Paxil 40mg 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 (OCD), panic attacks, and premenstrual dysphoric disorder (PMDD). 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.
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.
Some formulations of this medication may need to be swallowed whole. If you're unsure about your specific brand, consult with your doctor or pharmacist. Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult with 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Some formulations of this medication may need to be swallowed whole. If you're unsure about your specific brand, consult with your doctor or pharmacist. Unless your doctor advises otherwise, take your medication in the morning.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult with 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take paroxetine 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.
- Be cautious when driving or operating machinery until you know how this medication affects you.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, as serious interactions can occur.
- Regular exercise, a balanced diet, and good sleep hygiene can complement the medication's effects.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg once daily, typically in the morning. For specific conditions, higher doses may be used.
Dose Range:
10 - 60 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 20 mg/day; Maintenance: 20-50 mg/day
Obsessive-Compulsive Disorder (OCD):
Initial: 20 mg/day; Maintenance: 40-60 mg/day
Panic Disorder:
Initial: 10 mg/day; Maintenance: 20-40 mg/day
Social Anxiety Disorder (SAD):
Initial: 20 mg/day; Maintenance: 20-50 mg/day
Generalized Anxiety Disorder (GAD):
Initial: 20 mg/day; Maintenance: 20-50 mg/day
Post-Traumatic Stress Disorder (PTSD):
Initial: 20 mg/day; Maintenance: 20-50 mg/day
Premenstrual Dysphoric Disorder (PMDD):
20 mg/day (daily or luteal phase dosing)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for MDD; for OCD (7-17 years): Initial 10 mg/day, target 20-50 mg/day
Adolescent:
Not established for MDD due to Black Box Warning; for OCD (7-17 years): Initial 10 mg/day, target 20-50 mg/day
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
Initial dose 10 mg/day, maximum 40 mg/day
Severe:
Initial dose 10 mg/day, maximum 40 mg/day
Dialysis:
No specific recommendations, but caution and dose reduction are advised due to increased plasma levels.
Hepatic Impairment:
Mild:
Initial dose 10 mg/day, maximum 40 mg/day
Moderate:
Initial dose 10 mg/day, maximum 40 mg/day
Severe:
Initial dose 10 mg/day, maximum 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 (for conventional tablets)
FoodEffect:
Food does not significantly affect absorption, but may slightly delay Tmax.
Distribution:
Vd:
Approximately 9.8 L/kg
ProteinBinding:
Approximately 95% (primarily to plasma proteins)
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 21 hours (range 7-65 hours, dose-dependent due to saturable metabolism)
Clearance:
Variable, decreases with increasing dose due to saturable metabolism
ExcretionRoute:
Approximately 64% via urine (2% as unchanged drug, remainder as metabolites); approximately 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, allowing for 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) in patients 7-17 years of age.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ 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 a severe and potentially life-threatening condition called serotonin syndrome may occur, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance or coordination
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild symptoms, it is essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating
If any of these side effects bother you or persist, consult your doctor. Remember that this is not an exhaustive list of possible side effects. If you have concerns or questions, discuss them with your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing or memory problems
+ Feeling confused or weak
+ Seizures or changes in balance
Signs of infection, such as:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased sputum production or a change in sputum color
+ Pain while urinating or mouth sores
+ A wound that will not heal
Signs of bleeding, including:
+ Vomiting or coughing up blood
+ Vomit that resembles coffee grounds
+ Blood in the urine or black, red, or tarry stools
+ Bleeding from the gums or abnormal vaginal bleeding
+ Unexplained bruises or bruises that enlarge
+ 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 a severe and potentially life-threatening condition called serotonin syndrome may occur, especially when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance or coordination
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
While many people may not experience side effects or may only have mild symptoms, it is essential to be aware of the following potential side effects:
Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating
If any of these side effects bother you or persist, consult your doctor. Remember that this is not an exhaustive list of possible side effects. If you have concerns or questions, discuss them with your doctor.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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, restlessness, panic attacks, irritability, aggression, impulsivity, severe restlessness, mania)
- Symptoms of serotonin syndrome: fever, sweating, confusion, severe muscle stiffness or twitching, shivering, diarrhea, loss of coordination, fast heartbeat
- Symptoms of hyponatremia (low sodium): headache, confusion, weakness, unsteadiness, memory problems, seizures
- Unusual bleeding or bruising
- Eye pain, vision changes, or swelling or 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 conditions and situations to ensure safe treatment:
Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A diagnosis of narrow-angle glaucoma.
* Current or recent use of specific medications, including:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
+ Certain drugs for depression or Parkinson's disease taken within the last 14 days, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: taking these medications with this drug may lead to very high blood pressure)
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
A diagnosis of narrow-angle glaucoma.
* Current or recent use of specific medications, including:
+ Linezolid
+ Methylene blue
+ Pimozide
+ Thioridazine
+ Certain drugs for depression or Parkinson's disease taken within the last 14 days, such as:
- Isocarboxazid
- Phenelzine
- Tranylcypromine
- Selegiline
- Rasagiline (note: taking these medications with this drug may lead to very high blood pressure)
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Stopping the Medication
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this drug, your doctor will instruct you on how to gradually stop taking 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 potential risk with your doctor.
Bleeding: This medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this potential risk.
* Eye Problems: Certain individuals may be more susceptible to eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
Special Considerations
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 adolescents. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
Reproductive Considerations
This medication may affect fertility in males, although it is unclear if this effect is reversible.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, particularly if taken during the first trimester (which may increase the risk of birth defects, mainly heart defects) or the third trimester (which may increase the risk of bleeding after delivery and lead to health problems in the newborn).
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication to you and your baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Before taking this medication, inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Stopping the Medication
Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this drug, your doctor will instruct you on how to gradually stop taking 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 potential risk with your doctor.
Bleeding: This medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this potential risk.
* Eye Problems: Certain individuals may be more susceptible to eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.
Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.
Special Considerations
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 adolescents. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
Reproductive Considerations
This medication may affect fertility in males, although it is unclear if this effect is reversible.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately. This medication may harm the unborn baby, particularly if taken during the first trimester (which may increase the risk of birth defects, mainly heart defects) or the third trimester (which may increase the risk of bleeding after delivery and lead to health problems in the newborn).
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of this medication to you and your baby.
Breastfeeding
If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Nausea, vomiting
- Tremor
- Fast heartbeat
- Dilated pupils
- Agitation
- Sweating
- Rarely: seizures, coma, ECG changes
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 and arrhythmias
- Thioridazine - risk of QT prolongation and arrhythmias
Major Interactions
- Triptans (e.g., sumatriptan) - risk of serotonin syndrome
- Tramadol - risk of serotonin syndrome
- Linezolid - risk of serotonin syndrome
- Methylene blue - risk of serotonin syndrome
- Other serotonergic drugs (e.g., other SSRIs, SNRIs, TCAs, fentanyl, lithium, St. John's Wort, tryptophan) - risk of serotonin syndrome
- Warfarin - increased bleeding risk (monitor INR)
- NSAIDs/Aspirin - increased bleeding risk
- Metoprolol - increased metoprolol levels (paroxetine is a CYP2D6 inhibitor)
- Flecainide, Propafenone - increased levels (paroxetine is a CYP2D6 inhibitor)
- Atomoxetine - increased atomoxetine levels (paroxetine is a CYP2D6 inhibitor)
- Tamoxifen - reduced efficacy of tamoxifen (paroxetine is a strong CYP2D6 inhibitor, interfering with activation)
Moderate Interactions
- Cimetidine - increases paroxetine levels
- Phenobarbital, Phenytoin - may decrease paroxetine levels
- Digoxin - increased digoxin levels (monitor)
- Theophylline - increased theophylline levels (monitor)
- Risperidone - increased risperidone levels (paroxetine is a CYP2D6 inhibitor)
- Aripiprazole - increased aripiprazole levels (paroxetine is a CYP2D6 inhibitor)
- Codeine, Hydrocodone, Oxycodone (prodrugs activated by CYP2D6) - reduced analgesic effect
- Alcohol - additive CNS depressant effects
Minor Interactions
- Diazepam - may slightly increase diazepam levels
- Procyclidine - increased procyclidine levels
Monitoring
Baseline Monitoring
Psychiatric evaluation (diagnosis, symptom severity)
Rationale: To establish baseline and guide treatment decisions.
Timing: Prior to initiation
Suicidal ideation/behavior assessment
Rationale: To identify baseline risk, especially in pediatric/young adult patients.
Timing: Prior to initiation
Renal and hepatic function tests (BUN, creatinine, LFTs)
Rationale: To guide initial dosing adjustments in impaired patients.
Timing: Prior to initiation
Electrolytes (Sodium)
Rationale: To establish baseline, especially in elderly or those at risk for hyponatremia.
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, worsening symptoms, or emergence of new symptoms (e.g., suicidality)
Side effects assessment
Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated
Target: Tolerable side effect profile
Action Threshold: Intolerable side effects, emergence of serotonin syndrome symptoms, or severe adverse reactions
Suicidal ideation/behavior
Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then at 12 weeks, and as clinically indicated thereafter, especially in pediatric/young adults
Target: Absence of new or worsening suicidal thoughts/behaviors
Action Threshold: Any emergence or worsening of suicidal ideation or behavior
Weight
Frequency: Periodically (e.g., every 3-6 months)
Target: Stable weight or within acceptable range
Action Threshold: Significant weight gain or loss
Serum Sodium
Frequency: Periodically, especially in elderly, those on diuretics, or with symptoms of hyponatremia
Target: 135-145 mEq/L
Action Threshold: <135 mEq/L or symptomatic hyponatremia
Bleeding (e.g., bruising, petechiae, GI bleeding)
Frequency: As clinically indicated, especially if co-administered with anticoagulants/antiplatelets
Target: Absence of abnormal bleeding
Action Threshold: Any signs of abnormal bleeding
Symptom Monitoring
- Worsening depression or anxiety
- Emergence of suicidal thoughts or behaviors
- Agitation, restlessness, irritability
- Panic attacks
- Insomnia
- Aggressiveness, impulsivity
- Mania or hypomania
- Serotonin syndrome symptoms (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
- Hyponatremia symptoms (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
- Withdrawal symptoms upon discontinuation (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor)
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 are known risks associated with exposure.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital cardiac malformations (e.g., ventricular septal defects, atrial septal defects) compared to other SSRIs.
Second Trimester:
Potential for persistent pulmonary hypertension of the newborn (PPHN) if exposed late in pregnancy.
Third Trimester:
Risk of neonatal withdrawal syndrome (poor feeding, irritability, tremor, respiratory distress, seizures) and PPHN. Avoid abrupt discontinuation due to maternal withdrawal symptoms.
Lactation
Paroxetine is excreted into breast milk. The American Academy of Pediatrics considers it a drug for which the effect on a nursing infant is unknown but may be of concern. Other SSRIs with lower infant exposure (e.g., sertraline, escitalopram) may be preferred.
Infant Risk:
L3 (Moderate risk). Monitor infants for drowsiness, poor feeding, and weight gain. While levels in milk are generally low, some infants may experience adverse effects.
Pediatric Use
Not approved for Major Depressive Disorder (MDD) in pediatric patients due to increased risk of suicidal thoughts and behaviors (Black Box Warning). Approved for Obsessive-Compulsive Disorder (OCD) in patients aged 7-17 years, but close monitoring for suicidality is essential. Not recommended for children under 7 years.
Geriatric Use
Lower starting doses (e.g., 10 mg/day) are recommended due to reduced clearance and increased risk of adverse effects, particularly hyponatremia (SIADH) and falls. Monitor closely for side effects and drug interactions.
Clinical Information
Clinical Pearls
- Paroxetine is a potent CYP2D6 inhibitor, which can lead to significant drug interactions, especially with tamoxifen (reduced efficacy) and certain beta-blockers, antiarrhythmics, and antipsychotics.
- It has a relatively short half-life compared to other SSRIs, making withdrawal symptoms (SSRI discontinuation syndrome) more pronounced and common if discontinued abruptly. Tapering is crucial.
- Among SSRIs, paroxetine is often associated with a higher incidence of weight gain and sexual dysfunction.
- It is one of the more sedating SSRIs, often taken in the morning to avoid insomnia, but can cause drowsiness in some patients.
- Due to its pregnancy category D and cardiac malformation risk, it is generally avoided in women of childbearing potential who may become pregnant, if other SSRIs are suitable alternatives.
Alternative Therapies
- Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline (Zoloft), Fluoxetine (Prozac), Escitalopram (Lexapro), Citalopram (Celexa), Fluvoxamine (Luvox)
- Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine (Effexor), Duloxetine (Cymbalta), Desvenlafaxine (Pristiq)
- Atypical Antidepressants: Bupropion (Wellbutrin), Mirtazapine (Remeron), Trazodone
- Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
- Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine (used less commonly due to significant drug and food interactions)
- Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
- Electroconvulsive Therapy (ECT) for severe, refractory depression
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (generic 40mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.