Paxil 30mg Tablets

Paroxetine is a potent and highly 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 or seek medical attention immediately:

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, trouble breathing, swallowing, or talking, 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 bruises that get bigger, 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, such as decreased libido, difficulty having an orgasm, ejaculation problems, or erectile dysfunction (talk to your doctor if you have concerns)

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 medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast 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 minor ones, it's essential to discuss any concerns with your doctor. If you experience 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
Dry mouth
Sleep disturbances
Shakiness
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, 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 symptoms you experienced as a result of the allergy.
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 between this medication and other substances. It is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, 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 to confirm that it is safe to do so in conjunction with this medication.

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require alertness.

Stopping the Medication
Do not stop taking this medication abruptly 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 discontinue it.

Interactions with Other Substances
Avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) medications that may cause drowsiness.

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

Potential Risks
This medication may increase your risk of:

Broken bones: Discuss this risk with your doctor.
Bleeding: This medication may cause bleeding, which can be life-threatening in some cases. Consult your doctor about this risk.
Eye problems: Certain individuals may be more prone to eye issues 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.

Low Sodium Levels
This medication can cause low sodium levels, which can be life-threatening and lead to seizures, loss of consciousness, breathing difficulties, or death.

Special Considerations

Older adults (65 and older): Use this medication with caution, as you may be more susceptible to side effects.
Children and adolescents: This medication may affect growth in some cases. Regular growth checks may be necessary. Consult your doctor about this risk.
Fertility: This medication may impact fertility in males, although it is unclear if this effect is reversible.
Pregnancy: Taking this medication during pregnancy may harm the unborn baby. If you become pregnant or are planning to become pregnant, inform your doctor immediately. The risks and benefits of taking this medication during pregnancy will be discussed with you.
+ First trimester: Taking this medication during the first trimester may increase the risk of birth defects (mainly heart defects) in the unborn baby.
+ Third trimester: Taking this medication during the third trimester may increase your risk of bleeding after delivery and may lead to health problems in the newborn.
Breastfeeding: Inform your doctor if you are breastfeeding, as you will need to discuss the 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

• Other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome
• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - increased risk of arrhythmias
• Drugs metabolized by CYP2D6 (e.g., flecainide, propafenone, metoprolol, desipramine, risperidone, atomoxetine) - paroxetine is a potent CYP2D6 inhibitor, leading to increased plasma concentrations of these drugs
• Warfarin - increased risk of bleeding
• NSAIDs, aspirin, other antiplatelet agents - increased risk of bleeding

• Cimetidine - increases paroxetine plasma levels
• Phenobarbital, phenytoin - may decrease paroxetine plasma levels
• Fosamprenavir/ritonavir - may decrease paroxetine plasma levels
• Tamoxifen - paroxetine may reduce tamoxifen efficacy (due to CYP2D6 inhibition affecting tamoxifen's active metabolite formation)
• Digoxin - paroxetine may increase digoxin levels

• Alcohol - generally advised to avoid due to CNS depressant effects, though no direct pharmacokinetic interaction.

• Worsening depression
• Emergence of suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
• Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, GI symptoms)
• Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, falls, severe and more frequent seizures)
• Abnormal bleeding or bruising
• Visual disturbances (e.g., acute angle-closure glaucoma symptoms like eye pain, vision changes, redness/swelling in or around the eye)

Paroxetine is classified as Pregnancy Category D. Use should be avoided during pregnancy, especially the first trimester, unless the potential benefit justifies the potential risk to the fetus. Exposure during the first trimester has been associated with an increased risk of cardiovascular malformations (e.g., ventricular septal defects). Exposure in late pregnancy has been associated with persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

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.

Paroxetine is generally not recommended for use in pediatric patients for Major Depressive Disorder (MDD) or other psychiatric disorders due to an increased risk of suicidal thinking and behavior (Black Box Warning). It is approved for Obsessive-Compulsive Disorder (OCD) in patients aged 7-17 years, but close monitoring for suicidality is essential.

Lower starting doses (e.g., 10 mg/day) are recommended due to reduced clearance and increased susceptibility to adverse effects. Elderly patients are at increased risk for hyponatremia (SIADH), falls, and bleeding. Monitor closely for adverse effects and drug interactions.

• Paroxetine is a potent SSRI with a relatively short half-life, which can lead to more pronounced discontinuation symptoms if stopped abruptly. Tapering is crucial.
• It is a potent inhibitor of CYP2D6, which can lead to significant drug-drug interactions, particularly with other drugs metabolized by this enzyme (e.g., tamoxifen, tricyclic antidepressants, some antipsychotics, beta-blockers).
• Paroxetine has anticholinergic properties (though less pronounced than TCAs), which may contribute to side effects like constipation, dry mouth, and blurred vision, and may be more problematic in elderly patients.
• It is one of the more sedating SSRIs, often taken in the morning to avoid insomnia, but some patients may prefer evening dosing if sedation is a significant side effect.
• Due to its pregnancy category D, it is generally avoided in women of childbearing potential unless other options are not suitable and the benefits clearly outweigh the risks.
• Weight gain is a common side effect with long-term use of paroxetine compared to other SSRIs.

• Other SSRIs (e.g., Sertraline, Fluoxetine, Escitalopram, Citalopram, Fluvoxamine)
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., Venlafaxine, Duloxetine, Desvenlafaxine)
• Atypical Antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
• Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline, Imipramine)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., Phenelzine, Tranylcypromine, Selegiline)
• Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)

If your symptoms or health issues persist or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for safe use. Please read this guide carefully and review it each time you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider. In the event of a suspected overdose, promptly call the poison control center or seek immediate medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.