Paroxetine ER 37.5mg Tablets

Paroxetine is a potent and highly selective inhibitor of serotonin (5-hydroxytryptamine; 5-HT) reuptake in the central nervous system (CNS) neurons. This inhibition leads to an increase in the concentration of serotonin in the synaptic cleft, enhancing serotonergic neurotransmission. It has weak effects on norepinephrine and dopamine neuronal reuptake. It also has some anticholinergic activity, which may contribute to certain 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, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: headache, trouble focusing, memory problems, confusion, weakness, seizures, or changes in balance
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal
Signs of bleeding: vomiting or coughing up blood, coffee ground-like vomit, blood in the urine, black, red, or tarry stools, bleeding gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Severe dizziness or fainting
Bone pain
Seizures
Significant weight loss
Abnormal burning, numbness, or tingling sensations
Painful or prolonged erections (lasting more than 4 hours)
Sexual problems, including decreased libido, difficulty having an orgasm, ejaculation problems, or erectile dysfunction (talk to your doctor if you have concerns)

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
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

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 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
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating

Reporting Side Effects

If you have questions or concerns about side effects, talk to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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.
* It is crucial to note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication.

To ensure your safety, it is vital to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter medications, natural products, and vitamins, as well as any health problems you 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 modify the dosage of any medication without first consulting your doctor.

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

Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention.

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

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

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

Be aware that this drug may increase your risk of fractures. Discuss this potential risk with your doctor.

This medication may also increase your risk of bleeding, which can be life-threatening in some cases. Consult with 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 drug 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 years or older, use this medication with caution, as you may be more susceptible to side effects.

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

This drug may also impact fertility in males, although it is unclear whether this effect is reversible.

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

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

• Monoamine Oxidase Inhibitors (MAOIs) (risk of serotonin syndrome)
• Thioridazine (risk of QT prolongation and ventricular arrhythmias)
• Pimozide (risk of QT prolongation and ventricular arrhythmias)
• Linezolid (MAOI activity, risk of serotonin syndrome)
• Methylene blue (MAOI activity, risk of serotonin syndrome)

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) (risk of serotonin syndrome)
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) (additive QT prolongation risk)
• Warfarin and other oral anticoagulants (increased bleeding risk)
• NSAIDs and aspirin (increased bleeding risk)
• Drugs metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, atomoxetine, risperidone, desipramine) (paroxetine is a potent CYP2D6 inhibitor, leading to increased levels of these drugs)
• Tamoxifen (paroxetine can reduce tamoxifen efficacy by inhibiting its conversion to active metabolites)

• Cimetidine (increases paroxetine levels)
• Phenobarbital, phenytoin (may decrease paroxetine levels)
• Fosamprenavir/ritonavir (may decrease paroxetine levels)
• Digoxin (paroxetine may increase digoxin levels)
• Theophylline (paroxetine may increase theophylline levels)
• Alcohol (avoid concurrent use due to additive CNS depressant effects)

• Not specifically categorized as minor, but general caution with CNS depressants.

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Mania or hypomania
• Serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
• Abnormal bleeding or bruising
• Withdrawal symptoms upon discontinuation (e.g., dizziness, sensory disturbances, sleep disturbances, agitation, anxiety, nausea, sweating, tremor, confusion)

Paroxetine is classified as Pregnancy Category D. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Exposure during the first trimester may be associated with an increased risk of cardiovascular malformations (e.g., ventricular septal defects). Exposure late in the third trimester has been associated with complications in neonates requiring prolonged hospitalization, respiratory support, and tube feeding (persistent pulmonary hypertension of the newborn, PPHN). Neonatal withdrawal symptoms (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying) have also been reported.

Paroxetine is excreted into breast milk. 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. Monitor infants for drowsiness, poor feeding, and poor weight gain. Other SSRIs with lower milk transfer (e.g., sertraline) may be preferred.

Not approved for use in pediatric patients for major depressive disorder or other psychiatric disorders due to an increased risk of suicidal thoughts and behaviors. Safety and efficacy have not been established in this population. Use only if potential benefits outweigh risks in specific, severe cases, with close monitoring.

Elderly patients may be at increased risk for adverse effects, particularly hyponatremia (SIADH), falls, and bleeding. Lower starting doses and slower titration are recommended. Monitor closely for adverse reactions and drug interactions.

• Paroxetine is a potent CYP2D6 inhibitor, which can significantly impact the metabolism of co-administered drugs that are CYP2D6 substrates (e.g., tamoxifen, metoprolol, TCAs).
• Abrupt discontinuation of paroxetine can lead to significant withdrawal symptoms (discontinuation syndrome) due to its relatively short half-life. Tapering the dose slowly over several weeks is crucial.
• Paroxetine has a higher incidence of sexual dysfunction and weight gain compared to some other SSRIs.
• It has some anticholinergic properties, which may contribute to side effects like constipation or dry mouth, and should be used with caution in patients with narrow-angle glaucoma or prostatic hypertrophy.
• Take paroxetine ER in the morning with food to minimize gastrointestinal upset and ensure consistent absorption.

• Other SSRIs (e.g., Sertraline, Fluoxetine, Citalopram, Escitalopram, Fluvoxamine)
• SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
• Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
• Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
• MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases)
• Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
• Electroconvulsive Therapy (ECT) for severe or refractory depression

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.