Paxil CR 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. The antidepressant and anxiolytic effects are presumed to be related to its potentiation of serotonergic activity in the CNS resulting from this inhibition.

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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of low sodium levels: headache, difficulty 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, gum bleeding, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, 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 achieving orgasm, ejaculation issues, or erectile dysfunction. If you have concerns, discuss them with your doctor.

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. Seek immediate medical attention if you experience:

Agitation
Balance problems
Confusion
Hallucinations
Fever
Rapid or irregular heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you notice any of the following side effects or any other unusual symptoms, 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
Dry mouth
Sleep disturbances
Shakiness
Yawning
Back pain
* Sweating

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 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. To ensure your safety, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, share any health problems you have with your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose 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 engaging in activities that require alertness, 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 consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually taper off the drug.

While taking this medication, avoid consuming alcohol and consult your doctor before using marijuana, cannabis, or prescription and over-the-counter drugs that may impair your reactions.

It may take several weeks to experience the full effects of this medication. Be aware that it may increase the risk of fractures; discuss this with your doctor.

Additionally, this medication may elevate the risk of bleeding, which can be life-threatening in some cases. Consult your doctor about this potential risk.

Some individuals may be more prone to 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 adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary; discuss this with your doctor.

This medication's impact on fertility is unknown, and it is unclear if any effects on fertility will be reversible.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. Taking this medication during the first trimester may increase the risk of birth defects, primarily heart defects, in the unborn baby. Using this medication during the third trimester may increase the risk of postpartum bleeding and potentially cause health problems in the newborn. Your doctor will help you weigh the benefits and risks of taking this medication during pregnancy and breastfeeding.

• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, linezolid, methylene blue): Risk of serotonin syndrome. Must wait at least 14 days after discontinuing MAOI before starting paroxetine, and at least 14 days after discontinuing paroxetine before starting an MAOI.
• Pimozide: Increased pimozide levels and QT prolongation.
• Thioridazine: Increased thioridazine levels and risk of serious ventricular arrhythmias and sudden death.

• Triptans (e.g., sumatriptan, zolmitriptan): Risk of serotonin syndrome.
• Other serotonergic drugs (e.g., tramadol, fentanyl, lithium, St. John's Wort, tryptophan, other SSRIs/SNRIs, tricyclic antidepressants): Risk of serotonin syndrome.
• Warfarin and other oral anticoagulants: Increased risk of bleeding due to paroxetine's effect on platelet aggregation.
• NSAIDs and aspirin: Increased risk of bleeding.
• Drugs metabolized by CYP2D6 (e.g., metoprolol, flecainide, propafenone, atomoxetine, risperidone, desipramine): Paroxetine is a potent CYP2D6 inhibitor, leading to increased levels of these drugs.
• Tamoxifen: Paroxetine can significantly reduce the effectiveness of tamoxifen by inhibiting its conversion to active metabolites via CYP2D6.

• Cimetidine: May increase paroxetine levels.
• Phenobarbital, Phenytoin: May decrease paroxetine levels.
• Fosamprenavir/Ritonavir: May decrease paroxetine levels.
• Theophylline: Paroxetine may increase theophylline levels.
• Digoxin: Paroxetine may increase digoxin levels.
• Alcohol: Concomitant use is not recommended due to potential for additive CNS effects.

• Not available (most interactions are considered moderate to major due to paroxetine's potent CYP2D6 inhibition and serotonergic effects)

• Worsening depression
• New or worsening anxiety
• Agitation
• Restlessness
• Panic attacks
• Insomnia
• Irritability
• Hostility
• Aggressiveness
• Impulsivity
• Akathisia (psychomotor restlessness)
• Hypomania or mania
• Suicidal ideation or behavior
• Symptoms of Serotonin Syndrome (agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Symptoms of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more acute manifestations include hallucinations, syncope, seizure, coma, respiratory arrest)
• Unusual bleeding or bruising

Category D. Paroxetine is associated with an increased risk of congenital cardiac malformations (e.g., atrial and ventricular septal defects) when exposed during the first trimester. Exposure in late pregnancy has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor). Use only if the potential benefit justifies the potential risk to the fetus.

L3 (Moderate Risk). Paroxetine is excreted into breast milk. While levels in breast milk are generally low, some infants may experience adverse effects such as drowsiness, poor feeding, and weight loss. Monitor breastfed infants for adverse effects. Consider alternative antidepressants with lower infant exposure or risk, or weigh the benefits of breastfeeding against the potential risks.

Safety and efficacy have not been established in pediatric patients. Antidepressants, including paroxetine, increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (see Black Box Warning). Use is generally not recommended in this population.

Use with caution. Elderly patients may be more sensitive to the effects of paroxetine, particularly hyponatremia (SIADH) and bleeding. A lower starting dose (e.g., 12.5 mg/day) and slower titration are recommended. Monitor closely for adverse effects and drug interactions.

• Paxil CR is a controlled-release formulation; it should not be crushed, chewed, or divided, as this can lead to rapid release of the drug and increased side effects.
• Always counsel patients on the Black Box Warning regarding suicidality, especially in younger patients, and the importance of close monitoring.
• Paroxetine is a potent CYP2D6 inhibitor, which is a significant source of drug interactions. Be mindful of co-prescribing with other CYP2D6 substrates (e.g., tamoxifen, metoprolol, atomoxetine) or drugs with narrow therapeutic indices.
• Due to its relatively short half-life compared to some other SSRIs, paroxetine is associated with a higher incidence and severity of discontinuation syndrome if stopped abruptly. Taper slowly over several weeks when discontinuing.
• Take with food to minimize gastrointestinal side effects.
• Consider alternative SSRIs for pregnant or breastfeeding individuals due to the higher risks associated with paroxetine in these populations.

• Other Selective Serotonin Reuptake Inhibitors (SSRIs): Sertraline (Zoloft), Fluoxetine (Prozac), Escitalopram (Lexapro), Citalopram (Celexa), Fluvoxamine (Luvox)
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): Venlafaxine (Effexor), Duloxetine (Cymbalta), Desvenlafaxine (Pristiq)
• Atypical Antidepressants: Bupropion (Wellbutrin), Mirtazapine (Remeron), Trazodone
• Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline, Imipramine
• Monoamine Oxidase Inhibitors (MAOIs): Phenelzine, Selegiline (rarely used due to significant interactions)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
• Electroconvulsive Therapy (ECT) for severe, refractory depression

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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. It is essential 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 for clarification.

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, including the name of the medication taken, the amount consumed, and the time it occurred.