severe drowsiness, seizures)
- Unusual bleeding or bruising
- Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
- Eye pain, vision changes, or swelling/redness around the eye (may indicate angle-closure glaucoma)
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 any 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 (OTC) medications
Natural products
* Vitamins
Additionally, share any health problems you have with your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with narrow-angle glaucoma.
If you are currently taking or have recently taken any of the following medications: Linezolid, methylene blue, pimozide, or thioridazine.
If you have taken any 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 (OTC) medications
Natural products
* Vitamins
Additionally, share any health problems you have with your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will instruct you on how to gradually taper off the drug.
While taking this medication, avoid consuming alcohol and consult your doctor before using marijuana, cannabis, or prescription and over-the-counter drugs that may impair your reactions.
It may take several weeks to experience the full effects of this medication. Be aware that it may increase your risk of fractures; discuss this with your doctor.
Additionally, this medication may increase your risk of bleeding, which can be life-threatening in some cases. Talk to your doctor about this potential risk.
Some individuals may have a higher risk of developing 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.
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 or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; discuss this with your doctor.
This medication's impact on fertility is unknown, and it is unclear if any effects on fertility will be reversible.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects, in the unborn baby. Use during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication while pregnant or breastfeeding.
To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will instruct you on how to gradually taper off the drug.
While taking this medication, avoid consuming alcohol and consult your doctor before using marijuana, cannabis, or prescription and over-the-counter drugs that may impair your reactions.
It may take several weeks to experience the full effects of this medication. Be aware that it may increase your risk of fractures; discuss this with your doctor.
Additionally, this medication may increase your risk of bleeding, which can be life-threatening in some cases. Talk to your doctor about this potential risk.
Some individuals may have a higher risk of developing 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.
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 or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; discuss this with your doctor.
This medication's impact on fertility is unknown, and it is unclear if any effects on fertility will be reversible.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects, in the unborn baby. Use during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication while pregnant or breastfeeding.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea, vomiting
- Dizziness
- Tremor
- Dilated pupils
- Agitation
- Tachycardia (rapid heart rate)
- Serotonin syndrome (severe cases)
- Seizures
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.
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)
Major Interactions
- Serotonergic drugs (e.g., triptans, tramadol, fentanyl, lithium, St. John's Wort, other SSRIs, SNRIs, TCAs, tryptophan) - increased risk of serotonin syndrome.
- Drugs metabolized by CYP2D6 with narrow therapeutic index (e.g., flecainide, propafenone, metoprolol, atomoxetine, desipramine, risperidone, tamoxifen) - increased plasma concentrations of these drugs.
- Warfarin and other oral anticoagulants - increased bleeding risk.
- NSAIDs, aspirin, other antiplatelet agents - increased bleeding risk.
- Linezolid (MAOI activity) - increased risk of serotonin syndrome.
- Methylene blue (MAOI activity) - increased risk of serotonin syndrome.
Moderate Interactions
- Cimetidine (CYP inhibitor) - may increase paroxetine levels.
- Phenobarbital, phenytoin (CYP inducers) - may decrease paroxetine levels.
- Fosamprenavir/ritonavir - may decrease paroxetine levels.
- Tricyclic Antidepressants (TCAs) - increased TCA levels due to CYP2D6 inhibition.
- Digoxin - potential for increased digoxin levels.
- Theophylline - potential for increased theophylline levels.
- Alcohol - avoid concurrent use due to potential for additive CNS depression.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline mental status and guide treatment.
Timing: Prior to initiation
Weight and Height (BMI)
Rationale: SSRIs can cause weight changes.
Timing: Prior to initiation
Blood pressure and heart rate
Rationale: To establish baseline cardiovascular status.
Timing: Prior to initiation
Electrolytes (especially sodium)
Rationale: Risk of hyponatremia, particularly in elderly or those on diuretics.
Timing: Prior to initiation (consider in at-risk patients)
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 after adequate trial, worsening symptoms, or emergence of new symptoms.
Emergence of suicidal ideation/behavior
Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then monthly for 12 weeks, then periodically
Target: Absence of suicidal thoughts or behaviors
Action Threshold: Any new or worsening suicidal ideation or behavior requires immediate assessment and intervention.
Side effects (e.g., GI upset, sexual dysfunction, insomnia, somnolence, anxiety, agitation)
Frequency: Regularly, especially during dose titration and initial weeks
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects, requiring dose adjustment or change in therapy.
Weight
Frequency: Monthly for first few months, then every 3-6 months
Target: Stable weight or within acceptable range
Action Threshold: Significant weight gain or loss.
Sodium levels
Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia
Target: 135-145 mEq/L
Action Threshold: Sodium < 135 mEq/L or symptomatic hyponatremia.
Symptom Monitoring
- Worsening depression
- New or worsening anxiety/agitation
- Panic attacks
- Insomnia
- Irritability
- Hostility/aggressiveness
- Impulsivity
- Akathisia (psychomotor restlessness)
- Hypomania/mania
- Unusual changes in behavior
- Suicidal ideation or attempts
- Nausea, diarrhea, constipation
- Headache
- Dizziness
- Dry mouth
- Sweating
- Sexual dysfunction (decreased libido, anorgasmia, ejaculatory delay)
- Tremor
- Hyponatremia symptoms (headache, confusion, weakness, seizures)
Special Patient Groups
Pregnancy
Paroxetine is generally not recommended during pregnancy, especially in the first trimester due to an increased risk of congenital cardiac malformations (e.g., ventricular septal defects) and in the third trimester due to risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome. The decision to use paroxetine during pregnancy should be made after careful consideration of the potential risks to the fetus versus the benefits to the mother, particularly for severe maternal depression.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital cardiac malformations (e.g., ventricular septal defects).
Second Trimester:
Less data, but generally considered lower risk than first or third trimester for major malformations.
Third Trimester:
Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, weak cry).
Lactation
Paroxetine is excreted into breast milk. While levels in breast milk are generally low, and many infants show no adverse effects, some infants may experience drowsiness, poor feeding, or weight loss. The American Academy of Pediatrics considers paroxetine to be a drug for which the effect on a nursing infant is unknown but may be of concern. Other SSRIs with lower milk transfer (e.g., sertraline) may be preferred.
Infant Risk:
L3 (Moderately safe; detectable in milk, potential for mild adverse effects in infant; monitor infant for drowsiness, feeding issues, weight changes).
Pediatric Use
Safety and efficacy have not been established for pediatric patients for MDD, OCD, or SAD. Antidepressants, including paroxetine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (aged 18-24) compared to placebo. Use in this population is generally not recommended unless the clinical need is compelling and the potential benefits outweigh the risks, with close monitoring.
Geriatric Use
Elderly patients may be more sensitive to the effects of paroxetine, including a higher risk of hyponatremia (SIADH) and falls. Lower initial doses and slower titration are recommended. Max dose for MDD/PD is 50 mg/day, for SAD/PMDD is 25 mg/day. Monitor for adverse effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine is one of the most potent SSRIs for serotonin reuptake inhibition and is also a strong CYP2D6 inhibitor, leading to significant drug interactions.
- It has a relatively short half-life compared to some other SSRIs, making discontinuation syndrome (withdrawal symptoms) more pronounced if stopped abruptly. Tapering is crucial.
- The CR formulation aims to reduce the incidence of nausea and provide smoother plasma concentrations compared to the immediate-release formulation.
- Paroxetine is associated with a higher incidence of sexual dysfunction and weight gain compared to some other SSRIs.
- Consider alternative SSRIs in pregnant or breastfeeding individuals due to higher risks compared to other agents in its class.
- Monitor for activation syndrome (anxiety, agitation, insomnia) especially during initial treatment or dose increases.
Alternative Therapies
- Other SSRIs (e.g., sertraline, fluoxetine, escitalopram, citalopram, fluvoxamine)
- SNRIs (e.g., venlafaxine, duloxetine, desvenlafaxine)
- Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
- Tricyclic Antidepressants (TCAs)
- Monoamine Oxidase Inhibitors (MAOIs)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
- Electroconvulsive Therapy (ECT) for severe depression
Cost & Coverage
Average Cost:
Varies widely, typically $30-$150 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.