Paxil CR 37.5mg Tablets

Manufacturer APOTEX Active Ingredient Paroxetine Controlled-Release Tablets(pa ROKS e teen) Pronunciation PAR-ox-e-teen
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.
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Drug Class
Antidepressant
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Pharmacologic Class
Selective Serotonin Reuptake Inhibitor (SSRI)
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Pregnancy Category
Category D
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FDA Approved
May 1999
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Paroxetine controlled-release is a medication used to treat depression, panic attacks, social anxiety disorder, and premenstrual dysphoric disorder. It works by helping to restore the balance of a natural substance (serotonin) in the brain. The 'CR' means controlled-release, so the medication is released slowly over time.
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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 medication 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 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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily in the morning with food.
  • Do not crush, chew, or break the controlled-release tablet; swallow it whole.
  • Avoid sudden discontinuation; withdrawal symptoms can occur. Taper off slowly under medical supervision.
  • Avoid alcohol while taking this medication.
  • Be aware of potential for drowsiness or dizziness, especially when starting or changing dose. Avoid driving or operating machinery until you know how it affects you.
  • Report any new or worsening symptoms, especially suicidal thoughts, 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.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For Major Depressive Disorder (MDD), initial 25 mg once daily, target 25-62.5 mg once daily. For Panic Disorder, initial 12.5 mg once daily, target 12.5-75 mg once daily. For Social Anxiety Disorder, initial 12.5 mg once daily, target 12.5-37.5 mg once daily. For Premenstrual Dysphoric Disorder (PMDD), 12.5 mg or 25 mg once daily continuously or during luteal phase.
Dose Range: 12.5 - 75 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial 25 mg once daily, may increase by 12.5 mg/day at weekly intervals to a maximum of 62.5 mg/day.
Panic Disorder: Initial 12.5 mg once daily, may increase by 12.5 mg/day at weekly intervals to a maximum of 75 mg/day.
Social Anxiety Disorder (SAD): Initial 12.5 mg once daily, may increase by 12.5 mg/day at weekly intervals to a maximum of 37.5 mg/day.
Premenstrual Dysphoric Disorder (PMDD): 12.5 mg or 25 mg once daily, either continuously or during the luteal phase only.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established; generally not recommended due to increased risk of suicidality)
Adolescent: Not established (Safety and efficacy not established; generally not recommended due to increased risk of suicidality)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: Initial dose should be at the lower end of the dosing range (e.g., 12.5 mg/day for most indications).
Severe: Initial dose should be at the lower end of the dosing range (e.g., 12.5 mg/day for most indications).
Dialysis: Consider lower initial doses and careful titration due to increased exposure.

Hepatic Impairment:

Mild: Initial dose should be at the lower end of the dosing range (e.g., 12.5 mg/day for most indications).
Moderate: Initial dose should be at the lower end of the dosing range (e.g., 12.5 mg/day for most indications).
Severe: Initial dose should be at the lower end of the dosing range (e.g., 12.5 mg/day for most indications).

Pharmacology

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Mechanism of Action

Paroxetine is a potent and selective inhibitor of serotonin (5-hydroxytryptamine; 5-HT) reuptake in the central nervous system (CNS). It is believed that the antidepressant, anti-panic, and anti-social anxiety effects of paroxetine are related to its potentiation of serotonergic activity in the CNS resulting from this inhibition of neuronal reuptake of serotonin.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50-60% (oral)
Tmax: Approximately 6-10 hours (for CR formulation)
FoodEffect: Food does not significantly affect the absorption of paroxetine CR tablets, but it may delay Tmax slightly. Should be taken with food.

Distribution:

Vd: Approximately 9.8 L/kg
ProteinBinding: Approximately 95%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 15-20 hours (for CR formulation, can be longer with chronic dosing due to non-linear kinetics)
Clearance: Non-linear, decreases with increasing dose and duration of treatment.
ExcretionRoute: Approximately 64% in urine (2% unchanged, 62% as metabolites), 36% in feces (1% unchanged, 35% as metabolites).
Unchanged: Approximately 2% (urine), 1% (feces)
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Pharmacodynamics

OnsetOfAction: Typically 1-2 weeks for initial therapeutic effects; full antidepressant effect may take 4-6 weeks.
PeakEffect: 4-6 weeks for full therapeutic effect.
DurationOfAction: Maintained with once-daily dosing due to half-life.

Safety & Warnings

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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.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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 serotonin syndrome, a potentially life-threatening condition, 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 any side effects or only minor ones, it's 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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • Thoughts of harming yourself
  • Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, insomnia, irritability, aggression, impulsivity, mania)
  • Symptoms of serotonin syndrome: fever, sweating, confusion, severe muscle stiffness or twitching, shivering, diarrhea, loss of coordination, rapid heart beat
  • Unusual bleeding or bruising
  • Seizures
  • Severe skin rash or allergic reaction
  • Eye pain, vision changes, or swelling around the eye (signs of angle-closure glaucoma)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 with this medication. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will enable your healthcare team to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require your full attention, wait until you understand how this medication affects you.

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of experiencing side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis products, or prescription and over-the-counter medications that may cause drowsiness or impair your reactions.

You may need to wait several weeks to experience the full effects of this medication.

This medication may increase your risk of fractures. Discuss this potential risk with your doctor.

There is also a potential increased risk of bleeding associated with this medication, which can be life-threatening in some cases. Consult your doctor to understand this risk.

Some individuals may have a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor immediately.

This medication can cause low sodium levels in the blood, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

In children and adolescents, this medication may affect growth. Regular growth checks may be necessary, so discuss this with your doctor.

This medication's impact on fertility is not fully understood, and it is unclear whether any effects on fertility are reversible.

If you are pregnant, planning to become pregnant, or think you may be pregnant, consult your doctor to discuss the potential benefits and risks of taking this medication. Using this medication during the first trimester may increase the risk of birth defects, particularly heart defects, in the unborn baby. Taking this medication during the third trimester may increase your risk of postpartum bleeding and potentially cause health problems in the newborn.

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Nausea
  • Vomiting
  • Tremor
  • Tachycardia
  • Agitation
  • Dizziness
  • Dilated pupils
  • Serotonin syndrome (severe cases)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
  • Pimozide - risk of QT prolongation and arrhythmias
  • Thioridazine - risk of QT prolongation and arrhythmias
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Major Interactions

  • Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
  • Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - increased risk of arrhythmias
  • Warfarin and other oral anticoagulants - increased risk of bleeding
  • NSAIDs, aspirin, other antiplatelet agents - increased risk of bleeding
  • Tamoxifen - paroxetine can significantly reduce tamoxifen efficacy (due to CYP2D6 inhibition)
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Moderate Interactions

  • Metoprolol - increased metoprolol levels (CYP2D6 inhibition)
  • Flecainide, propafenone - increased levels of these antiarrhythmics (CYP2D6 inhibition)
  • Risperidone - increased risperidone levels (CYP2D6 inhibition)
  • Cimetidine - increased paroxetine levels
  • Phenobarbital, phenytoin - decreased paroxetine levels
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Minor Interactions

  • Alcohol - generally advised to avoid due to CNS depressant effects, though no direct pharmacokinetic interaction.

Monitoring

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Baseline Monitoring

Psychiatric evaluation (diagnosis, symptom severity)

Rationale: To establish baseline and guide treatment decisions.

Timing: Prior to initiation

Assessment for suicidal ideation/behavior

Rationale: Due to Black Box Warning, especially in young adults.

Timing: Prior to initiation

Medical history (including cardiac, seizure, bleeding disorders)

Rationale: To identify contraindications or precautions.

Timing: Prior to initiation

Concomitant medications review

Rationale: To identify potential drug interactions.

Timing: Prior to initiation

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Routine Monitoring

Clinical response (symptom improvement)

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated.

Target: Reduction in symptom severity scores (e.g., HAM-D, PHQ-9, GAD-7)

Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.

Adverse effects (e.g., nausea, insomnia, sexual dysfunction, 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, switching medication, or symptomatic treatment.

Suicidal ideation/behavior

Frequency: Weekly for first 4 weeks, then every 2 weeks for next 4 weeks, then monthly for 4 months, then periodically.

Target: Absence of new or worsening suicidal thoughts/behaviors.

Action Threshold: Any emergence or worsening requires immediate clinical assessment and intervention.

Weight

Frequency: Periodically (e.g., every 3-6 months)

Target: Stable weight or within healthy range.

Action Threshold: Significant weight gain/loss may require intervention.

Serum Sodium (especially in elderly or those on diuretics)

Frequency: Periodically, if risk factors for hyponatremia are present.

Target: 135-145 mEq/L

Action Threshold: Hyponatremia (<135 mEq/L) requires investigation and potential discontinuation.

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Symptom Monitoring

  • Worsening depression or anxiety
  • Emergence of suicidal thoughts or behaviors
  • Unusual changes in behavior (e.g., agitation, irritability, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)
  • Symptoms of withdrawal syndrome upon discontinuation (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor)
  • Signs of abnormal bleeding (e.g., bruising, petechiae, GI bleeding)

Special Patient Groups

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Pregnancy

Category D. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and cardiac malformations (especially in the first trimester).

Trimester-Specific Risks:

First Trimester: Increased risk of cardiovascular malformations (e.g., ventricular septal defects) with first-trimester exposure.
Second Trimester: Not specifically associated with unique risks beyond general SSRI exposure.
Third Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia).
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Lactation

L3 (Moderately Safe). Paroxetine is excreted into breast milk. Monitor infants for drowsiness, poor feeding, and weight gain. Consider alternative agents with lower milk levels if possible, especially in preterm or unstable infants.

Infant Risk: Low to moderate risk. Potential for drowsiness, irritability, and poor feeding in breastfed infants. Long-term effects unknown.
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Pediatric Use

Not approved for use in pediatric patients for MDD, Panic Disorder, or SAD due to increased risk of suicidality. Safety and efficacy have not been established. Use in children and adolescents should be carefully considered and generally avoided unless benefits clearly outweigh risks.

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Geriatric Use

Use with caution. Lower starting doses and slower titration are recommended due to increased risk of adverse effects, particularly hyponatremia (SIADH) and falls. Elderly patients may be more sensitive to the effects of paroxetine.

Clinical Information

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Clinical Pearls

  • Paroxetine CR is designed to reduce the incidence of nausea associated with immediate-release paroxetine.
  • It is a potent CYP2D6 inhibitor, which is a significant consideration for drug interactions, especially with tamoxifen, metoprolol, and certain antipsychotics/antidepressants.
  • Among SSRIs, paroxetine is associated with a higher incidence of discontinuation syndrome (withdrawal symptoms) due to its relatively short half-life and potent serotonin reuptake inhibition. Tapering should be very gradual.
  • It has a higher incidence of sexual dysfunction and weight gain compared to some other SSRIs.
  • Consider alternative antidepressants for patients on tamoxifen due to the significant reduction in tamoxifen's active metabolite (endoxifen) by paroxetine.
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Alternative Therapies

  • Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline, Fluoxetine, Citalopram, Escitalopram, Fluvoxamine
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine, Duloxetine, Desvenlafaxine, Levomilnacipran
  • Atypical Antidepressants: Bupropion, Mirtazapine, Trazodone, Vilazodone, Vortioxetine
  • Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
  • Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Tranylcypromine (reserved for refractory cases)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: $100 - $300 per 30 tablets (for brand Paxil CR 37.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic; Tier 3 or higher for brand, depending on insurance plan.
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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 detailed patient fact sheet. It is crucial 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. 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 information on the medication taken, the quantity, and the time it occurred.