Paroxetine 7.5mg Capsules

Manufacturer PERRIGO Active Ingredient Paroxetine Capsules(pa ROKS e teen) Pronunciation pa ROKS 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 hot flashes caused by menopause.
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Drug Class
Selective Serotonin Reuptake Inhibitor (SSRI)
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Pharmacologic Class
Antidepressant, SSRI
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Pregnancy Category
Category X
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FDA Approved
Jun 2013
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Paroxetine 7.5mg capsules are a medication used to help reduce hot flashes and night sweats that women experience during menopause. It works by affecting a chemical in the brain called serotonin.
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How to Use This Medicine

Taking Your Medication

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. It's best to take this medication at bedtime.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature, away from light and moisture. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any 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 the capsule whole, do not crush, chew, or divide it.
  • Take it once daily at bedtime, with or without food.
  • Avoid alcohol while taking this medication, as it can increase side effects.
  • Be aware that it may take several weeks to notice the full benefit.
  • Do not stop taking this medication suddenly without talking to your doctor, as it can cause withdrawal symptoms.
  • Discuss all other medications, supplements, and herbal products with your doctor to avoid interactions, especially St. John's Wort.

Dosing & Administration

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Adult Dosing

Standard Dose: 7.5 mg orally once daily at bedtime
Dose Range: 7.5 - 7.5 mg

Condition-Specific Dosing:

vasomotor_symptoms_of_menopause: 7.5 mg orally once daily at bedtime
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: Initial dose 7.5 mg every other day; may increase to 7.5 mg once daily if tolerated and needed after 1 week.
Severe: Initial dose 7.5 mg every other day; may increase to 7.5 mg once daily if tolerated and needed after 1 week.
Dialysis: Initial dose 7.5 mg every other day; may increase to 7.5 mg once daily if tolerated and needed after 1 week.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Initial dose 7.5 mg every other day; may increase to 7.5 mg once daily if tolerated and needed after 1 week.
Severe: Initial dose 7.5 mg every other day; may increase to 7.5 mg once daily if tolerated and needed after 1 week.

Pharmacology

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Mechanism of Action

Paroxetine is a selective serotonin reuptake inhibitor (SSRI). It is believed to exert its therapeutic effect by potently and selectively inhibiting the reuptake of serotonin (5-HT) by neurons in the central nervous system, thereby potentiating serotonergic activity in the CNS. The exact mechanism by which paroxetine alleviates vasomotor symptoms is not fully understood but is thought to involve its effects on thermoregulatory centers in the hypothalamus.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60-70% (variable due to first-pass metabolism)
Tmax: Approximately 5-8 hours (for 7.5mg capsule)
FoodEffect: Food does not significantly affect the absorption of paroxetine 7.5mg capsules.

Distribution:

Vd: Approximately 2.8 L/kg
ProteinBinding: Approximately 95%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 15-20 hours (for 7.5mg capsule)
Clearance: Highly variable due to non-linear kinetics at higher doses; approximately 1.5 L/min at steady state for lower doses.
ExcretionRoute: Approximately 64% renally (2% as unchanged drug), 36% fecally (1% as unchanged drug).
Unchanged: Approximately 2% (renal), 1% (fecal)
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Pharmacodynamics

OnsetOfAction: Weeks for full antidepressant effect; for VMS, improvement may be seen within 1-4 weeks.
PeakEffect: Steady-state plasma concentrations are generally achieved within 7-14 days.
DurationOfAction: Due to its half-life, effects persist for approximately 24 hours with once-daily dosing.

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. This risk must be balanced with the clinical need. Paroxetine is not approved for use in pediatric patients. Brisdelle is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and is not indicated for the treatment of any psychiatric disorder. Brisdelle is contraindicated in pregnancy.
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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, 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Difficulty 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 get bigger
+ 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 interest in sex, difficulty having an orgasm, ejaculation problems, or trouble getting or maintaining an erection

Serotonin Syndrome: A Rare but Serious Condition

There is a risk of developing serotonin syndrome, a potentially life-threatening condition, especially when taking certain other medications. If you experience any of the following symptoms, seek medical help immediately:

Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or stiffness
Seizures or shivering and shaking
Excessive sweating or severe diarrhea, nausea, 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 mild ones, it's essential to discuss any concerns with your doctor. If you notice 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, nausea, vomiting, or decreased appetite
Gas or bloating
Dry mouth
Trouble sleeping
Shakiness or yawning
* Back pain or sweating

Reporting Side Effects

If you have questions or concerns about side effects, contact 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:

  • New or worsening depression, anxiety, or panic attacks
  • Feeling agitated, restless, irritable, or having trouble sleeping
  • Unusual changes in behavior or mood
  • Thoughts about suicide or harming yourself
  • Severe headache, confusion, rapid heart rate, sweating, muscle stiffness, tremors, twitching, nausea, vomiting, or diarrhea (signs of serotonin syndrome)
  • Unusual bleeding or bruising
  • Seizures
  • Eye pain, changes in vision, or swelling or redness in or around the eye (signs of angle-closure glaucoma)
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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
Use of certain depression or Parkinson's disease medications within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (Note: Combining these medications can lead to very high blood pressure)
* Pregnancy or suspected pregnancy. This medication is contraindicated during pregnancy and should not be taken if you are pregnant.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health issues. Never start, stop, or adjust the dosage of any medication without 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 engaging in activities that require your full attention, 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 first consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it.

While using this medication, avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter drugs that may cause drowsiness or 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.

There is also a potential increased risk of bleeding, which can be life-threatening in some cases. Talk to your doctor about this risk. Furthermore, certain 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 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 teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary; discuss this with your doctor. Additionally, this medication may impact fertility in males, although it is unclear if this effect is reversible.

If you are pregnant, planning to become pregnant, or may be pregnant, inform your doctor. You will need to discuss the potential benefits and risks to both you and your baby. Taking this medication during the first trimester may increase the risk of birth defects, particularly heart defects, in the unborn baby. Using 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
  • Tachycardia (fast heart rate)
  • Tremor
  • Agitation
  • Dilated pupils
  • Serotonin syndrome (severe cases)

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
  • Pimozide (risk of QT prolongation)
  • Thioridazine (risk of QT prolongation and sudden death)
  • Linezolid (MAOI activity)
  • Methylene blue (MAOI activity)
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Major Interactions

  • Triptans (risk of serotonin syndrome)
  • Tricyclic Antidepressants (TCAs) (increased TCA levels due to CYP2D6 inhibition)
  • Fentanyl (risk of serotonin syndrome)
  • Tramadol (risk of serotonin syndrome)
  • Warfarin (increased bleeding risk)
  • NSAIDs (increased bleeding risk)
  • Aspirin (increased bleeding risk)
  • Other serotonergic drugs (e.g., other SSRIs, SNRIs, St. John's Wort, tryptophan) (risk of serotonin syndrome)
  • Drugs metabolized by CYP2D6 with narrow therapeutic index (e.g., flecainide, propafenone, metoprolol, atomoxetine, risperidone, tamoxifen)
  • Cimetidine (increases paroxetine levels)
  • Phenobarbital, Phenytoin (decreases paroxetine levels)
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Moderate Interactions

  • Digoxin (increased digoxin levels)
  • Theophylline (increased theophylline levels)
  • Lithium (potential for increased serotonergic effects)
  • Alcohol (additive CNS depression)
  • Fosamprenavir/Ritonavir (decreased paroxetine levels)
  • Procyclidine (increased procyclidine levels)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To assess baseline kidney function, especially in patients with moderate to severe impairment, for dose adjustment.

Timing: Prior to initiation

Hepatic function (ALT, AST, bilirubin)

Rationale: To assess baseline liver function, especially in patients with moderate to severe impairment, for dose adjustment.

Timing: Prior to initiation

Medication history (including OTCs, herbals)

Rationale: To identify potential drug-drug interactions, especially with MAOIs, serotonergic agents, and CYP2D6 substrates.

Timing: Prior to initiation

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Routine Monitoring

Efficacy for vasomotor symptoms

Frequency: Periodically (e.g., monthly for first few months, then every 3-6 months)

Target: Reduction in frequency and severity of hot flashes/night sweats

Action Threshold: Lack of improvement or worsening of symptoms may warrant re-evaluation or alternative therapy.

Adverse effects (e.g., nausea, insomnia, fatigue, sexual dysfunction, suicidal ideation)

Frequency: Regularly, especially during initial weeks and dose changes

Target: Absence or tolerability of side effects

Action Threshold: Intolerable side effects, emergence of suicidal ideation, or signs of serotonin syndrome require immediate intervention.

Blood pressure

Frequency: Periodically

Target: Within normal limits

Action Threshold: Significant hypertension or hypotension.

Weight

Frequency: Periodically

Target: Stable or within healthy range

Action Threshold: Significant weight gain or loss.

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Symptom Monitoring

  • Nausea
  • Insomnia
  • Fatigue
  • Dizziness
  • Headache
  • Dry mouth
  • Constipation
  • Diarrhea
  • Sexual dysfunction (decreased libido, anorgasmia)
  • Anxiety
  • Nervousness
  • Agitation
  • Tremor
  • Sweating
  • Serotonin syndrome symptoms (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination)
  • Suicidal thoughts or behavior (especially in young adults)
  • Abnormal bleeding or bruising

Special Patient Groups

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Pregnancy

Contraindicated. Paroxetine 7.5mg capsules (Brisdelle) are indicated for postmenopausal women and are not for use in women of reproductive potential. Exposure to paroxetine during the first trimester of pregnancy has been associated with an increased risk of cardiovascular malformations, particularly atrial and ventricular septal defects. Persistent pulmonary hypertension of the newborn (PPHN) has also been reported with SSRI exposure in late pregnancy.

Trimester-Specific Risks:

First Trimester: Increased risk of cardiovascular malformations (e.g., atrial and ventricular septal defects).
Second Trimester: Not specifically studied for this formulation, but general SSRI risks apply.
Third Trimester: Risk of persistent pulmonary hypertension of the newborn (PPHN) and withdrawal symptoms in the neonate (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulty, irritability, constant crying, tremor, hypotonia, hypertonia, hyperreflexia).
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Lactation

Paroxetine is excreted into breast milk. The amount of paroxetine in breast milk is generally low, and infant exposure is typically low. However, some infants may experience adverse effects (e.g., irritability, poor feeding, drowsiness). The decision to breastfeed should consider the risk of infant exposure, the benefits of breastfeeding, and the mother's clinical need for the drug. For Brisdelle, lactation is generally not relevant as it's for postmenopausal women.

Infant Risk: L3 (Moderate risk) - Monitor infant for drowsiness, poor feeding, and weight gain. Consider alternative if infant is premature or has underlying medical conditions.
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Pediatric Use

Not indicated for use in pediatric patients. Safety and effectiveness have not been established. Antidepressants carry a Black Box Warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults.

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Geriatric Use

No dosage adjustment is generally needed based solely on age. However, elderly patients may be more sensitive to the effects of paroxetine and may have age-related decreases in renal or hepatic function, which would necessitate dose adjustments as per renal/hepatic impairment guidelines. Monitor for hyponatremia and falls.

Clinical Information

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Clinical Pearls

  • Paroxetine 7.5mg (Brisdelle) is specifically approved for moderate to severe vasomotor symptoms associated with menopause, not for depression or anxiety.
  • It should be taken at bedtime to help manage potential side effects like nausea or drowsiness.
  • Due to its potent CYP2D6 inhibition, careful consideration of drug interactions is crucial, especially with other antidepressants, antiarrhythmics, and tamoxifen.
  • Abrupt discontinuation can lead to withdrawal symptoms (SSRI discontinuation syndrome); taper dose gradually if discontinuing.
  • Patients should be advised about the potential for increased bleeding risk, especially if also taking NSAIDs, aspirin, or anticoagulants.
  • The pregnancy category X for Brisdelle is due to its indication in postmenopausal women and the known teratogenic risks of paroxetine.
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Alternative Therapies

  • Other SSRIs/SNRIs (e.g., venlafaxine, escitalopram, citalopram for VMS off-label)
  • Hormone Replacement Therapy (HRT) (estrogen-based therapies)
  • Gabapentin
  • Clonidine
  • Non-pharmacological interventions (e.g., lifestyle modifications, cognitive behavioral therapy, acupuncture)
  • Other non-hormonal options for VMS
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Cost & Coverage

Average Cost: Varies, typically $150-$300+ per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for Brisdelle, may require prior authorization)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 about its safe use. It is vital to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the quantity, and the time it occurred. This information is critical for receiving appropriate treatment and care.