Paroxetine ER 12.5mg 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 weak anticholinergic 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

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly 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 minor ones, it is essential to discuss any concerns with your doctor. If you notice any of the following side effects, contact your doctor or seek medical help 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
Difficulty sleeping
Shakiness or tremors
Yawning
Back pain
* 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
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 certain 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. Therefore, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, 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.

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

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

Avoid consuming alcohol while taking this medication.

Before using marijuana, cannabis, or prescription and over-the-counter medications that may cause drowsiness, consult your doctor.

It may take several weeks to experience the full effects of this medication.

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

Additionally, this medication may increase the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this potential 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, 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 some cases, this medication may affect growth in children and adolescents, and regular growth checks may be necessary. Discuss this with your doctor.

This medication 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. You will need to discuss the benefits and risks of taking this medication during pregnancy, as it may increase the risk of birth defects (primarily heart defects) in the first trimester and bleeding after delivery in the third trimester, as well as potentially causing health problems 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)
• Pimozide (risk of QT prolongation)
• Thioridazine (risk of QT prolongation and sudden death)
• Linezolid (MAOI activity)
• Methylene blue (MAOI activity)

• Other serotonergic drugs (e.g., triptans, fentanyl, tramadol, tryptophan, buspirone, St. John's Wort, other SSRIs, SNRIs, TCAs) - increased risk of serotonin syndrome.
• Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, phenothiazine antipsychotics, Type 1C antiarrhythmics like propafenone and flecainide, atomoxetine, metoprolol) - increased plasma levels of these drugs.
• Warfarin and other anticoagulants/antiplatelets (e.g., NSAIDs, aspirin) - increased risk of bleeding.
• Tamoxifen (paroxetine may reduce tamoxifen efficacy due to CYP2D6 inhibition).

• Alcohol (avoid due to CNS depressant effects)
• 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)

• Worsening depression or anxiety
• New or worsening suicidal thoughts or behaviors
• Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
• Symptoms of serotonin syndrome (e.g., confusion, hallucinations, sweating, tremor, muscle rigidity, rapid heart rate)
• Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness)
• Abnormal bleeding or bruising
• Symptoms of withdrawal (e.g., dizziness, sensory disturbances, anxiety, agitation, nausea, sweating) if discontinuing or missing doses.

Generally not recommended during pregnancy, especially in the first trimester, due to increased risk of congenital cardiac malformations (e.g., atrial and ventricular septal defects). Use only if the potential benefit justifies the potential risk to the fetus. If used in late pregnancy, monitor neonates for withdrawal symptoms or persistent pulmonary hypertension of the newborn (PPHN).

Paroxetine is excreted into breast milk. While levels in breast milk are generally low, potential for adverse effects in the infant exists (e.g., drowsiness, poor feeding, weight loss). Use with caution; monitor infant for adverse effects. Consider alternative SSRIs with lower milk transfer (e.g., sertraline).

Not approved for use in pediatric patients for MDD or other psychiatric disorders due to increased risk of suicidal ideation and behavior (Black Box Warning). Safety and efficacy have not been established.

Increased risk of adverse effects, particularly hyponatremia (SIADH), falls, and bleeding. Start with lower doses and titrate slowly. Monitor closely for adverse effects and drug interactions.

• Paroxetine is a potent SSRI with a relatively short half-life, making it more prone to withdrawal symptoms (discontinuation syndrome) if stopped abruptly. Taper slowly over several weeks to months.
• It is a potent inhibitor of CYP2D6, which can lead to significant drug interactions, particularly with other medications metabolized by this enzyme (e.g., tamoxifen, TCAs, certain antiarrhythmics).
• Paroxetine has some anticholinergic properties, which may contribute to side effects like constipation, dry mouth, and blurred vision, especially at higher doses or in sensitive individuals.
• The ER formulation is designed to reduce the incidence of nausea compared to immediate-release formulations.
• Due to its pregnancy category D, it is generally avoided in women of childbearing potential unless other options are not suitable and the patient is fully informed of the risks.

• Other SSRIs (e.g., Sertraline, Fluoxetine, Escitalopram, Citalopram)
• SNRIs (e.g., Venlafaxine, Duloxetine)
• Atypical antidepressants (e.g., Bupropion, Mirtazapine)
• Tricyclic Antidepressants (TCAs)
• Monoamine Oxidase Inhibitors (MAOIs) (reserved for refractory cases)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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, a patient fact sheet that provides crucial information. 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.