Paroxetine ER 25mg Tablets

Paroxetine is a potent and selective inhibitor of serotonin (5-hydroxytryptamine, 5-HT) reuptake in the central nervous system (CNS). It has weak effects on norepinephrine and dopamine neuronal reuptake. Its antidepressant and anxiolytic effects are presumed to be related to its potentiation of serotonergic activity in the CNS.

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
+ 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 problems, or erectile dysfunction

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. Seek medical help immediately if you experience:

Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching/stiffness
Seizures or shivering/shaking
Excessive sweating or severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

While many people may not experience side effects or only have mild ones, it's essential to be aware of the following:

Dizziness, drowsiness, fatigue, or weakness
Nervousness or excitability
Headache
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas or bloating
Dry mouth
Sleep disturbances
Shakiness or yawning
* Back pain or sweating

If you're concerned about any side effects or have questions, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 them 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.

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

When starting this medication, be cautious and avoid driving or engaging in activities that require alertness until you understand how it affects you.

To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will provide guidance on how to gradually stop taking it.

While taking this medication, it is recommended that you avoid consuming alcohol. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or 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.

There are potential risks associated with this medication that you should discuss with your doctor. These include an increased risk of fractures, which may be a concern. Furthermore, this medication may increase the risk of bleeding, which can be life-threatening in some cases.

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 even 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.

There is also a potential impact on fertility, as this medication may affect a man's ability to father a child. However, it is unclear whether 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 benefits and risks of taking this medication during pregnancy, as it may increase the risk of birth defects (particularly heart defects) in the first trimester and bleeding complications in the third trimester, as well as potential health issues in the newborn.

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

• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome
• Thioridazine - risk of QT prolongation and sudden death
• Pimozide - risk of QT prolongation and cardiac arrhythmias

• Other serotonergic drugs (e.g., triptans, other SSRIs, SNRIs, fentanyl, lithium, tramadol, St. John's Wort, tryptophan) - increased risk of serotonin syndrome
• Drugs metabolized by CYP2D6 (e.g., metoprolol, flecainide, propafenone, tricyclic antidepressants like desipramine, nortriptyline) - increased levels of these drugs
• Warfarin - increased risk of bleeding
• NSAIDs/Aspirin - increased risk of bleeding
• Linezolid - risk of serotonin syndrome
• Methylene blue - risk of serotonin syndrome

• Cimetidine - increases paroxetine levels
• Phenobarbital/Phenytoin - decreases paroxetine levels
• Fosamprenavir/Ritonavir - decreases paroxetine levels
• Tamoxifen - reduced efficacy of tamoxifen (due to CYP2D6 inhibition)
• Digoxin - increased digoxin levels

• Alcohol - may potentiate CNS effects, generally advised to avoid.

• Worsening depression
• New or worsening anxiety/agitation
• Panic attacks
• Insomnia
• Irritability
• Hostility/aggressiveness
• Impulsivity
• Akathisia (psychomotor restlessness)
• Hypomania/mania
• Unusual changes in behavior
• Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)

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.

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 sedation, poor feeding, and poor weight gain.

The extended-release formulation of paroxetine is not approved for use in pediatric patients. Antidepressants, including paroxetine, increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with MDD and other psychiatric disorders.

Use with caution. Start with a lower dose (e.g., 12.5 mg ER once daily) and titrate slowly. Elderly patients may be more sensitive to the effects of paroxetine and are at increased risk for hyponatremia and falls. Maximum dose for elderly is generally 50 mg ER once daily.

• Paroxetine has a relatively short half-life among SSRIs, which can lead to more pronounced and rapid onset of withdrawal symptoms if discontinued abruptly. Tapering slowly is crucial.
• It is a potent inhibitor of CYP2D6, which can lead to significant drug-drug interactions with medications metabolized by this enzyme (e.g., tamoxifen, metoprolol, TCAs).
• Paroxetine is often associated with a higher incidence of sexual dysfunction and weight gain compared to some other SSRIs.
• Take paroxetine ER in the morning to minimize potential for insomnia.
• The ER formulation is designed to reduce the incidence of nausea compared to immediate-release paroxetine.

• Other SSRIs (e.g., sertraline, fluoxetine, escitalopram, citalopram, fluvoxamine)
• SNRIs (e.g., venlafaxine, duloxetine, desvenlafaxine)
• Atypical antidepressants (e.g., bupropion, mirtazapine, vortioxetine, vilazodone)
• Tricyclic Antidepressants (TCAs)
• Monoamine Oxidase Inhibitors (MAOIs)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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 valuable resource that provides important information about its use. 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, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediate action is necessary. Call your local poison control center or seek emergency medical attention right away. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.